Celltrion DiaTrust™ COVID-19 Ag Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid
protein and receptor binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected and adult-collected direct mid-turbinate swab samplesfrom individuals aged 14 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
This test is also authorized for non-prescription home use with self-collected and adult-collected mid-turbinate swab samples from individual 14 years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
Look for the “PEEL HERE” sign to peel openthe swab package halfway. Make sure the softtip is still covered with the packaging.
Identify the breakpoint on the swab and
break off the handle.
Remove the swab from the package. Do not touch the soft tip or lay it down on any surfaces.
You will see two notches on the handle. Make sure to hold the swab at the second notch, as pictured.
Insert the entire soft end of the swab straight
back into your nostril less than one inch (about 2 cm) or until resistance is felt.
Slowly rotate the swab, gently rubbing it alongthe insides of your nasal passage several times.
Gently remove the swab.
Using the same swab, repeat this process in
your other nostril with the same end of the swab.
Put the tip of the swab into the test tube.
Move the swab up and down at least
10 times to ensure sufficient sample
extraction is extracted.
Remove the swab while pressing against the
sides of the tube to ensure maximum amount
of liquid has been squeezed from the swab.
Put the filter cap on the opening of the test tube and immediately dispense three drops of sample extract into the sample well of device.
Click the “Completed” button and the 15 minute timer will start on the mobile application.
Read results at 15 minutes after applying the
sample. Do not read results after 20 minutes.
Click the “YES” or “NO” button on the application for the presence of red colored lines in the device window next to each of the two letters,C (Control) and T (Test). Follow the
instructions based on your test result.
PICTURE
FDA EUA #
EUA210501
EUA210501
AUTHORIZED SETTINGS
NON-PRESCRIPTION HOMEUSE
(OVER THE COUNTER)
NON-PRESCRIPTION HOMEUSE
(OVER THE COUNTER)
CATEGORY
LATERAL FLOWIMMUNOASSAY
LATERAL FLOWIMMUNOASSAY
TIME
READ RESULTS AT 15 MINS.
READ RESULTS AT 15 MINS.
SAMPLE TYPE
MID-TURBINATE NASAL SWAB (NS)
MID-TURBINATE NASAL SWAB (NS)
INTENDED USE
DETECTION OF ANTIGEN FROM
SARS-CoV-2
DETECTION OF ANTIGEN FROM
SARS-CoV-2
TEST KITS PER BOX
2
25
CONTENTS
2 TEST DEVICES
2 TEST TUBES
2 FILTER CAPS
2 SWABS
1 INSTRUCTION FOR USE
25 TEST DEVICES
25 TEST TUBES
25 FILTER CAPS
25 SWABS
1 INSTRUCTION FOR USE
SENSITIVITY SPECIFITY
SARS-CoV-2
86.7% / 99.8%
SARS-CoV-2
86.7% / 99.8%
SERIAL SCREENING TESTING
Y
Y
SHELF LIFE
12 MONTHS
12 MONTHS
MANUFACTURED IN
REPUBLIC OF KOREA
(South Korea, TAA Compliant)
REPUBLIC OF KOREA
(South Korea, TAA Compliant)
SALES INQUIRY
DiaTrust@celltrion.com
DiaTrust@celltrion.com