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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Triplex PCR kit

Manufactured by Astra Biotech GmbH, Germany - astrabiotech.de/eng/ 

Device identification number
1132
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Endogeneous internal control (transcript of one of human «housekeeping genes»); targets ORF1ab, ORF8, and N protein coding regions; nasopharyngeal swabs, oropharyngeal swabs and saliva samples; Diagnostic Sensitivity 100%; Diagnostic Specificity 100% https://astrabiotech.de/eng/products/molekulargenetische_diagnostik/sars-cov-2_/sars-cov-2_triplex/
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
Positive control
included (in vitro transcribed RNA of target regions: ORF1ab, ORF8, and N protein)
Negative control
included
Analytical Sensitivity
1000 copies of SC2 genomic RNA per 1 mL of sample
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
100 tests
Notes
Information provided by manufacturer + website

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