Nucleic Acid Amplication Test

1. Early Detection of Female Genital Tuberculosis is the Key for Reducing Female Infertility & Mortality Nucleic Acid Amplifcation Test - TB DNA PCR For Diagnosis of Female Genital Tuberculosis

2. About Female Genital Tuberculosis Female Genital Tuberculosis can result in irreversible harm to the genital tract of women at progressive levels. Therefore, early detection and management at the subclinical level is essential to stop the enduring harm and sequelae of the genital area of the woman with a thriving result of pregnancy. FGTB is responsible for 27% cases of extra- pulmonary TB FGTB accounts for 5% of all female pelvic infections FREQUENCY OF FEMALE GENITAL ORGANS AFFECTED BY TB ( IN % ) 95-100 50-60 20-30 5-15 2.5 1 FALLOPIAN TUBES UTERINE ENDOMETRIUM UTERINE MYOMETRIUM VAGINA AND/OR VULVA OVARIES CERVIX Advantages of Nucleic Acid Amplification Tests (NAAT) Real-time Polymerase chain reaction (PCR): Limitations: Dierentiation between live and dead bacteria is not possible, and the results might be positive during anti-tuberculous therapy or after completion of therapy. Rapid detection with high sensitivity and specificity Even few DNA copies (less than 10 bacteria/ml of specimen) is suicient for detection of FGTB A study reported higher overall positivity with real-time PCR alone (23.78%) than culture (8.28%), and AFB smear examination (2.70%) Diagnostic Challenges with FGTB Varied clinical manifestations High misdiagnosis rate Several associated comorbidities Diiculty in obtaining clinical samples Paucibacillary nature Emergence of drug resistance Lack of point of care, Obscure positioning of the organs

3. Limitations of Conventional Diagnostic Approaches: Conventional Diagnostic Approach Limitations Requires large number of bacteria in the sample (>104 ml), limiting its utility since FGTB is paucibacillary Acid fast bacilli (AFB) smear Has low sensitivity and slow growth (3 to 6 weeks), thereby delaying diagnosis Requires multiple cultures to confirm positive result if only few mycobacteria are present at the site of infection AFB culture Histopathological detection of epithelioid granuloma on biopsy Not specific due to shedding of the endometrium Increased risk of bleeding due to many adhesions covering the pelvic organs, which may obstruct the diagnosis Subtle clinical manifestations might be unnoticeable in laparoscopy during early stages of infection Laparoscopy Complications, such as excessive bleeding, perforation, inability to distinguish and distend cavity, and flare-up of genital TB, which can cause abortions and infertility Hysteroscopy Choose Lupin Diagnostics for Female Genital Tuberculosis Testing At Lupin Diagnostics, female genital tuberculosis testing is performed using nucleic acid amplification tests – one of the most advanced methods to diagnose TB. All the equipment are latest, advanced and state-of-the-art, and have high precision.

4. Benefits of GeneXpert MTB/ RIF assay: Rapid identification of possible multidrug-resistant TB (MDR-TB). Detection of as low as 133 colony-forming units (CFU)/ ml of specimen. An Indian study reported higher positivity with Xpert MTB/RIF compared to culture in the detection of FGTB (4.6% vs. 8.05% cases). Xpert MTB/ RIF assay showed improvement rate in detection of FGTB by 55.55% compared to microscopy and culture. Also Available: Quantiferon TB Gold XPERT XDR PLUS XDR PLUS Reflex to GeneXpert Test Details Test Code Test Name Sample Type Lab Cut-O TAT LDMOL1183 TB DNA PCR, Qualitative Tissue, sputum, BAL, urine and other body fluids Mon-Wed-Fri, 1:30 PM Same Day, 8:00 PM References 1. Christine Tzelios, Werner M Neuhausser, David Ryley, Nhi Vo, Rocio M Hurtado, Ruvandhi R Nathavitharana, Female Genital Tuberculosis, Open Forum Infectious Diseases, Volume 9, Issue 11, November 2022, ofac543, hps://doi.org/10.1093/ofid/ofac543 2. Wang Y, Shao R, He C, Chen L. Emerging progress on diagnosis and treatment of female genital tuberculosis. Journal of International Medical Research. 2021;49(5). doi:10.1177/03000605211014999 3. Kesharwani H, Mohammad S, Pathak P (September 02, 2022) Tuberculosis in the Female Genital Tract. Cureus 14(9): e28708. 4. Dian Tjahyadi, Bejo Ropii, Kevin Dominique Tjandraprawira, Ida Parwati, Tono Djuwantono, Wiryawan Permadi, Tinchiu Li, "Female Genital Tuberculosis: Clinical Presentation, Current Diagnosis, and Treatment" , Infectious Diseases in Obstetrics and Gynecology, vol. 2022, Article ID 3548190, 6 pages, 2022. 5. Gupta S, Gupta P. Etiopathogenesis, Challenges and Remedies Associated With Female Genital Tuberculosis: Potential Role of Nuclear Receptors. Front Immunol. 2020; 11:02161. 6. Malhotra B, Sinha P, Hooja S, Vyas L. Rapid Diagnosis of Genital Tuberculosis by Real-time Polymerase Chain Reaction. J South Asian Feder Obst Gynae.2012;4(1):39-42. 7. Sharma, J.B., Sharma, E., Sharma, S. etal. Recent Advances in Diagnosis and Management of Female Genital Tuberculosis. J Obstet Gynecol India. 2021;71: 476–487. 8. Farhana, A., Zahoor, D., Manzoor, M., & Kanth, F. (2018). Evaluation of Xpert MTB/ RIF Assay for the Detection of Female Genital Tuberculosis in a Tertiary Care Center- A Descriptive Cross-sectional Study. Microbiology Research Journal International, 23(2), 1-6. For any queries, please contact: National Reference Laboratory (NRL) C 533 TTC Industrial Area MIDC Pawane, Navi Mumbai, Mumbai, Maharashtra, India - 400 705 www.lupindiagnostics.com Name: ............................................................ Contact Number:........................................ Contact us at: 7030 300 400