Group B Streptococcus Colonization Detection, NAA With Reflex to Susceptibilities

CPT: 87081; 87150. If susceptibilities are performed, an additional charge will be added (87184).
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Test Details

Use

Antepartum detection of group B β-hemolytic streptococci in patients who are at high risk for anaphylactic shock due to penicillin allergy.

Limitations

A positive result does not necessarily indicate the presence of viable organisms. Patients who have used systemic or topical (vaginal) antibiotic treatment in the week prior as well as patients diagnosed with placenta previa should not be tested using this assay.

Methodology

Selective broth enrichment culture and real-time PCR

Additional Information

In the US, group B Streptococcus (GBS) remains a leading cause of early-onset neonatal sepsis. The most common mode of acquisition by the neonate is exposure to the maternal genital flora in utero through ruptured membranes or by contamination during passage through the birth canal.

Infection is manifested in two major forms, early-onset septicemic infection manifest in the first few days of life and late-onset meningitis that occurs during the first few months of life. The Centers for Disease Control and Prevention (CDC) and the American Congress of Obstetricians and Gynecologists (ACOG) practice guidelines recommend universal antepartum screening at 35 to 37 weeks of gestation. These guidelines specify co-collection of a vaginal and rectal swab specimen to maximize sensitivity of GBS detection. Per the CDC and ACOG, swabbing both the lower vagina and rectum substantially increases the yield of detection compared with sampling the vagina alone. Rates of maternal colonization have not changed, but universal antepartum screening along with the use of intrapartum antibiotic prophylaxis has resulted in a decrease of early-onset GBS disease. In November 2010, the CDC published revised guidelines recommending that, in addition to culture, antepartum vaginal/rectal specimens could be tested using a nucleic acid amplification (NAA) test following incubation in a selective enrichment broth medium to enhance the detection of GBS.

Susceptibility testing is not routinely performed, as this organism is universally susceptible to penicillin, and surveillance for resistance is not recommended. The CDC and the ACOG recommend reflex susceptibility testing to clindamycin and erythromycin (D-zone test to detect inducible clindamycin resistance) for group B Streptococcus only for those patients at high risk for anaphylactic shock due to penicillin allergy.

For those patients without likely evidence of severe anaphylaxis, the CDC and ACOG recommend the use of cefazolin as the agent of choice for intrapartum chemoprophylaxis without the need for susceptibility testing. For those patients with GBS that is resistant to clindamycin, treatment with vancomycin is recommended without the need for additional susceptibility testing. Even though it is tested together with clindamycin in the D-zone test, erythromycin is no longer an acceptable alternative for intrapartum GBS prophylaxis for penicillin-allergic women at high risk for anaphylaxis, and susceptibility results for this agent will not be reported.

Specimen Requirements

Specimen

Swab of vaginal and rectal specimen

Volume

Single or double bacterial swab in Amies agar gel transport or equivalent (non-nutritive transport medium)

Minimum Volume

Single bacterial swab in Amies agar gel transport or equivalent (non-nutritive transport medium)

Collection

Collection of both a vaginal and rectal swab specimen is strongly recommended. Swab the lower vagina (vaginal introitus), followed by the rectum (ie, insert swab through the anal sphincter) using the same swab. Move swab from side to side, or rotate the swab at the collection site, allowing several seconds for absorption of organisms by the swab. Cervical, perianal, perirectal or perineal specimens are not acceptable, and a speculum should not be used for culture collection.

Storage Instructions

Specimen is stable for 24 hours at room temperature. If arrival at lab will extend beyond 24 hours, then refrigerate.

Causes for Rejection

Inappropriate specimen transport; use of ESwab™; inappropriate transport conditions; improper labeling; specimen received after 24 hours and not refrigerated; cervical/endocervical, perianal, perirectal or perineal specimen, or any source other than vagina and rectum

Clinical Information

References

American College of Obstetricians and Gynecologists Committee on Obstetric Practice. ACOG Committee Opinion N° 485: Prevention of early-onset group B streptococcal disease in newborns. Obstet Gynecol. 2011 Apr; 117(4):1019-1027. 21422882
Haberland CA, Benitz WE, Sanders GD, et al. Perinatal screening for group B streptococci: Cost-benefit analysis of rapid polymerase chain reaction. Pediatrics. 2002 Sep; 110(3):471-480. 12205247
Park JS, Cho DH, Yang JH, et al. Usefulness of a rapid real-time PCR assay in prenatal screening for group B Streptococcus colonization. Ann Lab Med. 2013 Jan; 33(1):39-44. 23301221
Picard FJ, Bergeron MG. Laboratory detection of group B Streptococcus for prevention of perinatal disease. Eur J Clin Microbiol Infect Dis. 2004 Sep; 23(9): 665-671. 15258832
Verani JR, McGee L, Schrag SJ; Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). Prevention of perinatal group B streptococcal disease--revised guidelines from CDC, 2010.MMWR Recomm Rep. 2010 Nov 19; 59(RR-10):1-36. 21088663

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
188139 Strep Gp B NAA+Rflx 188105 Strep Gp B NAA+Rflx 48683-7
Reflex Table for Strep Gp B NAA+Rflx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 180797 Strep Gp B Susceptibility 183633 Strep Gp B Susceptibility N/A
Reflex Table for Strep Gp B NAA+Rflx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 180797 Strep Gp B Susceptibility 188140 Organism Identification N/A
Reflex 2 000000 RSLT05 000000 N/A
Reflex Table for Strep Gp B NAA+Rflx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 180797 Strep Gp B Susceptibility 998650 Clindamycin 194-1

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