To help you get set up and running as quickly as possible, this page outlines the current requirements for laboratories/patient care settings that must be in place prior to beginning COVID-19 patient testing.

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The Thermo Fisher Scientific Accula SARS-CoV-2 Test received Emergency Use Authorization (EUA)* from the FDA on March 23, 2020. To help you get set up and running as quickly as possible, this page outlines the current requirements for laboratories/patient care settings that must be in place prior to beginning COVID-19 patient testing. Please read the information below carefully and follow all instructions.  Please forward this important information to your Technical team as well, and provide us the primary Technical contact name and phone number for future reference

Before beginning patient testing, facilities must:

1. Notify relevant public health authorities of the intent to run this test (the requirements for notification vary by location and may include state, county, and/or city authorities).
2. Have a process in place for reporting test results to healthcare providers and relevant public health authorities, and for maintaining any records associated with the use of the test.
3. Perform testing only as outlined in the Accula SARS-CoV-2 Test Instructions for Use (IFU).
4. Train all operators in performing and interpreting the results of the test, and ensure that appropriate personal protective equipment (PPE) is used.
5. Distribute authorized PATIENT and HEALTHCARE PROVIDER FACT SHEETS as directed (see below).
6. Report any suspected occurrence of false positive or false negative results, or significant deviations from the established performance characteristics to the Center for Devices and Radiological Health (CDRH) and Mesa Biotech (see below).

Required training & product documents

All required documents and training videos can also be found at thermofisher.com/mesa under Resources and support.

Each operator must receive training on the test before testing patient samples and carefully read the  Instructions for Use (IFU),  Quick Reference Guide (QRG), and  Self-Collection Quick Reference Guide (Self-Collection QRG) that accompany the test, as well as the  Operator’s Guide provided with your Accula Dock. It is suggested that a copy of the Quick Reference Guide (QRG) and Self-Collection Quick Reference Guide (Self-Collection QRG) be posted near each testing station.

  • All operators must view the following training modules prior to testing patient samples, located at thermofisher.com/mesa under Resources and support.
    • Running the Test
    • Interpretation of Results
  • All operators must use appropriate personal protective equipment.
  • Records should be maintained for all operator training.
     

Result reporting, fact sheets & technical support

There are several requirements for reporting patient results:

  • All healthcare providers ordering the test must receive the  Fact Sheet for Healthcare Provider (Dated January 7th, 2020).
  • All patients tested with this assay must receive the  Fact Sheet for Patients.
  • All facilities using this test must follow confirmatory testing and reporting guidelines according to their appropriate public health authorities.
  • Report any suspected occurrence of false positive or false negative results, or significant deviations from the established performance characteristics via email to both CDRH-EUA-Reporting@fda.hhs.govAND to Thermo Fisher Scientific, at USSD2.customercare@thermofisher.com or by phone at (858) 284-0198.
  • TECHNICAL SUPPORT:  For product questions, additional training needs, product complaints or potential adverse events, please contact tech support at (800) 955-6288 or techservices@thermofisher.com.


Thank you for all you are doing to provide patient testing and critical care during these unprecedented times.

For additional assistance, please contact:
USSD2.customercare@thermofisher.com
(858) 800-4929


*NOTE:  This test has not been FDA cleared or approved but has been authorized for emergency use by 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.  90033-B
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