COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2134

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

IgG

Specimen

Plasma, Serum, Whole blood

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza A H1N1, Influenza A H3N2, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A

Lineages detected

B.1.427 (Epsilon), B.1.429 (Epsilon)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

TestNOW® - COVID-19 NAb Quantitative Test is an in vitro Rapid “Sandwich” immunochromatography test for the “Quantitative” detection of circulating functional Neutralizing Antibodies (NAb) Titer post COVID-19 Vaccination or after SARS-CoV-2 Infection using a Reader. TestNOW® - COVID-19 NAb Quantitative Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. TestNOW® - COVID-19 NAb Quantitative Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https://www.jimmunol.org/content/206/10/2393) TestNOW® - COVID-19 NAb Quantitative Test has been standardized against “First WHO International Standard for anti-SARS-CoV-2 Immunoglobulins” (NIBSC Code: 20/136) with excellent Correlation Coefficient (R2 = 0.99). Limit of Detection (LOD): 25 – 50 BAU/ml (Test Lot dependent).

Assay Type

Immuno-Antibody

Reader Required

Yes

Method

Immunochromatography

Measurement

Quantitative

Time

15 minutes

Subclass

Sandwich

LOD

AU 0

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

Precision

Evaluated

Accuracy

98.97 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

99.17 %

Clinical Specificity

98.67 %