User's Manual

PROOF DIAGNOSTICS COVID-19 TEST SYSTEM
16 17
IF THE TEST RESULT IS NEGATIVE, SARS-COV-2
HAS NOT BEEN DETECTED
Negative Result: COVID-19 has not been detected in the tested
sample. Although highly accurate, there is a small possibility that
the test will give a false negative reading. It is the responsibility
of the healthcare provider to determine the best care options
based on the test result, possible exposure to the virus, the
patient’s symptoms and their medical history.
IF THE TEST RESULT IS POSITIVE, SARS-COV-2
HAS BEEN DETECTED.
Positive Result: COVID-19 has been detected. Follow your local
or state protocols for the reporting and treatment of patients
with COVID-19. Although highly accurate, there is a small
possibility that the test will give a false positive reading. It is the
responsibility of the healthcare provider to determine the best
care options based on the test result, possible exposure to the
virus, the patient’s symptoms and their medical history.
IF THE TEST RESULT IS INVALID, THE RESULT
IS INCONCLUSIVE
Invalid Result: The test result is inconclusive. Repeat the test
using the specimen collected in the existing sample vial and a
new Test Cartridge.
See “Error Alerts” on page 26 for further information.
Test Result Limitations
• A negative test result may occur if the level of SARS-
CoV-2 RNA in a sample is below the detection limit of the
test or if the sample was collected or handled improperly.
• Failure to follow the Test Procedure may adversely affect
test performance and/or invalidate the test result.
• Positive test results do not rule out co-infections with
other pathogens.
• Negative test results are not intended to rule out other non-SARS
viral or bacterial infections.
• Negative results do not preclude SARS-CoV-2 infection and should
not be used as the sole basis for patient management decisions.
• Negative results should be treated as presumptive and, if consistent
with clinical signs and symptoms or necessary for patient
management, should be tested with a different authorized or
cleared molecular test.
• If a test is determined to be invalid, discard the Test Cartridge and
re-run the retained patient sample.