Comparative analysis of methods for detection of FGTB cases-control groups (n = 302).

Abbreviations: Multi-gene PCR: Multi-gene/multi-primer Polymerase Chain Reaction; H & E staining: Hematoxylin and Eosin; L-J egg medium: Lowenstein-Jensen; AFB+Ve: Acid fast bacilli positive; Z-N staining: Ziehl-Neelsen's; PCR: Polymerase Chain Reaction; 19 kDa (131 bp): 19 kDa antigen gene; TRC4 (173 bp): TRC4 element; MPB64 (240 bp): MPB64 antigen gene; 32 kDa (506 bp): 32 kDa protein (MTP-59 α-antigen) gene. FGTB: female genital tuberculosis. The following terms were described based on demographic details, clinical symptoms, and hysteroscopic/laparoscopic findings of infertile women highly suspected with female genital tuberculosis (FGTB) and control women (without tuberculosis): True Positive: Infertile women with asymptomatic clinical presentations; radiologically may or may not be indicating tuberculosis (TB); positive diagnosis of TB on laparoscopic examinations; Indication of proliferative solid epitheliod granulomas, dense polymorphornuclear cells etc on histopathology; demonstration of acid fast bacilli in culture, Z-N staining of menstrual blood fluids, pelvic aspirated fluids and endo-ovarian tissue biopsies; detection of mycobacetrial DNA on multi gene PCR; and positive response to assisted reproductive technology (ART) after anti TB therapy among suspected FGTB cases. True Negatives: Fertile and healthy women; radiologically negative for TB; normal diagnosis (without TB) or absence of abnormal clinical findings on laparoscopic examinations; normal or negative finding on histopathology; absence of tubercle bacilli in culture and AFB negative on Z-N staining of menstrual blood or pelvic aspirated fluids or endo-ovarian tissue biopsies; absence of mycobacetrial DNA on multi gene PCR; Anti TB therapy is not required. False Positive: Detection of TB among control women (group without TB) by conventional and molecular methods; detection of TB among fertile and healthy women/negative findings of TB on laparoscopic examination. False Negative: Detection of negative TB by conventional and molecular methods among infertile asymptomatic women highly suspected of FGTB and among women diagnosed with positive TB on laparoscopic examinations.