Evaluation of GeneXpert MTB/RIF for detection of pulmonary tuberculosis at peripheral tuberculosis clinics

Shao, Yan; Peng, Hong; Chen, Cheng; Zhu, Tao; Ji, Ming; Jiang, Wei; Zhu, Wei; Zhai, Xiang; Lü, Wei

doi:10.1016/j.micpath.2017.02.040

Cited by 10 publications

(14 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In the Flow and Timing domain, we considered 72 studies (84%) to have low risk of bias because all participants were included in the analysis. We considered eight studies (9%) to have high risk of bias: in seven studies, results for index or reference tests were not available for many participants ( Barmankulova 2015 ; Barnard 2015 ; Boum 2016 ; Davis 2014 ; Mutingwende 2015 ; Shao 2017 ; Van Rie 2013 ); in one study, participants who were treated for tuberculosis on the basis of clinical and radiological findings (smear‐negative, culture‐negative) were not included in the analysis ( Boehme 2011 ). We considered six studies (7%) to have unclear risk of bias because we could not tell if all participants were included in the analysis ( Chaisson 2014 ; Dorman 2018 ; Hanrahan 2014 ; Helb 2010 ; Rachow 2011 ; Tsuyuguchi 2017 ).…”

Section: Resultsmentioning

confidence: 99%

“…There were 10 studies (5816 participants) that ran Xpert MTB/RIF at point of care or in a peripheral setting ( Al‐Darraji 2013 ; Calligaro 2017 ; Chaisson 2014 ; Chew 2016 ; Geleta 2015 ; Hanrahan 2013 ; Huang 2015 ; Kurbaniyazova 2017 ; Shao 2017 ; Theron 2014a ), and 60 studies (31,421 participants) that ran Xpert MTB/RIF in an intermediate or central‐level laboratory. In studies running Xpert MTB/RIF at point of care or in a peripheral setting, the pooled sensitivity (95% CrI) was 83% (75% to 89%), lower than the sensitivity of 85% (83% to 88%) in studies running Xpert MTB/RIF in an intermediate or central‐level laboratory.…”

Section: Resultsmentioning

confidence: 99%

“…We considered 16 studies (19%) to have high risk of bias because the study did not avoid inappropriate exclusions: 13 studies enrolled participants whose sputum specimens were primarily or exclusively smear‐positive or smear‐negative (Barnard 2015; Friedrich 2011; Jo 2016; Lee 2013; Le Palud 2014; Meyer 2017; Mok 2016; Moure 2011; Tadesse 2016; Theron 2013; Van Rie 2013; Walusimbi 2013a; Williamson 2012) and three studies exclusively enrolled participants who had previously received tuberculosis treatment (Meawed 2016; Metcalfe 2015; Pimkina 2015). In addition, we considered 15 studies (17%) to have unclear risk of bias because the manner of participant selection was not stated (Atwebembeire 2016; Barmankulova 2015; Bates 2013a; Boum 2016; Chen 2017; Huang 2015; Kim CH 2015; Luetkemeyer 2016; Mbelele 2017; Moussa 2016; Mutingwende 2015; Nosova 2013a; Reechaipichitkul 2017; Shao 2017; Shenai 2016). With respect to applicability, we considered 46 studies (53%) to have low concern because participants in these studies were evaluated in primary care facilities, local hospitals, or both settings (Adelman 2015; Al‐Darraji 2013; Balcells 2012; Balcha 2014; Barmankulova 2015; Bjerrum 2016; Boehme 2010; Boehme 2011; Boum 2016; Calligaro 2017; Carriquiry 2012; Chen 2017; Dorman 2018; Friedrich 2011; Hanrahan 2013; Hanrahan 2014; Henostroza 2016; Huang 2015; Kurbaniyazova 2017; Kurbatova 2013; …”

