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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Cora Gentest-19

Manufactured by Abioteq GmbH, Germany - www.abioteq.de 

Device identification number
2374
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Strip
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, MERS-CoV, Mumps Virus (MuV), Respiratory Syncytial V (RSV), SARS-CoV, Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2021-07-27 11:55:31 CET
Comments
The product is intended for in vitro diagnosis only. The test result must not be used as the sole index to evaluate the patient's condition, and the patient's clinical manifestation and other laboratory tests must be combined to perform a comprehensive analysis of the condition. Inspection of the product packaging and seal and expiration date is required before performing the test. The test should be performed as soon as possible. Exposure of the test to air and moisture for an extended period of time will result in invalid results. Overloading the specimen may cause unexpected results, such as false positives. The accuracy of the test may be affected by ambient temperature (40°C) and relative humidity (>80%).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Calibrant / control sample
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
1231 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
231 AU
Fn
1000 AU
Precision
Evaluated
Accuracy
99.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.7 %
Clinical Specificity
32676 Lügde
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