VERI-Q COVID-19 Ag Rapid Test
Manufactured by MiCo Biomed Co. Ltd., South Korea - www.micobiomed.com/
Device identification number
2792
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The VERI-Q COVID-19 Ag Rapid Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swab and nasopharyngeal swab from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in sterilized swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The VERI-Q COVID-19 Ag Rapid Test is intended for use by medical professionals who are proficient in performing rapid lateral flowtests.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
1000 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
12.5 %
False negatives
0 %
Precision
Evaluated
Accuracy
96.85 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96 % (95% CI: 86.3 % ~ 99.9 %)
Clinical Specificity
100 % (95% CI: 97.7 % - 100 %)
Type of antigen
Nucleocapsid protein
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