Evaluation of the 'HG Group B ' loop-mediated isothermal amplification assay for accurate identification of .

This study evaluated the HiberGene Group B Streptococcus test, a CE-IVD-approved molecular assay for rapid detection of [Group B Streptococcus (GBS)] in human clinical specimens. Performance of the assay in terms of specificity, sensitivity and genotype inclusivity was investigated using an extended specificity panel of 113 human and animal GBS isolates, and eight isolates from other streptococcal species, from the isolate collection of the German National Reference Center for Streptococci. Broth cultures were tested according to the manufacturer's protocol, including lysis, heat denaturation and isothermal amplification.