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 9 of 16
If used for serial testing and the test result is negative, a second test should be obtained two or
three days with at least 24 hours and no more than 48 hours between tests.
Interpretation of Results
The test results will be interpreted by visual reading following the in-app interpretation
instructions or provided Quick Reference Instructions.
NOTE: The test results should be read by visual and interpreted at 10 minutes after the
sample application and the reading and interpretation of the results should not exceed 15
minutes as it may yield inaccurate results.
COVID-19 Detected (Positive):
One purple-colored line next to “C” and one blue-
colored line next to “T” indicates COVID-19 positive
result.
NOTE: The color intensity of the blue-colored test line will vary depending
on the amount of SARS-CoV-2 nucleocapsid protein antigen present in the
sample. Any faint blue-colored line in the test line should be considered as
positive.
A positive test result for COVID-19 indicates that antigens from SARS-CoV-2
were detected, and the patient is very likely to be infected with the virus and
presumed to be contagious. Test results should always be
considered in the
context of clinical observations and epidemiological data (such as local
prevalence rates and current outbreak/epicenter locations) in making a final
diagnosis and patient management decisions. Patient management should
follow current CDC guidelines. Additional confirmatory testing with a molecular