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.
Frequently asked questions
Why perform a SKUP evaluation?
What equipment/components can be SKUP evaluated?
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.
What does a SKUP evaluation include?
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.
How are the analytical performance specifications set in SKUP evaluations?
For information about how SKUP set performance specifications, please see:
How much does a SKUP evaluation cost?
For information about the costs of a SKUP evaluation, please see:
How long time will a SKUP evaluation take?
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.
When and how will the report be published?
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.
What is a premarket evaluation?
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.
Can the requesting company comment on the evaluation or the report?
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.
What other subjects can SKUP help me with?
Based on a previous SKUP evaluation, SKUP offers supplementary evaluations following product modifications and new models.
Upon request SKUP can also perform additional experiments.
How can I get a SKUP evaluation of my measuring system?
If you are a manufacturer or a supplier of a measuring system, you can order an evaluation by contacting us: