SARS-CoV-2 Real Time RT-PCR Kit
Manufactured by Baicare(Tianjin) Biotechnology Co. Ltd., China - http://www.bai-care.com/index.php?catid=27
Device identification number
2738
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-CoV-2 Real-time RT-PCR Kit is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of ORF1ab/N gene from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum) collected from individuals suspected of SARS-CoV-2 by their healthcare provider.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Qualitative
Time
35 minutes
Subclass
JRC-S
LOD
200 cpm
Analytical Sensitivity
96 %
Analytical Specificity
97.7 %
Clinical Sensitivity
96 %
Clinical Specificity
97.7 %
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements