Technical Bulletin

Clinical Specimens Study Report

STANDARDTM Q COVID-19 IgM/IgG Duo Test (Whole blood/Serum/Plasma)

1. Purpose and Scope

Purpose
This technical bulletin is a result of experiments conducted by China medical center in Wuhan to confirm the
performance of sensitivity and specificity with clinical specimens.

Scope
STANDARDTM Q COVID-19 IgM/IgG Duo Test
Lot No. : QCO1020001, Sub : A, Buffer : COD120001
MFG Date : 2020.02.28
EXP date : 2022.02.27

Method
The STANDARDTM Q COVID-19 IgM/IgG Duo Test has been evaluated with each paired sera specimens collected from
40 patients who came to the hospital with respiratory or pneumonia symptoms. All specimens were collected at regular
time invervals and have been tested with STANDARD Q COVID-19 IgM/IgG Duo Test(tested with capillary blood) and
RT-PCR(tested with nasopharyngeal swab specimen).

Test procedure
Followed the Instructions for Use

Results
The IgM test result of the specimens collected within 9 days from the initial PCR confirmation was as follows.
PCR
Within 9 days Total
Positive Negative
Positive 24 0 24
COVID-19 IgM
Negative 0 16 16
Total 24 16 40

The IgG test result of the specimens collected within 12 days from the initial PCR confirmation was as follows.
PCR
Within 12 days Total
Positive Negative
Positive 24 0 24
COVID-19 IgG
Negative 0 16 16
Total 24 16 40

C-4th & 5th Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Tel : +82-31-300-040 FAX : +82-31-300-0499 E-mail : sales@sdbiosensor.com Website : www.sdbiosensor.com
Conclusion
In tests with paired sera specimens, the sensitivity of the IgM test is 100%(24/24) and the specificity is 100%(16/16)
compared to RT-PCR.
In tests with paired sera specimens, the sensitivity of the IgG test is 100%(24/24) and the specificity is 100%(16/16)
compared to RT-PCR.

Attachment

C-4th & 5th Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Tel : +82-31-300-040 FAX : +82-31-300-0499 E-mail : sales@sdbiosensor.com Website : www.sdbiosensor.com
C-4th & 5th Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Tel : +82-31-300-040 FAX : +82-31-300-0499 E-mail : sales@sdbiosensor.com Website : www.sdbiosensor.com
Discussion
STANDARDTM Q COVID-19 IgM / IgG Duo Test can be used as an adjunct to COVID-19 diagnostics. Especially this
product may be particularly useful if the test result of false-negative RT-PCR test result could have occurred during the
convalescent phase of patients.

C-4th & 5th Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Tel : +82-31-300-040 FAX : +82-31-300-0499 E-mail : sales@sdbiosensor.com Website : www.sdbiosensor.com