바이오젠텍

BZ QPCR COVID-19 kit is an in vitro diagnostic medical device for qualitatively analyzes of novel coronavirus(COVID-19) N gene and RdRP gene from human sputum, oropharyngeal swab and nasopharyngeal swab by real-time RT-PCR

Performance Data

■ Analytical sensitivity (Limit of Detection)

Target	Nasopharyngeal Swab	Sputum
N gene	10 copies/µl	10 copies/µl
RdRP gene	10 copies/µl	10 copies/µl

■ Inclusivity
2324 alignments showed 100% identity of N gene primer set of the BZ QPCR COVID-19 Kit to the available 2019-nCoV sequences with the exception of one nucleotide mismatch in 8 strain sequences (3 forward primers, 2reverse primers and 3 probes).
3230 alignments showed 100% identity of RdRP gene primer set of the BZ QPCR COVID-19 Kit to the available SARS-Cov-2 sequences with the exception of one nucleotide mismatch in 3 strain sequences (1 forward primer and 2 probes).
In silico analysis showed 100% identity of N gene & RdRP gene primer set of the BZ QPCR COVID-19 kit to the available SARS-Cov-2 sequences.

■ Cross-Reactivity

Organisms	Test
Avian Coronavirus, Massachusetts (formerly Avian Infectious Bronchitis Virus)	N/A
Human Coronavirus (HCoV), NL63	N/A
Canine Coronavirus, UCD1	N/A
Middle East Respiratory Syndrome Coronavirus (MERS-CoV), EMC/2012, Heat-Inactivated	N/A
SARS-CoV, Gamma-Irradiated and Sucrose-Purified	N/A
Kilbourne F113: A/England/42/1972 (HA, NA) x A/Puerto Rico/8/1934 (H3N2), Reassortant X-37	N/A
Influenza B Virus, B/Florida/4/2006 (Yamagata Lineage)	N/A
Human Respiratory Syncytial Virus, A2000/3-4	N/A
Measles Virus, Edmonston	N/A
Human Astrovirus Type 1, Oxford	N/A
Human Astrovirus Type 2, Oxford	N/A
Klebsiella pneumoniae, Isolate 1	N/A
Klebsiella oxytoca, Strain MIT 10-5244	N/A
Leptospira interrogans, Strain HAI0156 (Serovar Copenhageni)	N/A
Mycobacterium abscessus, Strain #103	N/A
Mycobacterium avium subsp.avium, Strain 2285 Smooth	N/A
Mycobacterium intracellulare, Strain 1956	N/A
Staphylococcus aureus strain AIS	N/A
Staphylococcus aureus strain MRSA	N/A
Streptococcus pneumoniae, Strain TCH8431	N/A
D.W	N/A

■ Clinical Evaluation

		Comparator #1		Total
		Positive	Negative
BZ QPCR COVID-19 kit	Positive	2	0	2
	Negative	0	5	5
Total		2	5	7

Clinical sensitivity : 100% (2/2)
Clinical specificity : 100% (5/5)
Positive % agreement : 100.00% (95% CI : 15.81 to 100.00%)
Negative % agreement : 100.00% (95% CI : 47.82 to 100.00%)

		Comparator #2		Total
		Positive	Negative
BZ QPCR COVID-19 kit	Positive	32	0	32
	Negative	1	30	31
Total		33	30	63

Clinical sensitivity : 96.97 (32/33)
Clinical specificity : 100% (30/30)
Positive % agreement : 96.97% (95% CI : 84.24 to 99.92%)
Negative % agreement : 100.00% (95% CI : 88.43 to 100.00%)

■ Other Features
Specimen : Nasopharyngeal or Sputum
Target genes : N & RdRP gene
Kit unit : 100 test/kit

IFU