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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST

Manufactured by Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti., Turkey - www.cesnalaboratuvarsistemleri.com 

Device identification number
2696
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Pathogens detected
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-12-21 10:55:10 CET
Comments
This test is for clinical laboratory use only or for immediate inspection by medical personnel, not for home testing, and cannot and is not intended to be used as a basis for diagnosing and ruling out pneumonia caused by a new Covid-19 infection Screening appropriate by the general population. A positive test result must be further confirmed. A negative test result cannot rule out an infection. The kit and test results are intended for clinical reference only. It is recommended to combine the patient's clinical manifestations and other laboratory tests for a comprehensive analysis of the condition.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Other
LOD
100 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
If you react later than 15 minutes, this can lead to a false positive result
Fn
Reacting earlier than 15 minutes can lead to a false negative result.
Precision
Evaluated
Accuracy
99.07 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.3 %
Clinical Specificity
98.8 %
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