Throat swabs used for detection of Group A Strep changed from rapid Group A Strep antigen assay to a rapid PCR-based assay on May 9. This impacts what type of throat swabs are acceptable for Rapid Group A Strep testing.
The manufacturer lists the following FDA-approved swab types for use with the Xpert® Xpress Strep A assay:
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GROUP A STREP BY NAA [LAB5101]
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Test Code: 1230170001
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Synonym: STRAL.
The diagnosis of Group A Streptococcal pharyngitis
traditionally relies on the use of rapid antigen detection testing, with a
reflex to throat culture with negative results.
However, the overall sensitivity of these rapid antigen
tests compared to throat culture is low (86 to 91% versus 90 to 95%). Throat
culture remains the gold standard for detection of Group A strep but requires
additional laboratory time (18 to 24 hours) to isolate any potential pathogens.
Compared to rapid antigen detection testing, PCR has a
higher sensitivity and specificity for the detection of Group A Streptococcus
in patients with bacterial pharyngitis. PCR testing also has the advantage of providing
a shorter turnaround time to results versus throat culture (less than 30
minutes versus 18 to 24 hours from time of collection).
The PCR test (Xpert® Xpress Strep A test) reports a
sensitivity of 100%, specificity of 94.1%, positive predictive value (PPV) of
84.1%, and a negative predictive value (NPV) of 100% from 577 samples in the U.S.
Based on this data, the need for confirmation of negative PCR results by throat
culture is not recommended unless clinical symptoms persist, or if the patient
has an outbreak of acute rheumatic fever (ARF).
Penicillin or amoxicillin is the antibiotic of choice to
treat Group A Streptococcal pharyngitis. In patients with an allergy to
penicillin, recommended treatment regimens include narrow spectrum
cephalosporins (cephalexin, cefadroxil), clindamycin, azithromycin and
clarithromycin. A throat culture is recommended in this case to allow for
antimicrobial susceptibility testing to be performed, if clinically indicated.
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Negative PCR results for Group A Strep will not
receive an automatic reflex to throat culture.
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This test is not intended to monitor treatment
for Group A Streptococcus infections.
Contact Jeff Luong, senior technical specialist in the molecular/microbiology department.