1500 Forest Glen Road Silver Spring, MD 20910-1484 HC HOLY CROSS HOSPITAL Phone: (301)754-7000 www.holycrosshealth.org Memo TO: All Holy Cross Hospital Affiliated Physicians - Obstetrics All Nursing Staff - Labor and Delivery Department FROM: Pablo Gutman, MD Medical Director, Microbiology Laborat DATE: July 26, 2012 SUBJECT: Group B Streptococcus PCR Effective August 1, 2012, the Microbiology laboratory will implement a real-time polymerase chain reaction (PCR) assay for the intrapartum detection of Group B Streptococcus colonization for pregnant patients presenting in labor with no history of prenatal care. The test parameters are as follows: TEST ORDER: SPECIMEN COLLECTION TEST PERFORMED: RESULTS REPORTED: RESULTS: Group B Strep PCR 1. This test (Rapid GBS) requires a special collection swab obtainable from the laboratory. DO NOT USE THE ROUTINE CULTURETTE SWAB FOR THIS SPECIMEN COLLECTION. AND 2. Submit a routine GBS (LIM Broth) culture with this specimen collection for antimicrobial susceptibility testing if needed for a penicillin allergic patient with a positive PCR result. 1. Once per day; Sunday - Saturday Day Shift 2. specimens submitted after the daily test run will be stored and run on the next day shift 1. upon completion of testing 2. Positive result = Critical value 1. Positive: GBS target nucleic acid is detected. Presumptive for GBS colonization. 2. Negative: GBS target nucleic acid is NOT detected. Presumed not colonized for GBS. 3. invalid: Presence or absence of GBS cannot be determined. Quality Control Monitors did not meet acceptance criteria with repeat testing. Repeat testing with an alternate method is recommended. Holy C r o s s . E x p e r t s in M e d i c i n e , S p e c i a l i s t s in C a r i n g . P a g e 1 of 2 IK 1500 Forest Glen Road Silver Spring, MD 20910-1484 HOLY CROSS HOSPITAL IMPORTANT NOTES: Phone: (301) 754-7000 www.holycrosshealth.org 1. A positive test result does not indicate the presence of viable organisms. 2. A positive result does not preclude the presence of other pathogens. 3. This assay does not provide antimicrobial susceptibility results. Culture isolates are needed to provide antimicrobial susceptibility testing as recommended for penicillin allergic patients. 4. This assay should be used as an adjunct to other available methods, it should not be used to replace antepartum (35 - 37 weeks gestation) testing. Group B streptococcus and streptococcal infection. 6. Test results may be affected by concurrent antibiotic therapy. Therapeutic success or failure cannot be assessed using this test because PIMA may persist after antimicrobial therapy. Thank you for allowing us to help you serve your patients. Please contact the laboratory director, Jay Marchwinski (301-754-7321), the Microbiology laboratory manager, Sheryl stuckey (301-754-7325) or myself if you have any questions or concerns regarding our laboratory's practices or service to your patients. References: 1. Garcia, Lynne. (Editor): Clinical Microbiology Procedures Handbook, 3rd Edition, Section 12, American society for Microbiology, Washington, DC, 2010. 2. Product insert, x p e r r GBS, Revision D, Cepheid, Sunnyvale, California, September 2011. cc: S. Mitchell, MD B. Eig, MD A. Burke, MD M. Cameron, MD J. Marchwinski M. Mohyla, RN, CIC Holy C r o s s . E x p e r t s in M e d i c i n e , S p e c i a l i s t s in C a r i n g . P a g e 2 of 2