Evaluation of a rapid optical immunoassay-based test for group B streptococcus colonization in intrapartum patients

Objective : To compare an optical immunoassay (OIA) rapid diagnostic kit to standard culture for the diagnosis of vaginal colonization with group B streptococcus (GBS) and to assess the accuracy and reproducibility of the OIA results. Method : A total of 301 patients in labor were prospectively eval...

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Bibliographic Details
Published in:The Journal of maternal-fetal medicine 2001, Vol.10 (3), p.203-208
Main Authors: Samadi, R., Stek, A., Greenspoon, J. S.
Format: Article
Language:English
Subjects:
Accuracy
Cell Culture Techniques - methods
Colony Count, Microbial - methods
Female
Group B Streptococcus
Humans
Immunoassay - methods
Labor, Obstetric
Optical Immunoassay
Optics and Photonics
Predictive Value of Tests
Pregnancy
Pregnancy Complications
Pregnancy Outcome
Prospective Studies
Rapid Diagnostic Test
Rectum - microbiology
Reproducibility of Results
Sensitivity and Specificity
Streptococcal Infections - diagnosis
Streptococcus agalactiae - isolation & purification
Time Factors
Vagina - microbiology
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Summary:Objective : To compare an optical immunoassay (OIA) rapid diagnostic kit to standard culture for the diagnosis of vaginal colonization with group B streptococcus (GBS) and to assess the accuracy and reproducibility of the OIA results. Method : A total of 301 patients in labor were prospectively evaluated for GBS colonization with a test approved by the Food and Drug Administration (STREP B OIA kit, Biostar, Boulder, CO, USA) and by culture. The vagina was simultaneously sampled with two swabs. Rectal culture was obtained separately. Results : By the criterion of a positive culture, the vagina was colonized by GBS in 33 of 301 (11%) patients; and the rectum in 42 of 301 (13.9%). The vagina or rectum or both were colonized by GBS in 54 of 301 (17.9%) of patients. The OIA had sensitivity, specificity, positive predictive value and negative predictive value of 63.6%, 86.3%, 37.5% and 94.8%, respectively. The OIA had a kappa statistic score of 0.59. Conclusion : The OIA is not an adequately sensitive rapid kit for reliable detection of GBS colonization of the vagina. The results of the OIA were only moderately accurate and reproducible.
ISSN:1476-7058
1057-0802
1476-4954
DOI:10.1080/jmf.10.3.203.208