Context.—: Many studies have depended on qualitative antibody assays to investigate questions related to COVID-19 infection, vaccination, and treatment.
Objective.
Purpose: Summarize and interpret results from exercises distributed to laboratories offering cell-free (cf) DNA screening for Down syndrome.
Methods: The College of American Pathologists distributed three patient-derived plasma specimens twice in 2018. Sequencing platforms, test methods, results, and responses to supplemental questions were collected.
An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house.
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