Molecular diagnosis of Tuberculous meningitis: sdaA-based multi-targeted LAMP and GeneXpert Ultra - 29/05/23

Doi : 10.1016/j.tube.2023.102339

Bhavana Yadav ^a,^{^{1
All three contributed equally as first author.}}, Megha Sharma ^b,^{^{1
All three contributed equally as first author.}}, Neeraj Singla ^c,^{^{1
All three contributed equally as first author.}}, Ritu Shree ^c, Manoj Goyal ^c, Tanish Modi ^d, Ananya Sharma ^d, Aman Sharma ^e, Navneet Sharma ^f, Pallab Ray ^a, Manish Modi ^c, Kusum Sharma ^a,^⁎
^a Department of Microbiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
^b Department of Microbiology, All India Institute of Medical Sciences, Bilaspur, HP, India
^c Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
^d Government Medical College and Hospital, Sector 32, Chandigarh, India
^e Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
^f Department of Emergency Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India

^∗Corresponding author. Department of Medical Microbiology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.Department of Medical MicrobiologyPost Graduate Institute of Medical Education and ResearchChandigarhIndia

Abstract

Setting

Nucleic acid amplification techniques like GeneXpert and GeneXpert Ultra (Xpert Ultra), the first-line tests for diagnosing Tuberculous meningitis (TBM), are expensive and depend on sophisticated equipment.

Objective

The diagnostic potential of multitargeted loop-mediated isothermal assay (MLAMP), a low-cost simple test using novel gene combination, was evaluated for TBM.

Design

300 CSF specimen (200 TBM patients, 100 controls) processed between January 2017 and December 2021 were subjected to MLAMP (using sdaA, IS1081 and IS6110 gene targets), sdaA PCR and Xpert Ultra. The performance was evaluated against uniform case definition as per Marais criteria, and against culture.

Results

Uniform case definition classified 50 as definite TBM and 150 as probable or definite TBM. Against this uniform case definition, the sensitivity and specificity of MLAMP was 88% and 100%, respectively. The sensitivity was 96% against culture-positive cases and 85.3% against culture-negative cases. The sensitivity of sdaA-LAMP, IS1081-LAMP, IS6110-LAMP, Xpert Ultra and sdaA-PCR was 82.5%, 80.5%, 85.3%, 67% and 71%, respectively against uniform case definition. sdaA-LAMP detected additional two cases and IS1081-LAMP detected nine. 11 of 134 (8.2%) cases were reported rifampicin resistant by Xpert Ultra.

Conclusion

MLAMP, incorporating sdaA and IS1081, is a cheap, easy and accurate first-line diagnostic test for TBM.

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Keywords : sdaA, GeneXpert ultra, Rifampicin resistance, LAMP

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Vol 140

Article 102339- mai 2023 Retour au numéro

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Molecular diagnosis of Tuberculous meningitis: sdaA-based multi-targeted LAMP and GeneXpert Ultra - 29/05/23

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