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Evaluation and subsequent optimizations of the quantitative AmpliSens Florocenosis/Bacterial vaginosis‐ FRT multiplex real‐time PCR assay for diagnosis of bacterial vaginosis
Author(s) -
Rumyantseva Tatiana,
Shipitsyna Elena,
Guschin Alexander,
Unemo Magnus
Publication year - 2016
Publication title -
apmis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 88
eISSN - 1600-0463
pISSN - 0903-4641
DOI - 10.1111/apm.12608
Subject(s) - bacterial vaginosis , pyrosequencing , gardnerella vaginalis , multiplex , microbiology and biotechnology , biology , vaginitis , gene , bioinformatics , genetics
Traditional microscopy‐based methods for diagnosis of bacterial vaginosis ( BV ) are underutilized in many settings, and molecular techniques may provide opportunities for rapid, objective, and accurate BV diagnosis. This study evaluated the quantitative AmpliSens Florocenosis/Bacterial vaginosis‐ FRT multiplex real‐time PCR (Florocenosis– BV ) assay. Vaginal samples from a previous study including unselected female subjects (n = 163) and using Amsel criteria and 454 pyrosequencing for BV diagnosis were examined with the Florocenosis– BV test and additionally tested for the presence and quantity of Gardnerella vaginalis clades 3 and 4. The Florocenosis– BV assay demonstrated 100% and 98% sensitivity compared with the Amsel criteria and 454 pyrosequencing, respectively, with 91% specificity. The modified Florocenosis– BV assay (detecting also G. vaginalis clades 3 and 4) resulted in 100% sensitivity vs the Amsel criteria and 454 pyrosequencing with specificity of 86% and 88%, respectively. Further optimizations of thresholds for the quantitative parameters used in the kit resulted in 99–100% accuracy vs Amsel criteria and 454 pyrosequencing for selected parameters. The Florocenosis– BV assay is an objective, accurate, sensitive, and specific method for BV diagnosis; however, the performance of the test can be further improved with some minor optimizations.