Accuracy of GenoQuick MTB test in detection of Mycobacterium tuberculosis in sputum from TB presumptive patients in Uganda

Sylvia Kaswabuli; Emmanuel Musisi; Patrick Byanyima; Abdul Sessolo; Ingvar Sanyu; Josephine Zawedde; William Worodria; Laurence Huang; Alfred Okeng; Freddie Bwanga

doi:10.1177/20503121221116861

Accuracy of GenoQuick MTB test in detection of Mycobacterium tuberculosis in sputum from TB presumptive patients in Uganda

Sylvia Kaswabuli, Emmanuel Musisi, Patrick Byanyima, Abdul Sessolo, Ingvar Sanyu, Josephine Zawedde, William Worodria, Laurence Huang, Alfred Okeng, Freddie Bwanga^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Objective

The objective of the study was to determine the diagnostic performance of the GenoQuick MTB test on heated sputum against the conventional Lowenstein–Jensen Mycobacterium tuberculosis culture as the reference method for tuberculosis diagnosis.

Introduction

Fast, reliable, and easy-to-use tests for tuberculosis diagnosis are essential to achieving the Sustainable Development Goal of diagnosing and treating 90% of tuberculosis patients by 2030. We evaluated the diagnostic performance of the GenoQuick MTB, a polymerase chain reaction–lateral flow test, in Uganda, a resource-constrained, high tuberculosis- and HIV-burden setting.

Methods

Fresh sputum samples from presumptive tuberculosis patients at Mulago Hospital were tested for M. tuberculosis using smear microscopy, GenoQuick MTB test, and Lowenstein–Jensen culture. For the GenoQuick MTB test, mycobacterial DNA was extracted by heating sputum at 95°C for 30 min while DNA amplification and detection were done following the manufacturer’s protocol (Hain Lifescience, Nehren, Germany). Sensitivity, specificity, and kappa agreements were calculated against Lowenstein–Jensen M. tuberculosis culture as a reference test using STATA V12.

Results

Of the 86 tested samples, 30.2% had culture-confirmed pulmonary tuberculosis. Overall, sensitivity was higher for GenoQuick MTB (81%, 95% confidence interval: 60%−93%) than for smear microscopy (69%, 95% confidence interval: 48%−86%). Among people living with HIV, sensitivity was identical for GenoQuick MTB and smear tests (75%, 95% confidence interval: 42%−95%). Contrastingly, smear had a higher overall specificity (98%, 95% confidence interval: 91%−100%) than for GenoQuick MTB (92%, 95% confidence interval: 81%−97%). A similar trend of specificity was observed among the people living with HIV for smear microscopy (100%, 95% CI: 87%−100%) and for GenoQuick MTB (96%, 95% confidence interval: 81%−100%).

Conclusion

The GenoQuick MTB test could be a potential tuberculosis diagnostic test given its higher sensitivity. Evaluation of this test in larger studies is recommended.

Original language	English
Number of pages	8
Journal	SAGE Open Medicine
Volume	10
Early online date	16 Aug 2022
DOIs	https://doi.org/10.1177/20503121221116861
Publication status	Published - 1 Dec 2022

Keywords

Diagnosis
Mycobacterium tuberculosis
GenoQuick MTB
Nucleic acid amplification
Diagnostic accuracy
Resource-limited settings

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Final published version, 331 KBLicence: CC BY-NC

Cite this

@article{b8795763360049da869b000e457aaada,

title = "Accuracy of GenoQuick MTB test in detection of Mycobacterium tuberculosis in sputum from TB presumptive patients in Uganda",

abstract = "ObjectiveThe objective of the study was to determine the diagnostic performance of the GenoQuick MTB test on heated sputum against the conventional Lowenstein–Jensen Mycobacterium tuberculosis culture as the reference method for tuberculosis diagnosis.IntroductionFast, reliable, and easy-to-use tests for tuberculosis diagnosis are essential to achieving the Sustainable Development Goal of diagnosing and treating 90% of tuberculosis patients by 2030. We evaluated the diagnostic performance of the GenoQuick MTB, a polymerase chain reaction–lateral flow test, in Uganda, a resource-constrained, high tuberculosis- and HIV-burden setting.MethodsFresh sputum samples from presumptive tuberculosis patients at Mulago Hospital were tested for M. tuberculosis using smear microscopy, GenoQuick MTB test, and Lowenstein–Jensen culture. For the GenoQuick MTB test, mycobacterial DNA was extracted by heating sputum at 95°C for 30 min while DNA amplification and detection were done following the manufacturer{\textquoteright}s protocol (Hain Lifescience, Nehren, Germany). Sensitivity, specificity, and kappa agreements were calculated against Lowenstein–Jensen M. tuberculosis culture as a reference test using STATA V12.ResultsOf the 86 tested samples, 30.2% had culture-confirmed pulmonary tuberculosis. Overall, sensitivity was higher for GenoQuick MTB (81%, 95% confidence interval: 60%−93%) than for smear microscopy (69%, 95% confidence interval: 48%−86%). Among people living with HIV, sensitivity was identical for GenoQuick MTB and smear tests (75%, 95% confidence interval: 42%−95%). Contrastingly, smear had a higher overall specificity (98%, 95% confidence interval: 91%−100%) than for GenoQuick MTB (92%, 95% confidence interval: 81%−97%). A similar trend of specificity was observed among the people living with HIV for smear microscopy (100%, 95% CI: 87%−100%) and for GenoQuick MTB (96%, 95% confidence interval: 81%−100%).ConclusionThe GenoQuick MTB test could be a potential tuberculosis diagnostic test given its higher sensitivity. Evaluation of this test in larger studies is recommended.",

keywords = "Diagnosis, Mycobacterium tuberculosis, GenoQuick MTB, Nucleic acid amplification, Diagnostic accuracy, Resource-limited settings",

author = "Sylvia Kaswabuli and Emmanuel Musisi and Patrick Byanyima and Abdul Sessolo and Ingvar Sanyu and Josephine Zawedde and William Worodria and Laurence Huang and Alfred Okeng and Freddie Bwanga",

note = "Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: MIND study was funded by National Institutes of Health (NIH) (NIH K24 HL087713, R01 HL090335, and R01 HL128156). MBN Clinical Laboratories provided PCR reagents, other laboratory consumables, and workspace. Sylvia Kaswabuli received a partial scholarship from the Pulmonary Complications of AIDS Research Training Program (NIH D43TW009607).",

year = "2022",

month = dec,

day = "1",

doi = "10.1177/20503121221116861",

language = "English",

volume = "10",

journal = "SAGE Open Medicine",

issn = "2050-3121",

publisher = "SAGE Publications Ltd STM",

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TY - JOUR

T1 - Accuracy of GenoQuick MTB test in detection of Mycobacterium tuberculosis in sputum from TB presumptive patients in Uganda

AU - Kaswabuli, Sylvia

AU - Musisi, Emmanuel

AU - Byanyima, Patrick

AU - Sessolo, Abdul

AU - Sanyu, Ingvar

AU - Zawedde, Josephine

AU - Worodria, William

AU - Huang, Laurence

AU - Okeng, Alfred

AU - Bwanga, Freddie

N1 - Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: MIND study was funded by National Institutes of Health (NIH) (NIH K24 HL087713, R01 HL090335, and R01 HL128156). MBN Clinical Laboratories provided PCR reagents, other laboratory consumables, and workspace. Sylvia Kaswabuli received a partial scholarship from the Pulmonary Complications of AIDS Research Training Program (NIH D43TW009607).

