Information about SKUP evaluations

Use of appropriate measuring systems are an important factor to secure acceptable analytical quality. To enable the users to choose measuring systems to best suit their needs, it is essential to have access to simple, concise and neutral information regarding analytical quality and user-friendliness.

A SKUP evaluation gives objective and supplier-independent information on analytical quality and user-friendliness of measuring system intended for point of care testing. The evaluations follow common guidelines.

The evaluation model

SKUP offers evaluations of various kind of components and measurement systems intended for point of care use. In principle, the end-users always participate in the evaluation. The end-users also give their opinion on the user-friendliness in a structured and detailed questionnaire compiled by SKUP. Further details about the evaluations can be found in evaluation reports published at SKUPs website.

The evaluations are carried out on assignment from the manufacturer or the supplier of the equipment. An initial written response to a request for an evaluation is given within a month. The epidemiology of some pathogens (e.g., Influenza A/B, Streptococcus pyogenes) are strongly related to season for outbreaks, and the practical work must therefore be carried out during this relevant season for such evaluations.

Some SKUP evaluations are partially performed by trained laboratory personnel in a hospital laboratory, in addition to the intended users in primary health care. If possible, SKUP evaluations are carried out with three lot numbers of test cartridges from separate productions.

SKUP evaluations follow pre-set and common guidelines. However, since SKUP evaluation protocols are continually revised and developed, results from different evaluations of the same component are not always directly comparable.

The evaluation protocol

For each evaluation, a detailed protocol is prepared by SKUP. The aim of the evaluation, the plan for the preanalytical and analytical work and the selected comparison method are presented. The protocol must be approved by both parties before the evaluation can begin.

Quality goals

To qualify for an overall “good” assessment in a SKUP evaluation, the measuring system must show satisfactory analytical quality as well as satisfactory user-friendliness.

Quality goals are determined by SKUP and presented in the protocol, together with principles for the assessments. The user-friendliness is assessed by a structured questionnaire.

Contract

A contract between SKUP and the company requesting the evaluation is signed when the protocol has been accepted by both parties. The contract contains details about the evaluation, time perspectives and evaluation costs.

Pre-marketing evaluations

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. Sometimes, equipment is not launched due to not having acceptable analytical quality and/or user-friendliness, thus SKUP helps ensure that unsuitable measuring systems are not marketed in Scandinavia.    

Supplementary evaluations

Based on a previous SKUP evaluation, SKUP offers supplementary evaluations following product modifications and new models. Prior to a supplementary evaluation, possible options must be discussed to clarify whether testing the modified properties alone is sufficient or if a full evaluation is recommended.

SKUP evaluations can also be organised with focus on a special issue or have supplementary/additional experiments. Please contact the SKUP secretariat for further information.

Costs

Information about approximate costs of a SKUP evaluations can be found at SKUP’s website. More detailed information will be provided on request.

One third of the costs agreed upon is due at acceptance of the SKUP proposal, 1/3 when the contract is signed, and the remaining 1/3 upon receival of the report. In addition, the requesting company must place the instruments, reagents, internal quality control solutions and other necessary supplementary equipment at SKUP’s disposal for the evaluation.

The evaluation report

SKUP is responsible for the processing of data and writing the evaluation report. The report is written in English. In addition, summaries will be published in English, Danish, Swedish and Norwegian. Attachments with raw data are included in the final report received by the requesting company. Raw data is not a part of the public report unless it is required for interpretation of the results.

Commenting on the report

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. Depending on its content, there may be an additional response from SKUP attached as well.

Rights and responsibilities

SKUP will contact the requesting company if any technical problems with the equipment occur during the evaluation. If preliminary calculations show unexpectedly poor analytical quality, SKUP will notify the requesting company and assist in identifying the problem.

SKUP takes no responsibility for any indirect effects of results or assessments in a SKUP report, such as loss of business profit.

For further information on rights and responsibility, please see SKUPs website.

The raw data are owned by SKUP, and SKUP reserves the right to publish results from evaluations that are not kept confidential. If the evaluated measuring system is already marketed in Scandinavia, the report will always be published at SKUPs website.

If you are interested in a SKUP evaluation or have any questions, please contact SKUP secretariate:

Christine Morken
christine.morken@noklus.no
+47 404 72 928