📋 Workflow
Full workflow, products add-to-cart directly1
Protocol & parameter design
2 hDefine validation items such as specificity, linearity, accuracy and precision
💡 Tip Design per ICH/CLIA guidance
⚠️ Caution Set criteria based on method purpose
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2
Linearity & range
4 hMeasure a series of concentrations to assess linearity and LLOQ/ULOQ range
💡 Tip Use at least 5-6 concentration levels
⚠️ Caution Evaluate R² and intercept
🧪 Materials for this step (click to shop by spec/brand)
3
Accuracy & precision
8 hAssess accuracy and precision by spike recovery and repeated measurements
💡 Tip Assess across batches/days
⚠️ Caution Calculate recovery and RSD
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4
Specificity & detection limit
4 hVerify no interference from co-existing substances and establish LOD/LOQ
💡 Tip Compare blank vs spiked
⚠️ Caution Calculate by S/N or standard deviation
🧪 Materials for this step (click to shop by spec/brand)
5
Robustness & report
4 hAssess the effect of small condition changes and write a validation report
💡 Tip Assess small changes in temp/flow
⚠️ Caution Summarize against acceptance criteria
🧪 Materials for this step (click to shop by spec/brand)
⚠️ 5 Common Beginner Mistakes
- ① Missing validation items
- ② Insufficient replicates giving unreliable conclusions
- ③ Unreasonable acceptance criteria
- ④ Poor data record keeping
- ⑤ Matrix effect not evaluated
❓ FAQ
+Which validation items?
Specificity, linearity, accuracy, precision, LOD/LOQ, robustness.
+How many batches?
Precision usually across 3 batches/days.
+Assay vs analysis validation?
Qualitative vs quantitative methods differ per guidance.