Qualitative DNA Test for Streptococcus Group B (GBS) - Vietnam Registration 2300066ĐKLH/BYT-TB-CT

BD MAX™ GBS Testing is performed on the BD MAX System and is a qualitative test designed for in vitro diagnostic use to detect the DNA of Group B Streptococcus (GBS) in vaginal-cloacal swab samples collected from pregnant women prior to delivery and cultured in Lim Broth media ≥18 hours. The BD MAX GBS test combines automated DNA extraction to isolate the target nucleic acid from the clinical sample and real-time polymerase chain reaction (PCR) to detect the 124 bp region of the cfb gene on the chromosome of Group B Streptococcus agalactiae. The results from the BD MAX GBS test can be used to support the determination of colonization status in pregnant women. The BD MAX GBS test does not provide information on antibiotic resistance. Culturing and isolation are required to perform the antibiotic resistance testing as recommended for women who are allergic to penicillin. Solid media sub-culturing is required to perform additional tests when indicated.