Second Edition (NCCLS document CA2) is written for users of diagnostic laboratory tests. It offers a .. CLSI Laboratories (PA) HA3. Procedures for the Collection of Arterial Blood Specimens; Approved Standard—. CLSI CA3. November Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third. For guidance on establishing or validating reference intervals, Dr. Horowitz recommends that a laboratory obtain a copy of CA3, which was.

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The RIs for uncommon sample types [e. For example, although samples remains the recommended standard, reasonable estimates of reference intervals can be made with fewer samples.

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Reference intervals: current status, recent developments and future considerations

But, once I got to the sections with specific examples, the concepts were much easier to understand. This method is an iterative approach for the derivation of multiple reference RIs simultaneously, when no exclusion of values has been made in the initial computation of the RIs. A new protocol outlined in CA3 allows a laboratory to validate a reference interval with a smaller number of samples.

Whichever method is used in the calculation of the RIs, detection and exclusion of the outliers are very important to obtain reliable RIs. This standard is also available to be included in Standards Subscriptions. Partitioning of nongaussian distributed biochemical reference data into subgroups.

At a more complex level, Bhattacharya analysis can be used to assess the proposed intervals Clinical chemistry reference values for year-old apparently healthy persons. The most suitable transformation method must be selected e. Written informed consent from participants is needed from each reference individual who agrees to participate in the study.


Common reference intervals the IFCC position. Author information Article notes Copyright and License information Disclaimer.

Transference and Validation of Reference Intervals

Published online Feb 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.

Open in a separate window. Prerequisites for use of common reference intervals. Reference values are calculated specific to health whereas CDLs indicate sensitivity to disease If more than 2 of the 20 samples fall outside these limits, a second 20 reference specimens 20 should be obtained.

Reference intervals: current status, recent developments and future considerations

It has also been reported that genetic and environmental factors are important in modulating HDL cholesterol concentrations in Turks Recent developments to determine accurate, age-specific reference values for glucose, protein concentrations and white blood cell counts in CSF, amniotic fluids and aspirations in a large population of neonates and young infants will bring literature up to date at a time when molecular tools are commonly used in clinical practice 83 When an analyte requires age or sex partitioning, CLSI suggests that validation of 1 partition may lead to accepting the validity of other partitions.

The common RIs reported in the multicenter study should be validated locally, using reference specimens from healthy individuials in the local population as recommended by CA3 and recent C-RIDL studies.

Stratification by age and gender is the minimum pre-requisite and other means include race, ethnicity, body mass index or nutritional habits Lower and upper reference limits were determined for the 4 platforms from slope and y -intercept values determined by either least squares or Deming regression analysis.


However, this may depend on various factors such as analyte concentrations, different forms, or matrix issues, in particular for pediatric partitions The results of measurements on these samples for a given analyte will produce a temporal series, forming a baseline against which future results will be judged. Colour coding for blood collection tube closures-a call for harmonisation.

Where a laboratory uses a method known to be biased compared with the method used to set the reference interval, this interval cannot be used. Validating common reference intervals in routine laboratories.

Transference and Validation of Reference Intervals | Clinical Chemistry

You may delete a document from your Alert Profile at any time. Prossesing data for outliers. This problem can be overcome by gathering large populations of reference individuals The most significant step in this area has been taken by Adeli et al.

Add to Alert PDF. Due to the increasing numbers of multi-centric studies in recent years, there was seen to be a need for a detailed protocol. The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter C8-a3 studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs. Before the calculation of intervals, subjects were first excluded according to various parameters including increased body mass index, history of chronic or metabolic disease, acute illness, or use of prescribed medication a month before sample collection.

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