Sue Jovanovich

Recommendations for standardized reporting of protein electrophoresis in Australia and New Zealand

Background Although protein electrophoresis of serum (SPEP) and urine (UPEP) specimens is a well-established laboratory technique, the reporting of results using this important method varies considerably between laboratories. The Australasian Association of Clinical Biochemists recognized a need to adopt a standardized approach to reporting SPEP and UPEP by clinical laboratories. Methods A Working Party considered available data including published literature and clinical studies, together with expert opinion in order to establish optimal reporting practices. A position paper was produced, which was subsequently revised through a consensus process involving scientists and pathologists with expertise in the field throughout Australia and New Zealand. Results Recommendations for standardized reporting of protein electrophoresis have been produced. These cover analytical requirements: detection systems; serum protein and albumin quantification; fractionation into alpha-1, alpha-2, beta and gamma fractions; paraprotein quantification; urine Bence Jones protein quantification; paraprotein characterization; and laboratory performance, expertise and staffing. The recommendations also include general interpretive commenting and commenting for specimens with paraproteins and small bands together with illustrative examples of reports. Conclusions Recommendations are provided for standardized reporting of protein electrophoresis in Australia and New Zealand. It is expected that such standardized reporting formats will reduce both variation between laboratories and the risk of misinterpretation of results.

Autoantibodies: has external quality control led to better standardisation?

Lack of standardisation in autoimmune assays has always been a problem for the Immunology QAP, and is why laboratories should evaluate their performance within their own method group. This presentation centres on whether standardisation has improved with participation in external quality assurance.

Monitoring laboratory performance: assessment criteria

The Royal College of Pathologists of Australasia (RCPA) Immunology Quality Assurance Program (QAP) is developing a system to monitor laboratory performance, to be introduced in 2013. Each of the Immunochemistry, Allergy, Autoimmune and Immunophe-notyping Working Parties have produced assessment criteria on which the system will be based.

RCPA immunology QAP report – data from recent pilot programs

Several pilot programs were provided in 2010, including ganglioside antibodies, CCP using patient sera, and monitoring amyloidosis with serum free light chains. Results from these will be discussed, along with updates to the 2011 program.

Assessment of variability in IgG subclass ranges in Australian laboratories using survey methodology and battacharya statistics

Quantitation of immunoglobulin G (IgG) subclasses has been used in the investigation of immunodeficiency, and more recently, in inflammatory syndromes. Although attempts have been made to standardise reference preparations, marked variability in the ranges quoted in literature and by individual laboratories using the same methodology still occur. We assessed the variation in methodology, reference ranges and reporting in Australian diagnostic laboratories. First we surveyed 25 laboratories subscribing to the RPCA IgG subclass QAP about their methods to determine differences in kit manufacturer, instrument/platform, age related reference ranges, and the source of reference intervals. Second, using a Battacharya statistical method, which identifies overlapping Gaussian distributions on the mathematical separation of healthy and diseased populations, we determined the most appropriate reference ranges for an Australian population. Twenty of 25 (80%) laboratories responded to the survey. Of these, 18 (90%) used a nephelometric method, one (5%) a turbidimetric method and one (5%) radial immunodiffusion (RID). Despite the homogeneity in methodology, reference intervals showed vast inconsistencies, despite the same source being cited by many laboratories. The Bhattacharya method shows wider overall reference intervals for all subclasses when compared with The Binding Site manufacturer’s range, which may affect the utility of this test.

Liver antibodies and the QAP

A review of the liver autoantibodies in the Royal College of Pathologists of Australasia (RCPA) Immunology Quality Assurance Program (QAP) and their detection by participating laboratories.

RCPA QAP immunopathology update: how can the immunology QAP help your laboratory?

The Immunology Quality Assurance Program (QAP) provides an accredited external quality assurance program to over 560 laboratories in Australia, New Zealand and overseas. Laboratories enrolled in the program have access to educational services such as case studies, participation in pilot programs, and online data analysis using the QAP database of results and methodologies. Other services provided include personalised consultation on your laboratory’s reports, available on request.