Validation Manager

The numbers we don’t see in COVID-19 news

By April 16, 2020January 14th, 2022No Comments


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It has been kind of frightening to see, how much criticism there is for the low amount of COVID-19 testing, where the underlying assumption seems to be that the pace of testing only depends on money.

Money is naturally needed to enable growing amounts of testing. Yet there are multiple things that affect the schedule in which funding can lead to reliable test results.

No test gives perfect results. With COVID-19 tests the situation is no better. On the contrary. At the moment the test manufacturers are under pressure to get their tests on the market fast in high volumes, and laboratories are in a hurry buying them. Because of this emergency situation, these tests are not as well examined and validated by the manufacturers as they normally would be. That’s why it’s crucial to thoroughly verify any tests before taking them into use, as we saw in Spain a few weeks ago.

On top of that, even when the tests work ok, a negative result does not guarantee the absence of the disease. That’s why diagnostics should never solely be based on a test result. Therefore it feels a little worrying to already see marketing of home test kits. Can the buyers of these kits really understand, what conclusions can be made based on those test results, when even experts may find it difficult?

So when the news reports give us numbers of how much testing is done, we are asking, how much false results have those tests given. Some insight can be found from FIND website that gathers evaluation results of Sars-Cov-2 molecular assays.

Why does it matter?

We as people tend to trust the results we are given. It feels unlikely that my own result would be false. But statistical fact is that some of us do get false results.

Both false positive and false negative results may lead to tragedies. That’s because decisions on isolation, treatment and prioritization are based on them.

A false negative may give false feeling of security that causes a person to be less careful about infecting others. A positive result on the other hand should lead to finding people who may have been infected. Which again requires resources that are wasted if it was a false positive.

At the moment, hospitals do their best to keep COVID-19 patients separated from all the other patients. They also seek to find infected staff members early to prevent them from infecting patients treated for other reasons than COVID-19.

In Denmark, false negative test results have lead to hospital staff getting infected.

This sad incident underlines the message that has been in the heart of our work for all these years. Tests need to be thoroughly validated as part of their development process. But their performance also need to be verified before they are taken to clinical use.

There are multiple things that may affect how well a test works in a laboratory. Not all of them can be ensured by a test manufacturer. Laboratories need to have time, knowledge and resources to make sure that a new test works as expected. At the moment, none of these can be taken for granted.

That’s why we should be at least as concerned about the performance of COVID-19 tests than we are of the amount of testing.

How can we help

At Finbiosoft, we’ve witnessed a wide range of the pains in laboratory diagnostics. For years we’ve worked to make it easier for laboratories to stay on track with the quality of their test results. Validation Manager helps our users in optimizing their validations and verifications, to get them through as  fast and efficiently as possible without compromising patient safety.

Even though most of our Validation Manager users work in the field of clinical chemistry, the product was originally created to help PCR test manufacturers in their validations. That’s why we can safely say that we have a robust tool for your COVID-19 verification needs.

If there’s anything we can help you with in your verifications or validations, do not hesitate to contact us. We are here for you.

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