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29 Sep

Stier Validation has always been part of the Hazard Analysis and Critical Control Point (HACCP) system, but it is an even greater issue in today’s food safety management systems.Even though this has been required since “day 1,” it is surprising how many companies’ HACCP plans contain no validation data.But PCT’s official FDA-approved uses are still only one facet of the assay’s actual role in addressing sepsis.By many accounts, it is procalcitonin’s unadvertised, unofficial applications, more than the approved uses, that have been drawing clinicians in many hospitals to order the assay in increasing numbers.Scroll down or click on your lab area of interest in the listing below to learn more.TESTING A medical device's package plays a key role in safely delivering treatment to patients.Requiring no reagent preparation or hands-on testing, the new test could make quick results more widely available, increasing the practicality of PCT’s off-label applications and reinforcing PCT’s increasingly central role in ameliorating sepsis “The literature coming from colleagues, especially those in Europe, makes it pretty clear that PCT has value in the management of sepsis,” says Joshua A.Hayden, Ph D, assistant director of the central laboratory at New York-Presbyterian Hospital–Cornell Campus.

In addition, cleaning and sanitizing programs must also be validated.(present) • Verification: Was the work done according to plan? (future) Validation is not a new concept to the food processing industry.In the early days of the low-acid canned-food regulations, protocols were established to validate the processing conditions for canning low-acid products. When movie stars appear in uncredited parts, it’s usually for a cameo, not a leading role.But in diagnostics, an uncredited or off-label use of an assay might be its main use—possibly even its most clinically important use.