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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CerTest SARS-CoV-2

Manufactured by CerTest Biotec, Spain - www.certest.es 

Device identification number
1173
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Pathogens detected
MERS-CoV, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.617.2 (Delta), B.1.621 (Mu), P.1 (Gamma), C.37 (Lambda), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The buffer has SARS2 inactivation capability. The test detects equally the nucleo proteins from Alpha, Beta, Delta, Gamma and Omicrom variants.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Magnetic Electrochemical
LOD
125 PFU/mL
Crossreactivity
Evaluated
Fp
0.21 % (Nasopharyngeal swab (1/456))
Fp
0.83 % (Nasal swab (7/834))
Fn
7 % (Nasopharyngeal swab (7/100))
Fn
17.3 % (Nasa swab (27/156))
Precision
Evaluated
Accuracy
NA
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 % (Nasopharyngeal swab)
Clinical Sensitivity
82.7 % (Nasal swab)
Clinical Specificity
99.8 % (Nasopharyngeal swab)
Clinical Specificity
99.2 % (Nasal swab)
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