LBP-1.04 International validation of AmpliSens NAAT systems manufactured in Russia for diagnosis of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium and Trichomonas vaginalis

Objectives Data regarding the performance characteristics of STI diagnostic tests used in Eastern Europe are very scarce. The objective of this study was to validate the AmpliSens test systems (Central Research Institute for Epidemiology, Moscow, Russia), compared to internationally acknowledged and validated tests, for genetic detection of N gonorrhoeae (NG) , C trachomatis (CT) , M genitalium (MG) and T vaginalis (TV) . Methods In total, 319 females and 127 males were recruited. For evaluation of the TV tests, additional 33 patients with diagnosed trichomoniasis at dermatovenereological dispensaries (VD) were involved. Conventional AmpliSens PCR assay (cPCR), real-time PCR assay (rtPCR), and a real-time nucleic acid sequence-based amplification assay for detection of NG or CT were evaluated. Furthermore, AmpliSens cPCR and rtPCR for detection of MG or TV were tested. As international reference tests an internationally validated real-time N gonorrhoeae porA pseudogene PCR, Cobas Amplicor CT PCR and LightMix 480HT CT PCR, MG rtPCR targeting the MgPa adhesin gene with positive results confirmed by two MG cPCRs targeting the 16S rRNA gene and MgPa gene, and a TV rtPCR targeting a TV specific repeat DNA fragment, respectively, were used. Results The overall prevalence of CT infection was 12.6%. The AmpliSens CT NAATs and the reference methods displayed a high level of concordance (97.9%–99.2%). The prevalence of NG was 2.7% and 16% among the urogenital and extragenital samples, respectively. The AmpliSens NG NAATs and the reference method displayed high level of concordance (99.4–100%). The prevalence of MG was 2.5% among females and 9.6% among males. The highest sensitivity (71.4%–100% in different specimens) was exhibited by the AmpliSens rtPCR. All tests had a 100% clinical specificity. The prevalence of TV was 1.2% among the females, and all additional VD patients tested positive. The sensitivity and the specificity of both Russian TV tests validated was 100%. Conclusion It seems clear that the biomedical industry in Eastern Europe has the potential for producing reliable reagents and tests kits at affordable prices for genetic diagnosis of STIs. This would open new perspectives for the whole region and could also be cost-effective for some other regions experiencing financial constraints. However, more comprehensive evaluations of regionally manufactured tests should be conducted according to internationally accepted guidelines.