SARS-COV-2 ANTIGEN TEST KIT (COLLOIDAL GOLD) - SALIVA
Manufactured by Shijiazhuang Hipro Biotechnology Co. Ltd., China
Device identification number
2545
CE Marking
×No
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The sensitivity was 98.60% (95%CI: 96.04%~99.24%). The specificity was 97.0% (95%CI: 96.62%~99.84%). The accuracy was 98.27% (95%CI: 97.46%~99.08%)
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.81 %
False negatives
0.67 %
Precision
Evaluated
Accuracy
98.27 % (95%CI: 97.46%~99.08%)
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
98.6 % (95%CI: 96.04%~99.24%)
Clinical Specificity
97 % (95%CI: 96.62%~99.84%)
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