바이오젠텍

Intended Use

BZ COVID-19 Ag Test is a rapid and convenient immune-chromatographic assay for the qualitative detection of COVID-19 antigen (viral nucleoprotein) from nasal swab, nasopharyngeal swab obtained from patient with signs and symptoms of respiratory infection. The device is designed to aid in the rapid differential diagnosis of COVID-19 Virus infection. This assay is not intended to be used for screening patients or as an aid for diagnosis of patients with suspected COVID-19 Ag infection, this assay is not intended for home testing (or self-testing) .The test results should be confirmed by Real-Time Reverse Transcriptase (RT)-PCR Diagnostic kit; they do not preclude COVID-19 Virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Clinical Evaluation

		Allplex™ 2019-nCoV Assay		Total
		Positive	Negative
BZ COVID-19 Ag Test	Positive	97	1	98
	Negative	3	149	152
Total		100	150	250

Clinical sensitivity : 97% (97/100)
Clinical specificity : 99.3% (149/150)
IFU