FHI members come up with faster testing methods for detecting corona

With a second wave of corona sweeping across the Netherlands, the demand for tests is high. The pressure on GGDs and laboratories is also increasing by the day. There is now some hope with the arrival of rapid tests in various forms. Many FHI members are busy developing such tests. We spoke to two members of the FHI Laboratory Technology sector. They are bringing products to the market that enable large-scale and rapid testing for the COVID 19 virus. Martin Donker of Isogen Life Science and Barry Leenders of Sanbio BV give us insight into the current state of affairs.

By: Dimitri Reijerman

At the end of October, Minister of Health Hugo de Jonge announced that seven extra large test locations will become available where rapid tests can also be performed. There, they can be subjected to the LAMP test developed by TNO, which can provide a result within three quarters of an hour. According to the ministry, this test is just as reliable as the regular PCR test, which takes an average of 24 to 48 hours.

In addition, antigen tests must be performed in the test lanes, as well as a breath test. These rapid tests serve as a gatekeeper to filter out negative cases immediately. Positive cases must still receive a PCR test.

Isogen Life Science

Isogen Life Science, the company of CEO and medical biologist Martin Donker, was involved in the development of the LAMP test of TNO. LAMP, which stands for Loop mediAted isotherMal amPlification, works with a constant process temperature, which saves time. Donker: “As Isogen, we are involved in the TNO project. We participated in the initial phase, not so much with products but with offering brainstorming and support. We are now working on making LAMP more efficient, in which we can use our own equipment.”

But Isogen is doing more in the field of corona tests, for example initiatives to improve PCR tests. Because some rapid tests may be too insensitive, says Donker: “But PCR tests have been used the most and most sensitive so far. The various rapid tests that work without an amplification step will certainly have a place in the fight against corona. To date, I hear that these tests can measure well up to a certain CT value. This may be able to determine a direct risk of infection for the environment. However, you cannot rule out that there is an infection.”

Isogen Life Science, a member of the FHI Laboratory Technology sector, has therefore started working with partners to accelerate the PCR process by developing Fast-PCRs. The CEO says: “The PCR kit remains the gold standard because this test amplifies what you get from the sample and is therefore very sensitive.”

Donker explains how the RT-PCRs work: “We are actually doing the same as current PCRs and even taking a step back in time from PCR. Each PCR cycle actually goes through three steps with increasing the temperature. In total, these cycles are repeated forty times for a corona test. We use the concept of the old water bath method. In the NEXTGENPCR machine, there are three positions between which the PCR plate is moved to perform a cycle. Because the heating time of the three steps in PCR is eliminated, you can reduce the total time enormously. As standard, we reduce between 40 and 60 percent of the time with this. With further optimizations, we can currently limit the RT-PCR step to 27 minutes, probably even to just 16 minutes. However, the need for 16 minutes is not there, because it takes time to get samples PCR-ready and that is about half an hour. “If we could shorten the turnaround time to the RT-PCR step, we expect we can make our tests even faster.”

He continues: “We also use a different well plate in the NEXTGENPCR. In addition to better heating of the samples, we also provide a different sourcing of PCR plates. This has major advantages as the pressure on all known and existing plastics is increasing enormously worldwide and we can therefore easily scale up.”

Isogen is working on the development of the RT-PCR step together with the manufacturer MBS, a company from Zeeland. By working together with other Dutch companies, Isogen hopes to keep the product sourcing in the Netherlands as much as possible. The main goal of this product is, according to the CEO, “of course to quickly increase the testing capacity in Dutch laboratories”.

The RT-PCR test is currently being validated in Nijmegen, among other places. “Other hospitals are looking over our shoulders,” says Donker. “In Paramaribo and Aruba, they are already working with this system, and in the US, labs have been working with it for some time. With four NEXTGENPCRs and a plate reader, together with people who work 15 hours a day in the lab, you can test approximately 10,000 samples per lab per day. And we estimate the costs at less than a hundred thousand euros per test street for the RT-PCR.”

Donker also wants to send a thank you to the lab workers: “I take my hat off to the lab technicians who have to do this work, because it really isn’t easy. Try opening three hundred tubes in a row, and you’ll really have tennis elbow. If you have to do that all day for a test street, that’s impossible. That’s why we’re now working with other companies, including MolGen, on a de-capping device.”

Want to know more? Then follow the Isogen webinar during the Life Science & COVID-19 online knowledge weekThis webinar is scheduled for Thursday, November 26 at 11:00 am.

Sanbio BV

FHI member Sanbio BV, active as a distributor of laboratory products in the Life Sciences market, is also busy developing and supplying corona tests, including rapid tests. Barry Leenders, sales manager at Sanbio, talks about a close collaboration with a Chinese partner: “We work together with Wantai, a reliable and market-recognized leading company from China with whom we have been doing business for more than ten years. This company has been developing and manufacturing ELISA tests for infectious diseases in particular for years. A major focus area of Beijing Wantai is hepatitis. They have developed hepatitis E ELISA kits, among other things. Many laboratories buy these tests from us.”

Leenders continues: “From that relationship, Wantai launched ELISA kits on the market in January for total antibodies, intended to determine antibodies, and an IgM ELISA kit. We started doing market research to see if these tests could mean something for laboratories we work with. At that time, Corona was still emerging in the Netherlands and initially there was a cautious response to these antibody tests. But eventually, several laboratories in Germany and the Benelux started testing, partly thanks to the good name Wantai has in the market. This resulted in: this test is fantastic and offers what we want to measure. An ELISA antibody test, a blood test, of about two hours.”

Because group immunity was gradually seen as the escape, laboratories started testing more frequently. One result was an order for a million tests by the Ministry of Health, Welfare and Sport so that immunity can be measured on a large scale in the Netherlands. The ELISA tests that Sanbio BV supplies will not appear in the test lanes of the GGDs. Leenders explains: “At the moment, sick people are tested by the GP or the GGD. They get a PCR test. Then you are positive or negative. If you are positive, you will start producing antibodies after a few days. These can be measured with the ELISA antibody test. These tests are therefore not used to determine whether someone has corona.”

In addition to the ELISA, the Chinese partner company also has an antibody rapid test available, says Leenders: “Wantai has launched a serological RAPID test on the market to be able to quickly perform antibody determinations. We have supplied this here and there, but we notice that the ELISA kits are easier to handle and a number is rolling out. The RAPID kit is still used for small studies in the “field”.”

Wantai has now developed 2 different antigen tests for the 'preliminary phase' that can be placed next to the PCR: "Another dimension is added because the next step is more rapid tests," says Leenders. "These are antigen tests, Wantai has the SARS-CoV-2 Ag Rapid Test (Colloidal Gold) and a SARS-CoV-2 Ag Rapid Test (FIA) available. The tests from Abbott and BD have already been approved. So Wantai also has such a rapid test to determine whether you are carrying the virus."

Currently, Wantai's Antigen rapid tests are being validated by a number of renowned laboratories in the Benelux and Germany. Leenders: "We are waiting for the test results before we start offering these rapid tests in large numbers. The quality of the products offered by Sanbio BV remains the most important. It is of social importance that only high-quality products are sold on the market."