TRACE ELEMENTS IN SERUM. Event #3, 2011

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1 TRACE ELEMENTS IN SERUM Event #, 0 November 5, 0

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. 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 9 µg/l (.0 µmol/l) to 00 µg/l (.4 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. Based on the above criteria, 9.% of test results reported were judged as satisfactory, with two out of 6 participant laboratories (.%) 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 Test Results, 0 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS SE- SE- SE- SE-4 SE-5 Robust Mean Robust Standard Deviation Standard Uncertainty RSD (%) Acceptable Range: Upper Limit: Lower Limit: notes: Results reported as less than the method detection limit are excluded from statistical calculations.

5 Serum Aluminum Test Results, 0 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE- SE- SE- SE-4 SE-5 Info Only Target Values: ETAAS-Z ETAAS-Z >00 > ETAAS-Z Info 56 ICP-MS ETAAS-Z ETAAS-Z ICP-MS DRC/CC-ICP-MS ICP-MS DRC/CC-ICP-MS Info 06 ICP-MS ETAAS-Z ICP-MS Info 05 ICP-MS HR-ICP-MS Info 5 ETAAS-Z Info 55 ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS ETAAS-Z Info 6 ETAAS-Z Info 40 ICP-AES/OES Info 458 ETAAS Other ICP-MS Percent satisfactory results for all participants: 9. % 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.

6 DRC/CC-ICP-MS New York State Department of Health Serum Aluminum Test Results, 0 Event # STATISTICAL SUMMARY BY METHOD ETAAS Other ETAAS-Z HR-ICP-MS ICP-AES/OES ICP-MS All Laboratories SE- SE- SE- SE-4 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. 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 956 µg/l (5.04 µmol/l) to 45 µg/l (8.59 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. Based on the above criteria, 9.4% of test results reported were judged as satisfactory, with two out of participant laboratories (9.5%) 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 Test Results, 0 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS SE- SE- SE- SE-4 SE-5 Robust Mean Robust Standard Deviation Standard Uncertainty RSD (%) Acceptable Range: Upper Limit: Lower Limit: notes: Results reported as less than the method detection limit are excluded from statistical calculations.

9 Serum Copper Test Results, 0 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE- SE- SE- SE-4 SE-5 Info Only Target Values: DRC/CC-ICP-MS Info 0 ICP-MS ICP-MS ICP-MS Info 56 FAAS ICP-AES/OES ETAAS-Z ICP-MS DRC/CC-ICP-MS ICP-MS ICP-MS Info 06 ICP-MS ICP-MS Info 05 ICP-MS HR-ICP-MS Info 5 FAAS Info 60 FAAS ICP-MS ETAAS other Info 40 DRC/CC-ICP-MS Info 45 ICP-AES/OES Info Percent satisfactory results for all participants: 9.4 % 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.

10 DRC/CC-ICP-MS New York State Department of Health Serum Copper Test Results, 0 Event # STATISTICAL SUMMARY BY METHOD ETAAS other ETAAS-Z FAAS HR-ICP-MS ICP-AES/OES ICP-MS All Laboratories SE- SE- SE- SE-4 SE notes: Insufficient data for calculation.

11 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 4+ at various concentrations. 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 0 µg/l (.5 µmol/l) to 64 µg/l (.4 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. 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 Test Results, 0 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS SE- SE- SE- SE-4 SE-5 Robust Mean Robust Standard Deviation Standard Uncertainty RSD (%) Acceptable Range: Upper Limit: Lower Limit: notes: Results reported as less than the method detection limit are excluded from statistical calculations.

13 Serum Selenium Test Results, 0 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE- SE- SE- SE-4 SE-5 Info Only Target Values: DRC/CC-ICP-MS Info 0 DRC/CC-ICP-MS ICP-MS ICP-MS Info 56 ICP-MS ETAAS-Z ICP-MS DRC/CC-ICP-MS ICP-MS DRC/CC-ICP-MS Info 06 ICP-MS DRC/CC-ICP-MS Info 05 ICP-MS HR-ICP-MS Info 66 ETAAS-Z Info 6 DRC/CC-ICP-MS Info 40 DRC/CC-ICP-MS Info Percent satisfactory results for all participants: 00.0 % 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.

