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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Quantivirus Anti-SARS-CoV-2 IgG Test

Manufactured by Diacarta Inc., United States - https://www.diacarta.com/ 

Device identification number
3035
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Biochip, Microplate
Target type
IgG
Antibody type
Polyclonal
Targets
spike protein
Specimen
Plasma, Serum, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
single drop of fingerstick blood can be quatitative for antibody down to 0.17 ug/mL. It is useful for vaccination evoluation. See our paper Du et al 2022 Emerging Microbes &Infection https://doi.org/10.1080/22221751.2021.2023328
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
170 minutes
Subclass
Sandwich
LOD
0.17 µg/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.8 % (NPA 98.2%)
False negatives
54 % (PPA 46% (0-7 days))
False negatives
38 % (62% (8-14 days))
False negatives
2 % (98% (>15 days for sample collected on))
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.5 %
Clinical Specificity
98.2 %
Type of antigen
Spike protein

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