SARS-CoV-2 Ag Self-test Kit (Nasal Swab)
Manufactured by Shenzhen Watmind Medical Co. Ltd., China - http://www.watmind.com
Device identification number
3040
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Pathogens detected
Coronaviruses (HCoV)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
This kit is used for in vitro qualitative detection of Nucleocapsid (N) Protein antigen from SARS-CoV-2 in human nasal swab samples.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
150 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.98 % (Specificity: 99.02%（95%CI:96.51%-99.73%）)
False negatives
8.6 % (Sensitivity:91.4% for CT values ≤30.)
False negatives
8.46 % (Sensitivity: 91.51% for onset of symptoms within 7 days.)
Precision
Evaluated
Accuracy
93.83 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
% Sensitivity:91.4% for CT values ≤30.
Clinical Sensitivity
8.46 % (Sensitivity: 91.51% for onset of symptoms within 7 days.)
Clinical Specificity
99.02 %
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