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