Laboratory Test Detail

Last Updated: November 29, 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 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.

The SARS-COV-2 by PCR Assay has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; the SARS-COV-2 by PCR Assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of the SARS-COV-2 by PCR Assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner.
Components:
  • 2785 - SARS-COV-2 by PCR
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