The ongoing fourth wave of the coronavirus has sharply increased the need for Covid-19 testing, prompting calls for the introduction of automation equipment. However, according to industry watchers, the lack of reagents for the automated installation will likely be a major stumbling block for automated testing.
Quarantine authorities and other concerned groups have been pushing for the introduction of automation equipment since last year to reduce work overload at test sites. However, such efforts came to naught, as the volume of reagents that could be supplied to national institutions was less than 10,000 cases per day, the sources said.
Currently, healthy workers perform 200,000 to 250,000 RT-PCR tests per day.
If the country introduces automated equipment priced at several hundred million won per unit and only performs about 10,000 tests, or about 5% of the total checks, the economic effects of the machine will be a problem, they noted.
Manufacturers of automated testing equipment for Covid-19 include Roche-diagnostics, Hologic and Abbott, all of which are US companies.
The Korean Society of Laboratory Medicine had done preparatory work, such as reviewing the number of diagnostic reagents that can be supplied to Korea, in meetings with these American companies last year earlier this year. However, it was found that each of the three companies could only deliver 3,000 cases per day, less than 10,000 in total.
Even that amount may not be available as a lump sum, but would come in gradually increased volume until the end of the year or early next year, according to US companies. They will have to prioritize supplying the United States, which still sees 40,000 new cases of the virus a day, and other countries in similar situations.
“Three companies manufacture laboratory automation facilities around the world. Korea has introduced around 20 units of Roche-diagnostics products with only a few institutions using equipment from the other two companies, ”said Professor Hong Ki-ho from the Department of Laboratory Medicine at Severance Hospital, who is also the secretary of the Covid-19 Working Group.
To provide some support, the company members met with the officials of these companies to discuss the supply of reagents. Still, the companies said they couldn’t supply enough reagents for use in Korea, he added.
“Around 200,000 Covid-19 tests are performed per day. However, companies could not supply less than 10,000 cases per day. So the maximum amount that each company can provide per month was only 100,000, ”Hong said.
It would be nice to test even overnight when setting up automation facilities. However, there aren’t enough diagnostic reagents available, he said. The cost of each unit reaches several hundred million won, which is quite expensive to purchase. Apart from the price, the quantity of reagents is not sufficient, making their use ineffective at the moment.
“We have discussed the possibility of an emergency use authorization with the health authorities. However, even that made no sense if the daily supply of reagents stopped at 10,000 cases, ”he said.
Professor Hong pointed out that it is better to maximize the use of the sample collection test method in the current situation.
“Collection testing may not be perfect, but it’s the best solution right now. We could increase the number of test cases to 200,000 per day through the sample collection method, ”he said. “There is not enough staff to take samples at the moment, which increases the workload. The government should secure more sample collectors.