SARS-CoV-2 Antigen Rapid Test Kit-PRO (Colloidal Gold)
Manufactured by JOYSBIO (Tianjin) Biotechnology Co. Ltd., China - https://en.joysbio.com/
Device identification number
2813
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, 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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, 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 test is evaluated by PEI in Germany and marked as passed evaluation. It is listed as "Joysbio SARS-CoV-2 Antigen rapid test kit - PRO (Colloidal Gold)" in the PEI evaluation list.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
120 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.44 % (1 out of 224 RT-PCR negative specimens)
False negatives
1.81 % (2 out of 110 RT-PCR positive specimens)
Precision
Evaluated
Accuracy
99.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.18 %
Clinical Specificity
99.55 %
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