COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2790

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based

Physical Support

Microplate

Target type

Antibody

Specimen

Plasma, Serum

Cross-reactivity (pathogens tested)

Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV), SARS-CoV

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit is in vitro diagnostic test intended for the qualitative detection of neutralization antibody to SARS-CoV-2 in human serum or plasma (EDTA, heparin, citrate). The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit should not be used to diagnose acute SARS-CoV-2 infection.

Assay Type

Immuno-Antibody

Reader Required

Yes

Method

ELISA

Measurement

Qualitative

Time

70 minutes

Subclass

Neutralization Antibody (NAb)

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

O.D. > 0.1

False negatives

O.D < 1.0

Precision

Evaluated

Accuracy

100 %

Reproducibility

Evaluated

Robustness

Not evaluated

Clinical Sensitivity

94.4 %

Clinical Specificity

100 %