FAM Expert Review Panel (ERP) Training

OMA MLV Study Designs

Method Type # Valid Data Sets Study Design per Collaborator

Statistics

Recovery, bias, LOD, LOQ, s r , s R

Quantitative

шϴ

шϱ DĂƚĞƌŝĂůƐ 2 Replicates per material 1 Matrix 12 Replicates High 12 Replicates Low (fractional pos.*) 12 Replicates Non-spiked

Qualitative

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LPOD s r ǁŝƚŚ ϵϱй / s R ǁŝƚŚ ϵϱй / s L If method comparison: dLPOD н / ; / ŵƵƐƚ ŝŶĐůƵĚĞ ͞Ϭ͟ )

Ύ&ƌĂĐƚŝŽŶĂů ƉŽƐŝƚŝǀĞƐ ĚĞĨŝŶĞĚ ĂƐ >WK с Ϭ͘ϮϬ - Ϭ͘ϴϬ Updates under consideration for qualitative MLV statistics: /ŶƚƌĂĐůĂƐƐ ŽƌƌĞůĂƚŝŽŶ ŽĞĨĨŝĐŝĞŶƚ ;/ Ϳ ƚŽ ĂƐƐĞƐƐ ŚŽŵŽŐĞŶĞŝƚLJ ŽĨ ĐŽůůĂďŽƌĂƚŽƌƐ ;ϵϬй / ŽŶ / фϬ͘ϰͿ͖ ƋƵŝǀĂůĞŶĐĞ ĂƐ ϵϬй / ŽŶ dLPOD CP (- Ϭ͘Ϯ͕ Ϭ͘ϮͿ͕ ϵϬй / ŽŶ dLPOD C (- Ϭ͘Ϯ͕ ϭ͘ϬͿ͘

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Review of MLV Validation Protocols

• Collaborators • YƵĂůŝƚĂƚŝǀĞ ŵĞƚŚŽĚƐ͗ шϭϬ ǀĂůŝĚ ĚĂƚĂ ƐĞƚƐ͕ ƌĞĐŽŵŵĞŶĚ ϭϮ -15 collaborators • YƵĂŶƚŝƚĂƚŝǀĞ ŵĞƚŚŽĚƐ͗ шϴ ǀĂůŝĚ ĚĂƚĂ ƐĞƚƐ͕ ƌĞĐŽŵŵĞŶĚ ϭϬ -12 collaborators • No more than 3 collaborators at one site (must work independently!) • At least 5 sites • Method training provided (in-person or virtual) • Recommend practice samples to qualify collaborators and familiarize them with the method • Coordinating Laboratory can also be collaborator (separate personnel preparing materials and analyzing sample set)

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