Korea’s first antibody test kit for COVID-19 closer to FDA’s nod with superiority data

2020.05.29 14:07:10 | 2020.05.29 14:07:35

Plexense Inc.이미지 확대

Plexense Inc."s chief executive Kim Ki-beom

A new COVID-19 antibody test kit developed by Plexense Inc., a Korean immunoassay platform developer, has demonstrated superiority to already FDA-approved American and German comparators in sensitivity and specificity endpoints in a recent clinical trial, the company’s chief executive Kim Ki-beom told Maeil Business Newspaper on Thursday.

The company is aiming to launch ACCEL ELISA COVID-19, Korea’s first approved antibody test kit, in the U.S. from the second week of June under the FDA’s emergency use authorization.

The new test kit was developed with a nucleic acid protein antigen produced at state-run BioNano Health Guard Research Center under the Korea Research Institute of Bioscience and Biotechnology (KRIBB).

The kit can detect COVID-19 infection and determine whether or not the patient is free from the virus within 30 minutes. It features high accuracy (98.5 percent) in determining full recovery of the patient, complementing the limitations of a gene amplification system that uses the PCR method. It is also affordable with a price of about 10,000 won ($8) per test, while 40 to 80 people can be tested in 30 minutes simultaneously.

[Photo provided by Plexense Inc.]이미지 확대

[Photo provided by Plexense Inc.]

In a second trial of 343 people, the new test kit identified 73 COVID-19 infected patients with 100 percent sensitivity (accuracy) five days after infection, which means there was no false detection. The test kit achieved 100 percent accuracy in specificity with 251 non-infected persons tested negative, according to Plexense. However, the overall sensitivity was 94.4 percent due to average computation with 76.6 percent of sensitivity within five days after infection.

“No COVID-19 test kit currently registered with the U.S. FDA has achieved positive detection with 100 percent sensitivity after five days,” claimed Kim, adding “ACCEL ELISA COVID-19 is the only test kit to identify COVID-19 detection within 30 minutes.”

According to Maeil Business Newspaper’s analysis of data from the company, ACCEL ELISA COVID-19 was superior to those from Bio-Rad and Euroimmune already sold under the FDA’s EUA. Bio-Rad and Euroimmune are global biotech firms that represent the U.S. and Germany, respectively. ACCEL ELISA COVID-19 was ahead of them in testing speed with some 30 minutes versus at least 90 minutes of Bio-Rad’s test kit and 120 minutes of Euroimmune’s, while its superiority in sensitivity and specificity remained intact.

By Kim Si-gyun and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]