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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (2019-nCoV）RT-PCR Detection Kit (Lyophilized)

Manufactured by Shanghai Chuangkun Biotech Inc., China - www.chkbiotech.com 

Device identification number
2421
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Chip
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, MERS-CoV, SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Information provided by the manufacturer. Target: Nucleic acid
Assay Type
Unknown
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Qualitative
Time
70 minutes
Subclass
JRC-S
LOD
500 cpu
LOD
500CPU
Positive control
100 % (All the positive controls detection results are positive (the positive detection rate=100%）and the CV of Ct Value is ≤5% for ORF1ab and N gene.)
Negative control
100 % (All the detection results are negative (ORFlab and N gene).)
Analytical Sensitivity
95 %
Analytical Sensitivity
95
Analytical Specificity
100 %
Analytical Specificity
100

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