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Laboratory Test Detail

Last Updated: March 2, 2021 @ 10:13 am

2785

SARS-CoV-2 by PCR

Specimen:Collect:
  • Nasopharyngeal Swab in Viral Transport Media

Also Acceptable:
  • Nasopharyngeal Swab in Sterile Tube w/Saline
  • Throat Swab in Nasopharyngeal Swab in Sterile Tube w/Saline
  • Throat Swab in Viral Transport Media
Submit:
  • Nasopharyngeal Swab in Viral Transport Media. Submit Frozen.

Also Acceptable:
  • Throat Swab in Viral Transport Media. Submit Frozen.
  • Nasopharyngeal Swab in Sterile Tube w/Saline. Submit Frozen.
  • Throat Swab in Sterile Tube w/Saline. Submit Frozen.
Special Handling:
  • Swab must be placed in VTM or Saline within 1 hour of collection
Rejection Criteria:
  • Swab not placed in VTM or Saline within 1 hour of collection.
    Calcium alginate swabs, cotton swabs, or swabs with wooden shafts
Stability:Ambient: Unacceptable; Refrigerated: 4 Day(s); Frozen: 2 Week(s); Incubated: Unacceptable
Methodology:
  • Real-Time Polymerase Chain Reaction
Performed:Mon-Fri
Reported:1-4 Day(s)
CPT Codes:
  • U0004
Interpretive Data:

THIS IS A REAL-TIME PCR ASSAY FOR THE RAPID AND PRESUMPTIVE QUALITATIVE DETECTION OF RNA FROM SARS-COV-2 (ETIOLOGICAL CAUSE OF COVID-19). POSITIVE RESULTS ARE INDICATIVE OF ACTIVE INFECTION WITH SARS-COV-2, BUT DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR OTHER PATIENT MANAGEMENT DECISIONS.

FOR INFORMATION ABOUT THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE EMERGENCY USE OF THIS SARS-COV-2 (COVID-19) TEST, GO TO: www.fda.gov/media/136599/download (FOR HEALTHCARE PROVIDERS), OR: www.fda.gov/media/136600/download (FOR PATIENTS).
Components:
  • 2785 - SARS-COV-2 by PCR
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