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

VivaDiag SARS-CoV-2 Neutralizing Antibody FIA Test Kit

Manufactured by VivaChek Biotech (Hangzhou) Co., Ltd, China - www.vivachek.com

Device identification number

2106

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC, Semi-automated

Physical Support

Cassette, Lateral flow

Target

Antibody

Specimen

Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants

Pathogens detected

Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), 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, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B

Lineages detected

B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India), P.1 (Japan/Brazil),

Commercial Status

Commercialised

Last Update

2021-05-27 03:19:21 CET

Comments

VivaDiag SARS-CoV-2 Neutralizing Antibody FIA Test Kit is for the rapid, qualitative detection of antibodies against SARS-CoV-2 in human whole blood (from fingerstick or venipuncture), serum or plasma.

Assay Type

Immuno-Antibody

Reader Required

Yes

Subcategory

Validity test kit

Method

Immunochromatography

Measurement

Quantitative

Time

15 minutes

Subclass

Neutralization Antibody (NAb)

Detection Principle

Fluorescence

LOD

30 AU

Calibration

Evaluated

Crossreactivity

Evaluated

0 % 326 negative Sample were tested and 0 of them were false positive

1.77 % (169 positive Sample were tested and 3 of them were false negative.)

Precision

Evaluated

Accuracy

99.39 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.22 %

Clinical Specificity

99.9 %

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