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 10 of 16
test for positive results may also be necessary, if there is a low likelihood of
COVID-19, such as in individuals without known exposures to COVID-
19 or
residing in communities with low prevalence of infection.
COVID-19 Not Detected (Negative):
One purple-colored line only next to “C” indicates a
negative result.
Negative results do not rule out SARS-CoV-2 infection. Individuals without
symptoms that test negative should be tested again with at least 24 hours and
no more than 36 hours between tests. All negative results are considered
presumptive, and confirmation with a molecular assay, if necessary for patient
management, may be performed.
The amount of antigen in a sample may
decrease as the duration of illness increases.
Negative results should be
considered in the context of an individual’s recent exposures, history, and the
presence of clinical signs and symptoms consistent with COVID19 and
confirmed with a molecular assay, if necessary, for patient management.
Invalid:
Invalid barcode or absence of a purple-colored line next
to “C”. Re-test with a COVID-19 test may be needed.
An invalid test result indicates that your test has
experienced an error and unable to interpret the result of
the test. You will need to retest with a new test or consult
a healthcare professional. If you still have symptoms, you
should self-isolate at home and avoid contact with others
prior to the retest
For questions, or to report a problem, please call
Technical Support at [phone] or visit
letsongo.com/Support.
Limitations
1. This test will indicate the presence of SARS-CoV-2 nucleocapsid protein antigen in the
specimen from both viable and non-viable SARS-CoV-2 virus. Test performance depends on
the amount of virus (antigen) in the sample and may or may not correlate with viral culture
results performed on the same sample.