Details:

Alternative Title:
Clin Chem
Personal Author:
Stepman, Hedwig C.M. ; Tiikkainen, Ulla ; Stöckl, Dietmar ; Vesper, Hubert W. ; Edwards, Selvin H. ; ... More +
Stepman, Hedwig C.M. ; Tiikkainen, Ulla ; Stöckl, Dietmar ; Vesper, Hubert W. ; Edwards, Selvin H. ; Laitinen, Harri ; Pelanti, Jonna ; Thienpont, Linda M. Less -
Description:
BACKGROUND

External quality assessment (EQA) with commutable samples is essential for assessing the quality of assays performed by laboratories, particularly when the emphasis is on their standardization status and interchangeability of results.

METHODS

We used a panel of 20 fresh-frozen single-donation serum samples to assess assays for the measurement of creatinine, glucose, phosphate, uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. The commercial random access platforms included: Abbott Architect, Beckman Coulter AU, Ortho Vitros, Roche Cobas, Siemens Advia, and Thermo Scientific Konelab. The assessment was done at the peer group level and by comparison against the all-method trimmed mean or reference method values, where available. The considered quality indicators were intraassay imprecision, combined imprecision (including sample–matrix interference), bias, and total error. Fail/pass decisions were based on limits reflecting state-of-the-art performance, but also limits related to biological variation.

RESULTS

Most assays showed excellent peer performance attributes, except for HDL- and LDL cholesterol. Cases in which individual assays had biases exceeding the used limits were the Siemens Advia creatinine (−4.2%), Ortho Vitros phosphate (8.9%), Beckman Coulter AU triglycerides (5.4%), and Thermo Scientific Konelab uric acid (6.4%), which lead to considerable interassay discrepancies. Additionally, large laboratory effects were observed that caused interlaboratory differences of >30%.

CONCLUSIONS

The design of the EQA study was well suited for monitoring different quality attributes of assays performed in daily laboratory practice. There is a need for improvement, even for simple clinical chemistry analytes. In particular, the interchangeability of results remains jeopardized both by assay standardization issues and individual laboratory effects.


Subjects:
[+]
Article Blood Glucose Cholesterol Clinical Laboratory Techniques Creatinine Humans Phosphates Sensitivity And Specificity Triglycerides Uric Acid
Source:
Clin Chem. 60(6):855-863
Pubmed ID:
24687951
Pubmed Central ID:
PMC5699466
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:72e737dc03dd672559610365026557dbac980e658c09ee2286c81f6f73fe5bd4
Download URL:
https://stacks.cdc.gov/view/cdc/49953/cdc_49953_DS1.pdf
File Type:

Supporting Files

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  	nihms920539f1.gif	gif
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