ABSTRACT

OBJECTIVE

To identify and synthesize the scientific knowledge produced regarding the effectiveness of the GeneXpert test in the diagnosis of pulmonary tuberculosis (TB) in people living with HIV/AIDS.

METHODS

Integrative literature review, which was searched on Embase, Scopus, PubMed, Cinahl, Academic Search Premier, Socindex, and LILACS platforms, in December 2019. The studies surveyed went through two stages of selection: reading of titles and abstracts by two reviewers independently; using the Rayyan platform and reading. Nineteen primary studies in English, Portuguese, and Spanish that answered the study’s guiding question were included: How effective is the GeneXpert test in the diagnosis of pulmonary TB in people living with HIV/AIDS?

RESULTS

The use of GeneXpert substantially increased the detection of TB cases among the population co-infected with HIV/AIDS, with sensitivity ranging from 68% to 100%, superior to sputum smear microscopy. Specificity ranged from 91.7% to 100%; the positive predictive value from 79.2% to 96.1%; and the negative predictive value from 84.6% to 99.3%. These values were considered similar to sputum smear microscopy by most studies. We also compared these results with different ways of performing culture and other molecular tests, being considered inferior only to the Xpert Ultra.

CONCLUSION

It is possible to affirm that places with a high incidence of HIV/AIDS would benefit from the implementation of the GeneXpert test, entailing effectiveness in diagnosing pulmonary TB in this population when compared to sputum smear microscopy, a widely used test for detection of cases.

Tuberculosis, Pulmonary, diagnosis; Molecular Diagnostic Techniques; HIV Infections; AIDS-Related Opportunistic Infections

INTRODUCTION

Since the 1980s, infection by the human immunodeficiency virus (HIV) has reinforced the concern with tuberculosis (TB)¹1. World Health Organization. Global tuberculosis control: WHO report 2011. Geneva (CH): WHO; 2011.. In 2015, according to the World Health Organization (WHO), 10.4 million people developed TB; 1.2 million corresponded to people with HIV/AIDS²2. World Health Organization. Global tuberculosis report 2016. Geneva (CH): WHO; 2016..

In the 1990s, TB control strategies were based on passive detection of the disease through sputum smear microscopy in patients with chronic cough. However, the clinical presentation of pulmonary TB among people living with HIV/AIDS is nonspecific in advanced stages, with less frequent coughing and negative sputum smears³3. Lawn SD, Wood R. Tuberculosis in antiretroviral treatment services in resource-limited settings: addressing the challenges of screening and diagnosis. J Infect Dis. 2011;204 Suppl 4:S1159-67. https://doi.org/;10.1093/infdis/jir411
https://doi.org/;10.1093/infdis/jir411... .

Although this microbiological diagnostic technique offers advantages in terms of costs and simplicity, specificity and sensitivity are still considered precarious, especially among people living with HIV/AIDS⁴4. World Health Organization. Roadmap for rolling out Xpert MTB/RIF for rapid diagnosis of TB and MDR-TB. Geneva (CH): WHO; 2010.,⁵5. Dewan R, Anuradha S, Khanna A, Garg S, Singla S, Agarwal S, et al. Role of cartridge-based nucleic acid amplification test (CBNAAT) for early diagnosis of pulmonary tuberculosis in HIV. JIACM. 2015;16(2):114-7., given the scarce production of sputum and the decrease in the bacillary load⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... . In addition to microbiological results, the diagnosis of TB must be supported by the clinical presentation⁷7. World Health Organization. Global tuberculosis report 2014. Geneva (CH): WHO; 2014. and radiographic findings⁸8. Palomino JC. Molecular detection, identification and drug resistance detection in Mycobacterium tuberculosis. FEMS Immunol Med Microbiol. 2009;56(2):103-11. https://doi.org/10.1111/j.1574-695X.2009.00555.x
https://doi.org/10.1111/j.1574-695X.2009... .

Another microbiological test used for the diagnosis of TB, considered the gold standard for laboratory confirmation of the disease, is the sputum culture. This test has high sensitivity in detecting Mycobacterium tuberculosis (MTB) and has been recommended for people with HIV/AIDS⁹9. Bassett IV, Wang B, Chetty S, Giddy J, Losina E, Mazibuko M, et al. Intensive tuberculosis screening for HIV-infected patients starting antiretroviral therapy in Durban, South Africa. Clin Infect Dis. 2010;51(7):823-9. https://doi.org/10.1086/656282
https://doi.org/10.1086/656282... . However, performing such examination requires resources, qualified technical skills, and time to obtain results, which delays the diagnosis and increases the risk of disease transmission¹⁰10. Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, et al. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010;363(11):1005-15. https://doi.org/10.1056/NEJMoa0907847
https://doi.org/10.1056/NEJMoa0907847... ,¹¹11. Iram S, Zeenat A, Hussain S, Yusuf NW, Aslam M. Rapid diagnosis of tuberculosis using Xpert MTB/RIF assay: report from a developing country. Pak J Med Sci. 2015;31(1):105-10. https://doi.org/10.12669/pjms.311.6970
https://doi.org/10.12669/pjms.311.6970... .

