Collect

culturette swab.
1. Wipe away excessive amount of secretion or discharge from the vaginal area.
2. Using the Copan Transport containing Liquid Stuart Transport Medium, remove the collection swabs. Carefully insert the swab in to the lower one-third part of the vagina, and sample secretions from the mucosa.
3. Carefully insert the same swab, approximately 2.5 cm beyond the anal sphincter, and gently rotate to sample anal crypts.
4. Replace the swab in its container.
5. Label the container.

Unacceptable Conditions

Improper collection device, improper labeling, improper collection

Storage/Transport Temperature

Swab refrigerated at 2-8°C

Stability (from collection to initiation)

Ambient: 24 hours; Refrigerated: 6 days

Performed

Mon-Sat

Remarks

Protect against freezing or excessive heat.

Performed

Mon-Sat

Methodology

PCR (Polymerase Chain Reaction)

Reported

Next day

Department

Microbiology

Reference Interval

Negative: No Group B Streptococcus (S. agalactiae) DNA is detected in the vaginal/rectal swab after NGS broth enrichment.

Positive: Group B Streptococcus (S. agalactiae) DNA is detected in the vaginal/rectal swab after GBS broth enrichment. If a patient is at 'high risk' for penicillin allergy and will be treated with clindamycin or erythromycin, microbiology must be called for susceptibility testing. If a patient is penicillin-allergic but not 'high-risk', cefazolin is the drug of choice to prevent neonatal Group B Streptococcus. Due to the predictable susceptibility of Group B streptococcus to cefazolin, routine testing is unnecessary. Morbidity and Mortality Weekly Report, August 16, 2002, 51 (RR11); 1-2.

Unresolved: A negative or positive result could not be determined with certainty. This may indicate a problem with the specimen. If clinically indicated, a new vaginal/rectal swab should be collected and submitted for repeat testing.

Interpretive Data

The Cepheid Xpert StrepB Assay for the detection of Group B Streptococcus (S. agalactiae) in vaginal/rectal specimens is a qualitative in vitro test designed to detect GBS DNA from specimens enriched in GBS broth using fully automated real-time PCR (polymerase chain reaction) with fluorogenic detection of the amplified DNA.  The accuracy of the test result is dependent on adequate specimen collection, absence of PCR inhibitors, and the presence of microorganism DNA in sufficient quantities to be detected by the assay.

Therapeutic success or failure cannot be determined using this assay since it is based upon the detection of microorganism DNA, not viable microorganisms.

CPT Codes

87653

Collection

Collect

culturette swab.
1. Wipe away excessive amount of secretion or discharge from the vaginal area.
2. Using the Copan Transport containing Liquid Stuart Transport Medium, remove the collection swabs. Carefully insert the swab in to the lower one-third part of the vagina, and sample secretions from the mucosa.
3. Carefully insert the same swab, approximately 2.5 cm beyond the anal sphincter, and gently rotate to sample anal crypts.
4. Replace the swab in its container.
5. Label the container.

Unacceptable Conditions

Improper collection device, improper labeling, improper collection

Storage/Transport Temperature

Swab refrigerated at 2-8°C

Stability (from collection to initiation)

Ambient: 24 hours; Refrigerated: 6 days

Performed

Mon-Sat

Remarks

Protect against freezing or excessive heat.

Ordering

Performed

Mon-Sat

Methodology

PCR (Polymerase Chain Reaction)

Reported

Next day

Department

Microbiology

Result Interpretation

Reference Interval

Negative: No Group B Streptococcus (S. agalactiae) DNA is detected in the vaginal/rectal swab after NGS broth enrichment.

Positive: Group B Streptococcus (S. agalactiae) DNA is detected in the vaginal/rectal swab after GBS broth enrichment. If a patient is at 'high risk' for penicillin allergy and will be treated with clindamycin or erythromycin, microbiology must be called for susceptibility testing. If a patient is penicillin-allergic but not 'high-risk', cefazolin is the drug of choice to prevent neonatal Group B Streptococcus. Due to the predictable susceptibility of Group B streptococcus to cefazolin, routine testing is unnecessary. Morbidity and Mortality Weekly Report, August 16, 2002, 51 (RR11); 1-2.

Unresolved: A negative or positive result could not be determined with certainty. This may indicate a problem with the specimen. If clinically indicated, a new vaginal/rectal swab should be collected and submitted for repeat testing.

Interpretive Data

The Cepheid Xpert StrepB Assay for the detection of Group B Streptococcus (S. agalactiae) in vaginal/rectal specimens is a qualitative in vitro test designed to detect GBS DNA from specimens enriched in GBS broth using fully automated real-time PCR (polymerase chain reaction) with fluorogenic detection of the amplified DNA.  The accuracy of the test result is dependent on adequate specimen collection, absence of PCR inhibitors, and the presence of microorganism DNA in sufficient quantities to be detected by the assay.

Therapeutic success or failure cannot be determined using this assay since it is based upon the detection of microorganism DNA, not viable microorganisms.

Administrative

CPT Codes

87653