바이오젠텍

PRODUCT

Intended Use

In vitro diagnostic medical device that qualitatively detects SARS-CoV-2 neutralizing antibody in human serum using immunochromatography

Clinical Evaluation

BZ COVID-19 Neutralizing Ab Test	PRNT90
BZ COVID-19 Neutralizing Ab Test	Positive	Negative	Total
Positive	31	0	31
Negative	2	39	41
Sub Total	33	39	72
Positive Percent Agreement(PPA)	93.94% (95% CI: 79.77 % –99.26 %)
Negative Percent Agreement(NPA)	100% (95% CI: 90.97% – 100%)

IFU