The CDIATM Group B Strep Colloidal Gold Test Strip (Female Vaginal Swab) is a rapid visual immunoassay for the qualitative presumptive detection of group B streptococcal antigen in female vaginal swab. This kit is intended to be used as an aid in the diagnosis of Group B Streptococcal infection.
The CDIATM Group B Strep Colloidal Gold Test Strip (Female Vaginal Swab) is a rapid qualitative one step assay for the detection of Streptococcus Group B antigen. The method employs a unique combination of monoclonal-dye conjugate and polyclonal solid phase antibodies to selectively identify streptococcus B with a high degree of sensitivity. As the test samples flows through the absorbent device, the labeled antibody-dye conjugate binds to the Strep-B antigen forming an antibody-antigen complex. This complex binds to the anti-Strep B antibody in the test zone producing a pink-rose color band. In the absence of Strep-B there is no line in the test zone. The reaction mixture continues flowing through the absorbent device. Unbound conjugate binds to the reagents in the control zone producing a pink-rose color band, demonstrating that the reagents are functioning correctly.
Group B streptococci are most notable for their role in causing neonatal sepsis and meningitis. Two forms of neonatal infection have been recognized on clinical and epidemiological grounds: (a) Early onset disease, which usually occurs within the first 10 days after delivery. (b) Late onset disease, which usually, though not always, occurs 10 days after birth. Late onset disease may be due to nosocomial acquisition of the organism and is rarely associated with material or obstetric complications. Early onset disease is thought to be due to acquisition, perhaps by aspiration, of the organism from the mother’s genital tract at the time of delivery. The incidence of Group B Streptococci range from 1 to 5% of live births with mortality rates from 22 to 80%. In order to properly treat the disease using antibiotic therapy, it is important to use an accurate diagnostic method to identify the pathologic agent. The CDIATM Group B Strep Colloidal Gold Test Strip (Female Vaginal Swab) is a rapid visual immunoassay for the qualitative presumptive detection of group B streptococcal antigen in female vaginal swab.