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DIRECT MID-TURBINATE SWAB SAMPLES

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NON-PRESCRIPTION HOME USE (OTC)

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RESULT IN 15 MINS

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.

 

Product Specifications

Sample type

DIRECT MID-TURBINATE SWAB SAMPLES

Storage Temperature

2 - 30°C (36 - 86°F)

Sample-to-answer time

15 mins

Clinical Performance

ㆍ All subjects
Positive Percentage Agreement: 86.7 % (95% CI: 73.8%-93.7%)
Negative Percentage Agreement: 99.8 % (95% CI: 98.7%-100.0%)

ㆍ Symptomatic subjects
Positive Percentage Agreement: 86.1% (95% CI: 71.3% - 93.9%)
Negative Percentage Agreement: 99.4% (95% CI: 96.8% - 99.9%)

ㆍ Asymptomatic subjects
Positive Percentage Agreement: 88.9 % (95% CI: 56.8%-98.0%)
Negative Percentage Agreemtn: 100.0% (95% CI: 98.6%-100.0%)

Contents

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1 Extraction buffer is provided in the sealed test tube.

OTC test device package

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Test Device Pouch for OTC Use
(Non-Prescription Home Use)

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