So the diagnosis of TB in people living with HIV/AIDS was often based on the clinical presentation, considering the lack of microbiological proof of infections¹²12. Harries AD, Zachariah R, Corbett EL, Lawn SD, Santos-Filho ET, Chimzizi R, et al. The HIV-associated tuberculosis epidemic–when will we act? Lancet. 2010;375(9729):1906-19. https://doi.org/10.1016/S0140-6736(10)60409-6
https://doi.org/10.1016/S0140-6736(10)60... . This led to the expectation of developing new diagnostic means for use by health services, among which the rapid molecular tests (TRM)¹³13. World Health Organization. Tuberculosis diagnostics: automated DNA test: WHO endorsement and recommendations. Geneva (CH): WHO; 2010., such as the GeneXpert^® MTB/RIF (GeneXpert). This is a nucleic acid amplification-based test, based on polymerase chain reaction (PCR) whereby it detects MTB and its resistance to rifampicin in a sputum sample within a period of two hours¹⁴14. Helb D, Jones M, Story E, Boehme C, Wallace E, Ho K, et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. J Clin Microbiol. 2020;48(1):229-37. https://doi.org/10.1128/JCM.01463-09
https://doi.org/10.1128/JCM.01463-09... .

This test was approved in 2010 by the WHO, which recommended its use for the initial diagnosis of TB and suspected cases of multidrug-resistant tuberculosis (MDR-TB) in sputum samples¹⁵15. World Health Organization. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system: policy statement. Geneva (CH): WHO; 2011., and expanded this recommendation in 2013, also for the diagnosis of TB in non-respiratory samples, that is, for extrapulmonary TB¹³13. World Health Organization. Tuberculosis diagnostics: automated DNA test: WHO endorsement and recommendations. Geneva (CH): WHO; 2010.. In 2014, as a result of these recommendations, 3,269 GeneXpert devices were made available to public sectors in 108 of the 145 countries eligible to obtain the equipment⁷7. World Health Organization. Global tuberculosis report 2014. Geneva (CH): WHO; 2014..

This review intends to identify and synthesize scientific knowledge about the effectiveness of the GeneXpert test in the diagnosis of pulmonary TB in people living with HIV/AIDS.

METHODS

This is an integrative review, which has the potential to gather information on a given topic and present the state of the art of the object of study. We also intend to guide the definition of concepts, identify gaps, and review theories and methodological analysis, besides informing and assist practices and policy initiatives related to the issue¹⁷17. Whittemore R, Knafl K. The integrative review: updated methodology. J Adv Nurs. 2005;52(5):546-53. https://doi.org/10.1111/j.1365-2648.2005.03621.x
https://doi.org/10.1111/j.1365-2648.2005... .

We took the following steps: elaboration of the study question; bibliographical survey and selection of primary studies; extracting information from selected studies; assessment of the methodological quality of the included studies; synthesis and discussion of the results found. This review is guided by the following question: How effective is the GeneXpert test in the diagnosis of pulmonary TB in people living with HIV/AIDS?

This question allowed the identification of descriptors, using the PICO strategy, proposed by The Joanna Briggs Institute (2017)¹⁸18. The Joanna Briggs Institute. Critical appraisal tools for use in JBI systematic reviews. Adelaide (AU): JBI; 2017 [cited 2020 Jan 22]. Available from: https://joannabriggs.org/ebp/critical_appraisal_tools
https://joannabriggs.org/ebp/critical_ap... and presented in Box 1.

The descriptors in bold, mentioned in Box 1, are part of the controlled vocabulary consulted in the Health Sciences Descriptors (DECS), whereby it was also possible to identify the corresponding terms in Spanish and English. For terms in English, we also consulted the Medical Subject Headings (MeSH). Finally, the free vocabulary used in the writing of publications was also sought, searching for synonyms in DECS and MeSH and databases selected for the study.

We carried bibliographic survey out in December 2019 using the vocabulary found (Box 2) and the Boolean operators OR (among words with the same meaning) and AND (among groups of words with the same meaning).

The bibliographic survey was executed in December 2019, in the following databases: Excerpta Medica dataBASE (EMBASE), SciVerse Scopus (SCOPUS) on behalf of Elsevier, Public/Medline or Publisher Medlin (PubMed), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Academic Search Premier (ASP), Bibliographic Database for Sociology Research (SocINDEX) and Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS). For the LILACS search, we used the vocabulary in the three mentioned languages; in other databases, the English vocabulary was used. It is important to emphasize that we did not use publication year nor language limits in the bibliographic survey.

This search resulted in the identification of 1,802 publications, which were exported to the systematic review application Rayyan QCRI from Qatar Computing Research Institute¹⁹19. Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan – a web and mobile app for systematic reviews. Syst Rev. 2016;5:210. https://doi.org/10.1186/s13643-016-0384-4
https://doi.org/10.1186/s13643-016-0384-... , which identified and allowed the exclusion of 597 duplicate publications. Two independent reviewers judged the eligibility of the remaining publications by reading their titles and abstracts. The following criteria guided the inclusion of 19 studies in this review: primary studies; having people with TB-HIV co-infection as the study population; address the diagnosis of pulmonary TB; and studies that answered the guiding questions of this review. We also highlight that all studies considered in this review were only based on the GeneXpert technology produced by the company Cepheid. Articles that studied cost-effectiveness, abstracts published in annals, and articles that did not compare the GeneXpert test with other diagnostic tests were excluded (Figure).

Data from the articles included in this review were extracted using a specific instrument based on Ursi (2005)²¹21. Ursi ES. Prevenção de lesões de pele no perioperatório: revisão integrativa da literatura [dissertação]. Ribeirão Preto, SP: Escola de Enfermagem da Universidade de São Paulo; 2005., allowing the narrative synthesis of its results. Finally, the methodological quality of the articles was assessed using the “Checklist for Studies on the Accuracy of Diagnostic Tests”, proposed by The Joanna Briggs Institute (JBI) (https://joannabriggs.org/critical-appraisal-tools). It includes ten evaluation items within dichotomous answers (yes/no), considering “yes” a positive answer. Two checklist items were not applicable to the selected studies, so we sorted them out during evaluations.

