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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 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