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The proposed method was validated according to ICH-guidelines [23] regarding linearity, sensitivity, accuracy, specificity, repeatability and reproducibility.
The proposed methods were validated according to the ICH-guidelines for validation of the analytical procedures [20] in terms of the linearity, sensitivity, accuracy, specificity, repeatability and reproducibility.
This new method design has significantly improved the detection in terms of rapidity, specificity, repeatability and accuracy compared to available methods.
The real-time PCR assay was optimized and performance criteria of the detection method, i.e. sensitivity, specificity, repeatability, reproducibility, and robustness, were assessed.
Besides, several experiments were carried out to find out improvements and limitations of this panel, including studies of species specificity, repeatability and concordance, sensitivity, mixtures, case-type samples and degraded samples, population genetics and pedigrees following the Scientific Working Group on DNA Analysis Methods (SWGDAM) guidelines.
Results of ROC analysis showed that the optimal DI threshold according to the Younden index was 1.67% and yielded a 95.1% sensitivity and 100% specificity (repeatability), corresponding to an overall accuracy of 96.7%.
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The methods were tested for linearity, specificity, accuracy, repeatability and precision according to ICH Q2B recommendations.
The method was evaluated by an intra-laboratory study for its specificity, linearity, repeatability and reproducibility.
The validity of the methods was tested regarding linearity, specificity, accuracy, repeatability and precision according to ICH Q2B recommendations [22].
The validity of the method was tested regarding; linearity, specificity, accuracy, repeatability and precision according to ICH Q2B recommendations [23].
The validity of the proposed methods was tested regarding linearity, specificity, accuracy, repeatability and precision according to ICH Q2 (recommendationsions [34].
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