Advanced Diagnostic Laboratories

COVID-19, Rapid PCR (On-Site/Point-of-Care use only)

Test Code

PPCOV

Description

Collect

Anterior Nasal Swab in Accula buffer transport media only.
Swab specimen should be collected using Accula kit recommended swabs by healthcare professional or on-site, supervised patient self-collections. Self-collection is
limited to patients 18 years and older. Sample Elution: Specimen swabs must be eluted in Accula buffer immediately after sample collection.
Minimum Volume: 1-3ml

Mid-turbinate Nasal Swabs in Accula buffer transport media only.
Swab specimen should be collected using Accula kit recommended swabs by healthcare professional. Sample Elution: Specimen swabs must be eluted in Accula buffer immediately after sample collection.
Minimum Volume: 1-3ml

Unacceptable Conditions

Eluted sample/specimens stored outside of storage/stability temperatures.

Patient nasal swabs previously stored in media other than Accula SARS-CoV-2 Buffer are not recommended and may yield invalid results or false results.

Storage Transport Temp

Specimens must be adequately labeled, packaged, and transported immediate to the clinical laboratory or within storage/stabilities noted.

Stability

Eluted samples in Accula buffer may be kept at room temperature (15°C to 30°C, 59°F to 86°F) for up to 2 hours or refrigerated at 2°C to 8°C and tested within 24 hours from the time of elution.

Eluted samples in Accula buffer may be stored for up to 1 week at -20°C; longer storage should be at -80°C or colder.

Notes

This test has not been FDA cleared or approved but has been authorized for emergency use by the FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Methodology

Molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA

Department

Core Lab

Synonyms

COVID-19, Polymerase chain reaction

Related Tests

COVD2