Section: Resultsmentioning

confidence: 99%

“…In addition, we considered 15 studies (17%) to have unclear risk of bias because the manner of participant selection was not stated (Atwebembeire 2016; Barmankulova 2015; Bates 2013a; Boum 2016; Chen 2017; Huang 2015; Kim CH 2015; Luetkemeyer 2016; Mbelele 2017; Moussa 2016; Mutingwende 2015; Nosova 2013a; Reechaipichitkul 2017; Shao 2017; Shenai 2016). With respect to applicability, we considered 46 studies (53%) to have low concern because participants in these studies were evaluated in primary care facilities, local hospitals, or both settings (Adelman 2015; Al‐Darraji 2013; Balcells 2012; Balcha 2014; Barmankulova 2015; Bjerrum 2016; Boehme 2010; Boehme 2011; Boum 2016; Calligaro 2017; Carriquiry 2012; Chen 2017; Dorman 2018; Friedrich 2011; Hanrahan 2013; Hanrahan 2014; Henostroza 2016; Huang 2015; Kurbaniyazova 2017; Kurbatova 2013; Kwak 2013; LaCourse 2016; Lawn 2011; Luetkemeyer 2016; Meawed 2016; Metcalfe 2015; Mollel 2017; Moure 2011; Mutingwende 2015; Ngabonziza 2016; Nliwasa 2016; O'Donnell 2015; Pimkina 2015; Reddy 2017; Rice 2017; Scott 2011; Scott 2017; Shao 2017; Shenai 2016; Sohn 2014; Ssengooba 2014; …”

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Horne

Kohli

Zifodya

et al. 2019

Cochrane Database of Systematic Reviews

182

157

View full text Add to dashboard Cite

Background Xpert MTB/RIF (Xpert MTB/RIF) and Xpert MTB/RIF Ultra (Xpert Ultra), the newest version, are the only World Health Organization (WHO)‐recommended rapid tests that simultaneously detect tuberculosis and rifampicin resistance in persons with signs and symptoms of tuberculosis, at lower health system levels. A previous Cochrane Review found Xpert MTB/RIF sensitive and specific for tuberculosis ( ). Since the previous review, new studies have been published. We performed a review update for an upcoming WHO policy review. Objectives To determine diagnostic accuracy of Xpert MTB/RIF and Xpert Ultra for tuberculosis in adults with presumptive pulmonary tuberculosis (PTB) and for rifampicin resistance in adults with presumptive rifampicin‐resistant tuberculosis. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, Web of Science, Latin American Caribbean Health Sciences Literature, Scopus, the WHO International Clinical Trials Registry Platform, the International Standard Randomized Controlled Trial Number Registry, and ProQuest, to 11 October 2018, without language restriction. Selection criteria Randomized trials, cross‐sectional, and cohort studies using respiratory specimens that evaluated Xpert MTB/RIF, Xpert Ultra, or both against the reference standard, culture for tuberculosis and culture‐based drug susceptibility testing or MTBDR plus for rifampicin resistance. Data collection and analysis Four review authors independently extracted data using a standardized form. When possible, we also extracted data by smear and HIV status. We assessed study quality using QUADAS‐2 and performed meta‐analyses to estimate pooled sensitivity and specificity separately for tuberculosis and rifampicin resistance. We investigated potential sources of heterogeneity. Most analyses used a bivariate random‐effects model. For tuberculosis detection, we first estimated accuracy using all included studies and then only the subset of studies where participants were unselected, i.e. not selected based on prior microscopy testing. Main results We identified in total 95 studies (77 new studies since the previous review): 86 studies (42,091 participants) evaluated Xpert MTB/RIF for tuberculosis and 57 studies (8287 participants) for rifampicin resistance. One study compared Xpert MTB/RIF and Xpert Ultra on the same participant specimen. Tuberculosis detection Of the total 86 studies, 45 took place in high tuberculosis burden and 50 in high TB/HIV burden countries. Most studies had low risk of bias. Xpert MTB/RIF pooled sensitivity and specificity (95% credible Interval (CrI)) were 85% (82% to 88%) and 98% (97% to 98%), (70 studies, 37,237 unselected participants; high‐certainty evidence). We found similar accuracy when ...

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Horne

Kohli

Zifodya

et al. 2019

Cochrane Database of Systematic Reviews

182

157

View full text Add to dashboard Cite

show abstract

“…GeneXpert assay is more sensitive than direct smear but as accurate as culture with less turanaround time. [13][14][15][16][17][18][19] The focus of these studies were on pulmonary tuberculosis while there is limited data on the diagnostic utility of extrapulmonary tuberculosis. [20][21][22][23][24][25][26][27] Studies of diagnostic utility of geneXpert study in the pediatric population is limited, more so from Indian population.…”

Section: Discussionmentioning

confidence: 99%

GeneXpert: a game changer in the detection and diagnosis of childhood tuberculosis

