TRACE ELEMENTS IN SERUM. Educational Event. Proficiency Test Report. Event #2, 2013

Transcription

1 TRACE ELEMENTS IN SERUM Educational Event Proficiency Test Report Event #, 0 May 8 th, 0

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3 Event #, 0 Serum Aluminum The test materials for serum Al were prepared from human serum obtained from Tennessee Blood Services, Inc. The units were tested by FDA approved methods and found to be Non-reactive for Anti-HIV-/, Anti-HCV.0 and HBsAg. The serum has also been found to be STS (RPR) Non-reactive and Negative for HIV- and HCV by PCR. Serum units were dispensed into acid-washed 500-mL polypropylene containers to make up five (5) serum pools. Each pool was spiked with a suite of additional trace elements including aluminum as Al + at various concentrations. These are archived PT materials previously circulated. The Target Value assigned for each PT material is the robust mean of the results reported by all participants in this event. The robust statistics were obtained utilizing algorithms based on those presented in ISO 58:005E Statistical methods for use in proficiency testing by interlaboratory comparisons. Values for serum aluminum range from 0 µg/l (0.7 µmol/l) to 67 µg/l (6.9 µmol/l). Acceptable ranges for serum aluminum are based on fixed criteria of ±0%, or ±5 µg/l below 5 µg/l. These criteria are based on consensus recommendations from several EQAS organizers (). Discussion. Although these PT materials were circulated as ungraded educational samples, Acceptable Ranges are included so that participants can evaluate their own laboratory bias. Upward and downward indicator arrows next to individual results should be used as part of a laboratory s on-going internal quality assessment scheme. Based on the above criteria, 9.5% of test results reported were judged as satisfactory, with two out of participant laboratories (9.%) reporting or more of the 5 results outside the acceptable ranges.. Taylor, A., Angerer, J., Claeys, F., Kristiansen, J., Mazarrasa, O., Menditto, A., Patriarca, M., Pineau, A., Schoeters, I., Sykes, C., Valkonen, S. and Weykamp, C. 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. Clinical Chemistry Trace Elements PT Program

4 Serum Aluminum Educational Test Results, 0 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS SE-6 SE-7 SE-8 SE-9 SE-0 Robust Mean Robust Standard Deviation Standard Uncertainty < < RSD (%) Number of Sample Measurements Acceptable Range: Upper Limit Lower Limit notes: Results reported as less than the method detection limit are excluded from statistical calculations.

5 Serum Aluminum Educational Test Results, 0 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE-6 SE-7 SE-8 SE-9 SE-0 Info Only Target Values: ETAAS-Z ICP-MS FAAS 5 65 Info 56 ICP-MS ETAAS-Z ICP-MS DRC/CC-ICP-MS ICP-MS 76 <0 <0 75 <0 00 DRC/CC-ICP-MS Info 06 DRC/CC-ICP-MS > ETAAS-Z ICP-MS Info 05 ICP-MS ICP-MS Info 5 ETAAS-Z Info 55 ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS ICP-AES/OES Info 58 ETAAS other Percent satisfactory results for all participants: 9.5 % NOTE: Grading is for educational purposes only notes: reported outside upper limit Info only: results included for informational purposes only. reported outside lower limit notes: Results reported as less than the method detection limit are excluded from statistical calculations. : Result not reported

6 DRC/CC-ICP-MS New York State Department of Health Serum Aluminum Educational Test Results, 0 Event # STATISTICAL SUMMARY BY METHOD ETAAS other ETAAS-Z FAAS ICP-AES/OES ICP-MS All Laboratories SE-6 SE-7 SE-8 SE-9 SE notes: Insufficient data for calculation.

