SARS-CoV-2 Ag Self-test Kit (Saliva)
Manufactured by Shenzhen Watmind Medical Co. Ltd., China - http://www.watmind.com
Device identification number
3042
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Saliva
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.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit is used for in vitro qualitative detection of Nucleocapsid(N) Protein antigen from SARS-CoV-2 in human saliva 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
Subclass
Sandwich, Double
LOD
150 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
9 %
Precision
Evaluated
Accuracy
95.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.79 % (95%CI:85.13%-94.43%for CT values ≤36)
Clinical Specificity
99.01 % (95%CI: 96.48%-99.73%)
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