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Patient safety – the value of SKUP evaluations of point of care instruments

Elisabet Eriksson Boija1,*

1Equalis, Uppsala, Sweden

How do you know that the tests you take at your doctor’s office, or at home, show the correct results? Can you trust that you get the right diagnosis, the right kind of treatment and the right dosage? Sure, the test system (instrument, test strip, test cassette etc) are CE marked, but the CE mark does not require as good performance as we would wish for. Sure, the test system has been validated by the producer of it, but is the producer objective? SKUP, Scandinavian evaluation of laboratory equipment for primary health care, offers an independent alternative with well documented quality goals both regarding the analytical quality and the user-friendliness. The first is self explaining, but why do we acknowledge the user-friendliness? It is simply because the point of care systems usually is used by non-laboratory educated persons, such as nurses or midwifes at hospital wards or doctor’s offices or by the patients themselves. It is of great importance that the test system is easy to use to be able to get as accurate test results as possible.

SKUP is an independent group with members from Sweden, Norway and Denmark founded in 1997 as a collaboration project to increase the patient safety by performing independent evaluations of point of care instruments. SKUP also offers pre-marketing evaluations that gives useful information to the producer when deciding whether to launch the new test system or not. These results are confidential unless the system is marketed in Scandinavia. As of today, over 100 evaluations has been performed of various instrumentation analyzing e.g., glucose, PT (INR), Strep A, haemoglobin, and HbA1c. Several instruments have been stopped from reaching the Scandinavian market. The knowledge and impact of SKUP evaluations has spread around several continents.

SKUP’s vision is that all point of care instruments bought by the healthcare systems in Sweden, Norway and Denmark have been evaluated by SKUP and fulfilled all quality goals given.

Keywords: Method