Assessment of the Xpert assay among new pulmonary tuberculosis suspects with and without diabetes mellitus

Citation: Deshmukh S, Atre S, Ramchandra, Chavan A, Raskar S, Mave V, Gupte N, Gaikwad S, Sahasrabudhe Tushar, Barthwal M, Kakrani A, Kagal A, Gupta A, Bharadwaj R, Pradhan N, Dharmshale S, Golub J. Assessment of the Xpert assay among new pulmonary tuberculosis suspects with and without diabetes mellitus. Int J Tuberc Lung Dis. 1 Jan 2020: 24(1); 11-117(5). doi: https://doi.org/10.5588/ijtld.19.0239

Access full article:

https://www.ingentaconnect.com/content/iuatld/ijtld/2020/00000024/00000001/art00017;jsessionid=6pppm0b097kpg.x-ic-live-03

SETTING:
Pune and Pimpri-Chinchwad Municipal Corporation area, Maharashtra State, India.

OBJECTIVE:
To assess the sensitivity and specificity of the Xpert® MTB/RIF assay among adults with suspected pulmonary tuberculosis (PTB) and with or without diabetes (DM).

DESIGN:
As part of a prospective cohort study, we screened 2359 adults presumed to have PTB with no history of TB. All individuals underwent testing for two sputum smears, culture, Xpert, glycated haemoglobin and fasting blood sugar. We calculated sensitivity and specificity of Xpert by comparing it with TB sputum culture result as a gold standard.

RESULTS:
Among screened individuals, 483 (20%) were diagnosed with DM and 1153 (49%) with pre-DM; 723 (31%) had no DM. Overall sensitivity of Xpert was 96% (95%CI 95–97) and specificity was 91% (95%CI 89–93). Xpert sensitivity was significantly higher among DM group (98%) than in the ‘No DM' (95%; P < 0.01) and pre-DM (96%; P < 0.05) groups. Among sputum smear-negative individuals, Xpert sensitivity was higher in the DM group than in the No DM (92% vs. 82%; P = 0.054) and pre-DM group (92% vs. 82%; P = 0.037).

CONCLUSION:
High sensitivity and specificity of Xpert underscores the need for its rapid scale up for the early detection of TB in settings with a high dual burden of TB and DM.

Categories

CRS
Topics

Clinical Trials

P1108: A Phase I/II, Open-Label, Single Arm Study to...

This purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of bedaquiline (BDQ) in...

Read More

P1070, Dose-Finding and Pharmacogenetic Study of Efavirenz...

Efavirenz (EFV) is an anti-HIV medicine that is commonly used to treat HIV infection in adults and children older than 3 years...

Read More

IMPAACT 2034 - Phase I Study of the Pharmacokinetics,...

This is a Phase I, multi-site, open-label, non-comparative study of the PK, safety, tolerability, and acceptability of a...

Read More

A5225: Phase I/II Dose-Finding Study of High-Dose...

A5225/HiFLAC is a Phase I/II dose escalation and validation study of the safety, tolerability, and therapeutic effect of an...

Read More

A5332: Randomized Trial to Prevent Vascular Events in HIV...

REPRIEVE (A5332) is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months....

Read More