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

Samadi, Ramin; Stek, A.; Greenspoon, Jeffrey S.

doi:10.1080/jmf.10.3.203.208

Cited by 13 publications

(9 citation statements)

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“…The specificity was uniformly high, 85 to 98%, similar to the 98.4% in our study. Conversely, previously reported test sensitivities varied widely but were generally higher (37 to 81%) (2,5,7,(12)(13)(14)(17)(18)(19) than the value we found (26.8%). The most important reason for this variability may be the extent to which the subjects were colonized.…”

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confidence: 97%

Infections in International Pregnancy Study: Performance of the Optical Immunoassay Test for Detection of Group B Streptococcus

et al. 2003

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We evaluated the Strep B optical immunoassay (OIA; ThermoBiostar, Inc.) for detecting light and heavy group B streptococcus colonization in 1,306 pregnant women. The women were examined at 20 to 32 weeks gestation and were from six countries. Compared to culture, the sensitivity and specificity of OIA were 13.3 and 98.4%, respectively, for light colonization and 41.5 and 97.7%, respectively, for heavy colonization.Heavy colonization with group B streptococcus (GBS) may place women at high risk of delivering preterm, low-birthweight infants (10,11,15). Earlier recognition of such high-risk women would be useful for intervention strategies. Detection of heavy colonization has traditionally relied on culture methods, which may not be feasible in some health care settings and require 1 to 3 days before results are available. Unfortunately, most rapid GBS tests have poor sensitivity (7, 13). The Strep B optical immunoassay (OIA; ThermoBiostar, Inc., Louisville, Colo.) is a rapid method which may have higher sensitivity for dense GBS colonization (14). We evaluated the performance of this test in an international, multicenter study.We conducted the study at institutions participating in the Global Network for Perinatal and Reproductive Health (http: //www.tju.edu/obgyn/rih/global.cfm). Centers were located in Khon Kaen and Bangkok, Thailand; Manila, The Philippines; Harare, Zimbabwe; Yangon, Myanmar; Dublin, Ireland; and Philadelphia, Pennsylvania. Participants were enrolled in the study between June 1999 and May 2001. Women attending prenatal care clinics and at 20 to 32 weeks gestation were eligible. Exclusion criteria included vaginitis symptoms, fever, vaginal bleeding, multiple pregnancy, use of antibiotics in the past 2 weeks, and active labor. Informed consent was obtained. The study was approved by institutional review boards at all study centers and supporting institutions.At enrollment, study personnel conducted an interview and collected specimens. A sample for GBS rapid testing was collected from the cervix and lower vagina using a ThermoBiostar swab. OIAs were read by study site laboratory personnel and by the manufacturer's laboratory personnel. OIA kits and swabs were supplied by ThermoBiostar.Methods for GBS culture and quantitation replicated those used in the Vaginal Infections and Prematurity Study (16). After collection of the OIA specimen, a Dacron swab (Copan swab) was used to collect a specimen from the cervix and lower vagina. Samples were streaked onto blood agar plates using the four-quadrant method and then placed into Lim broth (ToddHewitt broth containing selective antimicrobial agents). A clean catch urine specimen was collected for GBS culture on blood agar. Suspect colonies showing ␤-hemolysis were identified as GBS using latex agglutination. Heavy colonization was defined as isolation of GBS from either urine or direct plating on blood agar. Light colonization was defined as isolation of GBS from Lim broth alone. Dense GBS colonization was defined as growth in the third or fourth quadr...

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confidence: 97%

Infections in International Pregnancy Study: Performance of the Optical Immunoassay Test for Detection of Group B Streptococcus

et al. 2003

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“…Many patients are offered rapid antigen detection tests that are available from a number of different suppliers. Numerous independent studies show a lack of sensitivity for these tests (Samadi et al, 2001;Thinkhamrop et al, 2003) and they are not licensed and optimized for detecting S. agalactiae antigens in rectal swabs. If these tests are compared to the use of standard blood agar plates for detection of S. agalactiae the sensitivity values increase because standard blood agar plates will miss almost 40% of all cases that are positive in selective broth medium (Ferrieri and Blair, 1977).…”

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confidence: 99%

Epidemiology of Streptococcus agalactiae colonization in Germany

Brimil

Barthell

Heindrichs

et al. 2006

International Journal of Medical Microbiology

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“…When compared with the standard method, it has sensitivity between 47% and 63% with specificity between 86% and 96% (44)(45)(46). Although the rapidity of results is useful, the sensitivity and specificity of this test limit applicability.…”

Section: Gbs Sampling and Detection Methodsmentioning

confidence: 95%