EP5-A2. ISBN Volume 24 Number ISSN Evaluation of Precision Performance of Quantitative Measurement. Methods; Approved. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, EP05A2E. Clinical and Laboratory Standards Institute (CLSI) document EPA2 describes the protocols for determining the precision of a method. The precision of a.

Author: Goltikora Tauzshura
Country: Niger
Language: English (Spanish)
Genre: Marketing
Published (Last): 7 July 2007
Pages: 365
PDF File Size: 14.60 Mb
ePub File Size: 18.59 Mb
ISBN: 343-5-70130-977-9
Downloads: 83388
Price: Free* [*Free Regsitration Required]
Uploader: Kagalkree

Variance Component Analysis Description Usage Format References Description This data set consists of simulated measurements for an experiment conducted to z2 the precision performance of measurement methods. You should contact the package authors for that. Each level is run in duplicate, with two runs per day over 20 days, and each run separated by a minimum of two hours. These include pooled patient samples, quality control material, or commercial standard material with known values.

Requests to do so should be addressed to the Editor. User verification of performance for precision and trueness; approved guideline. Statements of opinion in AACB publications are those of the contributors. Note that we can’t provide technical support on individual packages. Precision claims by a manufacturer should be tested at at-least two levels, by running three replicates over five days.

For example, on day 1 the average of the three values is 2. On 20 days two separate runs with two replicates of the same sample are measured. It is generally assumed in the laboratory that the wp05 associated with repeated analysis will follow a normal distribution, also known as the Laplace-Gaussian or Gaussian distribution. The page or its content looks wrong.


CLSI now uses the term within-laboratory precision to denote the total precision within the same facility using the same equipment 1 and this term will be used for this concept throughout this paper. For more information on customizing the embed code, read Embedding Snippets. Selection and analytical evaluation of methods with statistical techniques.

Evaluating Assay Precision

Alternatively one can use the variance, which is simply the square of the SD. Open in a separate window.

There should be at least one quality control QC e0p5 in each run. Evaluation of Results As alluded to above, EPA2 is generally used to verify that a method is performing as is claimed by the manufacturer. If an outlier is found the pair should be rejected and the cause investigated and resolved before repeating the run. Description Usage Format References. Unfortunately this approach is insufficient, as it tends to under-estimate repeatability, as the operating conditions in effect at the time may not reflect usual operating parameters.

The first step is to calculate the mean of the replicates for each day, then for each result subtract the mean for that day and square the resultant value. You may delete a document from your Alert Profile at any time. No literary matter in The Clinical Biochemist — Reviews is to be reproduced, stored in a retrieval system or transmitted in any form by electronic or mechanical means, photocopying or recording, without permission.

For this, longer-term assessment is required. Linnet K, Boyd JC. We want your feedback! As alluded to above, EPA2 is generally used to verify that a method is performing as is claimed by the manufacturer.

Dr Douglas Chesher e-mail: Care must be taken in knowing which term is being referred to. R Package Documentation rdrr. We have no amendments or corrections for this standard. In order to compare the estimated repeatability to a claimed value we can calculate the critical or verification value using the equation:.


The procedures are designed for manufacturers or developers of clinical laboratory measurement methods, and for users of those methods who wish to determine ep005 own performance capabilities or to verify claims from a manufacturer.

A balance is created in the document between complexity of design and formulae, and simplicity of operation.

Evaluating Assay Precision

The next step is to calculate the variance for the daily means s b 2 using the equation. Repeatability Verification Value In order to compare the estimated repeatability to a claimed value we can calculate the critical or verification value q2 the equation: Various materials may be used to complete the assessment with either protocol.

Evaluation of precision performance of quantitative measurement methods. The following example relates to the verification of performance of calcium according to EPA2 using a five day protocol. Note, some authors refer to total variation as just the between-run component instead of combined between-run and within-run shown above.

A spreadsheet for assisting with the calculations described in this article is available from the AACB web-site. I have a suggestion.

Thus the variance of the daily means is:. Australasian Association of Clinical Biochemists Website. Embedding an R snippet on your website.