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Acceptance criteria for the bioanalytical runs were in line with current Food and Drug Administration FDAA) guidance on bioanalysis with respect to accuracy and precision on calibrators and QA samples.
Specifically, the output voltage from the radiation detector was calibrated to known radioactivity concentration, as measured by a dose calibrator and a precision scale.
The LLOQ was defined as the lowest calibrator of the calibration curve that could be analyzed with an accuracy and precision of CV <20% [ 12].
The LLOQ was defined as the lowest matrix-based calibrator of the calibration curve that could be measured with acceptable accuracy and precision (<20% error) in compliance with FDA regulations.
Uncertainty in measurement is positively correlated to the amount of error through the manufacturing lot-to-lot variability, precision of the analytical method and calibrator.
Each plate for PCR run included the cDNA samples from malignant and non-malignant tissue pairs, a non-template control, samples of a cDNA pool used as calibrator, and another one for precision control.
The precision of the interpolated values of all calibrators in the quantitative assay range was ≤3.8 % CV.
Ninety-three 177Lu sources from the manufacturer were measured in the radionuclide calibrator over 2.5 years to evaluate its calibration accuracy and precision compared to the manufacturer's value.
An error of −0.99 [1.31]%% was found for the radionuclide calibrator activity quantification, demonstrating its high accuracy and precision over time.
Lower limit of quantification (LLOQ) was 2 pg/ml, while the accuracy of the back-calculated calibrator concentration was 91 % 87-955 %) and precision (coefficient of variation, CV%) was <20 %.
The pulsar or in-beam calibrator is split out using this calibration.
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