Absology, a South Korean in vitro diagnostic system developer, has been cleared by domestic health authority to export its new rapid test kit used to confirm neutralizing antibodies (Nabs) within minutes after Covid-19 vaccination.
The point of care test kit dubbed `Absology Covid-19 Nab` can detect Nabs against SARS-CoV-2 within five minutes in all Covid-19 jabs available in the world, the company said on Wednesday.
Nabs, which are antibodies responsible for defending cells from pathogens, are produced naturally by the body as part of its immune response. There is a growing call for the need of Nab testing as breakthrough infections continue to be found amid vaccination push around the world.
In clinical trials conducted at Kangwon National University Hospital, the test kit demonstrated high accuracy with a sensitivity of 96.7 percent and specificity of 100 percent, said the company, adding it enables rapid and accurate monitoring of the formation of Nabs regardless of the vaccine type.
The company recently completed CE certification to allow sales in Europe. Talks are underway for exports to multiple countries including Germany, Italy, the Balkans, Japan and Southeast Asian countries. The company is also preparing for its emergency use approval application with the U.S. FDA.
Since neutralizing antibodies gradually decrease over time even after vaccination, it is important to continuously check for their presence or absence and receive booster shots at an appropriate time to maintain neutralizing antibodies in the body, said Absology CEO Jo Han-sang.
The Nab diagnosis can be confirmed simply with a small amount of blood at a medical institution or clinic equipped with an Absology assay platform, which is currently sold at around $3,000-5000 overseas. The Nab test kit is expected to be sold at around $20-30.
By Lee Byung-moon and Minu Kim
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