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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Test Kit

Manufactured by Shenzhen Ultra-Diagnostics Biotec. Co. Ltd., China - www.ud-bio.com 

Device identification number
2017
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
1. For in vitro diagnostic use only. 2. Proper specimen collection storage and transit are critical to the performance of this test. 3. Use only once. 4. Do not touch the reaction area of test strip. 5. Do not use test kit beyond the expiration date. 6. Do not use the kit if the pouch is punctured or sealed not well. 7. Testing should be applied by professionally trained staff working in certified laboratories or clinics. 8. The test result should be interpreted by the physician along with clinical findings and other laboratory test results. 9. Dispose of test cards and items in contact with samples as medical waste after use. 10.Do not freeze.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
625 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.59 % (1/170 - Nasopharyngeal)
False positives
0.97 % (1/103 - Nasal)
False negatives
4.07 % (5/123 - Nasal)
False negatives
3 % (8/266 - Nasopharyngeal)
Precision
Evaluated
Accuracy
97.35 % (95%CI:95.37%-97.74% - Nasal)
Accuracy
97.94 % (95%CI:96.90%-98.14% - Nasopharyngeal)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.48 % (95%CI:93.01%-96.01% - Nasopharyngeal)
Clinical Sensitivity
95.33 % (95%CI:91.31%-96.60% - Nasal)
Clinical Specificity
99.61 % (95%CI:97.85%-99.93% - Nasopharyngeal)
Clinical Specificity
99.16 % (95%CI:95.39%-99.85% - Nasal)
Type of antigen
Nucleoprotein

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