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© 2012 AOAC INTERNATIONAL

G

UIDELINES

FOR

S

TANDARD

M

ETHOD

P

ERFORMANCE

R

EQUIREMENTS

AOAC O

FFICIAL

M

ETHODS

OF

A

NALYSIS

(2012)

Appendix F, p. 2

policy. SMPR working groups are expected to apply their expertise

in the development of SMPRs.

TableA1: Performance Requirements

. Provides recommended

performance parameters to be included into an SMPR. Table A1

is organized by five method classifications: (

1

) main component

quantitative methods; (

2

) trace or contaminant quantitative

methods; (

3

) main component qualitative methods; (

4

) trace or

contaminant quantitative methods; and (

5

) identification methods.

The table is designed to accommodate both microbiological and

chemical methods. Alternate microbiological/chemical terms are

provided for equivalent concepts.

Table A2: Recommended Definitions

. Provides definitions

for standard terms in the SMPR Guidelines. AOAC relies on

The International Vocabulary of Metrology Basic and General

Concepts and Associated Terms

(VIM) and the International

Organization for Standadization (ISO) for definition of terms not

included in Table A2.

TableA3: Recommendations for Evaluation

. Provides general

guidance for evaluation of performance parameters. More detailed

evaluation guidance can be found in

Appendix D, Guidelines for

Collaborative Study Procedures to Validate Characteristics of

a Method of Analysis

(2);

Appendix I, Guidelines for Validation

of Biological Threat Agent Methods and/or Procedures

(3);

Appendix K, AOAC Guidelines for Single-Laboratory Validation

of Chemical Methods for Dietary Supplements and Botanicals

(4);

Codex Alimentarius Codex Procedure Manual (5); and ISO

Standard 5725-1-1994 (6).

Table A4: Expected Precision (Repeatability) as a Function

of Analyte Concentration

. The precision of a method is the

closeness of agreement between independent test results obtained

under stipulated conditions. Precision is usually expressed in terms

of imprecision and computed as a relative standard deviation

(RSD) of the test results. The imprecision of a method increases

as the concentration of the analyte decreases. This table provides

target RSDs for a range of analyte concentrations.

Table A5: Expected Recovery as a Function of Analyte

Concentration

. Recovery is defined as the ratio of the observed

mean test result to the true value. The range of the acceptable mean

recovery expands as the concentration of the analyte decreases.

This table provides target mean recovery ranges for analyte

concentrations from 1 ppb to 100%.

Table A6: Predicted Relative Standard Deviation of

Reproducibility (PRSD

R

)

. This table provides the calculated

PRSD

R

using the Horwitz formula:

PRSD

R

= 2C

–0.15

where C is expressed as a mass fraction.

Table A7: POD and Number of Test Portions

. This table

provides the calculated probability of detection (POD) for given

sample sizes and events (detections). A method developer can use

this table to determine the number of analyses required to obtain a

specific POD.

Informative annexes

.—The SMPR Guidelines contain

informative annexes on the topics of classification of methods, POD

model, HorRat values, reference materials, and method accuracy and

review. As with the informative tables, these annexes are intended to

provide guidance and information to the working groups.

Initiation of an SMPR

See

Figure 1 for a schematic flowchart diagram of the SMPR

development process.

Figure 1. Schematic flowchart diagram of the SMPR development process.