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BZ COVID-19 IgM/IgG

Home PRODUCT BZ COVID-19 IgM/IgG

Intended Use


BZ COVID-19 IgM/IgG is a rapid, qualitative and convenient immunochromatographic in vitro assay for the differential detection of IgM & IgG antibodies to SARS-COV-2 virus in human serum, plasma or whole blood samples.



Clinical Evaluation


BZ COVID-19 IgM/IgG Allplex™ 2019-nCoV Assay
Positive Negative Total
Positive IgG+/IgM+ 22 0 22
IgG+/IgM- 1 0 1
IgG-/IgM+ 5 0 5
Negative IgG-/IgM- 2 30 32
Sub Total 30 30 60
Clinical sensitivity : 93.3% (28/30)
Clinical specificity : 100% (30/30)
Positive % agreement : 93.3% (95% CI : 79.19 to 99.23%)
Negative % agreement : 100.00% (95% CI : 87.66 to 100%)

During the clinical evaluation study, 30 positive specimens were serially collected from
symptomatic subjects to observe any potential seroconversion status. Serum samples
were collected and tested from 1 to 32 days after the provided symptom onset date.
The evaluation study results are presented in the table below:
Days from symptom onset to blood collection Number of RT-PCR positive samples BZ COVID-19 IgM/IgG performance against days from sympton onset to blood collection
IgM-/IgG- IgM+/IgG- IgM+/IgG+ IgM-/IgG+
% Count % Count % Count % Count
≤7 days 8 25% 2/8 0% 0/8 62.5% 5/8 12.5% 1/8
8-14 days 5 0% 0/5 0% 0/5 60% 3/5 40% 2/5
15-21 days 10 0% 0/10 10% 1/10 90% 9/10 0% 0/10
22-28 days 4 0% 0/4 0% 0/4 75% 3/4 25% 1/4
29-32 days 3 0% 0/3 33.3% 1/3 66.7% 2/3 0% 0/3
Total 30 - 2 - 2 - 22 - 4


IFU