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Covid 19 – Types of Serology Assays

Learn about the role data has played in understanding Covid-19. Get information on the types of serology assays available

Since the outbreak of Covid-19 in December 2019, scientists, researchers, and doctors have been working to find ways of tackling the virus. Not so much has been uncovered, especially in regards to a cure and vaccine. So far, testing, observing data, and conducting clinical trials is the progress that has been made. It has done a lot in helping manage coronavirus as the data has been used to demonstrate the prevalence and establish efficient treatment options. 

Different types of serology assays are being used to look for coronavirus antibodies in the blood.

1. CRISPR-based lateral flow assay

The CRISPR-based lateral flow assay was developed in the US on March 10, 2020. The company behind the development of this serology assay is Broughton et al. (Mammoth Biosciences). CRISPR-based lateral flow assay demonstrates a sensitivity of 90% and a specificity of 100%, which meets the accuracy requirements of Covid-19 tests. 

This test is able to detect the RNA for both E and N genes. This assay, which is identified as the DETECTR assay, does not focus on looking at a patient’s antibodies. Instead, it targets the viral RNA. The test does so through the isothermal amplification of the patients’ DNA, a process that attributes to the assay’s accuracy. However, the release of the assay is yet to be decided upon as it is still in the pre-clinical development phase.

2. ELISA

ELISA serology assay was developed in the US on April 6, 2020. The company backing the development of this serology assay is Klein lab, JHSPH. ELISA serology assay tests IgM and IgG, where the spike protein’s receptor-binding domain is used to detect the presence of the mentioned antibodies. To further develop the test, the lab is working towards getting a mucosal IgA. 

The release date of the test is yet to be released. However, the test is being used for research. The ELISA serology kit is currently being used to test samples in John Hopkins Hospital, and it is still in the pre-clinical phase. 

3. RDT

Covid Antibody Diagnostics and Abacas Pharma International have an RDT serology assay for Covid-19. The company already has a Made in the USA test kit known as COVID RAPID for the Novel Corona Virus (SARS-CoV-2) A 15 minute IgM/IgG Rapid Test Kit. for the Novel Corona Virus (SARS-CoV-2) 

The IgM/IgG serology assay is for testing coronavirus antibodies in the patients’ blood samples. This can be done in conjunction with test kits for collection through nasal swabs to test for the SARS-CoV-2 antigen. 

As of May, 23 2020, our API kits show an aggregate of 93.44% Sensitivity & 98.04% Specificity on a sample size of 1,794. Switzerland, Belgium and Harvard showed 100% Specificity and accuracy on approximately 500 patients. 

Most of the test kits in the market have not been able to show accurate results, limiting the determination of the prevalence of the virus in a population. API kits have been shown to possess  100% specificity in the presence of Covid-19 antibodies. The best part is that the API kits capture even asymptomatic cases. That is 6 out of 10 of the cases. 

The kit is also able to capture current and past infections. Note that this is something that different agencies that are tackling Covid-19 are struggling with. This feature can be used as proof of immunity and play a big part in taking Covid-19 management to the next level. 

Paul Singh, MHA, BA

​Covid Antibody Diagnostics​™

A Natures Body Wellness Corporation, Lake Mary FL 32746 

Find us on Google under Antibody Diagnostics

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