NGHIÊN CỨU CHẾ TẠO BỘ KIT REALTIME PCR ĐA MỒI PHÁT HIỆN MỘT SỐ TÁC NHÂN GÂY BỆNH LÂY TRUYỀN QUA ĐƯỜNG TÌNH DỤC THƯỜNG GẶP TẠI HÀ NỘI

Abstract

Objective: 1) To establish a procedure and fabricate a multiplex realtime PCR kit for the detection of common sexually transmitted bacterial and fungal pathogens at the laboratory scale. 2) Determine the infection rate of selected sexually transmitted pathogens in women undergoing gynecological examinations in Hanoi. Subjects: 9 standard samples from Vircell; 135 samples previously confirmed using the commercial PANA RealTyper™ STD kit (Panagene) and careGene^TM STD-12 (Wellsbio); 200 cervical swab specimens from women with vaginal inflammation visiting the Hanoi Obstetrics and Gynecology Hospital between August 2023 and May 2024. Methods: Laboratory experimental combined with cross-sectional description study.  Results: The limit of detection (LOD) of the multiplex realtime PCR kit ranged from 1 to 88,81 copies/µl with an accuracy of 100%. The detection capability of the multiplex Realtime PCR kit for 9 pathogens is comparable to the commercial PANA RealTyper™ STD kit (Panagene) and careGene^TM STD-12 (Wellsbio). Among these pathogens, U. parvum has the highest prevalence (41.5%), followed by C. albicans at 19.5%. The remaining pathogens account for lower proportions ranging from 12.0% to 1.5%. Conclusion: A multiplex realtime PCR kit was successfully developed and validated for the simultaneous detection of 9 sexually transmitted pathogens with sensitivity and specificity equivalent to the PANA RealTyper™ STD kit (Panagene) and careGene^TM STD-12 (Wellsbio) certified CE-IVD; detection limit ranges from 1-88.81 copies/µl.