Informational:As of April 26, 2023 Accula products are no longer available for direct purchase through Thermo Fisher Scientific. Authorized distributors will continue to sell the Accula products until inventory runs out.
The Accula SARS-CoV-2 Control Kit provides positive and negative control swabs for use with the Accula SARS-CoV-2 Test. When used for quality control in the test, they are useful as an aid in verifying test and operator performance.
The Accula SARS-CoV-2 Control Kit contains:
Three high positive control swabs
Three low positive control swabs
Three negative control swabs
The Accula SARS-CoV-2 Control Kit is used in conjunction with the Accula Dock or the Silaris™ Dock, an RT-PCR platform, and Accula SARS-CoV-2 Test to deliver fast and convenient qualitative rapid PCR-based results in approximately 30 minutes. The Accula SARS-CoV-2 Control Kit is intended for in vitro diagnostic use in quality control testing. External controls may be used to show that the Accula SARS-CoV-2 Test system is working properly. We recommend running SARS-CoV-2 positive and negative controls:
Once for each new lot or shipment of kits received
Once for each new operator
As deemed additionally necessary to conform with your internal quality control procedures, with local, state and/or federal regulations, or accrediting groups
Intended use The Accula SARS-CoV-2 Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula SARS-CoV-2 Test.
The Accula SARS-CoV-2 Test Kit and Control Kit 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.
For Emergency Use Authorization (EUA) Only. For prescription use only. For in vitro diagnostic use.
For Use With (Application)
Accula SARS-CoV-2 Test to conduct external quality controls