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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/Flu A+B/RSV Antigen Rapid Test

Manufactured by Qingdao Hightop Biotech Co., Ltd, China - www.hightopbio.com 

Device identification number
2754
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Influenza A, Influenza B, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
10000 TCID50/ml (RSV Type B)
LOD
10000 TCID50/ml (RSV Type A)
LOD
525000 TCID50/ml (Flu B)
LOD
12200 TCID50/ml (Flu A)
LOD
160 TCID50/ml (SARS-CoV-2)
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.25 (SARS-CoV-2)
Fp
2.13 % (RSV)
Fp
2.16 % (Influenza B)
Fp
2.74 % (Influenza A)
Fn
5.88 % (RSV)
Fn
6.38 % (Influenza B)
Fn
6.98 % (Influenza A)
Fn
5 (SARS-CoV-2)
Precision
Evaluated
Accuracy
96.88 % (RSV)
Accuracy
96.77 % (Influenza B)
Accuracy
96.3 % (Influenza A)
Accuracy
98.8 % (SARS-CoV-2)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (SARS-CoV-2 at Ct lower or equal to 25)
Clinical Sensitivity
93.02 % (Influenza A)
Clinical Sensitivity
93.62 % (Influenza B)
Clinical Sensitivity
94.12 % (RSV)
Clinical Specificity
99.75 % (SARS-CoV-2)
Clinical Specificity
97.26 % (Influenza A)
Clinical Specificity
97.84 % (Influenza B)
Clinical Specificity
97.84 % (RSV)
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