CHECKUP COVID-INF A/B-RSV-ADENO RAPID TEST KIT
Manufactured by Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti., Turkey - www.cesnabiotechnology.com
Device identification number
5832
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
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, 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, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (-), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, SARS-CoV-2, Varicella Zoster Virus (VZV)
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, 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, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (-), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, SARS-CoV-2, Varicella Zoster Virus (VZV)
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
A.23.1, AT.1, 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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), Other (-), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2023-01-10 11:26:59 CET
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
Detection Principle
Colloidal gold
LOD
3200 TCID50/ml ((for Covid19))
Calibration
Evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analytical Specificity
99.01 % (ınfa)
Analysis of cross reactivity
Evaluated
False positives
0.32 % (1 out of 306)
False negatives
0.49 % (2 out of 407)
Precision
Evaluated
Accuracy
99.25 % (adeno)
Accuracy
98.18 % (ınfb)
Accuracy
98.09 % (ınfa)
Accuracy
98.98 % (rsv)
Accuracy
98.98 % (covid19)
Robustness
Evaluated
Clinical Sensitivity
99.03 % (rsv)
Clinical Sensitivity
98.04 % (ınfa)
Clinical Sensitivity
98.13 % (ınfb)
Clinical Sensitivity
99.3 % (covid19)
Clinical Sensitivity
99.26 % (adeno)
Clinical Specificity
98.04 % (rsv)
Clinical Specificity
99.7 % (covid19)
Clinical Specificity
99.04 % (ınfb)
Clinical Specificity
99.06 % (adeno)
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