User Manual

RCPM-00279, RCPM-00479, RCPM-02079
Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
on/go
TM
COVID-19 Antigen Self-Test
IFU-RCPM79-E / Rev. A
ACCESS BIO, INC.
Page 11 of 16
2. The detection of SARS-CoV-2 nucleocapsid antigen is dependent upon proper specimen
collection, handling, storage, and preparation. Failure to observe proper procedures in any
one of these steps can lead to incorrect results.
3. False negative results may occur in patients who have indicated or whose clinical status or
history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin
levels of 2.5 µg/mL and greater have been demonstrated to result in false negative test
results.
4. Failure to follow the instructions for use may adversely affect test performance and/or
invalidate the test result.
5. False negative results are more likely after seven days or more of symptoms.
6. Interpretation of any result after 15 minutes may yield inaccurate test results.
7. This test and the results from this test do not establish that the user has acquired immunity
to COVID-19.
8. Extracted specimens are stable for 4 hours in extraction buffer at room temperature.
9. Results from antigen testing should not be used as the sole basis to diagnose or exclude
SARS-CoV-2 infection or to determine infection status.
10. Negative results are presumptive in symptomatic individuals, do not rule out COVID-19
infection and it may be necessary to obtain additional testing with a molecular assay, if
needed for patient management.
11. This device has been evaluated for use with human specimen material only.
12. False-negative results may occur if the concentration of the target antigen in the clinical
specimen is below the detection limits of the device.
13. This device is a qualitative test and does not provide information on the viral concentration
present in the specimen.
14. This test cannot rule out diseases caused by other bacterial or viral pathogens.
15. The prevalence of infection will affect the test’s predictive values.
16. False positive results may occur, particularly in individuals without COVID-19 symptoms
and/or individuals who live in areas with low numbers of COVID-19 infections and without
known exposure to COVID-19.
17. Positive and negative predictive values are highly dependent on prevalence. False-negative
test results are more likely during peak activity when the prevalence of the disease is high.
False-positive test results are more likely during the periods of low SARS-CoV-2 activity
when prevalence is moderate to low.
18. Performance of nasal swabs collected from individuals without symptoms or other
epidemiological reasons to suspect COVID-19 infection or for serial screening, when tested
twice over two or three days with at least 24 hours and no more than 48 hours between tests
has not been determined, a study to support use will be completed.
19. If the differentiation of specific SARS viruses and strains is needed, additional testing, in
consultation with state or local public health departments, is required.