In 2021, the Estonian Institute for Health Development (TAI) conducted a pilot study on home testing for the human papillomavirus (HPV). During the study, women from the targeted screening group were offered the option to perform the HPV test at home if they wished. TAI partnered with Synlab Estonia OÜ and the joint laboratory of the University of Tartu Hospital for providing the home tests. The hospital used tests created by a specific manufacturer for home testing, whereas Synlab used tests based on methodologies developed in their own laboratory.

According to Anu Tamm, head of the joint laboratory at the University of Tartu Hospital, the test developed by Synlab at that time did not meet the necessary quality criteria.

"You can indeed conduct the test yourself, but it's not at all easy to ensure its reliability – it requires conducting a lot of comparative tests. That's why we buy commercial tests from companies, as the manufacturers themselves have checked them, and they have validated their checks in scientific articles and elsewhere. However, when you use an in-house methodology, it's very difficult to conduct these comparative tests – it's very time-consuming and expensive, etc. It's usually not done," explained Tamm.

As a result, some HPV cases may have gone undetected in 2021 due to Synlab's testing, stated Tamm.

"I can't provide any specific numbers or anything like that, and cases can always remain undetected with other tests as well. The issue is simply that when you conduct screening, you must use a reliable method. Currently, we cannot trust a laboratory that uses its own method for screening and, secondly, did not meet the procurement requirements."

Synlab and TAI: Suspicions baseless

In a written response to ERR radio news, Kaido Beljaev, a board member of Synlab Estonia, stated that the in-house methodology used in the pilot project does not fundamentally differ from the technologies of other commercial tests – Synlab has regularly participated in internationally recognized external comparative tests and has also conducted internal comparisons with other recognized methodologies.

Kaire Innos, director of research at TAI, also stated that there is no basis for the suspicions raised by the University of Tartu Hospital.

"The sensitivity and specificity of this methodology met the requirements. The project results show that the HPV infections detected in home tests analyzed at Synlab were a few percentage points higher than those analyzed in the University of Tartu Hospital's laboratory, and also more than in the conventional screening process. So, we have no reason to believe that some HPV infections could have gone undetected at Synlab," Innos confirmed.

However, Anu Tamm suggests that the higher detection of positive HPV cases in 2021 using Synlab's methodology might indicate the unreliability of the test.

"If you don't use a properly validated test, you might find more positive cases and then also lose some of them. So, the question really is about the reliability of this test," Tamm explained.

Innos mentioned that TAI was aware of Synlab's methodology, which was sufficiently reliable and met the procurement requirements.

"They only used the in-house methodology in 2021, and in subsequent years, Synlab has also used the same commercial methodologies referred to by the joint laboratory. So, that's not an issue. I can confirm that home testing is a completely reliable way to participate in screening. Home testing has enabled many women who cannot attend regular screenings to participate in the screening process."

Currently, Synlab Estonia OÜ is TAI's contract partner for HPV home testing. Since last August, they have been using a commercial-based test (Roche Cobas 8800 HPV test), according to Beljaev. He added that due to European Union regulations, Synlab will soon need to replace most of the in-house methodologies used in their laboratory with commercial methodologies.

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