2020-04-14| COVID-19

United States To Procure Test Kits from COVID-19 Curbing South Korea

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

After successfully controlling the spread of COVID-19 domestically through its massive testing program, South Korea began exporting testing kits to other countries. Now, the US is buying 750,000 tests worth coronavirus detection kits, according to the Federal Emergency Management Agency (FEMA) that tendered contracts to the manufacturers.

Following a telephonic conversation between US President Donald Trump and South Korea’s president Moon Jae-in on March 25th, things have fallen in place to benefit both countries, according to Seoul officials interviewed by the news agencies. The US is now set to receive PCR based testing kits from South Korean manufacturers whose preliminary FDA approvals were expedited following President Trump’s involvement. This isn’t the first time South Korean COVID-19 kits are shipped to the US. In March, Los Angeles City Council and the Los Angeles Board of Supervisors purchased 20,000 tests from Seegene Technologies, a US division of Korea’s Seegene Inc. However, the current procurement by the US federal government would qualify as the first bulk order from the country.

SolGent, SD Biosensor, and Osang Healthcare are the three South Korean manufacturers who had signed the contract. The first shipment of 150,000 tests manufactured by SolGent is reported to be already delivered over the weekend. The remaining 600,000 from SD Biosensor and Osang Healthcare are set to arrive before April 15th and would be purchased by FEMA for $5.2 and $3 million respectively. New reports claim that SolGent has received yet another order of 7,500 kits with each capable of performing 100 coronavirus tests. That will almost double the US’s testing capacity to 1.5 million tests.


South Korea’s Effective Coronavirus Battle

South Korea’s strategies against COVID-19 is an admirable one. With extensive contact tracing initiatives, systematic and rigorous early testing regimes, and social distancing measures, it has successfully managed to flatten the curve on Coronavirus. From being the largest outbreak outside of China at one time with 850 daily cases in early March, the number has now significantly plunged below 30.

A big breakthrough came when Korea’s Ministry of Food and Drug Safety (MFDS) and the Korea Centers for Disease Control and Prevention (KCDC) worked together to approve kits from a pool of 64 candidates submitted between January 28th to February 28th. Initially, four COVID-19 detection products were approved for urgent use. SolGent, SD Biosensor, Kogene Biotech, and Seegene were the four companies that received initial approval. All of them are members of the In-vitro Diagnostic Business Association, an affiliate of KoreaBio originally set up in 2011, and presently comprising of 80 local diagnostic product manufacturers. Following the outbreak of the disease, the association had worked energetically to meet both domestic as well as global demand for diagnostic kits. Apart from these four, companies like Wells Bio also exports its careGEN N-CoV RT-PCR Kit.


Antibody-Based COVID-19 Kits

Due to the long incubation nature of SARS-CoV-2, a surge in asymptomatic patients and increased demand for testing were anticipated ahead of time. KoreaBio had indeed stressed that the review of antibody-based detection products was one of KCDC’s priorities. To prevent community spread, rapid antibody-based test screenings were strongly recommended as a supplement to genetic tests. Although antibody-based test results increase in accuracy only a week after infection (when enough antibodies are developed), the ease of use, quick result, and lower variation make it a practical option.

KoreaBio had expressed that the requirement for diagnostic kits, especially the lab-free antibody tests are huge in some countries. While the export market is dominated by kits manufactured in China, there is still a preference for South Korean products in the global market. The country has also approved several antibody-based tests for export. The most prominent one, Sugentech Inc.’s antibody rapid diagnostic kit ‘SGTi-flex COVID-19 IgG/IgM’, has already received CE-IVD certification and is currently exported in over 20 countries.

Related article: India’s First Homemade COVID-19 PCR Kit Commercially Approved by Government



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