Quality specifications for the determination of copper, zinc, and selenium in human serum or plasma: evaluation of an approach based on biological and analytical variation.

BACKGROUND: Trace element external quality assessment schemes monitor laboratory performance and provide a stimulus for improvement in accuracy. However, monitoring of participant performance varies according to the scheme and can lead to conflicting conclusions. METHODS: Quality specifications based on biological intra- and interindividual variability were calculated and compared to those currently used by various trace element external quality assessment schemes for plasma or serum copper, zinc, and selenium concentrations. For this purpose, we evaluated results reported by participating laboratories in different schemes, at key concentrations, using z scores. RESULTS: Minimal quality specifications developed from the biological intra- and interindividual variability were, for Cu, +/-0.84 micromol/L or 12% of the assigned target concentration, whichever is greater; for Zn, +/-1.20 micromol/L or 15% of the assigned target concentration, whichever is greater; and for Se, +/-0.072 micromol/L or 12% of the assigned target concentration, whichever is greater. Reported performance of the participating laboratories depended on analyte, concentration, and the selected quality specification. In addition, the most commonly used methods for the determination of Cu, Zn, and Se may give different results. CONCLUSIONS: The proposed minimal quality specifications based on biological variation are generally slightly less stringent than those currently in use, although they do not drastically change the performance evaluation in the different schemes. These specifications are a first step in the harmonization of practices among the schemes and remain to be evaluated.

Behavior of aluminum in aluminum welders and manufacturers of aluminum sulfate--impact on biological monitoring.

OBJECTIVES: The suitability of determining aluminum in serum or urine as a form of biological monitoring was critically assessed. METHODS: Airborne and internal aluminum exposure was assessed for 12 aluminum welders in a shipyard and 5 manufacturers of aluminum sulfate. Particles were characterized with X-ray diffraction and scanning electron microscopy. Aluminum in air and biological samples was analyzed using electrothermal atomic absorption spectrometry. Basic toxicokinetic features were inferred from the data. RESULTS: The mean 8-hour time-weighted average concentration of aluminum was 1.1 (range 0.008-6.1) mg/m(3) for the shipyard and 0.13 (range 0.02-0.5) mg/m(3) for the aluminum sulfate plant. Welding fume contained aluminum oxide particles <0.1 microm in diameter and their agglomerates, whereas bauxite and aluminum sulfate particles ranged from 1 to 10 microm in diameter. The shipyard welders' mean postshift serum and urinary concentrations of aluminum (S-Al and U-Al, respectively) were 0.22 and 3.4 micromol/l, respectively, and the aluminum sulfate workers' corresponding values were 0.13 and 0.58 micromol/l. Between two shifts, the welders' S-Al concentration decreased by about 50% (P<0.01), but their U-Al concentration did not change (P=0.64). No corresponding temporal changes occurred among the aluminum sulfate workers. After aluminum welding at the shipyard had ceased, the median S-Al concentration decreased by about 50% (P=0.007) within a year, but there was no change (P=0.75) in the corresponding U-Al concentration. CONCLUSIONS: About 1% of aluminum in welding fume appears to be rapidly absorbed from the lungs, whereas an undetermined fraction is retained and forms a lung burden. A higher fractional absorption of aluminum seems possible for aluminum sulfate workers without evidence of a lung burden. After rapid absorption, aluminum is slowly mobilized from the lung burden and dominates the S-Al and U-Al concentrations of aluminum welders. For kinetic reasons, S-Al or U-Al concentrations cannot be used to estimate the accumulation of aluminum in the target organs of toxicity. However, using U-Al analysis to monitor aluminum welders' lung burden seems practical.

Differences in national legislation for the implementation of lead regulations included in the European directive for the protection of the health and safety of workers with occupational exposure to chemical agents (98/24/EC).

BACKGROUND: The European Council Directive 98/24 on the protection of the health and safety of workers exposed to chemical agents sets out provisions for environmental and biological monitoring, making specific reference to binding limit values and health surveillance measures for those with exposure to lead OBJECTIVES: To compare how the Directive has been implemented at a national level in EU countries and to determine whether workers receive equivalent protection. METHODS: Information on selected key issues was collected from 14 EU countries by means of a structured questionnaire. RESULTS: National occupational exposure limit values generally reflect that set by the Directive (0.15 mg/m(3)), but in five cases lower limits are set. National binding biological limit values range from 20 microg/100 ml blood in one country up to 80 microg/100 ml blood in others. The risk to the unborn child is generally recognised with specific measures for women of child-bearing potential or those that are pregnant or breast feeding. In only three countries are special arrangements included for young workers. Limits at which medical surveillance is put into effect are more consistent at 40 microg/100 ml in most countries. The Directive also refers to guidelines for health surveillance but none have been issued with respect to lead. Thus monitoring strategies and requirements for analytical performance vary considerably. CONCLUSIONS: The results of this survey suggest that protection of workers against the risk of exposure to lead at work is far from uniform across the European Union. Such disparity may also have implications on the requirements set at national level for laboratories measuring lead in blood and/or air. In the interest of harmonisation within the EU, further consideration should be given to the Annex II of the EC Directive 98/24, taking into account the suggestions for lower binding limit values for lead; this should include full guidelines for medical surveillance and requirements for laboratories should be issued.

Comparison of procedures for evaluating laboratory performance in external quality assessment schemes for lead in blood and aluminum in serum demonstrates the need for common quality specifications.

BACKGROUND: The different scoring methods used by eight European External Quality Assessment Schemes (EQASs) for occupational and environmental laboratory medicine were compared to develop suitable quality specifications as a step toward harmonization. METHODS: Real results for blood lead and serum aluminum assays, reported by participants in Italian and United Kingdom EQASs, were evaluated according to individual scheme scoring criteria. The same results were then used to produce z scores using scheme-based between-laboratory SDs as the estimate of variability to determine whether simple performance-derived quality specifications produced better agreement among schemes. RESULTS: The schemes gave conflicting assessments of participants' performance, and participants judged to be successful by one scheme could be defined as performing inadequately by another. An approach proposed by Kenny et al. (Scand J Clin Lab Invest 1999;59:585), which uses clinical inputs to set targets for analytical imprecision, bias, and total error allowable, was then used to elaborate quality specifications. CONCLUSIONS: We suggest that the CLIA '88 recommendations for blood lead (+/- 40 micro g/L or +/- 10% of the target concentration, whichever is the greater) could be used as a quality specification, although a revision to +/- 30 micro g/L or +/- 10% is recommended. For serum aluminum, a suitable quality specification of +/- 5 micro g/L or +/- 20% of the target concentration, whichever is the greater, is suggested. These specifications may be used to compare laboratory performance across schemes.

Finnish quality assurance programme for biological monitoring of organic solvents.

The FIOH quality assurance programme for organic solvents and their metabolites consists of analyses for 2,5-hexadione, phenol, mandelic acid, methylenedianiline, methylhippuric acid, trans,trans-muconic acid and trichloroacetic acid in urine, and creatinine and relative density for standardisation. Four times a year two levels of spiked urine or urine specimens collected from occupationally exposed workers are distributed to the participants in 22 countries. RSD and recovery were studied during 1997-2000. Average RSDs of all participants varied between 23 and 56% and were clearly dependent on the analytical method used and the concentration level of the samples. Since 1997 the target values have been determined in reference laboratories for five of the analytes. Lower RSDs (9-21%) and good recoveries were obtained for all analytes in these laboratories, indicating that good performance can be achieved even in the complex analyses performed in biological monitoring of exposure to industrial chemicals.