Rapid immunoassay for COVID-19 infection
Overview
The outbreak of the novel coronavirus (COVID-19) rapidly transmit all over China and lots of countries. Although molecular test (RT-PCR) has become the standard method for diagnosis of this disease, the method have many limitations. In addition, high false negative rates were reported. There is an urgent need for an accurate and rapid testing method that quickly identify large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. GenBody COVID-19 IgWIgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (IgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood.
Comparison with molecular test
Molecular test
GenBody COVID-19 IgM/IgG
Principle | Nucleic acid test of COVID-19 |Antibody (IgM & IgG) detection in the bloods
Accuracy in the fields
- China: - 50% (Jungangilbo.2020.02.13)
- Depending on the positive of specimen and yield of gene extraction
- Before Day 6: less than 50% - After Day 7: 50-81% for IgM, 81-95% for IgG (91% for IgM+IgG)
Test time
>6 hours
10 minutes
Test cost
Very expensive
Economic
Users
Skilled & trained
Normal
Specimen Test capacity
Throat, anal, nasopharyngeal, sputum
Limited
Whole blood, serum, plasma | Possible to bulk testing
Adv/ disadvantages
- Good accurate at early stage.
- Impossible to detect at latent or asymptomatic period.
- Appropriate for early stage with limited cases of patients
- Possible to detect at latent or asymptomatic period.
- Inaccurate at from Day 0 to Day 5 after infection
- Appropriate for 5 clay-after with bulk cases of patients
Manufacture:
Korea