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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/nasal specimen)

Manufactured by InTec Products Inc., China - http://www.intecasi.com 

Device identification number
1783
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Card, Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, 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), 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), Respiratory Syncytial V (RSV) Type A
Pathogens detected
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, SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
2 monoclonal antibodies are used in the design of the device: 1) Mouse anti-SARS-CoV-2 specific IgG1: targeted at 44-175aa 2) Mouse anti-SARS-CoV-2 specific IgG2: targeted at 74-105aa
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.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Intended use The Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal/nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. The test is suitable for use under healthcare professional supervision. Individuals should have appropriate training in how to administer the test correctly.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colorimetry
LOD
425 TCID50/ml
Analysis of cross reactivity
Evaluated
False positives
0.4 % (2 in 1026 cases)
False negatives
4.5 % (20 in 484 cases)
Precision
Evaluated
Accuracy
98.8 % (95%CI: 97.8%~99.0%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.5 % (95%CI: 93.7%~97.3%)
Clinical Specificity
99.6 % (95%CI: 99.3%~99.9%)
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