SERO: pioneering trust in medical laboratory diagnostics

Modern medicine is practiced just as much in the laboratory as in the clinic. Laboratory analyses of human samples are essential for accurate diagnosis and selecting the best course of treatment. But how can we be sure that the methods and equipment used yield reliable results? The answer lies in laboratory quality control, a field significantly advanced by innovations from Norway.

Read more: SERO – a pioneer in quality control materials

“Biotechnicians who work with laboratory analysis are like air traffic controllers. They ensure that everyone is safe and there are no accidents. In medicine, a catastrophe would be a wrong lab result,” explains Kernstock.

SERO provides high-quality materials for the quality control of laboratory analytical instruments. “We improve patient care by ensuring that analyses give reliable, comparable results from day to day and between laboratories,” says Kernstock.

The company has been a pioneer and leader in quality control materials since the 1950s, when control sera were first developed by Professor Lorentz Eldjarn at Oslo University Hospital. Thirteen years later, SERO was established, launching the world's first commercially available control serum, Seronorm®.

Read more: SERO – dedicated to laboratory quality since 1963

“We were the first to offer a consolidated control serum, and we have continued to innovate. Today, our Seronorm® Immunoassay Control contains more than 50 analytes within one bottle, capable of controlling a substantial number of different tests,” he adds.

SERO produces independent third-party control materials, meaning that the company does not collaborate with instrument manufacturers — a principle which aligns with the ISO standard for quality and competence in medical laboratories.

SERO’s patient-like materials engender trust

Only commutable, or patient-like, control material can be trusted to reveal how malfunctions in the analytical system may affect patient samples. Studies show that many quality control materials do not meet this standard, presumably as the materials are far from commutable or patient-like.

To ensure the best commutability, most of SERO’s products contain more than 95 per cent human serum with no stabilisers or preservatives added. “Our strength is our patient-like material. We use as much genuine human plasma as possible,” says Kernstock.

Additionally, the company aims to produce universal controls that are compatible on all analytical platforms.

The global in vitro diagnostics (IVD) quality control market is expected to reach USD 2.28 billion by 2031, growing at a rate of 4.5 per cent between 2024 and 2031. Globally SERO is the oldest, and one of the five most competitive companies, participating in this market. It has international partners on all continents and exports 90 per cent of its production.

“On the B2B side, our strength lies in our international reach. We can register products worldwide for IVD companies due to our established local presence,” Kernstock adds.

“SERO has proven its potential. It represents the mature side of the Norwegian health and life science industry,” he concludes.