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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

As-check

Manufactured by Asterion Otel Ä°nÅŸaat BiliÅŸim Medikal Maden Tic. Ltd. Åžti., Turkey - http://www.asterion.com.tr/ 

Device identification number
2454
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Rhinovirus A, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
As-check SARS-CoV-2 Antigen Rapid Test is intended for the qualitative detection of SARS-CoV-2 Antigen in nasopharyngeal swab specimens in vitro. The identification is based on the monoclonal antibodies specific for the Nucleocapsid (N)protein of SARS-CoV-2.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
1.7 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.008 % (3/363 with negative PCR result There 3 false positiv sample from the sample)
False negatives
0.042 % (5/117 positive PCR result 5 false negative samples did not come out of the sample)
Precision
Evaluated
Precision
Evaluated
Accuracy
98.3 % (480 samples)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.7 % (117 samples)
Clinical Specificity
99.2 % (363 samples)
Type of antigen
Nucleocapsid protein
Notes
Measles virus, Bacillus pertussis, Escherichia coli, Neisseria meningococcus, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivarius

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