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Pathology. 2004 Apr;36(2):174-81.

Anti-cardiolipin antibody testing and reporting practices among laboratories participating in a large external Quality Assurance Program.

Author information

1
Division of Immunology, Queensland Health Pathology Services, Princess Alexandra and Royal Brisbane Hospitals, Queensland, Australia. richard_wong@health.qld.gov.au

Abstract

AIMS:

To investigate differences in anti-cardiolipin antibody (aCL) testing and reporting practices among diagnostic laboratories participating in the RCPA Quality Assurance Program (QAP) Immunology Program.

METHODS:

A survey was sent to all 58 laboratories enrolled for aCL testing in the RCPA QAP Program requesting the following information: (1). manufacturer/type of assay; (2). isotype tested; (3). use of calibrators and controls; (4). whether calibrators, control and patient specimens were performed in singles or duplicates; (5). whether results were reported semi-quantitatively and/or numerically; (6). values used to define negative/positive and semi-quantitative cut-offs and how they were determined; and (7). whether interpretative comments were provided and their content.

RESULTS:

Thirty-two surveys (55%) were received. Significant differences were present particularly in the following areas: (1). whether IgM isotype aCL testing was performed routinely or only on specific request; (2). whether controls/calibrators/specimens were tested in singles or duplicates; (3). whether results were reported numerically and/or semi-quantitatively; (4). the values used to define negative/positive and semi-quantitative range cut-offs; and (5). whether interpretative comments were provided and their content.

CONCLUSIONS:

These differences in testing and reporting practices are likely to contribute to the variation in aCL results reported by different laboratories, particularly among those using the same assay.

PMID:
15203755
DOI:
10.1080/00313020410001672046
[Indexed for MEDLINE]

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