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Test Code STREPNAAT Strep A by NAAT

Additional Codes

Cerner

NextGen

Strep A by PCR-NAAT

Strep A by PCR-NAAT

Useful For/ Methodology

ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

Patient Preparation

None

Collection Instructions

Throat swab specimens should be collected according to clinical policies and procedures.

Specimen Requirements

Container

For optimal performance, use the swabs provided in the test kit. Alternatively, foam, polyester, HydraFlock® and nylon flocked throat swabs can be used to collect throat swab samples. The BBL™ CultureSwab™ Liquid Amies transport media system has been tested and is also acceptable.

or

Stability
  • Specimen should be submitted to Laboratory ASAP
  • At room temperature or refrigerated (2-8) up to 72 hours
  • The collection swab from the BBL™ CultureSwab™ Liquid Amies transport media system can be held at room temperature (approximately 22°C) or refrigerated at 2-8°C for up to six (6) hours prior to testing.

Rejection Criteria
  • Specimens not properly labeled with two patient identifiers
  • Specimens not submitted to the laboratory within stability time frame.

Result Reporting and Reference Values

Reference Range

Negative

Interpretive Comment

Testing performed by NAAT molecular in vitro diagnostic testing utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes

Reflex Testing

None

Limitations

  • For optimal performance, use the specimen collection swabs provided in the test kit. Analytical studies have demonstrated that rayon swabs and BBL CultureSwab Liquid Stuart Medium are not suitable for use with this assay and may produce false negative results.
  • ID NOW™ Strep A 2 does not distinguish between viable and nonviable organisms.
  • Performance of ID NOW™ Strep A 2 has not been established for monitoring treatment of pharyngitis caused by Group A Strep.
  • ID NOW™ Strep A 2 will not differentiate asymptomatic carriers of Group A Strep from those exhibiting streptococcal infection.
  • False results may occur if a Sample Receiver for an assay other than ID NOW™ Strep A 2 is used.
  • Additional follow-up testing using the culture method is required if the result is negative and clinical symptoms persist, or in the event of an acute rheumatic fever (ARF) outbreak.

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