Gandra¹,

Gali²

2017

Int J Contemp Pediatr

View full text Add to dashboard Cite

Background: Battling against tuberculosis (TB) is still a major challenge in India, despite measures undertaken by the government and medical fraternity. Delay in diagnosing tuberculosis is a challenge, causing hurdle in the prevention of spread of the disease.Methods: This retrospective study analysed the samples by geneXpert assay. Samples (n=403, from 359 children) included pulmonary (sputum and gastric aspirate, 359), extrapulmonary (lymph node aspirate (LNA), 41) cerebrospinal fluid (CSF, 03) pus from the lesion at the elbow joint (01). Only sputum was analysed for 315 children, both sputum and LNA for 41.Results: Mean age of patients was 9.08±2.85 years, range 3-15 years. There were 221 (61.56%) males and 138 (38.44%) females. Fever (71, 19.78%), fever with cough (87, 24.23%), fever with weight loss (41,11.42%) were the main symptoms. There were three patients with high fever, headache and seizures with neck rigidity, clinically diagnosed as Tuberculous meningitis. There was history of contact with Tuberculosis in 15 (4.18%) patients. Mean ESR was 112.09mm/1st Hr±56.05 (range 54 -750 mm/1st Hr). Mantoux test was positive in 270 (75.42%). Chest X-ray was normal in 33 (9.19%); consolidation in 189 (52.65%), mild pleural effusion in 94 (26.18%) mild pleural effusion associated with consolidation in 43 (11.98%) were reported. Positive GeneXpert assay (106 samples, 27.39%; sputum (87, 24.23% %), pus (01), CSF (03), LNA (15, 57.69%) was reported in 87 patients. Results were obtained ≤36 hours, mean 2 hours± 2.34 (range 6- 36 hours).Conclusions: GeneXpert is an effective tool for rapid detection of tuberculosis. Present study supports its inclusion in the battery of routine investigations. It can revolutionise the scenario in prevention and management of tuberculosis.

show abstract

Comparison of 3 diagnostic methods for pulmonary tuberculosis in suspected patients with negative sputum smear or no sputum

Cheng,

Chen,

Wan

et al. 2024

Medicine

View full text Add to dashboard Cite

Study design: To explore the diagnostic value of 3 methods for sputum smear-negative and non-sputum patients with suspected pulmonary tuberculosis (TB). Methods: This prospective study enrolled sputum smear-negative and non-sputum patients with suspected TB admitted to Jiangxi Chest Hospital between January 2020 and December 2022. The 3 methods were bronchoalveolar lavage fluid (BALF)-acid-fast bacillus (AFB) smear, GeneXpert MTB/RIF, and gene chip for Mycobacterium strain identification. The diagnostic performance of the 3 tests was evaluated with BALF Mycobacterium culture + BALF-AFB smear + GeneXpert MTB/RIF + Gene chip as the gold standard. Results: A total of 456 samples were collected from 114 patients with suspected TB. Twenty-four patients were diagnosed with TB. The combination of GeneXpert MTB/RIF and gene chip for Mycobacterium strain identification yielded the highest area under the receiver operating characteristics curve (AUC) of 0.953 and had sensitivity of 90.57%, specificity of 100%, positive predictive value (PPV) of 100%, negative predictive value (NPV) of 92.42%, accuracy of 95.61%. GeneXpert MTB/RIF achieved AUC of 0.906, sensitivity of 81.13%, specificity of 100%, PPV of 100%, NPV of 85.92%, accuracy of 91.23%. BALF-AFB smear had AUC of 0.519, sensitivity of 3.77%, specificity of 100%, PPV of 100%, NPV of 54.46%, and accuracy of 55.26%. The combination of GeneXpert MTB/RIF and gene chip for Mycobacterium strain identification yielded the highest κ of 0.911, while BALF-AFB smear had the lowest κ value of 0.040. Conclusion: For TB in sputum smear-negative and non-sputum patients using BALF Mycobacterium culture + BALF-AFB smear + GeneXpert MTB/RIF + Gene chip as the gold standard, BALF-AFB smear showed low diagnostic performance, while, though GeneXpert MTB/RIF and gene chip had good diagnostic performance, combining GeneXpert MTB/RIF and gene chip improved the diagnostic value to a great extent.

show abstract

Evaluation of GeneXpert MTB/RIF for detection of pulmonary tuberculosis at peripheral tuberculosis clinics

Cited by 10 publications

References 18 publications

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

GeneXpert: a game changer in the detection and diagnosis of childhood tuberculosis

Comparison of 3 diagnostic methods for pulmonary tuberculosis in suspected patients with negative sputum smear or no sputum

Contact Info

Product

Resources

About