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 3 of 16
defined by the Laboratory In Vitro Diagnostics (LVID) Test Code Mapping for SARS-CoV-2
Tests provided by CDC.
The on/go™ COVID-19 Antigen Self-Test is authorized for non-prescription self-use and/or, as
applicable for an adult lay user testing another person aged 2 years or older in a non-
laboratory setting. The on/go™ COVID-19 Antigen Self-Test is only for use under the Food
and Drug Administration’s Emergency Use Authorization.
Principles of the Test
The on/go™ COVID-19 Antigen Self-Test is a lateral flow immunochromatographic assay for the
detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in self-collected
direct anterior nasal (nares) swab specimens.
Nasal swabs require a sample preparation step in which the sample is eluted into the extraction
buffer solution. Extracted swab sample is added to the sample well of the test device to initiate
the test. When the swab sample migrates in the test strip, SARS-CoV-2 viral antigens bind to
anti-SARS-CoV-2 nucleocapsid protein antibodies conjugated to indicator and capture particles
in the test strip forming an immune complex. The immune complex is then captured by the test
line on the nitrocellulose membrane as it migrates through the strip.
The user should perform the test following the in-app self-paced, step-by-step instructions or
Quick Reference Instructions.
Test results are interpreted visually at 10 minutes after sample loading followed by the
instructions. The presence of two colored lines in the control line region “C” and test line region
“T” indicates COVID-19 positive. The presence of one colored line in the control line region “C”
indicates COVID-19 negative. No appearance of a colored line in the control region “C” indicates
an invalid test. Results should not be read after 15 minutes.
Quality Control
- The on/go™ COVID-19 Antigen Self-Test contains a built-in internal procedural control
that is included in the test device. A purple-colored line appearing in the control region “C”
is designed as an internal procedural control. The appearance of the procedural control
line indicates that sufficient flow has occurred, and the functional integrity of the test
device has been maintained. If the procedural control line does not develop in 10 minutes,
the test result is considered invalid and retesting with a new device is recommended. If
the internal procedural control line is still absent in the retest, please contact the Technical
Support at [phone] or visit letsongo.com/Support.
- The unique barcode on the test device contains essential device information and captured
during the test process using mobile application to ensure test validity. In the event the