RESULTS

From the 19 articles included in this review, 18 (94.7%) were published in English⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... and one (5.3%) in Spanish³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9.. 15 of them (78.9%) were from Africa ⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... ,²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... , two (10.5%) from the American Continent³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... ,³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9., one (5.3%), from Asia²⁴24. Sumangala V, Venkatesha DT, Chennaveerappa PK, Gayathree L. Role of GeneXpert® MTB/RIF assay for early diagnosis of pulmonar tuberculosis in people living with HIV. J Int Med Dent. 2017;4(2):56-60. https://doi.org/10.18320/JIMD/201704.0256
https://doi.org/10.18320/JIMD/201704.025... and one (5.3%) from a multicenter study³⁵35. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis. 2018;18(1):76-84. https://doi.org/10.1016/S1473-3099(17)30691-6
https://doi.org/10.1016/S1473-3099(17)30... that involves countries from Africa, America, Europe, and Asia.

The articles were published in 2011 (21,1%)⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... ,³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... , 2012 (15,8%)²⁹29. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo J, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis. 2012;55(9):1171-8. https://doi.org/10.1093/cid/cis631
https://doi.org/10.1093/cid/cis631... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... ,³⁸38. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clin Infect Dis. 2012;54(8):1071-9. https://doi.org/10.1093/cid/cir1039
https://doi.org/10.1093/cid/cir1039... , 2014 (15,8%)²⁶26. Balcha TT, Sturegård E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014;22;9(1):e85478. https://doi.org/10.1371/journal.pone.0085478
https://doi.org/10.1371/journal.pone.008... ,³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³⁶36. Auld SC, Moore BK, Killam WP, Eng B, Nong K, Pevzner EC, et al. Rollout of Xpert® MTB/RIF in Northwest Cambodia for the diagnosis of tuberculosis among PLHA. Public Health Action. 2014;4(4):216-21. https://doi.org/10.5588/pha.14.0082
https://doi.org/10.5588/pha.14.0082... , 2015 (5,3%)²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... , 2016 (5,3%)³³33. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in Western Kenya. PLoS One. 2016;11(3):e0152364. https://doi.org/10.1371/journal.pone.0152364
https://doi.org/10.1371/journal.pone.015... , 2017(15,8%)²⁴24. Sumangala V, Venkatesha DT, Chennaveerappa PK, Gayathree L. Role of GeneXpert® MTB/RIF assay for early diagnosis of pulmonar tuberculosis in people living with HIV. J Int Med Dent. 2017;4(2):56-60. https://doi.org/10.18320/JIMD/201704.0256
https://doi.org/10.18320/JIMD/201704.025... ,²⁸28. Akanbi MO, Achenbach C, Taiwo B, Idoko J, Ani A, Yetunde Isa Y, et al. Evaluation of gene xpert for routine diagnosis of HIV-associated tuberculosis in Nigeria: a prospective cohort study. BMC Pulm Med. 2017;17:87. https://doi.org/10.1186/s12890-017-0430-6
https://doi.org/10.1186/s12890-017-0430-... ,³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... and 2018 (21,1%)²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... ,³¹31. Mbu ET, Sauter F, Zoufaly A, Bronsvoort BMC, Morgan K, Noeske J, et al. Tuberculosis in people newly diagnosed with HIV at a large HIV care and treatment center in Northwest Cameroon: burden, comparative screening and diagnostic yields, and patient outcomes. PLoS One. 2018;13(6):e0199634. https://doi.org/10.1371/journal.pone.0199634
https://doi.org/10.1371/journal.pone.019... ,³⁵35. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis. 2018;18(1):76-84. https://doi.org/10.1016/S1473-3099(17)30691-6
https://doi.org/10.1016/S1473-3099(17)30... ,³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9.. Regarding the investigation time, four (21.1%) studies lasted up to 6 months²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... , five (26.3%), from 6 months to one year⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³⁵35. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis. 2018;18(1):76-84. https://doi.org/10.1016/S1473-3099(17)30691-6
https://doi.org/10.1016/S1473-3099(17)30... ,³⁶36. Auld SC, Moore BK, Killam WP, Eng B, Nong K, Pevzner EC, et al. Rollout of Xpert® MTB/RIF in Northwest Cambodia for the diagnosis of tuberculosis among PLHA. Public Health Action. 2014;4(4):216-21. https://doi.org/10.5588/pha.14.0082
https://doi.org/10.5588/pha.14.0082... ,³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9.,eight (42.1%), from one to two years²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... ,²⁶26. Balcha TT, Sturegård E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014;22;9(1):e85478. https://doi.org/10.1371/journal.pone.0085478
https://doi.org/10.1371/journal.pone.008... ,²⁸28. Akanbi MO, Achenbach C, Taiwo B, Idoko J, Ani A, Yetunde Isa Y, et al. Evaluation of gene xpert for routine diagnosis of HIV-associated tuberculosis in Nigeria: a prospective cohort study. BMC Pulm Med. 2017;17:87. https://doi.org/10.1186/s12890-017-0430-6
https://doi.org/10.1186/s12890-017-0430-... ,²⁹29. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo J, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis. 2012;55(9):1171-8. https://doi.org/10.1093/cid/cis631
https://doi.org/10.1093/cid/cis631... ,³¹31. Mbu ET, Sauter F, Zoufaly A, Bronsvoort BMC, Morgan K, Noeske J, et al. Tuberculosis in people newly diagnosed with HIV at a large HIV care and treatment center in Northwest Cameroon: burden, comparative screening and diagnostic yields, and patient outcomes. PLoS One. 2018;13(6):e0199634. https://doi.org/10.1371/journal.pone.0199634
https://doi.org/10.1371/journal.pone.019... ,³³33. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in Western Kenya. PLoS One. 2016;11(3):e0152364. https://doi.org/10.1371/journal.pone.0152364
https://doi.org/10.1371/journal.pone.015... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... ,³⁸38. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clin Infect Dis. 2012;54(8):1071-9. https://doi.org/10.1093/cid/cir1039
https://doi.org/10.1093/cid/cir1039... and two (10.5%), from 2 to 3 years²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... ,³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... .

