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INIST

COVID-19 IgM/ IgG Rapid Test Kit

Features

FAST
10 minutes turnaround time

SIMPLE
Tested with whole blood, serum, and plasma
10 μL of sample amount

EASY TO USE
No special knowledge required

ACCURATE
Sensitivity: 90.24%, Specificity: 97.82%
IgM/ IgG 2 tests at once

INIST COVID-19 IgM/ IgG Rapid gives clinical decision-making for patients
suspected of COVID-19 (coronavirus) infection.
INIST COVID-19 IgM/ IgG Rapid is a lateral flow chromatographic
immunoassay detecting antibodies against the SARS-CoV-2 virus.

Performance
<Total Results of Clinical Study>

AllplexTM 2019-nCoV Assay


Method
Positive Negative Total

Positive 37 2 39
INIST COVID-19
IgM/IgG Rapid
Negative 4 90 94

Total 41 92 133

- Clinical Sensitivity: 90.24 % (37/41)


- Clinical Specificity: 97.82% (90/92)

2020-06-02
Procedure

① Take Specimen
Dip the specimen collection tube into the
specimen(serum, plasma or whole blood) and take
the specimen (10㎕)

② Load Specimen
Add 10㎕ of specimen(serum, plasma or
whole blood) to sample well using
specimen collection tube or micropipette

③ Load Sample Diluent


Add 3 drops (100 ㎕) of sample diluent to
sample well

④ Read & Interpret


Read results after 10-15 minutes
(Results After 20 minutes are invalid)

Result & Interpretation Contents


1 Test Devices (25tests)
2 Sample collection tubes (25ea)
3 Sample diluent (4mL)
4 Instructions for use

Order information
1 RDT-COV

15F, U-Tower, 767 Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do 16827


Distributed By REPUBLIC OF KOREA
TEL: +82 31-660-8371 / E-mail: yooby@inistst.com

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