바이오젠텍

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