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Test Name:
Streptococcus, Group B, by PCR, Gynecological
- SBMF No:
21241 - Performance Lab Name:
Microbiology - Test Mnemonic:
GBS PCR - ABN:
Not required - CPT Code:
87653 - LOINC Code:
48683-7 - Also Known As:
GBS
Group B Strep by PCR
Gyn Strep - Also See:
21242 Streptococcus, Group B, by PCR, Gynecological, with MIC if Positive - Spec Type:
Vaginal introitus AND anorectal area (both sites must be sampled) - Spec Container:
Sterile swabs from "Culture Collection/Transport System" - Pref Vol:
Two (2) swabs - Min Vol:
One (1) swab - Fasting:
No - Patient Prep:
Collect swab samples prior to application of any preparatory agents - Spec Collect:
Vaginal Introitus - plus - anorectal area – use both sites:
– Do not use lubricant or speculum
– Swab lower vagina (vaginal introitus) with swab(s)
– Move swab(s) from side to side allowing several seconds for absorption of organisms
– Using same swab(s), insert through anal sphincter into rectum (anorectal area)
– Again move swab(s) from side to side allowing several seconds for absorption of organisms
Insert swab(s) into transport tube and ensure contact with media
Follow manufacturers directions for release of media within transport tube - Spec Store Transport:
Room temperature (24 hours) or refrigerated - Spec Stability:
24 hours room temperature (20-30°C)
Up to 6 days refrigerated (2-8°C) - Spec Reject:
Dry swab
Sources other than vaginal introitus/anorectal will be rejected - Methodology:
Polymerase Chain Reaction Culture-Enhanced (PCR-CE) - Use:
Prenatal screening for Group B Streptoccus colonization in vagina or rectum in pregnant women - Clinical Significance:
Group B Streptococci (GBS) are a leading cause of neonatal sepsis. Early onset GBS infection in newborns is transmitted from asymptomatic, colonized women to their newborns prior to or during birth. Approximately 10% to 30% of pregnant women are colonized with GBS in the vagina or rectum.In 1996, the American College of Obstetricians and Gynecologists (ACOG) recommended intrapartum prophylaxis for all women in labor who had identifiable factors associated with increased risk for delivering babies who will develop GBS disease – risk-based approach. The Centers for Disease Control (CDC) recommended a universal prenatal screening for vaginal and rectal GBS colonization of all women at 35-37 weeks’ gestation – culture-based screening approach. The broth culture method, such as selective broth culture, has been the recommended standard for recovery of GBS, which may take up to 3 days for completion. A molecular-based assay, IDI-Strep B Assay by GeneOhm Sciences, has been approved by the US Food and Drug Administration (FDA). The assay uses polymerase chain reaction (PCR). Since its introduction, it has been proved that LIM broth enhanced PCR (selective broth culture followed by the next day PCR) is the most sensitive and fastest method to detect GBS. A study at South Bend Medical Foundation also confirms this finding. In a study of 62 samples, the positive detection of GBS was present in 17 by LIM broth enhanced PCR, 14 by direct PCR and 10 by LIM broth culture.SBMF has replaced Group B Streptococcus culture with Group B Streptococcus by PCR, Culture-Enhanced to provide rapid detection of GBS with increased sensitivity. - Reference Range:
Negative for Group B Streptococcus DNA by PCR - Day Run:
Sun-Sat (daily) - Time Run:
Daily - Time Reported:
Daily - Test Type:
MICROBIOLOGY