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 (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Card, Cassette, Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
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
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
6.93 % (7 false positives in 101 samples)
False negatives
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