Healfo SARS-CoV-2 Ag Saliva Rapid Test
Manufactured by Healvet Medtech GZ Ltd., China - http://www.hnhealfo.com/
Device identification number
2974
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Specimen
Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
1. False negative results can occur if the saliva is not collected properly. 2. Do not eat or drink any things for 2 hours before the test.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
For in vitro diagnostic use.
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.85
False negatives
6.6
Precision
Evaluated
Accuracy
97.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.3
Clinical Specificity
99.1
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