| interference experiment | A method validation experiment which estimates the systematic error resulting from interference and lack of specificity. one test sample is prepared by adding the suspected interferer to a sample ... |
| jc |
joint commission for accreditation of healthcare organizations; |
| joint commission for accreditation of healthcare organizations |
jc; |
| laboratory accreditation program |
lap; |
| levey-jennings control chart | A commonly used control chart in which individual control measurements are plotted directly on a control chart with limit lines drawn either as mean ± 2s or mean ± 3s. time is displayed on the x-a... |
| limit of blank (lob) | Highest measurement result that is likely to be observed (with a stated probability) for a blank sample; typically estimated as a 95% one-sided confidence limit by the mean value of the blank plus... |
| limit of detection (lod) | - Lowest amount of analyte in a sample that can be detected with (stated) probability, although perhaps not quantified as an exact value; estimated as a 95% one-sided confidence limit by the mea...
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| limit of quantification (loq)/lower limit of quantification | Lowest amount of analyte that can be quantitatively determined with stated acceptable precision and trueness, under stated experimental conditions; the analyte concentration at which the 95% limit... |
| linear regression analysis, least-squares analysis, ordinary regression analysis | A statistical technique for estimating the best linear relationship between two variables. the estimated line has the property that the sum of the squares of the deviations from the line is a mini... |
| lot number | - “an alphanumeric and/or symbolic identification placed on the label by the manufacturer that enables the manufacturing history of the product to be traced.” [clsi]
- Номер партии. ком...
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| lower limit of detection, lld | Older term that was commonly used to refer to an estimate of detection limit calculated from replicate measurements of a blank sample. typically the estimate is given as the mean of the blank samp... |
| medical decision level, decision level, xc | A concentration of analyte where medical interpretation is critical for patient care. there may be several different medical decision levels for a particular analyte. xc should provide guidance fo... |
| medically important errors | Used here to indicate errors that, when added to the inherent imprecision and inaccuracy of a measurement procedure, cause the quality requirement to be exceeded. medically important random errors... |
| method development | Refers to the process of formulating the materials, conditions, and protocol for measuring an analyte. method development is mainly carried out by industry. laboratories may make minor modificatio... |
| method selection | The process of defining the laboratory requirements and choosing an analytical method which has the desired characteristics. application and methodology characteristics must be carefully considere... |
| method validation | - The process of testing a measurement procedure to assess its performance and to validate that performance is acceptable. the magnitudes of the analytical errors are experimentally determined a...
валидация метода; |
| methodology characteristics | Those properties of a method which in principle should contribute to the best analytical performance in the measurement of the analyte of interest. characteristics such as the specificity of the c... |
| moderate complexity tests | A clia category of tests that includes about 75% of all tests performed by healthcare laboratories, including most automated analytical systems. this category has more stringent requirements than ... |
| multi-rule quality-control procedure | A control procedure that uses two or more control rules for testing control measurements and determining control status. at least one rule is chosen for its ability to detect random errors and one... |
| non-waived tests | Used in the final clia rule as a category of tests that encompasses both moderate complexity and high complexity tests. qc regulations in the final clia rule are the same for all non-waived tests,... |
| near patient testing |
npt; |
| number of control measurements, n | Used here to indicate the total number of control measurements available for use in assessing the quality of an analytical run. we consider n to be the total number of control measurements availab... |
| operating specifications (opspecs) | Used here to describe the imprecision and inaccuracy that are allowable and the qc that is necessary to assure, at a stated level, that a defined quality requirement will be achieved in routine op... |
| opspecs chart | A plot of the inaccuracy (on the y-axis) and the imprecision (on the x-axis) that are allowable for different qc procedures. the chart is prepared for a defined quality requirement and for a state... |
| outliers | Discrepant values. values which do not agree with the pattern of the majority of other values. they may be due to mistakes or they may represent a significant finding. when outliers are suspected,... выпадающие величины; |
| paired t-test | A form of the t-test where the data consist of pairs of observations on one set of samples, either before and after experimental treatment, or by two different methods of measurement. this statist... |
| passing-bablock regression | An alternate regression calculation that can be employed when ordinary linear regression may not be reliable. this technique is non-parametric and therefore makes fewer assumptions about the natur... |
| performance characteristic | - “a property of a test that is used to describe its quality.” [clsi] for a measurement procedure, the performance characteristics include reportable range, imprecision, inaccuracy or bias, inte...
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| performance specification | - “a value or range of values for a performance characteristic, established or verified by the laboratory, that is used to describe the quality of patient test results.” [clsi]
- Тактик...
ps; боевые и эксплуатационные характеристики; грузоподъемность; |
| poc | - Point of contact; point of control
- Proof-of-concept, another name for a pre-launch release
- Point of contact (faa)
point of care; point of contact; point of control; |
| point of care |
poc; |
| physician office laboratory |
pol; |
| power curve | A line on a power function graph that describes the performance of a certain control rule and n. |
| power-function graph | A graphical presentation of the performance characteristics of qc procedures that describes the probability for rejection (on the y-axis) versus the size of analytical error occurring (on the x-ax... |
| provider performed microscopy |
ppm; |
| primary standard material | "substance of known chemical composition and sufficient purity to be used in preparing a primary standard solution" [ifcc]. |
| primary standard solution | "solution used as calibration standard in which the concentration is determined solely by dissolving a weighed amount of primary standard material in an appropriate solvent, and making a stated vo... |
| probability for error detection, ped | A performance characteristic of a qc procedure that describes how often an analytical run will be rejected when results contain errors in addition to the inherent imprecision of the measurement pr... |
| probability for false rejection, pfr | A performance characteristic of a qc procedure that describes how often an analytical run will be rejected when there are no errors occurring, except for the inherent imprecision of the measuremen... |
| probability, p | The likelihood an event will occur, usually stated as a decimal fraction between 0 and 1, 0 meaning that the event will never occur and 1 meaning that the event will always occur. for example, p=0... |
| process capability | - An industrial term used to describe how the inherent variability of a production process under stable operation compared to the allowable variation. secrit is an index of process capability fo...
