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    ASTM D6259 - 15(2019)

    Standard Practice for Determination of a Pooled Limit of Quantitation for a Test Method

    Active Standard ASTM D6259 | Developed by Subcommittee: D02.94

    Book of Standards Volume: 05.02

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    Significance and Use

    5.1 Background—In a single laboratory, the limit of quantitation, LOQ, equal to ten times the standard deviation obtained under repeatability conditions extrapolated to zero concentration (s0) based on samples with close to zero concentrations has been recommended.3 A test result at this LOQ has an uncertainty of ±30 % at the 99 % confidence level.

    5.1.1 This practice uses a regression technique to determine a similar limit for a test method (PLOQ) using statistically pooled repeatability standard deviations over multiple operators/laboratories/samples from ILS data. This PLOQ can be used by industry to assess the reliability of a test method, or, compare reliability of different test methods, for quantitative measurement at concentrations near zero. Similarly, quantitative test results obtained using the test method for levels at or below the PLOQ can be expected by industry to have an uncertainty of ±30 % or greater at the 95 % confidence level.

    5.1.2 The regression technique described in this practice can also be used to determine a limit of quantitation specific for a single laboratory (LLOQ). The limit thus quantified for one laboratory is defined by this standard as the laboratory limit of quantitation (LLOQ).

    5.1.3 It should be noted that since differences in repeatability testing capabilities between different laboratories can exist, therefore, LLOQ determined at a single laboratory can be different than the PLOQ determined for the test method.

    5.2 Values below the PLOQ are deemed by this practice to be too uncertain for meaningful use in commerce, or in regulatory activities.

    1. Scope

    1.1 This practice covers the use of standard regression techniques and data from an interlaboratory study to determine a lower quantitative limit for a test method. This determined lower limit represents the numerical limit at or above which the test results are considered to be quantitatively meaningful for commerce or regulatory activities by this practice. It is defined by this standard as the pooled limit of quantitation (PLOQ) for the test method.

    1.2 This practice is applicable to test methods that are capable of producing numerical test results close to zero. Examples are those test methods that determine quantitatively the concentration of analyte(s) near zero.

    1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D6300 Practice for Determination of Precision and Bias Data for Use in Test Methods for Petroleum Products and Lubricants

    E456 Terminology Relating to Quality and Statistics

    E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

    ICS Code

    ICS Number Code 19.020 (Test conditions and procedures in general)

    UNSPSC Code

    UNSPSC Code

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/D6259-15R19

    Citation Format

    ASTM D6259-15(2019), Standard Practice for Determination of a Pooled Limit of Quantitation for a Test Method, ASTM International, West Conshohocken, PA, 2019, www.astm.org

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