Featured products include an unsaturated iron binding capacity assay from Sekisui Diagnostics, the scalable Labdaq laboratory information system from CompuGroup Medical US, and a high-purity intrinsic factor protein from BBI Solutions.
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According to FDA, today’s laboratory-developed tests are frequently manufactured using components and instruments that are not legally marketed for clinical use, and often rely on high-technology instrumentation and software to generate results and clinical interpretations.
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Experts from the clinical lab community gathered on January 8–9, 2015, to comment on FDA’s proposed regulatory structure for laboratory-developed tests. This selection of comments from the first day of the workshop offers a glimpse into the depth of participants’ observations.
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Shifting interpretations of the CLIA guidelines will allow clinical laboratories to develop alternative quality control policies, replacing equivalent quality control procedures, as of January 1, 2016. Rose Mary Casados, president of COLA Resources Inc, outlines the steps involved in establishing an Individualized Quality Control Plan.
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Featured products include virtual slide database management software from Zeiss, a walk-away clinical chemistry analyzer from the Diatron Group, and a drugs-of-abuse testing platform from Siemens Healthcare Diagnostics.
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