14 DRC/CC-ICP-MS New York State Department of Health Serum Selenium Test Results, 0 Event # STATISTICAL SUMMARY BY METHOD ETAAS-Z HR-ICP-MS ICP-MS All Laboratories SE- SE- SE- SE-4 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 zinc as Zn + at various concentrations. 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 606 µg/l (9. µmol/l) to 5 µg/l (.8 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. Based on the above criteria, 95.6% of test results reported were judged as satisfactory, with one out of 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

16 Serum Zinc Test Results, 0 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS SE- SE- SE- SE-4 SE-5 Robust Mean Robust Standard Deviation Standard Uncertainty RSD (%) Acceptable Range: Upper Limit: Lower Limit: notes: Results reported as less than the method detection limit are excluded from statistical calculations.

17 Serum Zinc Test Results, 0 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE- SE- SE- SE-4 SE-5 Info Only Target Values: DRC/CC-ICP-MS Info 0 ICP-MS ICP-MS ICP-MS Info 56 ICP-MS ICP-AES/OES FAAS ICP-MS DRC/CC-ICP-MS ICP-MS ICP-MS Info 06 ICP-MS FAAS ICP-MS Info 05 ICP-MS HR-ICP-MS Info 5 FAAS Info 55 ICP-MS ICP-MS ICP-MS FAAS ICP-MS ICP-MS FAAS Info 40 DRC/CC-ICP-MS Info 45 ICP-AES/OES Info 458 FAAS Percent satisfactory results for all participants: 95.6 % 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.

18 DRC/CC-ICP-MS New York State Department of Health Serum Zinc Test Results, 0 Event # STATISTICAL SUMMARY BY METHOD FAAS HR-ICP-MS ICP-AES/OES ICP-MS All Laboratories SE- SE- SE- SE-4 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. Results for additional trace elements are reported here, but no target value is implied nor are any acceptable ranges provided. These data are provided solely for educational and informational purposes. In addition to Al, Cu, Se and Zn, the serum pools were supplemented with additional trace elements as indicated below. Additional Elements Mn, Cr, V, Tl, Co Trace Elements PT Program

20 Serum Additional Elements, 0Event # Page Serum Antimony (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS <0.058 <0.058 <0.058 <0.058 <0.058 Serum Arsenic (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS DRC/CC-ICP-MS <0 <0 <0 <0 <0 Serum Barium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS ICP-MS <.0 <.0 <.0 <.0 <.0 Serum Beryllium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS <.4 <.4 <.4 <.4 <.4 9 ICP-MS <0. <0. <0. <0. <0. Serum Bismuth (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS Serum Cadmium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS <0.04 <0.04 <0.04 <0.04 < DRC/CC-ICP-MS <0.5 <0.5 <0.5 <0.5 <0.5 Serum Chromium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS ICP-MS DRC/CC-ICP-MS ICP-MS ICP-MS Arithmetic mean (n=5) SD Serum Cobalt (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS ICP-MS ICP-MS.0.0 <.0 <.0. Arithmetic mean (n=) SD Serum Iodine (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS

21 Serum Additional Elements, 0Event # Page Serum Lead (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS <4.44 <4.44 <4.44 <4.44 < DRC/CC-ICP-MS <0.4 <0.4 <0.4 <0.4 <0.4 Serum Lithium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS Serum Manganese (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 0 DRC/CC-ICP-MS ICP-MS DRC/CC-ICP-MS ICP-MS ICP-MS Arithmetic mean (n=5) SD Serum Molybdenum (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS Serum Nickel (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS <0.05 <0.05 Serum Silver (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS Serum Tin (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS <0.50 <0.50 <0.50 <0.50 < ICP-MS <5.0 <5.0 <5.0 <5.0 <5.0 Serum Tellurium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS <0.4 <0.4 <0.4 <0.4 <0.4 9 ICP-MS <.0 <.0 <.0 <.0 <.0 Serum Thallium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS ICP-MS <.0.9 < Serum Uranium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 4 ICP-MS <0.06 <0.06 <0.06 <0.06 <0.06 Serum Vanadium (µg/l) Lab Code Method SE- SE- SE- SE-4 SE-5 9 DRC/CC-ICP-MS

22 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-4 CV-AAS (Cold vapor atomic absorption spectrometry) A-5 HG-AAS (Hydride generation atomic absorption spectrometry) A-6 AFS (Atomic fluorescence spectrometry) A- 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-4 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- 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-4 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-4 Other OTHER METHODS If your method is not listed in the above list, please describe it briefly.

TRACE ELEMENTS IN SERUM

TRACE ELEMENTS IN SERUM Proficiency Test Report Event #, 05 November th, 05 Event #, 05 Serum Aluminum The test materials for serum Al were prepared from human serum obtained from Tennessee Blood Services,