SARS CoV 2 RT PCR Detection Kit
Manufactured by VivaChek Biotech (Hangzhou) Co. Ltd., China - www.vivachek.com
Device identification number
2113
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate, Strip
Target type
Nucleic acid
Specimen
Anterior nasal swab, Bronchoalveolar lavage fluid, Mid-turbinates swab, Nasal aspirate, Nasal aspiration, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS CoV 2 RT PCR Detection Kit for Detecting SARS CoV 2 is an in vitro diagnostic Real Time reverse transcription PCR assay for the qualitative detection of SARS CoV 2 nucleic acids in throat (oropharyngeal) swabs, nasopharyngeal swabs, anterio r nasal swabs, mid turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) from individuals suspected of COVID 19 by their healthcare provider.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Quantitative
Time
70 minutes
LOD
200 cpm
Positive control
RNA template
Negative control
DEPC-Treated Water
Analytical Sensitivity
99.07 %
Analytical Specificity
98.97 %
Clinical Sensitivity
99.07 %
Clinical Specificity
98.97 %
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