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.

Author: Mazukora Yoktilar
Country: Algeria
Language: English (Spanish)
Genre: Automotive
Published (Last): 27 November 2004
Pages: 117
PDF File Size: 16.68 Mb
ePub File Size: 13.31 Mb
ISBN: 928-3-14735-727-3
Downloads: 58881
Price: Free* [*Free Regsitration Required]
Uploader: Tern

In addition, they may be collected in a defined order and may not be mutually independent. Of 27 tested clei, 19 gave acceptable bias for a common reference interval Transference and Validation of Reference Intervals.

Reference intervals: current status, recent developments and future considerations

C228-a3 example, although samples remains the recommended standard, reasonable estimates of reference intervals can be made with fewer samples. The common RIs reported in the multicenter study should be validated locally, using reference specimens from healthy individuials in the local population as recommended c28-w3 CA3 and recent C-RIDL studies. As laboratories put new test systems into use, they are required by accreditation and certification bodies to verify or establish performance specifications, including reference ranges.

Any significant bias will result clsk misclassification of too many patients. Selection of individual for the production of reference value. Procedures for transfer and validation of reference intervals. The theory of reference values: The comprehensiveness of the population analyzed ages 3—79 years means the authors provide a considerably more meaningful account of biological changes to every analyte by age and sex, a feat rarely achieved in reference interval examination.

Reading this document and following the guideline will help you derive appropriate reference intervals. A study was made of the measurement of three enzymes aspartate aminotransferase – AST, alanine aminotransferase – ALT and gamma-glutamyltransferase – GGT measured with commercial analytical systems according to the standard methods recommended by the IFCC Although laboratories are well versed in method verification and validation to assess if methods c28-3 fit-for-purpose, less importance is commonly put on selecting the most appropriate reference interval to determine whether an individual is healthy.


Solberg HE, Stamm D. Reference Intervals for Serum Creatinine Concentrations. Although some criteria, such as alcohol, tobacco and some environmental factors, may be potential exclusion criteria, amounts of consumption of alcohol and tobacco can be recorded in detail on the clxi questionnaire and the effects are evaluated statistically, primarily using multiple regression analysis MRA 18 There are a number of laboratory tests where accuracy is more important than a traditional reference is a commonly ordered interval.

Although the CA3 recommends the nonparametric calculation method, the RIs calculated by the parametric and nonparametric methods were compared in the recent IFCC, C-RIDL study which concluded that the results of the two methods are very close and parametric methods can also be used as a first choice Laboratory reference intervals during pregnancy, delivery and the early postpartum period.

Multicentric reference values for some quantities measured with the Elecsys R analyser. Please first verify your email before subscribing to alerts. The reference values of many analytes do not display Gaussian distribution, so the parametric method can be applied clsl data transformation.

Conclusion Due to the increasing numbers of multi-centric studies in recent years, there was seen to be a need for a detailed protocol. Other examples of tests that have defined decision limits are cholesterol, glucose, and neonatal bilirubin. 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.

Whether a test is normal or abnormal is perhaps the most important element of a laboratory clso. Integrating genetic and laboratory information would increase the accuracy of RIs by eliminating extreme results related to genetic variation.


Reference intervals: current status, recent developments and future considerations

Utility of panel of sera for alignment of test results in the worldwide multicenter study on reference values. We have no amendments or corrections for this standard. In a posteriori sampling, the exclusion criteria are applied after the sampling.

Jung B, Adeli Cls.

Sensitivity of the population based-RIs can be increased and thereby, the usefulness of RIs is improved by stratification of age, gender, race, ethnicity and lifestyle. 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 Although there has been increasing interest c82-a3 this subject 7475this issue remains incomplete in the same way as for pediatric RIs.

Indirect estimation of clinical chemical reference intervals from hospital patient data. A new approach for the determination of reference intervals from hospital-based data. Complex biological profile of hematologic markers across pediatric, adult, and geriatric ages: But, once I got to the sections with specific examples, the concepts were much easier to understand.

Both of these methods are known as direct sampling, which is the primary recommendation of the IFCC. Clinical necessity of partitioning of human plasma haptoglobin reference xlsi by recently-discovered rs