Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test

• July 21, 2020
• SALE Medicine & Health Care China
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Introduction

The purpose of the report is to evaluate the performance of Shanghai Outdo Biotech Co., Ltd Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test for testing clinical samples(sample type is plasma, serum and whole blood). The Shanghai Outdo Biotech Co., Ltd Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test has been evaluated in three hospitals respectively comparison toRT-PCRor clinical diagnosis.

 

Materials

Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test Lot: 20200101, Exp: Feb.2021

 

Clinicalsamples information

Total 240 blood samples were collected from the recruited 80 patients of novel coronavirus pneumoni.

 

Method

80 patients provided plasma samples for testing, 80 patients provided serum samples for testing and the remaining 80 patients provided whole blood/serum/plasma samples for sample type consistency testing. All samples have been tested in single with Shanghai Outdo Biotech Co., Ltd device, the results were compared to RT-PCR or clinical diagnosis (including chest Computed Tomography and clinical signs etc.) of “Diagnosis and treatment of novel coronavirus pneumonia”.

 

Test procedure

Followed the package insert.

Results

 Regarding the test, the result comparison to RT-PCR.

Sensitivity: 90.20% (92/102)，Specificity: 99.28% (137/138)

Conclusion

The above results showed that: Compared with RT-PCR, the sensitivity of test is 90.20% and specificity is 99.28%.

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