The summary of the main results on the effectiveness of the GeneXpert is presented in Box 3. Eleven studied⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... the sensitivity of the test, nine⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... evaluated the specificity and eight, the positive predictive value (PPV) and the negative predictive value (NPV). The comparison tests used to assess the effectiveness of the GeneXpert test were: 14 (73.6%) sputum smear microscopy⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... , four (21.1%) culture in Lowenstein-Jensen (LJ)³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... ,³⁵35. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis. 2018;18(1):76-84. https://doi.org/10.1016/S1473-3099(17)30691-6
https://doi.org/10.1016/S1473-3099(17)30... ,³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9., 13 (68.4%) culture in liquid medium ⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... ,²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... , one (5.3%) Light Cycler Mycobacterium Detection (LCTB)⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... and one (5.3%) MTBDRplus (Hain Lifescience)⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... . Three articles³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... ,³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³³33. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in Western Kenya. PLoS One. 2016;11(3):e0152364. https://doi.org/10.1371/journal.pone.0152364
https://doi.org/10.1371/journal.pone.015... evaluated effectiveness of the test according to the results of CD4+ T lymphocyte counts and one article³³33. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in Western Kenya. PLoS One. 2016;11(3):e0152364. https://doi.org/10.1371/journal.pone.0152364
https://doi.org/10.1371/journal.pone.015... evaluated this effectiveness according to the time of sputum collection.

As for the methodological quality of the studies, five studies²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... ,²⁶26. Balcha TT, Sturegård E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014;22;9(1):e85478. https://doi.org/10.1371/journal.pone.0085478
https://doi.org/10.1371/journal.pone.008... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... ,³⁸38. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clin Infect Dis. 2012;54(8):1071-9. https://doi.org/10.1093/cid/cir1039
https://doi.org/10.1093/cid/cir1039... included all the essential items considered by The Joanna Briggs Institute. Only one (5.3%)²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... article presented sample size calculation.

DISCUSSION

The epidemic and the expansion of HIV/AIDS infection impacted the incidence of TB⁴⁰40. Mboma SM, Houben RMGJ, Glynn JR, Sichali L, Drobniewski F, Mpunga J, et al. Control of (multi)drug resistance and tuberculosis incidence over 23 years in the context of a well-supported tuberculosis programme in rural Malawi. PLoS One. 2013;8(3):e58192. https://doi.org/10.1371/journal.pone.0058192
https://doi.org/10.1371/journal.pone.005... , whose early detection followed by timely treatment represent the key to its control, so that laboratory diagnosis represents a challenge for health services³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9.. The population living with TB/HIV co-infection has some characteristics that limit the use of diagnostic tools, as it can more easily present a negative smear, advanced immunosuppression that provides delayed diagnosis, the subclinical manifestation of signs and symptoms characteristic of TB⁴¹41. Getahun H, Harrington M, O’Brien R, Nunn P. Diagnosis of smear negative pulmonary tuberculosis in people with HIV infection of AIDS in resource-constrained settings: informing urgent policy changes. Lancet. 2007;369(9578):2042-9. https://doi.org/10.1016/S0140-6736(07)60284-0
https://doi.org/10.1016/S0140-6736(07)60... .

In TB/HIV endemic regions with limited resources, sputum microscopy is usually the only method available for diagnosis⁴4. World Health Organization. Roadmap for rolling out Xpert MTB/RIF for rapid diagnosis of TB and MDR-TB. Geneva (CH): WHO; 2010.,³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... ,⁴²42. Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 2014;(1):CD009593. https://doi.org/10.1002/14651858.CD009593
https://doi.org/10.1002/14651858.CD00959... . The use of only this technique to screen for TB in the population co-infected with HIV restricts its potential diagnosis because approximately 10,000 organisms per milliliter are needed in the sputum to perform the test, an uncommon amount among the population living with HIV/AIDS³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... .

GeneXpert test is a sensitive, specific⁴³43. Deepak A, Neerja J, Renu B, Shilpa A. Rapid detection of Mycobacterium tuberculosis in sputum samples by Cepheid Xpert Assay: a clinical study. J Clin Diagn Res. 2015;9(5):DC03-5. https://doi.org/10.7860/JCDR/2015/11352.5935
https://doi.org/10.7860/JCDR/2015/11352.... , simple, and innovative method whose objective, since its implementation, has been to detect the presence of M. tuberculosis and resistance to rifampicin within 2 hours⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... . The method has an increased screening capacity⁴³43. Deepak A, Neerja J, Renu B, Shilpa A. Rapid detection of Mycobacterium tuberculosis in sputum samples by Cepheid Xpert Assay: a clinical study. J Clin Diagn Res. 2015;9(5):DC03-5. https://doi.org/10.7860/JCDR/2015/11352.5935
https://doi.org/10.7860/JCDR/2015/11352.... , besides requiring minimal bacillary concentrations in the samples for the examination³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... .

