EP05 A2 PDF

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.

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The assessment is performed on at least two levels, as precision can differ over the analytical range of an assay. Thus we need to find the For the purposes of this example the results of only a single level are shown Table 1. What can we improve?

Evaluating Assay Precision

As alluded to above, EPA2 is generally used to verify that a method is performing as is claimed by the manufacturer. Requests to do so should be addressed to the Editor.

It is generally assumed in the laboratory that the variation associated with repeated analysis will follow a normal distribution, also known as the Laplace-Gaussian or Gaussian distribution. Precision claims by a manufacturer should be tested at at-least two levels, by running three replicates over s2 days.

Introduction Part of the process of verifying or validating a method to confirm that it is suitable for use is an assessment of precision. However, if the values achieved are greater than those reported by the manufacturer, z2 statistical test eep05 to be performed to determine whether this difference is statistically significant. Please first log in with a verified email before subscribing to alerts.

Thus the variance of the daily means is:. Selection and analytical evaluation of methods with statistical techniques. Subscription pricing is determined by: Part of the process of verifying or validating a method to confirm that it is suitable for use is an assessment of precision. Clinical and Laboratory Standards Institute. Elsevier Saunders; St Louis: Dr Douglas Chesher e-mail: There should be at least one quality control Wp05 sample in each run. We have no amendments or corrections for this standard.

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If this is true then using the principle of analysis of variance components:. Summary When evaluating the precision of a method it is necessary to assess the repeatability within-run and the total or within-laboratory precision. For a normal distribution the measure of imprecision is the standard deviation SD.

ISSN — When undertaking the assessment the data must be assessed for outliers, which are considered to be present if the absolute difference between replicates exceeds 5. If QC material is being used for the precision assessment, it should be different to that used to control the assay. Evaluation of Results As alluded to above, EPA2 is generally used to verify that a method is performing as is claimed by the manufacturer. Proceed to Checkout Continue Shopping.

Table 2 shows the results of each of these calculations. This data set consists of simulated measurements for an experiment conducted to evaluate the precision performance of measurement methods. For more information on customizing the embed code, read Embedding Snippets.

The next step is to calculate the variance for the daily means s b 2 using the equation. Please first verify your email before subscribing to alerts. Using the values from our example the mean of all the results is 1. For n measurements we have:. Embedding an R snippet on your website. Open in a separate window.

ep50 I have a suggestion. Author information Copyright and License information Disclaimer. This standard is also available to be included in Standards Subscriptions. Linnet K, Boyd JC. On 20 days two separate runs with two replicates of the same sample are measured. These include pooled patient samples, quality control material, or commercial standard material with known values.

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Evaluating Assay Precision

The procedures are designed for manufacturers or developers of clinical laboratory measurement methods, and for users of those methods who wish to determine their own performance capabilities or to verify claims from a manufacturer. Included are guidelines for the duration, procedures, materials, data summaries, and interpretation techniques that are adaptable for the widest possible range of analytes and device complexity.

If the repeatability and within-laboratory SD are less than that indicated by the manufacturer, then the user has demonstrated precision consistent with the claim and no further calculations are required. For example, on day 1 the average of the three values is 2. As the period of assessment is quite short, the total SD or within-laboratory SD derived from these experiments should not generally be used to define acceptability limits for internal quality control.

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You may delete a document from your Alert Profile at any time. For this, longer-term assessment is required. Finally, we can calculate the total or within-laboratory SD s l using e0p5 equation:.

While the term precision relates to the concept of variation around a central value, imprecision is actually what is measured. This standard is not included in any packages.

When using quality control ep0, these should be different to those used to ensure the instrument is in control at the time of the assessment.

Instead total precision within a laboratory within-laboratory precision will be assessed.