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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

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

Device identification number
2484
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card, Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal 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
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), 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
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 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. This test is for self-testing. The test is for self-test with self-collected anterior nasal swab samples. It is indicated for the use of individuals aged 18 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
425 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
6.36 % (7 in 110 cases)
False negatives
0 % 0 in 470 cases
Precision
Evaluated
Accuracy
98.79 % (95%CI: 97.53%-99.51%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.64 % (95%CI: 87.33%-97.40%)
Clinical Specificity
100 % (95%CI: 99.22%-100.00%)
Type of antigen
Nucleocapsid protein
Notes
Other variants detected: Delta-Plus (AY.1), Natural Wild Variant. Other pathogens tested for cross-reactivity: H7N9 avian influenza virus, Legionella, Streptococcus Pneumoniae, Enterovirus A, Enterovirus B, Staphylococcus aureus

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