Due to these particularities, the relevance of sputum smear microscopy for the diagnosis of TB where GeneXpert is available is questioned, although evidence found shows that the concomitant use of both tests can result in an increase in the identification of cases not detected by both an exam and on the other²⁸28. Akanbi MO, Achenbach C, Taiwo B, Idoko J, Ani A, Yetunde Isa Y, et al. Evaluation of gene xpert for routine diagnosis of HIV-associated tuberculosis in Nigeria: a prospective cohort study. BMC Pulm Med. 2017;17:87. https://doi.org/10.1186/s12890-017-0430-6
https://doi.org/10.1186/s12890-017-0430-... ,³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... , mainly in people with T CD4+ lymphocyte count < 200 cells/µl³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... .

Other studies do not address the simultaneous performance of both tests but point out that the use of GeneXpert substantially increased the detection of TB cases among the population co-infected with HIV/AIDS²⁴24. Sumangala V, Venkatesha DT, Chennaveerappa PK, Gayathree L. Role of GeneXpert® MTB/RIF assay for early diagnosis of pulmonar tuberculosis in people living with HIV. J Int Med Dent. 2017;4(2):56-60. https://doi.org/10.18320/JIMD/201704.0256
https://doi.org/10.18320/JIMD/201704.025... ,²⁶26. Balcha TT, Sturegård E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014;22;9(1):e85478. https://doi.org/10.1371/journal.pone.0085478
https://doi.org/10.1371/journal.pone.008... ,³³33. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in Western Kenya. PLoS One. 2016;11(3):e0152364. https://doi.org/10.1371/journal.pone.0152364
https://doi.org/10.1371/journal.pone.015... ,³⁸38. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clin Infect Dis. 2012;54(8):1071-9. https://doi.org/10.1093/cid/cir1039
https://doi.org/10.1093/cid/cir1039... ,⁴²42. Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 2014;(1):CD009593. https://doi.org/10.1002/14651858.CD009593
https://doi.org/10.1002/14651858.CD00959... , which was accentuated in morning sputum samples and among people with lower CD4+ T lymphocyte counts³³33. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in Western Kenya. PLoS One. 2016;11(3):e0152364. https://doi.org/10.1371/journal.pone.0152364
https://doi.org/10.1371/journal.pone.015... .

The WHO recommendation to use GeneXpert, instead of sputum smear microscopy as the initial test of choice in HIV-infected individuals susceptible to TB⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... , corroborates the findings of studies that have shown that GeneXpert’s sensitivity in diagnosing TB in people living with HIV ranged from 68%³¹31. Mbu ET, Sauter F, Zoufaly A, Bronsvoort BMC, Morgan K, Noeske J, et al. Tuberculosis in people newly diagnosed with HIV at a large HIV care and treatment center in Northwest Cameroon: burden, comparative screening and diagnostic yields, and patient outcomes. PLoS One. 2018;13(6):e0199634. https://doi.org/10.1371/journal.pone.0199634
https://doi.org/10.1371/journal.pone.019... to 100%³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... (average 81.1%), being greater than the sensitivity of sputum smear microscopy⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... , which ranged from 23.0%²⁶26. Balcha TT, Sturegård E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014;22;9(1):e85478. https://doi.org/10.1371/journal.pone.0085478
https://doi.org/10.1371/journal.pone.008... to 66,7%³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... (average 43.3%). Given the above, the implementation of GeneXpert, a fast and accurate test in different clinical contexts, has led to a significant increase in the diagnosis of pulmonary TB, both when used as a first-choice test and as a complement⁴⁵45. Ardizzoni E, Farjado E, Saranchuk P, Casenghi M, Page AN, Varaine F, et al. Implementing the Xpert® MTB/RIF diagnostic test for tuberculosis and rifampicin resistance: outcomes and lessons learned in 18 countries. Plos One. 2015;10(12):e0144656. https://doi.org/10.1371/journal.pone.0144656
https://doi.org/10.1371/journal.pone.014... .

We highlight that sensitivity is calculated based on the sputum culture, which is considered the gold standard test for the diagnosis of TB. Although this is a reference test, some studies compare it with GeneXpert, pointing to lesser sensitivity of the latter in relation to culture using the LJ and BACTEC MGIT 960 methods³¹31. Mbu ET, Sauter F, Zoufaly A, Bronsvoort BMC, Morgan K, Noeske J, et al. Tuberculosis in people newly diagnosed with HIV at a large HIV care and treatment center in Northwest Cameroon: burden, comparative screening and diagnostic yields, and patient outcomes. PLoS One. 2018;13(6):e0199634. https://doi.org/10.1371/journal.pone.0199634
https://doi.org/10.1371/journal.pone.019... , while another study shows greater²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... sensitivity and other equal performance in relation to the LJ method³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... . Two studies brought other diagnostic methods that were also compared to GeneXpert: one indicated similar sensitivity between it and⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... the LCTB test, and another indicated lower sensitivity when compared to XpertUltra³⁵35. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis. 2018;18(1):76-84. https://doi.org/10.1016/S1473-3099(17)30691-6
https://doi.org/10.1016/S1473-3099(17)30... . Thus, we highlight the importance of using GeneXpert as the test of choice for the diagnosis of pulmonary TB in adults living with HIV, because it has similar and superior effectiveness compared to culture and even to other molecular methods, such as LCTB. However, it is worth point out the importance of further studies in relation to the comparison of the test with culture, because divergences came up in relation to the results regarding such effectiveness. The indication of Xpert Ultra stands out as a method of choice to replace all available tests, including GeneXpert, because only one study was found in this review that compared the two tests⁴⁶46. Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J. The New Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. mBio. 2017;8(4):e00812-17. https://doi.org/10.1128/mBio.00812-17
https://doi.org/10.1128/mBio.00812-17... .

