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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Support Center Support Center. When using quality control samples, these should be different to those used to ensure the instrument is in control at the time of the assessment. Selection and analytical evaluation of methods with statistical techniques.
For this, longer-term assessment is required.
Evaluating Assay Precision
Evaluation of precision performance of quantitative measurement methods. NCCLS document EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition provides guidance and procedures for evaluating the precision of in vitro diagnostic devices and includes recommendations for manufacturers in evaluating their devices and methods when establishing performance claims.
Estimation of Repeatability and Within-Laboratory Precision The following example relates to the verification of performance of calcium according to EPA2 using a five day protocol.
The figure of 5. For a normal distribution the measure of imprecision is the standard deviation SD. Note that we can’t provide technical support on individual packages. When undertaking the assessment the data must be assessed for outliers, which are considered to be present if the absolute difference between a exceeds 5. Proceed to Checkout Continue Shopping.
For the purposes of this example the results of only a single level are shown Table 1. The following example relates to the verification dp05 performance of calcium according to EPA2 using a five day protocol. The EPA2 protocol is similar except that the experiment is undertaken with three replicates over five days for at least two levels.
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R Package Documentation rdrr. Table 2 shows the results of each of these calculations. Precision claims by a manufacturer should be tested at at-least two levels, by running three replicates over five days. While the term precision relates to the concept of variation around a central value, imprecision is actually what is measured.
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Evaluating Assay Precision
If an outlier is found the pair should be rejected and the cause investigated and resolved before repeating the run.
The page or its content looks wrong. Alternatively one can use the variance, which is simply the square of the SD.
For example, on day 1 the average of the three values is 2. We have no amendments or corrections for this standard. I have a suggestion.
The procedures are designed for manufacturers or e0p5 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. Clinical and Laboratory Standards Institute.
Linnet K, Boyd JC. On 20 days two separate runs with two replicates of the same sample are measured. If QC material is being used for the precision assessment, it should be different to that used to control the assay. If this is true then using the principle of analysis of variance components:. Instead total precision within a laboratory within-laboratory precision will be assessed.
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