Product Manual

4 60061-7 (2021-01) Accula SARS-CoV-2 IFU
MATERIALS PROVIDED SEPARATELY
• Accula Dock (Catalog # D2000) or Silaris Dock (Catalog #1026)
• Accula SARS-CoV-2 Control Kit (Catalog #COV4100-1)
STORAGE AND HANDLING
• Store reagents at room temperature (15°C to 30°C, 59°F to 86°F). Do not refrigerate or freeze.
• Do not reuse kit contents: Collection Swabs, Test Cassettes, Transfer Pipettes, Control Swabs, or SARS-CoV-2 Buffer.
• Do not remove the Test Cassette from the foil pouch until immediately before use (within 30 minutes).
• Do not use kit or reagents past the expiration date.
• Specimen swabs must be eluted in Accula SARS-CoV-2 Buffer immediately after sample collection.
• 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.
PRECAUTIONS
• For in vitro diagnostic use under Emergency Use Authorization only.
• 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.
• Positive results are indicative of the presence of SARS-CoV-2 RNA.
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
• To be used in conjunction with the Accula Dock or Silaris Dock.
• Follow universal precautions when handling patient samples. All patient samples should be treated as if potentially infectious.
Follow standard BSL-2 guidelines when working with patient samples. Put on the appropriate personal protective equipment.
• If the buffer solution contacts the skin, wash the area with soap and clean water and rinse thoroughly. Consult a physician if
irritation develops.
• DNA Based Synthetic Oligo is used to make the positive control swabs. However, Control Swabs, patient samples and Test
Cassettes should be handled as though they could transmit disease. Observe established precautions against microbial
hazards during use and disposal.
• Dispose of kit reagents and patient samples according to all local, state, and federal regulations.
• Do not use swabs or SARS-CoV-2 Buffer other than those provided with the Accula SARS-CoV-2 Test Kit.
• Do not write on the Test Cassette except in the indicated area on the Test Cassette label for recording sample identification and
test date.
• Do not remove the foil tab from the Test Cassette until immediately before use. Once the tab is removed, add sample immediately
(within 5 minutes) and start testing.
• Once sample is added and the Dock lid is closed, the test has started. Do not move the Dock, open the lid, or unplug the
Dock until the Dock indicates the test has completed.
• Do not use any damaged kit contents.
• Do not use kit components after their expiration date.
• Sample collection and handling procedures require specific training and guidance.
• All test kit components are single-use items. Do not use with multiple specimens.
• To help obtain accurate results, follow all instructions, and regard all precautions in this Instructions for Use.
• Inadequate or inappropriate sample collection, handling, processing, and/or storage can yield inaccurate results.
• Use only the fixed volume Transfer Pipette provided in the kit to transfer the patient sample from the Accula SARS-CoV-2
Buffer tube into the Test Cassette port. Do not pour the patient sample from the Accula SARS-CoV-2 Buffer vial into the Test
Cassette sample port.
• Do not use visually bloody or overly viscous samples.