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The AccuProbe Group B Streptococcus Culture Identification Test is a rapid DNA probe test which utilizes the technique of nucleic acid hybridization for the identification of Group B Streptococcus isolated from culture. The new indication for use covered in this 510(k) is for culture identification of Group B Streptococcus from vaginal and/or anorectal swab specimens collected from pregnant women at 35 to 37 weeks gestation, and cultured in Lim broth for 18 to 24 hours.

The ACCUPROBE Group B Streptococcus Culture Identification Test is a rapid DNA probe test which is based on the detection of ribosomal RNA sequences that are unique to Streptococcus agalactiae. Nucleic acid hybridization tests are based on the ability of complementary nucleic acid strands to specifically align and associate to form stable double-stranded complexes. The ACCUPROBE test uses a single-stranded DNA probe with a chemiluminescent label that is complementary to the ribosomal RNA of the target organism. After the ribosomal RNA is released from the organism, the labeled DNA probe combines with the target organism's ribosomal RNA to form a double-stranded DNA:RNA hybrid. The Selection reagent allows for the differentiation of non-hybridized and hybridized probe. The labeled DNA:RNA hybrids are measured in the Gen-Probe luminometer. A positive result is a luminometer reading equal to or greater than the cut-off. A value below this result is a negative result.