BIOSYNEX AMPLIQUICK SARS-CoV-2
Manufactured by BIOSYNEX S.A., Switzerland - www.biosynex.com
Device identification number
1351
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
1 copies/μl (with extracted RNA)
Positive control
Yes, Positive Control (CTRL +) is supplied in the kit
Negative control
Yes, Positive Control (CTRL -) is supplied in the kit
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples per run
Notes
Information provided by the manufacturer: BIOSYNEX AMPLIQUICK SARS-CoV-2 is an in vitro molecular diagnostic test for the qualitative detection of SARS-CoV-2 (virus responsible for COVID-19) from an RNA extract obtained from a single nasopharyngeal or oropharyngeal swab. This test allows the detection of 2 specific molecular targets of SARS-CoV-2 located on RdRp and E genes.
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