It should also be noted that the sensitivity of the GeneXpert test in people living with HIV was greater than in HIV-negative people²⁹29. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo J, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis. 2012;55(9):1171-8. https://doi.org/10.1093/cid/cis631
https://doi.org/10.1093/cid/cis631... , in contrast to another study that stated that the sensitivity in people living with HIV was lower³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... . The increased sensitivity of the test in HIV-positive patients adds important advantages to its use in health services, such as the increase in the detection rate of microbiologically confirmed TB and the potential to institute a rapid treatment, aiming to reduce TB transmission⁴⁷47. Churchyard GJ, Stevens WS, Mametja LD, McCarthy KM, Chihota V, Nicol MP, et al. Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF. Lancet Glob Health. 2015;3(8):e450-7. https://doi.org/10.1016/S2214-109X(15)00100-X
https://doi.org/10.1016/S2214-109X(15)00... . Some individual characteristics, such as a negative sputum smear microscopy²⁶26. Balcha TT, Sturegård E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014;22;9(1):e85478. https://doi.org/10.1371/journal.pone.0085478
https://doi.org/10.1371/journal.pone.008... ,²⁹29. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo J, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis. 2012;55(9):1171-8. https://doi.org/10.1093/cid/cis631
https://doi.org/10.1093/cid/cis631... and a CD4+ T lymphocyte count ≤ 200 cells/µl³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... , were mentioned as elements that reduce the sensitivity of the GeneXpert test. Although these results are controversial in relation to the study by Cavanaugh et al. (2016)³³33. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in Western Kenya. PLoS One. 2016;11(3):e0152364. https://doi.org/10.1371/journal.pone.0152364
https://doi.org/10.1371/journal.pone.015... , which shows increased test sensitivity in people with lower CD4+ T lymphocyte counts, another study shows that the performance of GeneXpert in HIV-infected people with advanced immunosuppression has certain limitations³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... that may be caused by the lower concentration of mycobacteria in sputum and by the occult or subclinical presentation of the disease³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... .

The specificity of GeneXpert ranged from 91.7%³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... to 100%³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... (average 95.6%), and in comparison with sputum smear microscopy, some studies concluded that both exams showed similar performance in relation to the mentioned aspect⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... ,³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... , and others that GeneXpert has less specificity²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... ,³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... . Regarding other diagnostic tests, the study mentions that the specificity of the GeneXpert test is similar to that of culture²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... and LCTB⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... . The specificity of the test in people living with HIV/AIDS was also similar to people not infected by the virus²⁹29. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo J, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis. 2012;55(9):1171-8. https://doi.org/10.1093/cid/cis631
https://doi.org/10.1093/cid/cis631... . Based on the above, it appears that the specificity of the GeneXpert test is comparable to other diagnostic tests.

The PPV, understood as the probability of having the disease when the test is positive, ranged from 79.2% to 96.1% (average 91%) for GeneXpert in people living with HIV/AIDS infection, is considered similar to sputum smear microscopy⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... ,²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... ,³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... and to LCTB⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... , as well as when the test is performed in people who are not living with the virus³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... , although one of the studies has pointed out that the PPV was lower in these people²⁹29. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo J, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis. 2012;55(9):1171-8. https://doi.org/10.1093/cid/cis631
https://doi.org/10.1093/cid/cis631... . On the other hand, NPV, understood as the probability of not having the disease when the test is negative, ranged from 84.6% to 99.3% (average 92.6%) for GeneXpert in people living with HIV/AIDS, being considered similar³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... or greater⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... ,²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... in relation to sputum smear microscopy and similar to LCTB⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... and in people who do not live with the virus²⁹29. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo J, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis. 2012;55(9):1171-8. https://doi.org/10.1093/cid/cis631
https://doi.org/10.1093/cid/cis631... , although one of the studies has pointed out that the NPV is greater in these people³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... . Thus, as well as in the assessment of specificity, the results of the effectiveness of the GeneXpert test in terms of PPV and NVP showed evidence of being similar to the other comparison tests.

A study also presented the test’s likelihood ratio for diagnosing TB in co-infected patients, calculated by dividing the probability of positive (positive likelihood) or negative (negative likelihood) results, in people with the disease, by the probability of the same result in people without the disease⁴⁹49. Moreira WB, editor. Leitura crítica de artigos científicos. São Paulo: Sociedade Brasileira de Oncologia Clínica; 2016. Capítulo 5, Artigos sobre testes diagnósticos; p. 83-90.. Regarding the positive likelihood ratio, there was no difference between GeneXpert and sputum smear microscopy²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... . However, the negative likelihood ratio of GeneXpert was lower and close to “zero”²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... , favoring it if compared to sputum smear microscopy.

The effectiveness of the test in identifying cases resistant to rifampicin needs to be further studied, as one study²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... showed that of seven identified cases, three were false positives; as well as the fact that other studies⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... ,²⁴24. Sumangala V, Venkatesha DT, Chennaveerappa PK, Gayathree L. Role of GeneXpert® MTB/RIF assay for early diagnosis of pulmonar tuberculosis in people living with HIV. J Int Med Dent. 2017;4(2):56-60. https://doi.org/10.18320/JIMD/201704.0256
https://doi.org/10.18320/JIMD/201704.025... ,³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... have a very small population of resistant cases, limiting the conclusions that the test has similar effectiveness to sensitivity tests²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... ,²⁴24. Sumangala V, Venkatesha DT, Chennaveerappa PK, Gayathree L. Role of GeneXpert® MTB/RIF assay for early diagnosis of pulmonar tuberculosis in people living with HIV. J Int Med Dent. 2017;4(2):56-60. https://doi.org/10.18320/JIMD/201704.0256
https://doi.org/10.18320/JIMD/201704.025... ,³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... and even to MDRTB plus⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... . So diagnosing resistance to rifampicin still remains a challenge for health services, considering it would reduce the average time to detect resistant cases to up to two days³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... , which would be an admirable performance when compared to almost 40 days of the test of sensitivity/conventional culture²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... . The immediate diagnosis of these cases would allow a substantial reduction in the risks of nosocomial transmission of the resistant bacillus and its specific and early treatment, which would result in a reduction in the severe forms of TB, as well as an improvement in the prognosis and a reduction in loss of clinical follow-up²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... ,³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9..

