Product Manual
2 60061-7 (2021-01) Accula SARS-CoV-2 IFU
SARS-CoV-2
COV4100
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use
For use with Nasal and Nasal Mid-Turbinate Swabs
For use with the Accula Dock and Silaris Dock
Instructions for Use
INTENDED USE
-CoV-2 Test performed on the Accula Dock or the is a molecular in vitro diagnostic test utilizing
polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in
clinician-collected nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) nasal swab
specimens, collected from individuals suspected of COVID-19 by their healthcare provider. 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 Accula SARS-CoV-2 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.
Accula SARS-CoV-2 Test results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper
respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical
correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not
rule out bacterial infection or co-infection with other viruses. Testing facilities within the United States and its territories are required to
report all results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Accula SARS-CoV-2 Test is intended for use by trained operators who are proficient in performing tests on the Accula Dock and
Silaris Dock. The Accula SARS-CoV-
SUMMARY AND EXPLANATION
The Accula SARS-CoV-2 Test performed on the Accula Dock or the Silaris Dock is a 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. The
Accula SARS-CoV-2 Test uses a nasal or nasal mid-turbinate swab specimen collected from patients who meet CDC SARS-CoV-2
clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
PRINCIPLE OF THE TEST
The Accula SARS-CoV-2 Test is a Nucleic Acid Amplification Test (NAAT) for detection of SARS-CoV-2 viral RNA in approximately 30
minutes. To perform the test, nasal or nasal mid-turbinate specimens are added to the SARS-CoV-2 Buffer to solubilize the sample. An
aliquot of the SARS-CoV-2 Buffer is then dispensed into an Accula SARS-CoV-2 Test Cassette. The Test Cassette contains internal