Stochastic simulation software is developed and used to calculate and visualize the detection power of complex QC rule combinations, including traditional Westgard rules as well as statistical tests of multiple QC repeats, with arbitrary degrees of multiplexing and levels of control.
Accessible molecular diagnostics is fundamental to effective healthcare. While most current point-of-care devices detect only the presence of a molecular biomarker(s), biomarker quantification can be equally important for decision-making on disease treatment and containment. Here, we present a diagnostic platform that...
Baseline IQC practices for emergency immunoassays in the surveyed laboratories were inconsistent and lacked a standardized risk-based foundation, and it is recommended that clinical laboratories implement individualized RB-SQC protocols designed using the Westgard Sigma Rule with Run Length nomogram, and periodically r...
Guangjun Xiao, Juan Hu, Yanting Liu et al.· Frontiers in Medicine· 0 citations
Some of the recent work on dPCR-based RMPs are described and how this can be applied to improve nucleic acid analysis measurements on a global scale in EQA schemes, clinical laboratories and harmonization studies for infectious disease diagnostics are discussed.
S. Falak, D. O'Sullivan, M. Cleveland et al.· 150th anniversary of the Met...· 0 citations
Overall, this work establishes a metrologically characterized and transferable dPCR-based RMP for NRAS p.Q61R quantification that can support the harmonization of molecular measurements, the value assignment of RM, and the alignment of routine and secondary methods, thereby strengthening the reliability of quantitative...
Jessica Petiti, Sabrina Caria, L. Revel et al.· Methods· 0 citations
An automated assay platform that robustly quantifies antibodies against up to 100 antigens in a single reaction, using Luminex suspension array technology, alongside generating ample quality control measures is described.
Lea Kröller, Rima Jeske, Birgitta E. Michels et al.· Nature Protocols· 1 citation
This work sought to systematically apply CAP laboratory-developed test validation requirements for next-generating sequencing to targeted CFTR gene sequencing on an Illumina iSeq100 Sequencing System and to address assay-specific translational guidance gaps.
Muhammad Fareeduddin, Muhammad Usama, Shakir Hussain et al.· Laboratoriums Medizin· 0 citations
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