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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SC2Flu Triplex Fast Test (Colloidal Gold) For SARS-CoV-2 & influenza A/B antigens

Manufactured by AMPER Inc., United States - http://www.amperbio.com 

Device identification number
2872
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
See IFU
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
78 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3 %
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.12 % (SARS-CoV-2 antigen)
Clinical Sensitivity
96.88 % (influenza A antigen)
Clinical Sensitivity
97.5 % (Influenza B antigen)
Clinical Specificity
100 % (influenza A antigen)
Clinical Specificity
100 % (Influenza B antigen)
Clinical Specificity
100 % (SARS-CoV-2 antigen)
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