There are no general standards that describes what should be included in a good laboratory method description. Below, we have suggested a format that can be used as a template. However, the detail level of the description depends on the type of publication and what kind of laboratory methods are used. This may be illustrated by some examples.

1. Study types in which a detailed description is necessary (i.e. most or all of the items in the tables below):

- The laboratory methods or results are the focus of the study, e.g. diagnostic accuracy studies or method comparisons

- The laboratory results are critical for assigning patients to treatment arms, clinical decision making or for inclusion of patients

- The laboratory results are outcomes

- The laboratory tests are not commercially available (laboratory developed tests/in-house tests)

2. Study types where a detailed description is not necessary:

- Studies where well harmonized laboratory tests are used for general description of patients, or as “safety parameters” in clinical trials.

When there is a need for a detailed description a pragmatic solution can be to enter a short description in the method section and include tables with detailed information as Supplemental File. For projects that have a signed contract with the Department of Medical Biochemistry (MBK) we can assist in completing the tables below on request.

Possible example:

Laboratory analyses were performed between (time) and (time) at the Department of Medical Biochemistry, Oslo University Hospital. Preanalytical and analytical methods are described in Supplemental Table X and X.

Suggested table, particularly useful when several different sample types are used. The table can be replaced by a short text if this is more convenient, but remember to include all relevant items from the table. Information about stability of the analytes can be found for each analyte in Brukerhåndboken. RT:Room temperature, NA:Not applicable.

The table can be copied from the attached word file: Eksempel beskrivelse analysemetode.docx.

The table below is meant as an example. It will not always be necessary to include all items, and in some cases additional items may be important. In particular, remember to also include any diagnostic cut-offs that are relevant to the study. It is particularly important to get as much details as possible when collecting and comparing results on the same measurand from multiple laboratories, even for measurands quantified with the same type of instrument.

Short explanation for calibrators and traceability: The trueness of (most) laboratory tests are established with the calibrator. For tests that are traceable to an international reference material or reference method the trueness can in most cases be expected to be similar to laboratory tests performed in other laboratories that are traceable to the same calibrator (short and simplified: the level at OUS can be expected to be similar to measurement at other laboratories). For tests that do not have traceability to international reference methods stating the reference interval can help in describing the trueness of the method.

Information on instrument, reagents and calibrators is available upon request. The remaining information should be available in “brukerhåndboken”.

Remember to always include units when reporting results!

The examples in the table should not be used in publications without enquiry to MBK for updated information.

The table can be copied from the attached word file: Eksempel beskrivelse analysemetode.docx.