COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

NADAL COVID-19 IgG/IgM Test (243003N-25 and 243001N-10)

Manufactured by Nal von minden GmbH, Germany - https://www.nal-vonminden.com/de/

Device identification number

289

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Physical Support

Lateral flow

Target

Antibody, IgG, IgM

Specimen

Whole blood

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

Method

Immunoassay

Measurement

Qualitative

Time

10 minutes

Calibration

Not Evaluated

Crossreactivity

Reported as possible

Precision

Not Evaluated

Robustness

Not Evaluated

Clinical Sensitivity

94.1 %

Clinical Specificity

98.2 %

Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2
Diagnostic accuracy of two commercially available rapid assays for detection of IgG and IgM antibodies to SARS-CoV-2 compared to ELISA in a low-prevalence population
Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies
Comparison of SARS-CoV-2 serological tests with different antigen targets

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