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Test Code GAPCR Streptococcus Group A, Molecular Detection, PCR, Throat


Specimen Required


Patient Preparation: Do not collect throat swab specimens immediately after use of antiseptic mouthwash.

Specimen Type: Throat swab

Supplies: BD E-Swab (T853)

Container/Tube:

Preferred: BD Liquid Amies Elution Swab (ESwab)

Acceptable: Copan Liquid Amies Elution Swab (ESwab)

Specimen Volume: Entire collection/1 ESwab

Collection Instructions:

1. Must be collected and transported using the ESwab collection kit.

2. Using a tongue blade to hold the tongue down, firmly rub the swab over the tonsils, posterior pharynx, and any areas of inflammation with exudate. Ensure that areas with exudate or inflammation are swabbed.

3. Avoid the tongue, teeth, and gums as the swab is withdrawn.

4. Insert the swab back into the ESwab transport tube and break the swab at the indicated score line.

5. Label specimen according to policy.

6. Send refrigerated. Do not freeze.


Secondary ID

610254

Useful For

Detecting group A streptococcal infections in patients with signs and symptoms of pharyngitis using a throat swab specimen

 

The test is not intended for monitoring treatment for group A Streptococcus infections.

Highlights

This test provides rapid detection of Streptococcus pyogenes/Group A Streptococcus in patients with pharyngitis.

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

Group A Streptococcus PCR, Throat

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 6 days
  Ambient  48 hours

Reject Due To

Specimens collected in media other than ESwab collection kit Reject

Clinical Information

Group A streptococci are gram-positive, beta-hemolytic disease-causing bacteria that commonly cause infections in the throat (pharyngitis or strep throat) or on skin (cellulitis and impetigo) and can cause a wide range of other infections (eg, sepsis, pneumonia, and meningitis). Pharyngitis may also be caused by other bacteria, including Neisseria gonorrhoeae and Corynebacterium diphtheriae, for which specific culture methods are required. If left untreated, mild infections can lead to more serious infections. The most severe but least common forms of invasive Group A streptococcal disease (GAS) are necrotizing fasciitis and streptococcal toxic shock syndrome. Several million cases of strep throat and impetigo occur each year with approximately 9000 to 11,500 cases of invasive GAS disease occurring in the United States, resulting in 1000 to 1800 deaths.(1) Treating an infected person with an appropriate antibiotic generally prevents the spread of the infection and reduces the risk of post-infectious complications, such as rheumatic fever and acute glomerular nephritis.(2)

Reference Values

Negative

Interpretation

Positive: Streptococcus pyogenes DNA is detected.

Negative: Streptococcus pyogenes DNA is not detected.

Method Description

The GeneXpert Dx System automates and integrates sample purification, nucleic acid extraction and amplification, and detection of the target sequence using real-time polymerase chain reaction (PCR). The system requires single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized.

 

The Xpert Xpress Strep A test, performed on the GeneXpert Instrument Systems, is a rapid, qualitative test using real-time PCR to detect Streptococcus pyogenes DNA. The assay includes a sample processing control to ensure an adequate amplification process and to monitor for the presence of inhibitors in the PCR reaction. A probe check control verifies reagent rehydration, PCR tube filling, and all reaction components, including probes and dyes, are present and functional in the cartridge.(Package insert: Xpert Xpress Strep A. Cepheid; 301-9326, Rev. D, 06/2019)

Day(s) Performed

Monday through Sunday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87651

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GAPCR Group A Streptococcus PCR, Throat 60489-2

 

Result ID Test Result Name Result LOINC Value
GAPCR Group A Streptococcus PCR, Throat 60489-2