Evaluation of variability and quality control procedures for a receptor-binding assay for paralytic shellfish poisoning toxins
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Single-laboratory evaluation of variability and quality control procedures for a receptor-binding assay for shellfish toxins; this is analytical assay validation and laboratory QC, the polysemy trap the rubric places OUT, not a study of research practice.
The work evaluates quality control for a specific laboratory assay, not research practice as a social or methodological system.
Single-lab evaluation of assay variability for shellfish toxin detection; food-safety method QC, not metaresearch.
Résumé
The receptor-binding assay (RBA) method for determining saxatoxin (STX) and its numerous analogues, which cause paralytic shellfish poisoning (PSP) in humans, was evaluated in a single laboratory study. Each step of the assay preparation procedure including the performance of the multi-detector TopCount® instrument was evaluated for its contribution to method variability. The overall inherent RBA variability was determined to be 17%. Variability within the 12 detectors was observed; however, there was no reproducible pattern in detector performance. This observed variability among detectors could be attributed to other factors, such as pipetting errors. In an attempt to reduce the number of plates rejected due to excessive variability in the method's quality control parameters, a statistical approach was evaluated using either Grubbs' test or the Student's t-test for rejecting outliers in the measurement of triplicate wells. This approach improved the ratio of accepted versus rejected plates, saving cost and time for rerunning the assay. However, the potential reduction in accuracy and the lack of improvement in precision suggests caution when using this approach. The current study has recommended an alternate quality control procedure for accepting or rejecting plates in place of the criteria currently used in the published assay, or the alternative of outlier testing. The recommended procedure involves the development of control charts to monitor the critical parameters identified in the published method (QC sample, EC₅₀, slope of calibration curve), with the addition of a fourth critical parameter which is the top value (100% binding) of the calibration curve.
Conservé avec la notice de tri, où il sert de preuve aux étiquettes ci-dessus.
La notice
- Revue
- Food Additives & Contaminants Part A
- Thématique
- Marine Toxins and Detection Methods
- Domaine
- Environmental Science
- Établissements canadiens
- —
- Organismes subventionnaires
- National Research Council CanadaNational Oceanic and Atmospheric Administration
- Mots-clés
- OutlierCalibrationDetectorParalytic shellfish poisoningStatisticsComputer scienceFalse positive paradoxMathematicsBiologyShellfishFish <Actinopterygii>Fishery
- Résumé présent dans OpenAlex
- oui