BIOSYNEX AMPLIQUICK Respiratory Triplex
Manufactured by BIOSYNEX S.A., Switzerland - www.biosynex.com
Device identification number
1352
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
Comments
Information provided by the manufacturer: BIOSYNEX AMPLIQUICK Respiratory Triplex is an in vitro molecular diagnostic test for the simultaneous qualitative detection of SARS-CoV-2 (virus responsible for COVID-19), Influenza A & B (virus responsible for Influenza), and Respiratory Syncytial Virus (RSV) from an RNA extract obtained from a single nasopharyngeal or oropharyngeal swab.
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
Yes
Method
RT-PCR
Time
90 minutes
LOD
1 cpu
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
97 samples/run
Notes
LOD: Influenza A&B: 0.5 cpu , RSV: 1 cpu
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