Development and analytical validation of real-time PCR for the detection of Streptococcus agalactiae in pregnant women.

ABSTRACT:

Background

Group B Streptococcus (GBS) is the leading cause of invasive neonatal infection. In this study, we aimed to evaluate the analytical validation of qualitative real-time polymerase chain reaction (qPCR) as a means to detect GBS.

Methods

Genomic DNA (gDNA) was purified from 12 ATCC bacterial strains, two belonging to GBS and the remainder acting as negative controls. Additionally, gDNA was isolated from 21 strains of GBS from various serotypes (Ia, Ib and II-VIII). All gDNA was used to evaluate the analytical validation of the qPCR method employing a specific Taqman probe. Inclusivity, exclusivity, anticipated reportable range, the limit of detection and robustness were evaluated. The methods used are described in international guidelines and other existing reports.

SUBMITTER: Escobar DF 

PROVIDER: S-EPMC7285471 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature