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What is a SKUP evaluation?

Information about SKUP evaluations

A SKUP evaluation is an examination of the analytical performance and user-friendliness of a measuring system. SKUP evaluations follow pre-set and common guidelines described in the protocol and are performed by the intended users of the measuring system, with fresh collected samples. The analytical performance is evaluated against pre-set analytical performance specifications, and the intended users participating in the SKUP evaluation gives their opinion on the user-friendliness in a structured and detailed questionnaire compiled by SKUP.

A SKUP evaluation gives objective and supplier-independent information on analytical performance and user-friendliness of measuring system intended for point of care testing. In addition, will a SKUP evaluation provide information about how the measuring system performs when used by the intended users of the instrument.

SKUP offers evaluations of various kind of components and measurement systems intended for point of care use, from small rapid tests to more complex systems that can measure several different components.

A SKUP evaluation includes an evaluation of the analytical performance of the measuring system when used by the intended users of the equipment.

In addition, the SKUP evaluation includes a rating of the user-friendliness of the measuring system, also rated by the intended users.

For information about how SKUP set performance specifications, please see:

Performance specifications

For information about the costs of a SKUP evaluation, please see:

Approximate costs

A SKUP evaluation takes approximately 6-7 months to complete, excluding holidays, given that no unforeseen problems arise.

Note that the epidemiology of some components (e.g., Influenza A/B, Streptococcus pyogenes) are strongly related to season for outbreaks, and the practical work must therefore be carried out during the relevant season for such evaluations.

If the measuring systems/test are available (launched) on the Scandinavian market, SKUP will always publish the report. For measuring systems/test that are not launched on the Scandinavian market, the report can be kept confidential upon request.

If the results from a confidential SKUP evaluation are used in marketing, or publicly by the requesting company in any form, the report will be published by SKUP.

A premarket evaluation is a SKUP evaluation of a measuring system that is not yet on the market. A pre-marketing evaluation gives useful information to the manufacturer when deciding whether to launch new measuring system or not. The results from a pre-marketing evaluation are confidential but will be published if the equipment is launched in Scandinavia.

SKUP writes the protocol for the evaluation, but both parties must accept the protocol before the evaluation can start.

SKUP writes the report from the evaluation. The report will be submitted to the requesting company for comments. SKUP will consider any proposed alterations and, if accepted, modify the report. If the requesting company disagrees with SKUP’s interpretation of the results, the requesting company may add an attachment to the report.

Based on a previous SKUP evaluation, SKUP offers supplementary evaluations following product modifications and new models.

Upon request SKUP can also perform additional experiments.

If you are a manufacturer or a supplier of a measuring system, you can order an evaluation by contacting us:

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