Single Lab Validation for Laboratory Methods

Table of Contents

I.                    Method Application and Single Lab Validation Checklist For Acceptance of a Method for Use in the NSSP      
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II.                 Definitions 

III.               Single Laboratory Validation (SLV) Protocol For Submission to the Interstate Shellfish Sanitation Conference (ISSC) For Method Approval

IV.                Summary Table for QPCR Methods

V.                  SLV Documents for QPCR Methods

V.         #1  QPCR based SOP - Accuracy / Trueness &
                  Measurement Uncertainty

V.         #2  QPCR based SOP - Ruggedness

V.         #3  QPCR based SOP - Precision & Recovery

V.         #4  QPCR based SOP - Specificity

V.         #5  QPCR based SOP - Linear Range, Limit of 
                  Detection, Limit of Quantitation/Sensitivity

VI.        SLV Documents for MPN Based Microbiological Methods:

VI.        #1. MPN based SOP - Accuracy/Trueness & Measurement
                  Uncertainty
VI.        #2. MPN based SOP - Ruggedness
VI.        #3. MPN based SOP - Precision & Recovery
VI.        #4. MPN based SOP - Specificity
VI.        #5. MPN based SOP - Linear Range, Limit of Detection,
                  Limit of Quantitation/Sensitivity

VII.       SLV Documents for Marine Biotoxin and Non-MPN Based Microbiological Methods:

            VII.       #1. Marine Biotoxin & Non MPN based SOP - Accuracy/Trueness
                   & Measurement Uncertainty

            VII.       #2. Marine Biotoxin & Non MPN based SOP – Ruggedness

            VII.       #3. Marine Biotoxin & Non MPN based SOP – Precision
                   & Recovery

            VII.       #4. Marine Biotoxin & Non MPN based SOP – Specificity

            VII.       #5. Marine Biotoxin & Non MPN based SOP - Linear Range,
                   Limit of Detection, Limit of Quantitation/Sensitivity

VIII.     SLV Documents for Qualitative Analytical Methods

            VIII.     #1. SOP for the Single Laboratory Validation of Qualitative
                  Analytical Methods - Specificity

            VIII.     #2. SOP for the Single Laboratory Validation of Qualitative
                  Analytical Methods -Ruggedness

IX.        SLV Documents for New or Modified Methods as Alternatives to NSSP Methods

            IX.        #1. SOP for the Single Laboratory Validation of New or
                  Modified Analytical Methods Intended as Alternatives to
                  Officially Recognized NSSP Methods –Comparing
                  Methods

            IX.        #2. SOP for the Single Laboratory Validation of New or
                  Modified Analytical Methods Intended as Alternatives to
                  Officially Recognized NSSP Methods – Ruggedness

            IX.        #3. SOP for the Single Laboratory Validation of New or
                  Modified Analytical Methods    Intended as Alternatives
                  to Officially Recognized NSSP Methods – Specificity

X.         Flowchart for Emerging Methods