Just before Christmas, Dagbladet wrote about Trond-Arild Johansen and his wife, who together with his wife’s assistant took eleven home tests which gave a negative response to the coronavirus.
However, a PCR test gave the exact opposite answer: There, all three were infected with covid-19.
In the past year, head of department Uffe Vest Schneider at the Department of Clinical Microbiology at Hvidovre Hospital in Denmark has researched coronary tests.
To Danish TV 2 he describes the market for home tests as “the wild west” – and claims that consumers have no chance of knowing if the tests live up to what they promiser.
– We spend billions on purchasing tests, and approximately zero kroner on quality assurance of the tests. We must have a monitoring of these tests nationally or in the EU, he says to the newspaper.
– Capacity can be challenged
– Affects reliability
Also in Norway, there is now a large selection of antigen rapid tests for self-testing, which you can buy at pharmacies, in stores or via various websites.
“Self-initiated testing at home means that private individuals carry out all parts of the test chain themselves, ie purchasing, sampling, analysis and reading of the test”, writes FHI on its website.
«There are many different tests available, and both the quality of the test, ease of use and how it has been stored until sale will affect the reliability of the test. The health authorities do not have an overview of the various tests that can be purchased “, it is further stated.
Assistant health director Espen Rostrup Nakstad explains what many people do wrong when they use self-tests. Video: Dagbladet TV
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– Artificially good numbers
Uffe Schneider believes that one can not trust the data that the companies behind the home tests themselves state.
“The manufacturers are responsible for generating the data that is used for the authority’s approval, so they use samples that contain a lot of coronavirus, which makes the numbers artificially good,” he claims.
He is supported by Peter Busk, associate professor of medical biology at Roskilde University. He warns against attributing any significant value to the producers’ own figures.
– A number of manufacturers lack an independent assessment. When some of the over-the-counter quick tests say that there is a sensitivity of up to 98 percent, we know that it is wrong, he claims.
Lack of test: – Very worried
Proof of compliance with regulations
The Norwegian Institute of Public Health believes that a self-test should use antigen rapid tests that are CE-IVD mark, which can be bought at the pharmacy, among other places.
«The CE mark is the visible proof that the manufacturer has assessed the equipment in conformity and declared that the requirements in the regulations have been met. CE marking is the manufacturer’s responsibility and does not imply that the authorities have approved the equipment », informs the Norwegian Medicines Agency in Norway.
Also in Denmark, the rapid tests for home use have entered the Danish market via the so-called CE marking, but according to Danish TV 2, it is not a requirement from the manufacturers that they carry out independent scientific tests.
Uffe Schneider therefore also does not believe that the CE marking can confirm that the home tests maintain the required quality.
QUALITY ASSURED: Steinar Madsen, Director of the Norwegian Medicines Agency, emphasizes to Dagbladet that the rapid tests that are for sale for self-testing in Norway are quality assured by being CE marked. Photo: Nina Hansen / DAGBLADET
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– Never 100 percent
Steinar Madsen, subject director at the Norwegian Medicines Agency, emphasizes to Dagbladet that the rapid tests that are for sale for self-testing in Norway are quality assured by being CE marked.
– In this way, they satisfy the current rules, says Madsen.
Whether an independent assessment or scientific assessment of the tests is to be made is up to the companies that produce them, he continues.
– All tests are judged on two criteria. One is the sensitivity – that is, it has the ability to measure what it is supposed to measure. The second is the specificity – that is, what it measures is not wrong.
– At the same time, it is the case that none of these rapid tests score 100 percent on both sensitivity and specificity. Here there will be variations. In general, however, the idea is that the rapid tests are a useful supplement, at the same time as the PCR test is the key, says Madsen.
New test chaos in Oslo: – Very shocked
The Consumer Council: – No knowledge
In the article for Danish TV2, director of the Consumer Council Think, Mads Reinholdt, says that he understands that consumers are unsure whether they can rely on home tests that can be bought in Danish supermarkets.
Gunstein Instefjord, head of consumer policy at the Norwegian Consumer Council, tells Dagbladet that they have no knowledge of quality differences in self-tests in the Norwegian market.
– We believe that the health authorities, including the Norwegian Medicines Agency, must answer these questions, says Instefjord.
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