Single Lab Validation for Laboratory Methods

Table of Contents

1. Method Application and Single Lab Validation Summary of Required Elements For Acceptance of a Method for Use in the NSSP
   (Click here to download as Word document)
2. Definitions
3. Single Laboratory Validation (SLV) Protocol For Submission to the Interstate Shellfish Sanitation Conference (ISSC) For Method Approval
4. Summary Table for QPCR Methods
5. SLV Documents for QPCR Methods
   1. QPCR based SOP - Accuracy / Trueness & Measurement Uncertainty
   2. QPCR based SOP - Ruggedness
   3. QPCR based SOP - Precision & Recovery
   4. QPCR based SOP - Specificity
   5. QPCR based SOP - Linear Range, Limit of
      Detection, Limit of Quantitation/Sensitivity
6. SLV Documents for MPN Based Microbiological Methods
   1. MPN based SOP - Accuracy/Trueness & Measurement Uncertainty
   2. MPN based SOP - Ruggedness
   3.  MPN based SOP - Precision & Recovery
   4. MPN based SOP - Specificity
   5. MPN based SOP - Linear Range, Limit of Detection, Limit of Quantitation/Sensitivity
7. SLV Documents for Marine Biotoxin and Non-MPN Based Microbiological Methods
   1. Marine Biotoxin & Non MPN based SOP - Accuracy/Trueness & Measurement Uncertainty
   2. Marine Biotoxin & Non MPN based SOP – Ruggedness
   3. Marine Biotoxin & Non MPN based SOP – Precision & Recovery
   4. Marine Biotoxin & Non MPN based SOP – Specificity
   5. Marine Biotoxin & Non MPN based SOP - Linear Range, Limit of Detection, Limit of Quantitation/Sensitivity
8. SLV Documents for Qualitative Analytical Methods
   1. SOP for the Single Laboratory Validation of Qualitative Analytical Methods - Specificity
   2. SOP for the Single Laboratory Validation of Qualitative Analytical Methods -Ruggedness
9. SLV Documents for New or Modified Methods as Alternatives to NSSP Methods
   1. SOP for the Single Laboratory Validation of New or Modified Analytical Methods Intended as Alternatives to Officially Recognized NSSP Methods –Comparing Methods
   2. SOP for the Single Laboratory Validation of New or Modified Analytical Methods Intended as Alternatives to Officially Recognized NSSP Methods – Ruggedness
   3. SOP for the Single Laboratory Validation of New or Modified Analytical Methods    Intended as Alternatives to Officially Recognized NSSP Methods – Specificity
10.  Flowchart for Emerging Methods
11.  Matrix Extension Guidelines Flowchart
12.  Matrix Extension - Application Format for Biotoxin Methods
13.  Matrix Extension - Application Format for Microbiology Methods