A rapid and low-cost microscopic observation drug susceptibility assay for detecting TB and MDR-TB among individuals infected by HIV in South India

S. Solomon, P. Balakrishnan, R. Vignesh, G. Waldrop, Sunil Solomon, K. Murugavel, N. Kumarasamy, T. Yepthomi, S. Poongulali, C. Swathirajan, V. Sreenivasan, C. Chandrasekar, J. Suriakumar, A. Mahilmaran, G. Manoharan, Daj Moore

Research output: Contribution to journalArticle

Abstract

Background: The converging epidemics of HIV and tuberculosis (TB) pose one of the greatest public health challenges of our time. Rapid diagnosis of TB is essential in view of its infectious nature, high burden of cases, and emergence of drug resistance. Objective: The purpose of this present study was to evaluate the feasibility of implementing the microscopic observation drug susceptibility (MODS) assay, a novel assay for the diagnosis of TB and multi-drug-resistant tuberculosis (MDR-TB) directly from sputum specimens, in the Indian setting. Materials and Methods: This study involved a cross-sectional, blinded assessment of the MODS assay on 1036 suspected cases of pulmonary TB in HIV-positive and HIV-negative patients against the radiometric method, BD-BACTEC TB 460 system. Results: Overall, the sensitivity, specificity, positive predictive value, and negative predictive value of the MODS assay in detecting MTB among TB suspected patients were 89.1%, 99.1%, 94.2%, 95.8%, respectively. In addition, in the diagnosis of drug-resistant TB, the MODS assay was 84.2% sensitive for those specimens reporting MDR, 87% sensitivity for those specimens reporting INH mono-resistance, and 100% sensitive for specimens reporting RIF mono-resistance. The median time to detection of TB in the MODS assay versus BACTEC was 9 versus 21 days (P <0.001). Conclusion: Costing 5 to 10 times lesser than the automated culture methods, the MODS assay has the potential clinical utility as a simple and rapid method. It could be effectively used as an alternative method for diagnosing TB and detection of MDR-TB in a timely and affordable way in resource-limited settings.

Original languageEnglish (US)
Pages (from-to)130-137
Number of pages8
JournalIndian Journal of Medical Microbiology
Volume31
Issue number2
DOIs
StatePublished - Apr 2013
Externally publishedYes

Fingerprint

Multidrug-Resistant Tuberculosis
India
Tuberculosis
HIV
Costs and Cost Analysis
Pharmaceutical Preparations
Sputum
Pulmonary Tuberculosis
Drug Resistance
Public Health
Sensitivity and Specificity

Keywords

  • HIV/TB
  • Low-cost
  • MDR-TB
  • Microscopic Observation Drug Susceptibility assay
  • TB diagnosis
  • Tuberculosis

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

A rapid and low-cost microscopic observation drug susceptibility assay for detecting TB and MDR-TB among individuals infected by HIV in South India. / Solomon, S.; Balakrishnan, P.; Vignesh, R.; Waldrop, G.; Solomon, Sunil; Murugavel, K.; Kumarasamy, N.; Yepthomi, T.; Poongulali, S.; Swathirajan, C.; Sreenivasan, V.; Chandrasekar, C.; Suriakumar, J.; Mahilmaran, A.; Manoharan, G.; Moore, Daj.

In: Indian Journal of Medical Microbiology, Vol. 31, No. 2, 04.2013, p. 130-137.

Research output: Contribution to journalArticle

Solomon, S, Balakrishnan, P, Vignesh, R, Waldrop, G, Solomon, S, Murugavel, K, Kumarasamy, N, Yepthomi, T, Poongulali, S, Swathirajan, C, Sreenivasan, V, Chandrasekar, C, Suriakumar, J, Mahilmaran, A, Manoharan, G & Moore, D 2013, 'A rapid and low-cost microscopic observation drug susceptibility assay for detecting TB and MDR-TB among individuals infected by HIV in South India', Indian Journal of Medical Microbiology, vol. 31, no. 2, pp. 130-137. https://doi.org/10.4103/0255-0857.115225
Solomon, S. ; Balakrishnan, P. ; Vignesh, R. ; Waldrop, G. ; Solomon, Sunil ; Murugavel, K. ; Kumarasamy, N. ; Yepthomi, T. ; Poongulali, S. ; Swathirajan, C. ; Sreenivasan, V. ; Chandrasekar, C. ; Suriakumar, J. ; Mahilmaran, A. ; Manoharan, G. ; Moore, Daj. / A rapid and low-cost microscopic observation drug susceptibility assay for detecting TB and MDR-TB among individuals infected by HIV in South India. In: Indian Journal of Medical Microbiology. 2013 ; Vol. 31, No. 2. pp. 130-137.
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abstract = "Background: The converging epidemics of HIV and tuberculosis (TB) pose one of the greatest public health challenges of our time. Rapid diagnosis of TB is essential in view of its infectious nature, high burden of cases, and emergence of drug resistance. Objective: The purpose of this present study was to evaluate the feasibility of implementing the microscopic observation drug susceptibility (MODS) assay, a novel assay for the diagnosis of TB and multi-drug-resistant tuberculosis (MDR-TB) directly from sputum specimens, in the Indian setting. Materials and Methods: This study involved a cross-sectional, blinded assessment of the MODS assay on 1036 suspected cases of pulmonary TB in HIV-positive and HIV-negative patients against the radiometric method, BD-BACTEC TB 460 system. Results: Overall, the sensitivity, specificity, positive predictive value, and negative predictive value of the MODS assay in detecting MTB among TB suspected patients were 89.1{\%}, 99.1{\%}, 94.2{\%}, 95.8{\%}, respectively. In addition, in the diagnosis of drug-resistant TB, the MODS assay was 84.2{\%} sensitive for those specimens reporting MDR, 87{\%} sensitivity for those specimens reporting INH mono-resistance, and 100{\%} sensitive for specimens reporting RIF mono-resistance. The median time to detection of TB in the MODS assay versus BACTEC was 9 versus 21 days (P <0.001). Conclusion: Costing 5 to 10 times lesser than the automated culture methods, the MODS assay has the potential clinical utility as a simple and rapid method. It could be effectively used as an alternative method for diagnosing TB and detection of MDR-TB in a timely and affordable way in resource-limited settings.",
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T1 - A rapid and low-cost microscopic observation drug susceptibility assay for detecting TB and MDR-TB among individuals infected by HIV in South India

