Biocore 2019-nCoV
Real Time PCR Kit
HOW DOES IT WORK
This product qualitatively confirms the presence or absence of a new coronavirus (2019-nCoV, COVID-19) using reverse-transcription Real Time Polymerase Chain Reaction in sputum, oropharyngeal and nasopharyngeal specimens. It is an in vitro diagnostic medical device.
CONTENTS
REAGENTS
VOLUME
2019-nCoV RT PCR Reaction Mixture
1,100 ㎕
2019-nCoV RT PCR Primer/Probe Mixture
550 ㎕
2019-nCoV RT PCR Positive control
50 ㎕
2019-nCoV RT PCR Negative control
50 ㎕
SAMPLE TYPES
- Sputum
- Oropharyngeal and nasopharyngeal swabs
- RNA extract
CLINICAL PERFORMANCE
SAMPLE TYPE
Clinical Sensitivity
Clinical Specificity
Sputum
100%
95% CI: 95.4-100.0
100%
95% CI: 95.4-100.0
OP and NP swabs
100%
95% CI: 95.4-100.0
100%
95% CI: 95.4-100.0