INTENDED USE

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 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-2 Test is only for use
under the Food and Drug Administration’s Emergency Use Authorization.

INTERPRETATION OF RESULTS

NOT DETECTED (NEGATIVE): A “Not Detected” result means that the virus that causes COVID-19 infection (SARS-CoV-2) was not present in the specimen above the limit of detection of the
assay. A negative result does not rule out the possibility of COVID-19 and should not be used as the sole basis for treatment or patient management decisions. Test results should be
interpreted in conjunction with your medical history, clinical signs and symptoms, and the results of other diagnostic tests performed. If COVID-19 is still suspected based on exposure history
together with other clinical findings, re-testing should be considered by healthcare providers in consultation with public health authorities.

DETECTED (POSITIVE): This result means that SARS-CoV-2 was detected in your body. Please follow CDC guidelines such as Stay home except to get medical care. Monitor your symptoms. If
you have an emergency warning sign (including trouble breathing), seek emergency medical care immediately. Stay in a separate room from other household members, if possible. Use a
separate bathroom, if possible. Avoid contact with other members of the household and pets. Do not share personal household items, like cups, towels, and utensils. Wear a mask when
around other people if you can.