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Status of serum-calcium and -albumin measurement in Argentina assessed in 300 representative laboratories with 20 fresh frozen single donation sera

Hedwig Stepman, Dietmar Stöckl, Rosana Acheme, Sandra Sesini, Daniel Mazziotta and Linda Thienpont (2011) CLINICAL CHEMISTRY AND LABORATORY MEDICINE. 49(11). p.1829-1836
abstract
Background: The Fundacion Bioquimica Argentina (FBA) performs external quality assessment (EQA) >3200 laboratories. However, FBA realizes that sample non-commutability and predominant use of heterogeneous systems may bias the estimated performance and standardization status. To eliminate these confounding factors, a study using frozen single donation sera was undertaken with the focus on serum-calcium and -albumin measurement. Methods: Target values were established from the results produced with homogeneous systems. In groups of n=7, system effects were investigated. Laboratory performance was evaluated from the correlation coefficient r between the measurement results for all sera and the target values. This allowed ranking of the laboratories and judgment of the deviation for individual samples (total error) against a 10% limit. The total error specification was a deviation for >= 5 samples exceeding 10% and/or causing a result outside the laboratory's reference interval. Results: For calcium (n=303) (range: 2.06-2.42 mmol/L), 81 laboratories had an r-value <0.6, 43 even <0.4; the total error was relevant for 97 (10% limit) and 111 (reference interval) laboratories. For albumin (n=311) (range: 34.7-45.7 g/L) r was <0.7 (<0.4) in 44 (16) laboratories; 83 and 36 laboratories exceeded the total error criteria. Laboratories using homogeneous systems were generally ranked higher by correlation. System effects were moderate for calcium, but significant for albumin. Conclusions: The study demonstrated the need to improve the quality and harmonization of calcium and albumin testing in the investigated laboratories. To achieve this objective, we promote co-operation between laboratories, EQA provider and manufacturers.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
harmonization, external quality assessment, laboratory performance, standardization, EXTERNAL QUALITY ASSESSMENT, OF-THE-ART, CLINICAL-CHEMISTRY, ASSESSMENT SCHEMES, TRUENESS, COMMUTABILITY, ACCURACY, ANALYTES, TIME
journal title
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
Clin. Chem. Lab. Med.
volume
49
issue
11
pages
1829 - 1836
Web of Science type
Article
Web of Science id
000296772300009
JCR category
MEDICAL LABORATORY TECHNOLOGY
JCR impact factor
2.15 (2011)
JCR rank
10/32 (2011)
JCR quartile
2 (2011)
ISSN
1434-6621
DOI
10.1515/CCLM.2011.681
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1988348
handle
http://hdl.handle.net/1854/LU-1988348
date created
2012-01-17 08:54:55
date last changed
2016-12-19 15:42:53
@article{1988348,
  abstract     = {Background: The Fundacion Bioquimica Argentina (FBA) performs external quality assessment (EQA) {\textrangle}3200 laboratories. However, FBA realizes that sample non-commutability and predominant use of heterogeneous systems may bias the estimated performance and standardization status. To eliminate these confounding factors, a study using frozen single donation sera was undertaken with the focus on serum-calcium and -albumin measurement. 
Methods: Target values were established from the results produced with homogeneous systems. In groups of n=7, system effects were investigated. Laboratory performance was evaluated from the correlation coefficient r between the measurement results for all sera and the target values. This allowed ranking of the laboratories and judgment of the deviation for individual samples (total error) against a 10\% limit. The total error specification was a deviation for {\textrangle}= 5 samples exceeding 10\% and/or causing a result outside the laboratory's reference interval. 
Results: For calcium (n=303) (range: 2.06-2.42 mmol/L), 81 laboratories had an r-value {\textlangle}0.6, 43 even {\textlangle}0.4; the total error was relevant for 97 (10\% limit) and 111 (reference interval) laboratories. For albumin (n=311) (range: 34.7-45.7 g/L) r was {\textlangle}0.7 ({\textlangle}0.4) in 44 (16) laboratories; 83 and 36 laboratories exceeded the total error criteria. Laboratories using homogeneous systems were generally ranked higher by correlation. System effects were moderate for calcium, but significant for albumin. 
Conclusions: The study demonstrated the need to improve the quality and harmonization of calcium and albumin testing in the investigated laboratories. To achieve this objective, we promote co-operation between laboratories, EQA provider and manufacturers.},
  author       = {Stepman, Hedwig and St{\"o}ckl, Dietmar  and Acheme, Rosana and Sesini, Sandra  and Mazziotta, Daniel and Thienpont, Linda},
  issn         = {1434-6621},
  journal      = {CLINICAL CHEMISTRY AND LABORATORY MEDICINE},
  keyword      = {harmonization,external quality assessment,laboratory performance,standardization,EXTERNAL QUALITY ASSESSMENT,OF-THE-ART,CLINICAL-CHEMISTRY,ASSESSMENT SCHEMES,TRUENESS,COMMUTABILITY,ACCURACY,ANALYTES,TIME},
  language     = {eng},
  number       = {11},
  pages        = {1829--1836},
  title        = {Status of serum-calcium and -albumin measurement in Argentina assessed in 300 representative laboratories with 20 fresh frozen single donation sera},
  url          = {http://dx.doi.org/10.1515/CCLM.2011.681},
  volume       = {49},
  year         = {2011},
}

Chicago
STEPMAN, HEDWIG, Dietmar Stöckl, Rosana Acheme, Sandra Sesini, Daniel Mazziotta, and Linda Thienpont. 2011. “Status of Serum-calcium and -albumin Measurement in Argentina Assessed in 300 Representative Laboratories with 20 Fresh Frozen Single Donation Sera.” Clinical Chemistry and Laboratory Medicine 49 (11): 1829–1836.
APA
STEPMAN, H., Stöckl, D., Acheme, R., Sesini, S., Mazziotta, D., & Thienpont, L. (2011). Status of serum-calcium and -albumin measurement in Argentina assessed in 300 representative laboratories with 20 fresh frozen single donation sera. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 49(11), 1829–1836.
Vancouver
1.
STEPMAN H, Stöckl D, Acheme R, Sesini S, Mazziotta D, Thienpont L. Status of serum-calcium and -albumin measurement in Argentina assessed in 300 representative laboratories with 20 fresh frozen single donation sera. CLINICAL CHEMISTRY AND LABORATORY MEDICINE. 2011;49(11):1829–36.
MLA
STEPMAN, HEDWIG, Dietmar Stöckl, Rosana Acheme, et al. “Status of Serum-calcium and -albumin Measurement in Argentina Assessed in 300 Representative Laboratories with 20 Fresh Frozen Single Donation Sera.” CLINICAL CHEMISTRY AND LABORATORY MEDICINE 49.11 (2011): 1829–1836. Print.