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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 İnşaat Bilişim Medikal Maden Tic.Ltd.Şti., Turkey - www.asterion.com.tr 

Device identification number
2454
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-16 04:58:24 CET
Comments
Intended Use The As-check SARS-CoV-2 rapid diagnostic test is an immunochromatographic per-patient test based on the sandwich principle, which contains two specific antibodies for qualitative detection of N-protein antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. An antigen is generally detectable in upper respiratory specimen during the acute phase of the infection (within the first 5 to 7 days from symptom onset). The As-check CoV-2 rapid diagnostic test can be used in symptomatic and asymptomatic people for lay users.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
1.7 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % 517 with negative PCR result There was no false positiv sample from the sample. 0/517
Fn
4.09 % ((342 positive PCR result 14 false negative samples did not come out of the sample. 14/342))
Precision
Evaluated
Accuracy
98.37 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
95.91 %
Clinical Specificity
100 %

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