SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)
Manufactured by Shenzhen Microprofit Biotech Co. Ltd., China - www.microprofit-bio.com
Device identification number
1178
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
spike protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
www.microprofit-bio.com
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
39 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
13.71 %
Precision
Evaluated
Accuracy
95.99 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
86.29 % ((Antigen))
Clinical Specificity
100 % ( (Antigen))
Type of antigen
Spike 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