7 Event #, 0 Serum Copper The test materials for serum Cu were prepared from human serum obtained from Tennessee Blood Services, Inc. The units were tested by FDA approved methods and found to be Non-reactive for Anti-HIV-/, Anti-HCV.0 and HBsAg. The serum has also been found to be STS (RPR) Non-reactive and Negative for HIV- and HCV by PCR. Serum units were dispensed into acid-washed 500-mL polypropylene containers to make up five (5) serum pools. Each pool was spiked with a suite of additional trace elements including copper as Cu + at various concentrations. These are archived PT materials previously circulated. The Target Value assigned for each PT material is the robust mean of the results reported by all participants in this event. The robust statistics were obtained utilizing algorithms based on those presented in ISO 58:005E Statistical methods for use in proficiency testing by interlaboratory comparisons. Values for serum copper range from 00 µg/l (5.80 µmol/l) to µg/l (. µmol/l). Acceptable ranges for serum copper are based on fixed criteria of ±5%, or ±95 µg/l below 65 µg/l. These criteria are consistent with those proposed by the OELM Network of EQAS organizers (, ) for trace elements in serum, and are slightly less stringent than those previously suggested for NYS (±0%). Discussion. Although these PT materials were circulated as ungraded educational samples, Acceptable Ranges are included so that participants can evaluate their own laboratory bias. Upward and downward indicator arrows next to individual results should be used as part of a laboratory s on-going internal quality assessment scheme. Based on the above criteria, 95.% of test results reported were judged as satisfactory, with one out of 7 participant laboratories (5.9%) reporting or more of the 5 results outside the acceptable ranges.. A. Taylor, J. Angerer, J. Arnaud, F. Claeys, R.L. Jones, O. Mazarrasa, E. Mairiaux, A. Menditto, P.J. Parsons, M. Patriarca, A. Pineau, S. Valkonen, J.-P. Weber and C. Weykamp Accreditation and Quality Assurance J. Arnaud, J.-P. Weber, C.W. Weykamp, P.J. Parsons, J. Angerer, E. Mairiaux, O. Mazarrasa, S. Valkonen, A. Menditto, M. Patriarca, and A. Taylor Clinical Chemistry Trace Elements PT Program

8 Serum Copper Educational Test Results, 0 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS SE-6 SE-7 SE-8 SE-9 SE-0 Robust Mean Robust Standard Deviation Standard Uncertainty 60 9 RSD (%) Number of Sample Measurements Acceptable Range: Upper Limit Lower Limit notes: Results reported as less than the method detection limit are excluded from statistical calculations.

9 Serum Copper Educational Test Results, 0 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE-6 SE-7 SE-8 SE-9 SE-0 Info Only Target Values: DRC/CC-ICP-MS Info 0 ICP-MS ICP-MS ICP-MS Info 56 ICP-AES/OES ETAAS-Z ICP-MS DRC/CC-ICP-MS ICP-MS ICP-MS ICP-MS Info 05 ICP-MS ICP-MS Info 5 ICP-MS Info 59 ICP-MS DRC/CC-ICP-MS Info 57 ICP-AES/OES Info Percent satisfactory results for all participants: 95. % NOTE: Grading is for educational purposes only notes: reported outside upper limit Info only: results included for informational purposes only. reported outside lower limit notes: Results reported as less than the method detection limit are excluded from statistical calculations. : Result not reported

10 DRC/CC-ICP-MS New York State Department of Health Serum Copper Educational Test Results, 0 Event # STATISTICAL SUMMARY BY METHOD ETAAS-Z ICP-AES/OES ICP-MS All Laboratories SE-6 SE-7 SE-8 SE-9 SE notes: Insufficient data for calculation.

11 Educational Event #, 0 Serum Selenium The test materials for serum Se were prepared from human serum obtained from Tennessee Blood Services, Inc. The units were tested by FDA approved methods and found to be Non-reactive for Anti-HIV-/, Anti-HCV.0 and HBsAg. The serum has also been found to be STS (RPR) Non-reactive and Negative for HIV- and HCV by PCR. Serum units were dispensed into acid-washed 500-mL polypropylene containers to make up five (5) serum pools. Each pool was spiked with a suite of additional trace elements including selenium as Se + at various concentrations. These are archived PT materials previously circulated. The Target Value assigned for each PT material is the robust mean of the results reported by all participants in this event. The robust statistics were obtained utilizing algorithms based on those presented in ISO 58:005E Statistical methods for use in proficiency testing by interlaboratory comparisons. Values for serum selenium range from 9 µg/l (.9 µmol/l) to 5 µg/l (.8 µmol/l). Acceptable ranges for serum selenium are based on fixed criteria of ±0%, or ± µg/l below 0 µg/l. These criteria are a little less stringent than those proposed by the OELM Network of EQAS organizers (±5% or ±8 µg/l below 55 µg/l) (, ) for trace elements in serum. As performance for serum Se improves among NYS-permit laboratories, consideration will be given to adopting the OELM criteria. Discussion. Although these PT materials were circulated as ungraded educational samples, Acceptable Ranges are included so that participants can evaluate their own laboratory bias. Upward and downward indicator arrows next to individual results should be used as part of a laboratory s on-going internal quality assessment scheme. Based on the above criteria, 00% of test results reported were judged as satisfactory, with none of the participant laboratories reporting or more of the 5 results outside the acceptable ranges.. A. Taylor, J. Angerer, J. Arnaud, F. Claeys, R.L. Jones, O. Mazarrasa, E. Mairiaux, A. Menditto, P.J. Parsons, M. Patriarca, A. Pineau, S. Valkonen, J.-P. Weber and C. Weykamp Accreditation and Quality Assurance J. Arnaud, J.-P. Weber, C.W. Weykamp, P.J. Parsons, J. Angerer, E. Mairiaux, O. Mazarrasa, S. Valkonen, A. Menditto, M. Patriarca, and A. Taylor Clinical Chemistry Trace Elements PT Program

