There is limited availability of clinical samples that can be used for proficiency testing, assay validations, and run controls. LGC SeraCare has developed a new technology and formulation to provide a sustainable source of patient-like noninvasive prenatal testing (NIPT) reference materials.
The fetal-maternal match signifies that the material is compatible with a broad range of NIPT assays. This poster describes how to assure quality of NIPT tests and concordance of test results between various platforms. The Artel whitepaper “Process Optimization for Assays: A framework for controlling variability and optimizing assay performance” details how to detect and address these factors. It offers a framework that details how pipetting, mixing, centrifuging, washing, and incubating steps all offer opportunities for minimizing controllable sources of variability. It also includes recommendations for optimizing each type of step in the assay process.
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