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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen)

Manufactured by InTec PRODUCTS, INC., China - http://www.intecasi.com 

Device identification number
2419
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Card, Cassette, Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Respiratory Syncytial V (RSV) Type A
Commercial Status
Commercialised
Last Update
2021-10-20 12:54:27 CET
Comments
PEI positive evaluated, Test-ID AT574/21.
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
425 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
6.93 % (7 false positives in 101 samples)
Fn
0 % 0 false negatives in 299 samples
Precision
Evaluated
Accuracy
98.3 % (95% CI: 96.4% - 99.2%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.1 % (95% CI: 86.4% - 96.6%)
Clinical Specificity
100 % (95% CI: 98.7% - 100%)
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