12 Serum Selenium Educational Test Results, 0 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS SE-6 SE-7 SE-8 SE-9 SE-0 Robust Mean Robust Standard Deviation Standard Uncertainty 5 RSD (%) Number of Sample Measurements Acceptable Range: Upper Limit 7 0 Lower Limit notes: Results reported as less than the method detection limit are excluded from statistical calculations.

13 Serum Selenium Educational Test Results, 0 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE-6 SE-7 SE-8 SE-9 SE-0 Info Only Target Values: DRC/CC-ICP-MS Info 0 DRC/CC-ICP-MS ICP-MS DRC/CC-ICP-MS Info 56 ICP-MS DRC/CC-ICP-MS DRC/CC-ICP-MS DRC/CC-ICP-MS Info 06 DRC/CC-ICP-MS DRC/CC-ICP-MS Info 05 ICP-MS ICP-MS Info 67 DRC/CC-ICP-MS Info 0 DRC/CC-ICP-MS Info Percent satisfactory results for all participants: 00.0 % NOTE: Grading is for educational purposes only notes: reported outside upper limit Info only: results included for informational purposes only. reported outside lower limit notes: Results reported as less than the method detection limit are excluded from statistical calculations. : Result not reported

14 DRC/CC-ICP-MS New York State Department of Health Serum Selenium Educational Test Results, 0 Event # STATISTICAL SUMMARY BY METHOD ICP-MS All Laboratories SE-6 SE-7 SE-8 SE-9 SE notes: Insufficient data for calculation.

15 Event #, 0 Serum Zinc The test materials for serum Zn were prepared from human serum obtained from Tennessee Blood Services, Inc. The units were tested by FDA approved methods and found to be Non-reactive for Anti-HIV-/, Anti-HCV.0 and HBsAg. The serum has also been found to be STS (RPR) Non-reactive and Negative for HIV- and HCV by PCR. Serum units were dispensed into acid-washed 500-mL polypropylene containers to make up five (5) serum pools. Each pool was spiked with a suite of additional trace elements including copper as Zn + at various concentrations. These are archived PT materials previously circulated. The Target Value assigned for each PT material is the robust mean of the results reported by all participants in this event. The robust statistics were obtained utilizing algorithms based on those presented in ISO 58:005E Statistical methods for use in proficiency testing by interlaboratory comparisons. Values for serum zinc range from 57 µg/l (8.78 µmol/l) to 859 µg/l (.7 µmol/l). Acceptable ranges for serum zinc are based on fixed criteria of ±5%, or ±5 µg/l below 00 µg/l. These criteria are consistent with those proposed by the OELM network of EQAS organizers () for trace elements in serum. Discussion. Although these PT materials were circulated as ungraded educational samples, Acceptable Ranges are included so that participants can evaluate their own laboratory bias. Upward and downward indicator arrows next to individual results should be used as part of a laboratory s on-going internal quality assessment scheme. Based on the above criteria, 87.5% of test results reported were judged as satisfactory, with four out of participant laboratories (6.7 %) reporting or more of the 5 results outside the acceptable ranges.. A. Taylor, J. Angerer, J. Arnaud, F. Claeys, R.L. Jones, O. Mazarrasa, E. Mairiaux, A. Menditto, P.J. Parsons, M. Patriarca, A. Pineau, S. Valkonen, J.-P. Weber and C. Weykamp Accreditation and Quality Assurance J. Arnaud, J.-P. Weber, C.W. Weykamp, P.J. Parsons, J. Angerer, E. Mairiaux, O. Mazarrasa, S. Valkonen, A. Menditto, M. Patriarca, and A. Taylor Clinical Chemistry Trace Elements PT Program

16 Serum Zinc Educational Test Results, 0 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS SE-6 SE-7 SE-8 SE-9 SE-0 Robust Mean Robust Standard Deviation Standard Uncertainty RSD (%) Number of Sample Measurements Acceptable Range: Upper Limit Lower Limit notes: Results reported as less than the method detection limit are excluded from statistical calculations.

