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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 NASOPHARYNGEAL ANTIGEN TEST

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

Device identification number
2746
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, 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 10:55:34 CET
Comments
This kit is used for in vitro qualitative detection of SARS-CoV-2 antigen. It is a lateral flow immunoassay designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 directly in the nose. This test is for clinical laboratory use only or for emergency examination by medical personnel, is not home tested and cannot and is not intended to be used as a basis for diagnosing and excluding pneumonia caused by a recent Covid-19 infection. general population. A positive test result should be further confirmed. A negative test result cannot rule out an infection. The kit and test results are for clinical reference only. It is recommended to combine the patient's clinical findings and other laboratory tests for a comprehensive analysis of the condition.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Other
LOD
TCID50/ml 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
99.69 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.3 %
Clinical Specificity
99.7 %
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