Table. 1.
Indication and performance evaluation for verification and validation
| Verification | Validation | |
|---|---|---|
| Indication | - Korean Food and Drug Administration (KFDA)–cleared/approved tests, the approved protocol and intended use | - Laboratory development testing - Modified use of KFDA-approved medical equipment for in vitro diagnosis - Additional sample types on an established platform |
| Performance evaluation | - Accuracy testing (15 abnormal samples that represent abnormalities that the array is designed to detect) - Precision testing (establishment by running a minimum of two abnormal samples, ech run multiple times in separate experiments) - Reportable ranges |
- Accuracy testing (30 previously characterized abnormal samples that the array is designed to detect) - Precision testing (establishment by running a minimum of two abnormal samples, each run multiple times in separate experiments) - Reportable ranges - Sensitivity - Specificity - The allelic differentiation potential of SNP detecting platform - Determining percentage of cells with abnormality: mosaicism and clonality |
*Accuracy tests in cases where it is difficult to obtain 30 abnormal samples such as amniotic fluid and chorionic villous samples can be a good method of sample exchanges in a blind, split-sample comparison with a laboratory. Exchange of validated data sets (e.g., array files) between laboratories is recommended for additional experience in data analysis.
Lab Med Online 2023;13:141~153 https://doi.org/10.47429/lmo.2023.13.3.141
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