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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

TestNOW® - COVID-19 NAb Quantitative Test

Manufactured by Affimedix, Inc., United States - www.affimedix.com 

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
2022-04-20 12:09:38 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
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
98.97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.17 %
Clinical Specificity
98.67 %

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