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

Importancia y uso:

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.

Subcomité:

D02.94

Referida por:

D7372-21, D7372-21, D8056-24, D7039-15AR20, D7039-15AR20, D4294-21, D4294-21, D7372-21, D2622-24, D8252-23, D2622-24, D4294-21, D8146-22, D2622-24, D7039-15AR20, D4294-21

Volúmen:

05.02

Número ICS:

19.020 (Test conditions and procedures in general)

Palabras clave:

limit of quantitation; pooled limit of quantitation;