NGSP 认证的测定糖化血红蛋白方法.pdf
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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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