*Detection of Group B Streptococcus (Streptococcus agalactiae) using nucleic acid hybridization (Gen-Probe AccuProbe) and realtime PCR.

Reflex to antimicrobial susceptibility for penicillin allergic patients also available (please indicate clearly) - will delay reporting

Click on the below image to view the package insert for the BactiSwab.  Collection instructions are found below.

Bactiswab only

Group B Strep Specimen Collection Instructions:

1. Remove swab from packaging. DO NOT touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new swab.

2. Carefully insert the swab approximately 2 cm into the vagina.

3. Remove, and insert the same swab 1 cm into anus.

4. Immediately place the swab into the transport tube and close tightly.

5.  Please mark clearly on the requisition either "Group B strep" or "Group B strep Penicillin allergy with sensitivity reflex".

6.  Fill out the requisition completely and place a CPA sticker on it and the bag, or write with a sharpie "CPA" on the requisition and bag so that it shows for the courier.

7.  Place the sample and requisition in a CPA Biohazard Transport Bag

8. Store and transport specimens at room temperature (15 to 30°C) or refrigerated (2 to 8°).

9. Make sure that the courier picks up the specimen to take to the lab on the same day.

Compared to a comparator method, this GBS assay was 98.8% sensitive and 94.5% specific.  The specificity is lower because there were positive results by this assay that were negative by the comparator method.  These are likely true positives that were “false negatives” by the comparator method.  Regarding specificity, ProPath tested multiple organisms including other strep species and saw no cross reactivity with our test.

* Method: Real-time PCR.  This test was developed and its performance characteristics determined by ProPath Services, LLC.  It has not been cleared or approved by the U.S. Food and Drug Administration (FDA).  The laboratory is regulated under CLIA as qualified to perform high-complexity testing.  This test is used for clinical purposes.  It should be regarded as investigational or for research.   Performed by reference lab, ProPath,1355 River Bend Drive, Dallas, TX 75247 1-800-258-1253.  For detailed performance characteristics, limitations and collection method please visit www.ProPath.com/test-menu and Obstetrics and Gynecology.