Veri-Q COVID-19 & Flu A/B Multiplex Detection Kit
Manufactured by MiCo Biomed Co. Ltd., South Korea - www.micobiomed.com/
Device identification number
2801
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Chip, Strip
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Veri-Q COVID-19 & Flu A/B Multiplex Detection Kit is a one-step reverse transcription real-time PCR method that uses nucleic acids extracted from NP(Nasopharyngeal) and NP/OP (Nasopharyngeal/ Oropharyngeal) mixed swab specimens from patients with respiratory infections. This is an in-vitro diagnostic medical device that simultaneously detects SARS-CoV-2 and flu-causing virus Influenza A/B.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
100 minutes
Subclass
JRC-S
LOD
cpr Influenza A/B - 6.3~100 cpr
LOD
cpr SARS-CoV-2 - 50 cpr
Positive control
Synthetic DNA of ORF3a and N gene of SARS-CoV-2, and M gene
Negative control
PCR grade water for negative control to check contamination
Analytical Sensitivity
95 %
Analytical Specificity
95 %
Clinical Sensitivity
97.14 %
Clinical 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