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| process stability | Used here to characterize the performance of the measurement procedure in terms of the frequency of analytic runs having medically important errors (f) that invalidate the medical usefulness. |
| proficiency sample | “a specimen containing analytes of unknown concentration or identification that is sent to laboratories participating in testing programs in order to independently verify the laboratory technical ... |
| proficiency testing criteria for acceptable performance, pt criteria | Defined limits about a target value (tv) that are used to classify analytical performance as acceptable or not. clia defines pt criteria for about 80 regulated analytes, using a format of tv ± a s... |
| proficiency testing, pt | “a program in which multiple specimens are periodically sent to members of a group of laboratories for analysis and/or identification; in which each laboratory’s results are compared with those of... |
| provider performed microscopy, ppm | A special subset of moderately complex tests that may be performed by physicians, dentists, nurse practioners and midwives, and physician assistants as part of a patient examination. |
| proficiency testing | - Проверка квалификации или профессионального соответствия
- Determination of laboratory testing performance by means of interlaboratory test comparisons. (iso)
pt; |
| qc acceptability criteria | The term used by clia to indicate the decision criteria or control rules used to monitor test performance during a run of patient specimens. |
| qc planning process, qc design, quality planning process | The steps to be followed to select control rules, n, and a total qc strategy that are appropriate for the quality needed and the imprecision and inaccuracy observed for a laboratory test. |
| qc, quality control | A generic term that refers to the monitoring and assessment of laboratory testing processes to identify problems and maintain performance. |
| quality assessment | - Clia’s term for the overall system for assuring the quality of laboratory test results. includes the monitoring and assessment of general laboratory systems, as well as pre-analytic, analytic,...
оценка качества; |
| quality management | - All activities of the overall management function that determine quality policy objectives and responsibilities; and implement them by means such as quality planning, quality processes, qualit...
общее руководство качеством, административное управление качеством; управление качеством; |
| quality planning model | Term used to describe an equation that shows the additive effects of different factors that influence the variation of a test result. the analytical model relates the imprecision and inaccuracy of... |
| quality system | - The organizational structure, resources, processes, and procedures needed to implement quality management. [clsi, iso]
- Система качества. совокупность организационной структуры, отве...
система качества; |
| random error, re | An error that can be either positive or negative, the direction and exact magnitude of which cannot be exactly predicted. in contrast, systematic errors are always in one direction. |
| recovery experiment | A method validation experiment performed to estimate proportional systematic error. a test sample is prepared by adding a standard solution of the analyte of interest to an aliquot of a patient sp... |
| reference change value (rcv) | An uncertainty term that expresses the difference that must be observed before a change of patient values should be considered clinically important. defined by fraser as a function of the analytic... |
| reference interval | A particular statistical range, rather than the entire range of observed reference values. commonly used to characterize the range of test results expected for a defined group of people. |
| reference interval experiment | A method evaluation experiment in which specimens are collected from selected individuals in defined states of health in order to characterize the expected range of test values for that population... |
| reference material, rm | “a material or substance, one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement met... |
| reference method | “a thoroughly investigated method, in which exact and clear descriptions of the necessary conditions and procedures are given for the accuracy determined of one or more property values, and in whi... |
| reference values | All of the values observed for a particular determination when sampling a population of individuals in defined states of health. |
| regression equation | - The equation for the line obtained in linear regression calculations (y = a + bx). this equation is used to calculate the amount of systematic error from the comparison of methods experiment. ...
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| regression statistics | Used here to refer to the terms that are commonly calculated, i.e., the slope, y-intercept, and standard deviation about the regression line. |
| replication experiment | A method validation experiment that estimates the random analytical error. it is performed by making measurements on a series of aliquots of a test solution within a specified time period, usually... |
| reportable range | The range of concentration of the substance in the specimen for which method performance is reliable and test results can be reported. |
| standard deviation, also abbreviated s |
sd; |
| sensitivity, analytical sensitivity | The ability of an analytical method to detect small quantities of the measured component. it has no numerical value. see detection limit. |
| sigma metric | A numeric value that characterize method performance in terms of the number of standard deviations or sigmas that fit within the tolerance limit or quality requirement of a test. for analytic proc... |
| six sigma | - A concept for world-class quality and a goal for process performance that requires 6 sds of process variation to fit within the tolerance limit or quality requirement of a process. applied in ...
шесть сигма; |
| slope, b | “the relationship between the change in y and the change in x between any two points along a line.” [nccls] used here to refer to a statistic that is calculated as part of linear regression analys... |
| state operations manual |
som; |
| standard deviation index, sdi | Generally used in reports from proficiency testing (pt) survey to describe how far a pt result is from the target value (tv). an sdi of +2.0 means that the laboratory`s reported result is 2 standa... |
| standard deviation of the differences, sd, sdiff | A statistic calculated as part of paired t-test analysis. it is the standard deviation of the individual differences between pairs of values (xi, yi), after those differences have been corrected f... |
| standard deviation of the intercept, sa | Indicates the dispersion or spread of values for the estimate of the y-intercept in linear regression analysis. |
| standard deviation of the slope, sb | Indicates the dispersion or spread of values for the estimate of the slope in linear regression analysis. |
| standard deviation of y about the regression line, sy/x | Also known as standard error about the regression line and standard deviation of the residuals (sres). a statistic calculated as part of linear regression analysis. it is the standard deviation of... |
