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 6 of 16
Chemical Name/CAS
Harms (GHS Code) for each Ingredient
Sodium Tetraborate
Pentahydrate/12179-04-3
H319 Causes serious eye irritation.
H360 May damage fertility or the unborn child.
Ethylenediaminetetraacetic acid
(EDTA)/13235-36-4
H302 Harmful if swallowed.
H318 Causes serious eye damage.
Sodium Chloride (NaCl)/ 7647-14-5
None
Triton X-100/9002-93-1
H302 Harmful if swallowed.
H315 Causes skin irritation.
H318 Causes serious eye damage.
H410 Very toxic to aquatic life with long-lasting effects.
N-Lauroylsarcosine sodium salt/137-16-6
H315 Causes skin irritation.
H318 Causes serious eye damage.
H330 Fatal if inhaled.
Storage and Stability
• Store the test kit as packaged between 1 ~ 30°C.
• The test device must remain in the sealed pouch until use.
• Do not freeze any contents of the kit.
Disposal
Dispose of all used test kit components and patient samples in household trash.
Specimen Collection and Handling
Acceptable specimen type for testing with the on/go™ COVID-19 Antigen is a direct anterior
nasal (nares) swab specimen. It is essential that correct specimen collection and preparation
methods be followed. Inadequate specimen collection, improper specimen handling and/or
transport may yield false results. Process the test swab sample immediately after collection
(specimens are stable up to 4 hours in extraction buffer). Refer to the CDC Interim Guidelines
for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease
2019 (COVID-19)
https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html
Instructions for Running the Test
IMPORTANT: Do not open kit components until instructions to do so. Follow the in-app self-
paced, step-by-step instructions or paper instructions printed on the QRI as below.