17 Serum Zinc Educational Test Results, 0 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE-6 SE-7 SE-8 SE-9 SE-0 Info Only Target Values: DRC/CC-ICP-MS Info 0 ICP-MS ICP-MS ICP-MS Info 56 ICP-AES/OES FAAS ICP-MS DRC/CC-ICP-MS ICP-MS ICP-MS FAAS ICP-MS Info 05 ICP-MS ICP-MS Info 5 ICP-MS Info 55 ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS DRC/CC-ICP-MS Info 57 ICP-AES/OES Info 58 ETAAS other Percent satisfactory results for all participants: 87.5 % NOTE: Grading is for educational purposes only notes: reported outside upper limit Info only: results included for informational purposes only. reported outside lower limit notes: Results reported as less than the method detection limit are excluded from statistical calculations. : Result not reported

18 DRC/CC-ICP-MS New York State Department of Health Serum Zinc Educational Test Results, 0 Event # STATISTICAL SUMMARY BY METHOD ETAAS other FAAS ICP-AES/OES ICP-MS All Laboratories SE-6 SE-7 SE-8 SE-9 SE notes: Insufficient data for calculation.

19 Event #, 0 Additional Trace Elements Reported in Serum Participant laboratories reported their analytical results for any additional trace elements (other than Al, Cu, Se and Zn) that are routinely reported so that a more complete characterization can be recorded for these PT materials. However, results for these additional trace elements are not reported here. Human serum samples were selected from archived PT material based upon selenium (Se) concentrations, and were relabeled for distribution with bovine serum samples with similar Se levels for analysis during 0 PT Event. The levels of aluminum (Al), copper (Cu) and Zinc (Zn), and the additional trace elements, if any, were not a consideration. We asked that participants consider analyzing both the bovine PT samples (SE-06 through 0) and the human educational samples (SE-6 through 0) within the same run, if possible, to minimize intralaboratory variability. We were only able to provide one set of the educational samples (SE-6 through 0), and the priority for analysis was for Se analysis, followed by Al, Cu and Zn. With any remaining material, analysis of serum additional elements should be considered. Consequently, the small number of values reported for the additional trace elements by participants for some of the educational PT materials reflects background levels that are largely below laboratory reportable limits. Trace Elements PT Program

20 ATOMIC SPECTROMETRY METHODS New York State Department of Health Trace Elements in Serum METHOD NOTES A- ETAAS-Z (Electrothermal atomic absorption spectrometry with Zeeman background correction) A- ETAAS other (i.e., D, S-H background correction) A- FAAS (Flame atomic absorption spectrometry) A- CV-AAS (Cold vapor atomic absorption spectrometry) A-5 HG-AAS (Hydride generation atomic absorption spectrometry) A-6 AFS (Atomic fluorescence spectrometry) A-7 Other INDUCTIVELY COUPLED PLASMA P- ICP-MS (Inductively coupled plasma - mass spectrometry) P- DRC/CC-ICP-MS (ICP-MS used in the Dynamic Reaction Cell or Collision Cell mode) P- ICP-AES/OES (ICP atomic/optical emission spectrometry) P- HR-ICP-MS (High resolution ICP-MS) P-5 ETV-ICP-MS (Electrothermal vaporization ICP-MS) P-6 ID-ICP-MS (Isotope dilution ICP-MS) P-7 Other ELECTROCHEMICAL METHODS E- ASV (Anodic stripping voltammetry without digestion) E- ASV-LeadCare (Anodic stripping voltammetry using the ESA LeadCare system) E- Fluoride specific electrode E- Other MOLECULAR FLUORIMETRY F- EtOAc (Ethyl acetate-acetic acid extraction method for determination of erythrocyte protoporphyrin) F- Aviv hematofluorometry (for determination of EP at hematocrit 5) F- Helena ZPP (for determination of zinc protoporphyrin in µmol ZPP/mol heme) F- Other OTHER METHODS If your method is not listed in the above list, please describe it briefly.