CLSI EP5 A2 PDF
NCCLS document EP5-A2 (ISBN ). NCCLS, West Valley Road, Suite , Wayne, Pennsylvania USA, THE NCCLS . Evaluation of Precision Performance (EP5-A2). (This feature is only available in GenEx Enterprise). Introduction. The EP5 module in Genex implements the. Buy CLSI EP5 A2 Ed. 2 () Evaluation Of Precision Performance Of Quantitative Measurement Methods from SAI Global.
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The runs should be separated by at least two hours, or if they take very long time to perform, one run per day is acceptable. We give below some of the main features of the EP5 guidelines, for a clis description see the EP2-A2 document.
The random error is modeled according to the hierarchical model. The model assumes that all the U d are identically distributed, and similarly that the V dr are identically distributed and that the W drs are identically distributed. If there is only one run per day, the Runs: Use the menus to the right under Columns to tell Genex which classification column that corresponds to days, and which column corresponds to runs.
Evaluation of Precision Performance (EP5-A2)
If testing against a claim is not desired, these fields can be left blank. The estimated between-samples variance the repeatabilityshown on line 9 is 2. Using the EP5 module in Genex.
Genex assumes that the experiment has been conducted according to the EP5-A2 instructions, producing data during 20 days with one or two runs per day. EP5 estimates the repeatability, defined as the between-sample precision, i.
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Finally, the last two lines indicate whether the claimed precisions were consistent with the precision estimated from the measurements. Clis experiment produces ep data set with one or two runs per day and two replicas per run.
Where X drs is the measurement on day d in run r on sample s. The purpose of EP5 is to evaluate the precision of clinical laboratory measurement methods. In EP5 there should be two runs on each day, where each run consists of two test samples.
The measurements continue for another 15 days. The between-runs and between-days precision estimates are also given on lines 10 and This period lasts until data are obtained without operational difficulty for five days.
Sp5, the protocol defines a procedure for dealing with outliers.
The picture only shows the first part of the data set, in total there are 80 sample rows, since the measurements are carried out for 20 days. Line 11 shows the same quantities as line 9, but for the total, within-laboratory, precision. After all fields have been set to appropriate values, press the run button to perform the analysis.
Device Familiarization Period is a period to learn the operation of equipment and preparation of samples required.
If two or more concentrations are used, they can be handled as separate data sets, and be analyzed independently of each other in Genex. The precision evaluation experiment is divided into three different periods. The alternative measurement protocol with one run per day, only requires the day classification column, and would have had 40 rows. Furthermore, EP5 allows testing of the estimated precisions against given precisions, e.
The days and runs should be given as classification a22 in the data input to Genex, as in the example. Note that it is the absolute value of the variance that should be entered.
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In total, data should be generated for 20 days, the five last days of the Protocol Familiarization plus the 15 days of the Precision Evaluation Experiment. The SD min and SD max values form a confidence interval for the precision estimate, hence the confidence interval is [2.
Each sample is displayed as a blue marker. The EP5 guidelines are intended both for developers of such methods and for users of methods who want to verify the validity of given precision claims, or just measure their own precision.
The control panel for EP5. The analysis produces two windows, one scatter plot of the data and one data window with the computed precisions. Genex will estimate the precision in flsi data rp5 the statistical methods required by the EP5-A2 document.
The average of the two samples that form the run is marked with a red bar. This period is intended for the experimenter to learn the experimental protocol, and also to put quality controls into place, and perform an initial evaluation of precision and other acceptance tests, e.
We refer to the EP5-A2 document for details about the experiment protocol. The fields under manufacturers claimed precisions allow testing against a claimed precision. This feature is only available in Eep5 Enterprise.
Quality controls should be made regularly, based on quality control samples that are measured along with the rest of the experiment. If the claim is given as a percentage, it has to be translated to a variance by multiplying the average of the measured values.
The EP5 module is found by selecting clzi Quality Ctrl tab, and clicking on the button labeled EP5, shown below as the second button from ep55 left. Furthermore, EP5 recommends that the experiment is performed at two different concentrations. EP5 clsk estimates the variance of the sum of the three errors, the so called within-laboratory precision.