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 5 of 16
 Children aged 13 years old and younger should be tested by a parent or legal guardian.
 Wear a safety mask or other face-covering when collecting anterior nares swab specimen
from a child or another individual.
 Wash hands thoroughly for at least 20 seconds before and after handling nasal swab
samples.
 In order to obtain accurate results, the user must follow the instructions for use.
 Immediately use after opening the test device in the pouch.
 Keep the test device on a flat surface during the testing.
 Keep testing kit and kit components away from children and pets before and after use.
 Excess blood or mucus on the swab specimen may interfere with test performance and may
yield a false-positive result. Avoid touching any bleeding areas of the nasal cavity when
collecting specimens.
 Inadequate or inappropriate sample collection, storage, and transport can result in incorrect
results. If specimen storage is necessary, swabs can be placed into the extraction vial for
up to four hours. Specimens should not be stored dry.
 When collecting a nasal swab sample, use only the Nasal Swab provided in the kit.
 Keep foreign substances and household cleaning products away from the test during the
testing process. Contact with foreign substances and household cleaning products may
result in an incorrect test result.
 Use appropriate precautions in the collection, handling, storage, and disposal of patient
samples and used kit contents.
 Handle all specimens as though they contain infectious agents.
 Do not operate your test outside of storage conditions.
 Do not use on anyone under 2 years of age.
 Do not close the App during processing as it may cause an error and you will need a new
test kit.
 Do not interpret the test result before 10 minutes and after 15 minutes starting the test.
 Do not use on anyone who is prone to nosebleeds or has had facial or head injury/surgery
in the last 6 months.
 Do not use if the test device package is damaged.
 Do not touch the tip (specimen collection area) of the swab.
 Do not use the kit contents beyond the expiration date.
 Do not eat, drink, or smoke in the area where the specimens and kit contents are handled.
 Do not interchange kit contents from different lots.
 Do not re-use any contents in the kit as they are single-use only.
 Eye and skin contact with the extraction solution should be avoided.
 Extraction solution should not be ingested.
 The extraction solution in the vial contains potentially harmful chemicals (see table below).
If the solution contacts the skin or eye, flush with copious amounts of water. If irritation
persists, seek medical advice: https://www.poison.org/contact-us or 1-800-222-1222.