Loop‑mediated isothermal amplification assay for detection of Mycobacterium tuberculosis complex in infertile women.

ABSTRACT

Background: Female genital tuberculosis (FGTB) has a profound impact on the reproductive health of patients including infertility. Conventional diagnostic techniques have low sensitivity and specificity as well as long turnaround time. There is a need of developing newer, rapid and practically adaptable technique, especially in low‑income countries. Objective: To standardize and evaluate loop‑mediated isothermal amplification (LAMP) technique for diagnosis of FGTB. Methods: A total of 300 endometrial biopsy samples from infertile females were subjected to Ziehl–Neelsen (ZN) staining, Lowenstein–Jensen culture, automated culture (BACTEC mycobacterial growth indicator tube), histopathological examination (HPE), nucleic acid amplification by polymerase chain reaction (PCR) and LAMP technique. Composite gold standard (either smear/culture/HPE/PCR positive) was considered for calculation of outcome parameters. Results: The observed sensitivities of ZN smear, culture, HPE, PCR and LAMP were 2.94%, 10.29%, 8.82%, 95.59% and 66.18%, respectively. Overall concordance between PCR and LAMP was 63%, which shows a good agreement. Conclusion: This study is the first to evaluate LAMP in the diagnosis of FGTB and found it to be a rapid and convenient technique, especially in low resource endemic settings.