Clinical Chemistry Link to Randox Laboratories Web Site
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Clinical Chemistry 52: 1624-1625, 2006; 10.1373/clinchem.2006.069773
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Submit an electronic Letter to
the Editor about this paper
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Bais, R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Bais, R.
Related Collections
Right arrow General Clinical Chemistry
(Clinical Chemistry. 2006;52:1624-1625.)
© 2006 American Association for Clinical Chemistry, Inc.

Letters to the Editor

What Information Should Manufacturers Provide on Their Procedures?

Renze Bais

Division of Clinical Biochemistry, Pacific Laboratory, Medicine Services, Royal North Shore Hospital, Sydney, New South Wales, Australia, Fax 61-2-9926-6069, E-mail rbais@med.usyd.edu.au

The first 20% of the full text of this article appears below.


To the Editor:

Recently, our laboratory received a bulletin (Technical Bulletin CC06-001, Calcium C.f.a.s. Set Point and PNU/PPU Target Value Reassignments: All Clinical Chemistry Systems, January, 2006) from Roche Diagnostics Australia indicating that the calcium value of their calibrator for automated systems (C.f.a.s.) had been reassigned. According to the bulletin, the calibration was performed against atomic absorption spectroscopy (AAS). The bulletin also stated that Roche’s quality assurance system did not reveal any substantial lot-to-lot changes over the 5 years since the last reference standardization. No data were provided on the quality assurance system results or on the standardization.

The change for the assigned value for the C.f.a.s. lot being used in our laboratory (lot 166275) was from 2.04 mmol/L to 1.93 mmol/L. We were concerned that the magnitude of this change (5.4%) was greater than the desirable total error for calcium, 2.4% (1), and we felt that such a change could have a substantial effect on patient data. Thus, we asked Roche Diagnostics to provide further information regarding the reassignment.

We were informed that the Roche Diagnostics in-house standardization procedure included the assays of 10 patient pools on either the Roche AAS or the . . . [Full Text of this Article]






HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2006 by the American Association for Clinical Chemistry.