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NGSP 认证的测定糖化血红蛋白方法.pdf

发布:2017-05-25约6.41万字共10页下载文档
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List of NGSP Certified Methods (updated 3/11, listed by date certified) The NGSP has certified the following methods and reagents as having documented traceability to the Diabetes Control and Complications Trial Reference Method. Manufacturers are awarded Certificates of Traceability for successfully completing bias testing for specific methods, reagent lots, calibrator lots and instrumentation used. Traceability to the DCCT applies only to results from fresh blood samples. Analysis of processed (e.g. lyophilized) material may be subject to matrix effects and any comparisons to the DCCT using results from processed specimens should be made with caution. The NGSP recommends that manufacturers certify their methods each year; the certificate of traceability expires after 1 year. During the year it is the responsibility of the manufacturer to insure that the results of their method remain consistent over time throughout the year and between lots. It is not the intent of the NGSP to certify each lot of reagents. Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Trinity TriSTAT Boronate Mar ‘11 128K5161 - - - Univ. of Biotech affinity Missouri.
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