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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Detection Kit

Manufactured by GeneFirst Ltd., United Kingdom - www.genefirst.com 

Device identification number
926
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene, ORF1ab polyprotein/gene
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19 Detection Kit is a qualitative in vitro real-time PCR-based test for the detection of two targets (ORF1ab and N gene) of SARS-COV-2 in a single closed tube assay. The kit is intended for use with extracted nucleic acid from nasopharyngeal and oropharyngeal swabs.
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Self Test
No
Method
RT-PCR
Measurement
Semiquantitative
Time
72 minutes
LOD
10 copies/reaction
Positive control
ORF1ab and N genes; GAPDH (internal control)
Negative control
0
Clinical Sensitivity
98 %
Clinical Specificity
99 %
Throughput
Single tubes

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