PY - 2022/12/1

Y1 - 2022/12/1

N2 - ObjectiveThe objective of the study was to determine the diagnostic performance of the GenoQuick MTB test on heated sputum against the conventional Lowenstein–Jensen Mycobacterium tuberculosis culture as the reference method for tuberculosis diagnosis.IntroductionFast, reliable, and easy-to-use tests for tuberculosis diagnosis are essential to achieving the Sustainable Development Goal of diagnosing and treating 90% of tuberculosis patients by 2030. We evaluated the diagnostic performance of the GenoQuick MTB, a polymerase chain reaction–lateral flow test, in Uganda, a resource-constrained, high tuberculosis- and HIV-burden setting.MethodsFresh sputum samples from presumptive tuberculosis patients at Mulago Hospital were tested for M. tuberculosis using smear microscopy, GenoQuick MTB test, and Lowenstein–Jensen culture. For the GenoQuick MTB test, mycobacterial DNA was extracted by heating sputum at 95°C for 30 min while DNA amplification and detection were done following the manufacturer’s protocol (Hain Lifescience, Nehren, Germany). Sensitivity, specificity, and kappa agreements were calculated against Lowenstein–Jensen M. tuberculosis culture as a reference test using STATA V12.ResultsOf the 86 tested samples, 30.2% had culture-confirmed pulmonary tuberculosis. Overall, sensitivity was higher for GenoQuick MTB (81%, 95% confidence interval: 60%−93%) than for smear microscopy (69%, 95% confidence interval: 48%−86%). Among people living with HIV, sensitivity was identical for GenoQuick MTB and smear tests (75%, 95% confidence interval: 42%−95%). Contrastingly, smear had a higher overall specificity (98%, 95% confidence interval: 91%−100%) than for GenoQuick MTB (92%, 95% confidence interval: 81%−97%). A similar trend of specificity was observed among the people living with HIV for smear microscopy (100%, 95% CI: 87%−100%) and for GenoQuick MTB (96%, 95% confidence interval: 81%−100%).ConclusionThe GenoQuick MTB test could be a potential tuberculosis diagnostic test given its higher sensitivity. Evaluation of this test in larger studies is recommended.

AB - ObjectiveThe objective of the study was to determine the diagnostic performance of the GenoQuick MTB test on heated sputum against the conventional Lowenstein–Jensen Mycobacterium tuberculosis culture as the reference method for tuberculosis diagnosis.IntroductionFast, reliable, and easy-to-use tests for tuberculosis diagnosis are essential to achieving the Sustainable Development Goal of diagnosing and treating 90% of tuberculosis patients by 2030. We evaluated the diagnostic performance of the GenoQuick MTB, a polymerase chain reaction–lateral flow test, in Uganda, a resource-constrained, high tuberculosis- and HIV-burden setting.MethodsFresh sputum samples from presumptive tuberculosis patients at Mulago Hospital were tested for M. tuberculosis using smear microscopy, GenoQuick MTB test, and Lowenstein–Jensen culture. For the GenoQuick MTB test, mycobacterial DNA was extracted by heating sputum at 95°C for 30 min while DNA amplification and detection were done following the manufacturer’s protocol (Hain Lifescience, Nehren, Germany). Sensitivity, specificity, and kappa agreements were calculated against Lowenstein–Jensen M. tuberculosis culture as a reference test using STATA V12.ResultsOf the 86 tested samples, 30.2% had culture-confirmed pulmonary tuberculosis. Overall, sensitivity was higher for GenoQuick MTB (81%, 95% confidence interval: 60%−93%) than for smear microscopy (69%, 95% confidence interval: 48%−86%). Among people living with HIV, sensitivity was identical for GenoQuick MTB and smear tests (75%, 95% confidence interval: 42%−95%). Contrastingly, smear had a higher overall specificity (98%, 95% confidence interval: 91%−100%) than for GenoQuick MTB (92%, 95% confidence interval: 81%−97%). A similar trend of specificity was observed among the people living with HIV for smear microscopy (100%, 95% CI: 87%−100%) and for GenoQuick MTB (96%, 95% confidence interval: 81%−100%).ConclusionThe GenoQuick MTB test could be a potential tuberculosis diagnostic test given its higher sensitivity. Evaluation of this test in larger studies is recommended.

KW - Diagnosis

KW - Mycobacterium tuberculosis

KW - GenoQuick MTB

KW - Nucleic acid amplification

KW - Diagnostic accuracy

KW - Resource-limited settings

U2 - 10.1177/20503121221116861

DO - 10.1177/20503121221116861

M3 - Article

SN - 2050-3121

VL - 10

JO - SAGE Open Medicine

JF - SAGE Open Medicine

ER -

Accuracy of GenoQuick MTB test in detection of Mycobacterium tuberculosis in sputum from TB presumptive patients in Uganda

Abstract

Keywords

UN SDGs

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