AU - Solomon, S.

AU - Balakrishnan, P.

AU - Vignesh, R.

AU - Waldrop, G.

AU - Solomon, Sunil

AU - Murugavel, K.

AU - Kumarasamy, N.

AU - Yepthomi, T.

AU - Poongulali, S.

AU - Swathirajan, C.

AU - Sreenivasan, V.

AU - Chandrasekar, C.

AU - Suriakumar, J.

AU - Mahilmaran, A.

AU - Manoharan, G.

AU - Moore, Daj

PY - 2013/4

Y1 - 2013/4

N2 - Background: The converging epidemics of HIV and tuberculosis (TB) pose one of the greatest public health challenges of our time. Rapid diagnosis of TB is essential in view of its infectious nature, high burden of cases, and emergence of drug resistance. Objective: The purpose of this present study was to evaluate the feasibility of implementing the microscopic observation drug susceptibility (MODS) assay, a novel assay for the diagnosis of TB and multi-drug-resistant tuberculosis (MDR-TB) directly from sputum specimens, in the Indian setting. Materials and Methods: This study involved a cross-sectional, blinded assessment of the MODS assay on 1036 suspected cases of pulmonary TB in HIV-positive and HIV-negative patients against the radiometric method, BD-BACTEC TB 460 system. Results: Overall, the sensitivity, specificity, positive predictive value, and negative predictive value of the MODS assay in detecting MTB among TB suspected patients were 89.1%, 99.1%, 94.2%, 95.8%, respectively. In addition, in the diagnosis of drug-resistant TB, the MODS assay was 84.2% sensitive for those specimens reporting MDR, 87% sensitivity for those specimens reporting INH mono-resistance, and 100% sensitive for specimens reporting RIF mono-resistance. The median time to detection of TB in the MODS assay versus BACTEC was 9 versus 21 days (P <0.001). Conclusion: Costing 5 to 10 times lesser than the automated culture methods, the MODS assay has the potential clinical utility as a simple and rapid method. It could be effectively used as an alternative method for diagnosing TB and detection of MDR-TB in a timely and affordable way in resource-limited settings.

AB - Background: The converging epidemics of HIV and tuberculosis (TB) pose one of the greatest public health challenges of our time. Rapid diagnosis of TB is essential in view of its infectious nature, high burden of cases, and emergence of drug resistance. Objective: The purpose of this present study was to evaluate the feasibility of implementing the microscopic observation drug susceptibility (MODS) assay, a novel assay for the diagnosis of TB and multi-drug-resistant tuberculosis (MDR-TB) directly from sputum specimens, in the Indian setting. Materials and Methods: This study involved a cross-sectional, blinded assessment of the MODS assay on 1036 suspected cases of pulmonary TB in HIV-positive and HIV-negative patients against the radiometric method, BD-BACTEC TB 460 system. Results: Overall, the sensitivity, specificity, positive predictive value, and negative predictive value of the MODS assay in detecting MTB among TB suspected patients were 89.1%, 99.1%, 94.2%, 95.8%, respectively. In addition, in the diagnosis of drug-resistant TB, the MODS assay was 84.2% sensitive for those specimens reporting MDR, 87% sensitivity for those specimens reporting INH mono-resistance, and 100% sensitive for specimens reporting RIF mono-resistance. The median time to detection of TB in the MODS assay versus BACTEC was 9 versus 21 days (P <0.001). Conclusion: Costing 5 to 10 times lesser than the automated culture methods, the MODS assay has the potential clinical utility as a simple and rapid method. It could be effectively used as an alternative method for diagnosing TB and detection of MDR-TB in a timely and affordable way in resource-limited settings.

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