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Visby Covid & Flu PCR Test

$0.00

  • Tests for Covid-19, Flu A, Flu B

  • Results in 30 minutes

  • Nasopharyngeal or lower nasal

  • Covid: 97.4% PPA, 98.8% NPA

  • Flu A: 97.9% PPA, 99.3% NPA

  • Flu B: 100.0% PPA, 100.0% NPA

Quantity:
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  • Tests for Covid-19, Flu A, Flu B

  • Results in 30 minutes

  • Nasopharyngeal or lower nasal

  • Covid: 97.4% PPA, 98.8% NPA

  • Flu A: 97.9% PPA, 99.3% NPA

  • Flu B: 100.0% PPA, 100.0% NPA

  • Tests for Covid-19, Flu A, Flu B

  • Results in 30 minutes

  • Nasopharyngeal or lower nasal

  • Covid: 97.4% PPA, 98.8% NPA

  • Flu A: 97.9% PPA, 99.3% NPA

  • Flu B: 100.0% PPA, 100.0% NPA

Specifications

  • CLIA Waived

  • Test type: PCR (integrated disposable PCR cassette)

  • Run time: 30 minutes

  • Collection type: Nasopharyngeal or lower nasal swab

  • For use with sterile nylon, foam, or polyester flocked swabs.

  • SARS-CoV-2: 97.4% PPA, 98.8% NPA

  • Flu A: 97.9% PPA, 99.3% NPA

  • Flu B: 100.0% PPA, 100.0% NPA

  • CPT Code: 87636-QW

  • Manufacturer: Visby Medical

Storage & Expiration

  • Store at 2-30°C (35-86°F)

  • Do not freeze any contents of the kit.

  • Reagents and materials are stable until expiration date printed on outer packaging.

  • Test device must remain in the sealed pouch until use.

Intended use

The Visby Medical Respiratory Health Test is a single-use, instrument-free molecular in vitro diagnostic test utilizing reverse transcription polymerase chain reaction (RT-PCR) technology for the qualitative detection and differentiation of nucleic acid from influenza A, influenza B, and SARS-CoV-2. It is designed for use with clinician-collected nasopharyngeal and anterior nasal swab specimens, or clinician-instructed self-collected nasal swabs (collected on-site) from individuals showing symptoms of respiratory tract infection consistent with COVID-19. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The Visby Medical Respiratory Health Test is authorized for use at the Point of Care (POC), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.