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Laboratory Test Detail

Last Updated: September 25, 2022 @ 9:13 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 Polymerase Chain Reaction (PCR) or Transcription Mediated Amplification (TMA) assays (TaqPath COVID-19 Combo, Aptima SARS-CoV-2 or Panther Fusion SARS-CoV-2) have not been FDA cleared or approved, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. The SARS-COV-2 by Polymerase Chain Reaction (PCR) or Transcription Mediated Amplification (TMA) assays (TaqPath COVID-19 Combo, Aptima SARS-CoV-2 or Panther Fusion SARS-CoV-2) have 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 Polymerase Chain Reaction (PCR) or Transcription Mediated Amplification (TMA) assays (TaqPath COVID-19 Combo, Aptima SARS-CoV-2 or Panther Fusion SARS-CoV-2) are 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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