NCCLS document EP5-A2 (ISBN ). THE NCCLS consensus process, which is the mechanism for moving a document through two or more. CLSIEP05A2-Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition-NCCLS document EP5-A2. 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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[Epub ahead of print]. Clinical Laboratory Standards CLSI Document EP6-A, Clinical Laboratory CLSI Document EP5–A2, Craig, D.B., Arriaga. Jul 1, Hercules, CA, USA) according to the Clinical and Laboratory Standards Institute (CLSI) guideline EP5-A2 . After preliminary evaluation for. CLSI EPA2: User Protocol for Evaluation of Qualitative Test. Performance: Approved EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline. — Second .. Epub Apr 2. Forest plot of.
EPA2 should be used to validate a method against user requirements, and is generally used by reagent and instrument suppliers to demonstrate the precision of their methods.
However, for a method developed in-house a higher level of proof is required to validate the method, in which case EPA2 would be the appropriate guideline to use. Various materials may be used to complete the assessment with either protocol. These include pooled patient samples, quality control material, or commercial standard material with known values.
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. 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. For this, longer-term assessment is required.
Assessment Protocols The EPA2 protocol recommends that: The assessment is performed on at least two levels, as precision can differ over the analytical range of an assay.
Each level is run in duplicate, with two runs per day over 20 days, and each run separated by a minimum of two hours. There should be at least one quality control QC sample in each run.
If QC material is being used for the precision assessment, it should be different to that used to control the assay. The order of analysis of test materials and QC for each run or day should be changed.
To simulate actual operation, include at least ten patient samples in each run. When entering new data we recommend using New Dataset to create a new precision dataset.
Using the test To start the test: Excel Select any cell in the range containing the dataset to analyse, then click Precision on the Analyse-it tab, then click 1 and 2 Run over Days. Leave Run 2 empty to perform a 1 run analysis.
Enter Pre-assigned concentration of the analyte, if known. If left blank Analyse-it will use the mean of all observations as an estimation of the true concentration. Click OK to run the test. The report shows the total number of observations analysed, number of days analysed including the number of days excluded due to outliers or missing values, runs per day, and replicates per run are shown.
Evaluating Assay Precision
The Concentration if the pre-assigned concentration was specified and the Mean concentration of all replicates are shown. If the pre-assigned concentration is not known, the mean is used as an estimate of the true concentration.
A precision plot see below shows the standardized observations for each day. Nature ;— The diagnosis and medical management of advanced neuroendocrine tumors.
Endocr Rev ;— Serum neuron-specific enolase: a marker for disease extent and response to therapy of small-cell lung cancer. Evaluation of serum neuron-specific enolase as a tumor marker for carcinoma of the lung. Gan ;— Serum neuron-specific enolase.
A marker for disease extent and response to therapy for small-cell lung cancer. Chest ;— Diagnostic relevance of circulating biomarkers in patients with lung cancer. Cancer Biomark ;— Anticancer Res ;— The fluctuations of neuron-specific enolase NSE levels of cerebrospinal fluid during bacterial meningitis: The relationship between the fluctuations of NSE levels and neurological complications or outcome.
Acta Paediatr Jpn ;— Serum neurone-specific enolase as an indicator of stroke volume. Eur J Clin Invest ;— SB and NSE as useful postmortem biochemical markers of traumatic brain injury in autopsy cases. J Neurotrauma ;—Integration and immediate therapeutic response using these results allows for prompt treatment and improvement of prognosis.
In this study, we evaluated 11 analytes, which are available in reagents provided with the instrument JEOL Ltd. However, for a method developed in-house a higher level of proof is required to validate the method, in which case EPA2 would be the appropriate guideline to use.
Interferences in immunoassays. Chemiluminescence enzyme immunoassay using magnetic nanoparticles for detection of neuron specific enolase in human serum. Jap Assoc Clin Lab Auto ;— For this, longer-term assessment is required.
N Engl J Med ;—
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