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 (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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