The expansion of the GeneXpert test in diagnosing TB among HIV-infected individuals is essential, given its effectiveness and especially in countries with a high burden of coinfection, as this test would bring gains in case detection by replacing or complementing the sputum smear microscopy and would make the treatment time opportune²⁸28. Akanbi MO, Achenbach C, Taiwo B, Idoko J, Ani A, Yetunde Isa Y, et al. Evaluation of gene xpert for routine diagnosis of HIV-associated tuberculosis in Nigeria: a prospective cohort study. BMC Pulm Med. 2017;17:87. https://doi.org/10.1186/s12890-017-0430-6
https://doi.org/10.1186/s12890-017-0430-... in relation to the culture, which has cost limitations and technical requirements³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³³33. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in Western Kenya. PLoS One. 2016;11(3):e0152364. https://doi.org/10.1371/journal.pone.0152364
https://doi.org/10.1371/journal.pone.015... . We also emphasize that GeneXpert’s diagnostic accuracy, based on 85% sensitivity and 97% specificity, would potentially save more than 400,000 lives per year³⁴34. Mollel EW, Chilongola JO, Mpagama SG; Kibiki GS. Evaluation of XpertMTB/RIF performance for diagnosis of tuberculosis among HIV positive patients in northern Tanzania. Tanzan J Health Res. 2017;19(1):1-9. https://doi.org/10.4314/thrb.v19i1.1
https://doi.org/10.4314/thrb.v19i1.1... , even if some cases undergo empirical treatment, which would be reduced by locations with the implementation of testing²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... ,³⁸38. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clin Infect Dis. 2012;54(8):1071-9. https://doi.org/10.1093/cid/cir1039
https://doi.org/10.1093/cid/cir1039... .

