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Background: A new blood lead testing instrument has qualities that make the instrument attractive for on-site testing of occupational lead exposures. This study evaluated the accuracy of the instrument when used in a manufacturing setting, and examined the impact of blood storage and shipment on results., Methods: Venous blood specimens (n=121) were obtained and immediately analyzed on-site using the new instrument. They were then shipped to a reference laboratory and analyzed using electro-thermal atomization atomic absorption spectrometry (ETAAS), and retested using the new instrument., Results: The cohort blood lead concentration averaged 40.1 microg/dl. Results obtained on the new analyzer with freshly collected blood averaged 38.7 microg/dl. The mean difference of 1.2 microg/dl on paired samples was not statistically significant. Following blood shipment and storage, results on the analyzer increased to an average of 42.4 microg/dl. The mean increase of 3.0 microg/dl on stored blood samples also failed to reach statistical significance. Under OSHA proficiency test acceptability requirements, 94% of the results had satisfactory agreement., Conclusions: The new analyzer might be a useful tool for on-site monitoring of occupational lead exposures. The manufacturer's instructions should be adhered to with respect to specimen age and storage requirements.

Background: Most proficiency testing (PT) programs operate with an open design in which clearly identified performance samples are distributed directly to participating laboratories on a shipping schedule announced in advance. In this study, we examine the effectiveness of assessing clinical laboratory performance for blood lead with an open PT by comparing its results with a double-blinded testing protocol., Methods: Aliquots from up to 72 blood lead performance pools from the New York State Department of Health and the Wisconsin State Laboratory of Hygiene were disguised as routine patient specimens and submitted in two phases to up to 42 certified clinical laboratories for blood lead analysis. These 42 laboratories also received aliquots of the same performance samples for blood lead analysis directly from the "open" PT program provider., Results: Data reported under blind and open strategies were scored against acceptable target ranges using the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) criteria established for blood lead, i.e., +/- 0.19 micromol/L (+/- 4 microg/dL) or +/- 10%, whichever is greater. Performance differences between the strategies were also assessed. We found that 17.7% of all blind PT results were classified as unacceptable compared with only 4.5% of open PT results (P <0.001). In phase 1, 13 of 22 laboratories (60%) exhibited a statistically significant difference (P <0.05) between their blind and open PT performances, although for 6 laboratories the poorer blind performance may not necessarily have led to unsuccessful PT participation under CLIA '88 criteria. Seven (32%) laboratories had unsuccessful aggregate performance (<80%) under blind testing while maintaining successful performance in open testing. Of these seven, two had gross discrepancies motivating further investigation., Conclusions: The data suggest that although approximately 60% of clinical laboratories make special efforts to improve analytical performance on open PT samples relative to performance achieved for routine patient specimens, in most cases the differences are clinically insignificant and would not likely affect cumulative PT performance. Occasional use of blind PT may deter the inclination to treat performance samples more carefully.

Background: Lead testing on dried filter paper (FP) blood spots is used routinely by some laboratories for lead poisoning screening. Proficiency testing (PT) as required under CLIA '88 laboratory regulations has not been available for these methods., Methods: We describe a suitable PT scheme and evaluate FP laboratory performance based on program results. Monthly testing events consisting of five FP specimens were provided to six participating laboratories. Results were evaluated against target values determined by referee laboratories., Results: Preliminary FP laboratory results showed poor agreement with specimen target values, exhibiting a mean absolute bias of 0.29 micromol/L (5.9 microg/dL). Five of six participating laboratories demonstrated significant improvement in later testing events, with bias decreasing to 0.12 micromol/L (2.5 microg/dL). Performance varied widely between the participating laboratories and appeared to be method dependent. When evaluated using CLIA blood lead acceptability criteria, the proportion of acceptable individual specimen results (n = 35) ranged from 54% to 100%. On a testing event basis (n = 7), the proportion of acceptable events ranged from 29% to 100%., Conclusions: A suitable FP PT program now exists to capably assist and monitor FP laboratories. Based on overt PT results, properly utilized FP testing methods can accurately measure blood lead concentration.

A recently introduced hematofluorometer, the "Protofluor-Z" (Helena Laboratories, Beaumont, TX), has several novel features, most notably reporting units expressed as the molar ratio of zinc protoporphyrin (ZPP) to heme, i.e., micromoles of ZPP per mole of heme. We analyzed human blood specimens on the Protofluor-Z and by an ethyl acetate/acetic acid extraction procedure. Data from three laboratories were pooled and used to provide a comparison of the two methods. Results indicate that, with the Protofluor-Z, a value of 70 mumol of ZPP per mole of heme is approximately equivalent to the recommended screening cutoff of 35 micrograms of erythrocyte protoporphyrin per 100 mL of whole blood used in programs for pediatric lead-poisoning prevention. This empirically determined value is slightly lower than either that recommended by the manufacturer or a theoretical cutoff value that was determined mathematically.

This interlaboratory study was conducted to examine four erythrocyte protoporphyrin control materials from Aviv Biomedical, Helena Laboratories, Kaulson Laboratories, and the New York State Department of Health for use with hematofluorometers. Our principal aims were to monitor the stability of these materials at three different storage temperatures (room, refrigerator, freezer) and, where appropriate, to validate the manufacturer's target values. Measurements for the study were generated in three reference laboratories that used a total of five hematofluorometers, three from Environmental Science Associates and two from Aviv Biomedical. Each instrument was calibrated against a consensus acetic acid-ethyl acetate extraction procedure. We found the materials from Aviv to be the most stable, followed by the New York State material. However, the target values assigned by Aviv were not within the acceptable range determined by consensus. The target values assigned by Kaulson Laboratories for their materials did fall within the acceptable consensus range, but they were the least stable of the materials evaluated. The materials from Helena Laboratories were originally designed for use as calibrators with Helena's "ProtoFluor Z" hematofluorometer, which reports in different units. They were deemed unsuitable for use as control materials with the Aviv or Environmental Science Associates hematofluorometers because of the narrow range of values and the wide scatter of results.