Transference and Validation of Reference Intervals

(ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.

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“…Tate et al [20] published recently a critical review. Some examples are given, including the Canadian study from …”

Section: Other Procedures For Transferring and Validating Reference Imentioning

confidence: 99%

“…Tate [20] also offers as an alternative approach to mining data from its own laboratory. This approach is acceptable only if the laboratorian is able to identify healthy individuals not affected by a disease.…”

Section: Adeli Et Al and Those From Koerbin Et Al In Australiamentioning

confidence: 99%

Recommendation for the review of biological reference intervals in medical laboratories

Henny

Vassault²,

Boursier

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…The linear structural relationship (reduced major axis regression) is used to convert the RIs. A cross comparison study with another laboratory is an approach to compare the laboratories participating in the multicenter study, using a panel of sera from healthy individuals, and recalibrating the results based on regression analysis, especially in cases where there are no standardized materials for harmonization of test results ( 18 , 19 , 61 ). The steps for the scheme of a multicenter study when all the samples from healthy individuals are collected in the participating laboratories and sent to the central laboratory for analysis are summarised in Table 1 .…”

Section: Multicenter Reference Interval Studiesmentioning

confidence: 99%

Reference intervals: current status, recent developments and future considerations

2016

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Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area. The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.

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“…The most likely reasons for this are that laboratories use different sources of information and different study designs with diverse quality when they establish their reference intervals and also when they validate them. The diversity of reference intervals may affect the interpretation of analysis results and have implications for the clinical treatment of patients (17 ). There is a need for standardization or at least harmonization of reference intervals for different immunoassays (16 ).…”

Section: Discussionmentioning

confidence: 99%

Analytical Bias Exceeding Desirable Quality Goal in 4 out of 5 Common Immunoassays: Results of a Native Single Serum Sample External Quality Assessment Program for Cobalamin, Folate, Ferritin, Thyroid-Stimulating Hormone, and Free T4 Analyses

Kristensen¹,

Rustad²,

Berg

et al. 2016

Clinical Chemistry

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Transference and Validation of Reference Intervals

Cited by 43 publications

References 10 publications

Recommendation for the review of biological reference intervals in medical laboratories

Recommendation for the review of biological reference intervals in medical laboratories

Reference intervals: current status, recent developments and future considerations

Analytical Bias Exceeding Desirable Quality Goal in 4 out of 5 Common Immunoassays: Results of a Native Single Serum Sample External Quality Assessment Program for Cobalamin, Folate, Ferritin, Thyroid-Stimulating Hormone, and Free T4 Analyses

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