As for the methodological quality of the studies, five studies contemplated all the essential items considered by The Joanna Briggs Institute related to accuracy evaluation of tests²³23. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay: a clinical validation study. PLoS One. 2011;6(6):e20458. https://doi.org/10.1371/journal.pone.0020458
https://doi.org/10.1371/journal.pone.002... ,²⁵25. Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011;8(7):e1001067. https://doi.org/10.1371/journal.pmed.1001067
https://doi.org/10.1371/journal.pmed.100... ,²⁶26. Balcha TT, Sturegård E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014;22;9(1):e85478. https://doi.org/10.1371/journal.pone.0085478
https://doi.org/10.1371/journal.pone.008... ,³⁷37. Balcells ME, García P, Chanqueo L, Bahamondes L, Lasso M, Gallardo AM, et al. Rapid molecular detection of pulmonary tuberculosis in HIV-infected patients in Santiago, Chile. Int J Tuberc Lung Dis. 2012;16(10):1349-53. https://doi.org/10.5588/ijtld.12.0156
https://doi.org/10.5588/ijtld.12.0156... ,³⁸38. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clin Infect Dis. 2012;54(8):1071-9. https://doi.org/10.1093/cid/cir1039
https://doi.org/10.1093/cid/cir1039... . Of the methodological limitations found in the studies, the small sample size stands out²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... ; sample losses above 20%⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²⁹29. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo J, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis. 2012;55(9):1171-8. https://doi.org/10.1093/cid/cis631
https://doi.org/10.1093/cid/cis631... ,³⁵35. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis. 2018;18(1):76-84. https://doi.org/10.1016/S1473-3099(17)30691-6
https://doi.org/10.1016/S1473-3099(17)30... ; the lack of clarification regarding the sampling process³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9. and the sampling process²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... ; the use of secondary data³²32. Ssengooba W, Nakiyingi L, Armstrong DT, Cobelens FG, Alland D, Manabe YC, et al. Clinical utility of a novel molecular assay in various combination strategies with existing methods for diagnosis of HIV-related tuberculosis in Uganda. PLoS One. 2014;9(9):e107595. https://doi.org/10.1371/journal.pone.0107595
https://doi.org/10.1371/journal.pone.010... ,³⁶36. Auld SC, Moore BK, Killam WP, Eng B, Nong K, Pevzner EC, et al. Rollout of Xpert® MTB/RIF in Northwest Cambodia for the diagnosis of tuberculosis among PLHA. Public Health Action. 2014;4(4):216-21. https://doi.org/10.5588/pha.14.0082
https://doi.org/10.5588/pha.14.0082... ,³⁹39. Mederos Cuervo LM, Martinez Romero MR, Sardiñas Aragón M, García Léon G, Chilemo TS, Díaz Rodrígues R. Importancia diagnóstica del GeneXpert Mtb – Rif¨ en pacientes infectados por el Virus de Inmunodeficiencia Humana (VIH). AVFT Arch Venez Farmacol Ter. 2018;37(4):355-9.; doubts about performance⁶6. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med. 2011;8(7):e1001061. https://doi.org/10.1371/journal.pmed.1001061
https://doi.org/10.1371/journal.pmed.100... ,²²22. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes New Infect. 2015;8):24-7. https://doi.org/10.1016/j.nmni.2015.09.001
https://doi.org/10.1016/j.nmni.2015.09.0... ,²⁷27. Griesel R, Stewart A, Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in human immunodeficiency virus-infected inpatients meeting the criteria of seriously ill in the World Health Organization algorithm. Clin Infect Dis. 2018;66(9):1419-26. https://doi.org/10.1093/cid/cix988
https://doi.org/10.1093/cid/cix988... and nonperformance³¹31. Mbu ET, Sauter F, Zoufaly A, Bronsvoort BMC, Morgan K, Noeske J, et al. Tuberculosis in people newly diagnosed with HIV at a large HIV care and treatment center in Northwest Cameroon: burden, comparative screening and diagnostic yields, and patient outcomes. PLoS One. 2018;13(6):e0199634. https://doi.org/10.1371/journal.pone.0199634
https://doi.org/10.1371/journal.pone.019... of blind studies in relation to the results of the tests performed; and the use of different reference tests for the study participants ³⁶36. Auld SC, Moore BK, Killam WP, Eng B, Nong K, Pevzner EC, et al. Rollout of Xpert® MTB/RIF in Northwest Cambodia for the diagnosis of tuberculosis among PLHA. Public Health Action. 2014;4(4):216-21. https://doi.org/10.5588/pha.14.0082
https://doi.org/10.5588/pha.14.0082... or the use of sputum smear microscopy as a reference test²⁴24. Sumangala V, Venkatesha DT, Chennaveerappa PK, Gayathree L. Role of GeneXpert® MTB/RIF assay for early diagnosis of pulmonar tuberculosis in people living with HIV. J Int Med Dent. 2017;4(2):56-60. https://doi.org/10.18320/JIMD/201704.0256
https://doi.org/10.18320/JIMD/201704.025... ,²⁸28. Akanbi MO, Achenbach C, Taiwo B, Idoko J, Ani A, Yetunde Isa Y, et al. Evaluation of gene xpert for routine diagnosis of HIV-associated tuberculosis in Nigeria: a prospective cohort study. BMC Pulm Med. 2017;17:87. https://doi.org/10.1186/s12890-017-0430-6
https://doi.org/10.1186/s12890-017-0430-... ,³⁶36. Auld SC, Moore BK, Killam WP, Eng B, Nong K, Pevzner EC, et al. Rollout of Xpert® MTB/RIF in Northwest Cambodia for the diagnosis of tuberculosis among PLHA. Public Health Action. 2014;4(4):216-21. https://doi.org/10.5588/pha.14.0082
https://doi.org/10.5588/pha.14.0082... . Moreover, a possible population selection bias is identified in a study, within the GeneXpert test was only performed on samples that were positive for the culture³¹31. Mbu ET, Sauter F, Zoufaly A, Bronsvoort BMC, Morgan K, Noeske J, et al. Tuberculosis in people newly diagnosed with HIV at a large HIV care and treatment center in Northwest Cameroon: burden, comparative screening and diagnostic yields, and patient outcomes. PLoS One. 2018;13(6):e0199634. https://doi.org/10.1371/journal.pone.0199634
https://doi.org/10.1371/journal.pone.019... .

Despite the fact that the test is more costly than microscopy, the benefits of the time of diagnosis and indication of drug resistance proved to be greater, because they bring greater sensitivity and specificity. In addition, the test establishes the diagnosis in a significant proportion of smear-negative patients and has a cut-off consolidated for TB-MDR³⁰30. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011;184(1):132-40. https://doi.org/10.1164/rccm.201101-0056OC
https://doi.org/10.1164/rccm.201101-0056... ,⁴⁵45. Ardizzoni E, Farjado E, Saranchuk P, Casenghi M, Page AN, Varaine F, et al. Implementing the Xpert® MTB/RIF diagnostic test for tuberculosis and rifampicin resistance: outcomes and lessons learned in 18 countries. Plos One. 2015;10(12):e0144656. https://doi.org/10.1371/journal.pone.0144656
https://doi.org/10.1371/journal.pone.014... . Based on this, GeneXpert can be used as a first-line diagnostic method²⁴24. Sumangala V, Venkatesha DT, Chennaveerappa PK, Gayathree L. Role of GeneXpert® MTB/RIF assay for early diagnosis of pulmonar tuberculosis in people living with HIV. J Int Med Dent. 2017;4(2):56-60. https://doi.org/10.18320/JIMD/201704.0256
https://doi.org/10.18320/JIMD/201704.025... .

Some limitations should be noted. This review may not have included relevant studies that were not indexed in the searched databases, nor included the gray literature that could enable the identification of other topics/relevant points on the subject to be addressed.

It is possible to conclude that places with a high incidence of HIV/AIDS could benefit from the implementation of the GeneXpert test, because its effectiveness in diagnosing pulmonary TB in this population is expressive when compared to sputum smear microscopy, a test that has been used for a long time and widely used for case detection. When compared to other tests, there was controversy regarding the effectiveness of GeneXpert and the different types of cultures, similar to that of LCTB and lower than that of Xpert Ultra. In addition to increasing the detection of pulmonary TB cases among people living with HIV, the GeneXpert test can provide benefits such as faster results than those obtained by culture (the most sensitive method for confirming TB), culminating in timely detection and treatment, making GeneXpert a tool in the fight against TB. Along with the innovation in the use of GeneXpert, we stand for the support and strengthen of health services in the applicability of this technique in order to achieve the goals of sustainable development and the End TB Strategy.

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