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TRACE ELEMENTS IN SERUM Event #, 00 June 8, 00

Event #, 00 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 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 µg/l (.9 µmol/l) to 07 µg/l (.97 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, 88.8% of test results reported were judged as satisfactory, with three out of 5 participant laboratories (.0%) 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 00 8 000-007. Trace Elements PT Program www.wadsworth.org/testing/lead/index.htm

Serum Aluminum Test Results, 00 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS Results (µg/l) SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 Robust Mean 07 6 8 6 Robust Standard Deviation.. 7.0 8.8.8 Standard Uncertainty..8.8. 0.9 RSD (%).6 0.6. 0.7 0.7 Acceptable Range: Upper Limit: 8 8 76 98 Lower Limit: 6 86 50 66 9 notes: Results reported as less than the method detection limit are excluded from statistical calculations.

Serum Aluminum Test Results, 00 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE0-06 SE0-07 Results (µg/l) SE0-08 SE0-09 SE0-0 Info Only Target Values: 07 6 8 6 0 ETAAS-Z 70 88 6 ETAAS-Z 50 68 86 7 ETAAS-Z 7 8 7 9 0 Info 56 ICP-MS 66 9 8 59 ETAAS-Z 97 60 80 60 ETAAS-Z 05 60 69 6 6 ICP-MS 0 06 58 77 5 79 DRC/CC-ICP-MS 8 0 60 79 00 DRC/CC-ICP-MS 09 7 89 Info 06 ICP-MS 65 88 8 87 ETAAS-Z 9 0 59 79 9 ICP-MS 9 86 5 69 9 Info 0 ETAAS-Z 7 0 79 0 6 05 ICP-MS 7 0 57 76 DRC/CC-ICP-MS 5 05 66 8 6 Info 5 ETAAS-Z 97 9 Info 55 ICP-MS 6 86 6 57 ICP-MS 00 6 77 58 ICP-MS 0 0 60 79 6 6 ICP-MS 7 7 7 9 6 ICP-MS 5 9 70 9 9 66 ETAAS-Z 9 56 75 Info 67 ETAAS-Z 69 87 7 Info 0 ICP-AES/OES 9 00 60 80 Info 58 ETAAS Other 5 86 5 7 Percent satisfactory results for all participants: 88.8 % 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.

DRC/CC-ICP-MS New York State Department of Health Serum Aluminum Test Results, 00 Event # STATISTICAL SUMMARY BY METHOD ETAAS Other ETAAS-Z ICP-AES/OES ICP-MS All Laboratories Results (µg/l) SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 5 0 6 9. 9 0 9.6 5 5.7 05 86 0 7 5.6 00 0 09.7 5 09. 67 7 5 0 6 9.6 60 0 6 6 8.9 5 6 9. 8 5 7 0 8 5 8.0 80 0 8 8 0.0 5 8.9 0 5 9. 0 6 9.5 5 5 6 6.5 notes: Insufficient data for calculation.

Event #, 00 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 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 9 µg/l (.65 µmol/l) to 0 µg/l (.80 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, 8.8% of test results reported were judged as satisfactory, with three 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 006 0-5.. 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 008 5 89-899. Trace Elements PT Program www.wadsworth.org/testing/lead/index.htm

Serum Copper Test Results, 00 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS Results (µg/l serum) SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 Robust Mean 90 0 90 9 Robust Standard Deviation 95 8 56 5 6 Standard Uncertainty 6 7 RSD (%) 8.5 6. 7.7 6.0 6.7 Acceptable Range: Upper Limit: 89 89 97 07 Lower Limit: 95 68 78 6 79 notes: Results reported as less than the method detection limit are excluded from statistical calculations.

Serum Copper Test Results, 00 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE0-06 Results (µg/l serum) SE0-07 SE0-08 SE0-09 SE0-0 Info Only Target Values: 90 0 90 9 07 DRC/CC-ICP-MS 89 996 9 9 Info 0 ICP-MS 07 968 077 009 9 ICP-MS 070 80 0 770 860 7 ICP-MS 5 89 07 98 9 Info 56 FAAS 090 870 950 90 90 59 ICP-AES/OES 0 890 980 880 900 60 ETAAS-Z 00 870 00 880 880 6 ICP-MS 87 977 856 9 79 DRC/CC-ICP-MS 80 000 0 000 960 97 ICP-MS 090 90 090 990 90 00 FAAS 060 9 78 8 Info 06 ICP-MS 90 660 760 980 850 9 ICP-MS 07 8 870 70 056 Info 05 ICP-MS 0 0 0 99 DRC/CC-ICP-MS 86 950 8 980 99 Info 5 FAAS 690 0 60 50 0 Info 60 FAAS 0 860 000 860 980 6 ICP-MS 60 60 00 50 0 66 ETAAS-Z 8 98 06 866 90 Info 0 DRC/CC-ICP-MS 5 99 00 967 Info 57 ICP-AES/OES 78 0 60 08 Info Percent satisfactory results for all participants: 8.8 % 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.

DRC/CC-ICP-MS New York State Department of Health Serum Copper Test Results, 00 Event # STATISTICAL SUMMARY BY METHOD ETAAS-Z FAAS ICP-AES/OES ICP-MS All Laboratories Results (µg/l serum) SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 79.8 9 7 0 5. 9 9 9 997. 065 50. 959 8.5 97 80 90 07. 996 50 9 75 60.9 88 9. 89. 058 68 870 7 9. 0 98 9 8 60. 97 7.9 978 0.0 87 0 5 677.5 00 70 9 769 6 5. 79 50 8.0 9 5.7 905 5 06 70 5.8 99 0 9 855 97.8 96 0.9 notes: Insufficient data for calculation.

Event #, 00 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 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. 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 (.9 µmol/l) to 99 µg/l (.79 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, 9.6% of test results reported were judged as satisfactory, with two of the 9 participant laboratories (0.5%) 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 006 0-5.. 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 008 5 89-899. Trace Elements PT Program www.wadsworth.org/testing/lead/index.htm

Serum Selenium Test Results, 00 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS Results (µg/l serum) SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 Robust Mean 99 0 6 5 Robust Standard Deviation 6.5 0.0 6.8 0.5 5. Standard Uncertainty.9 5.7.9.0. RSD (%).6 6.7 6.6 8. 7. Acceptable Range: Upper Limit: 7 59 5 58 Lower Limit: 9 8 0 7 notes: Results reported as less than the method detection limit are excluded from statistical calculations.

Serum Selenium Test Results, 00 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE0-06 Results (µg/l serum) SE0-07 SE0-08 SE0-09 SE0-0 Info Only Target Values: 99 0 6 5 07 DRC/CC-ICP-MS 9 95 98 0 0 Info 0 DRC/CC-ICP-MS 8 86 97 8 0 ICP-MS 8 0 0 7 ICP-MS 7 80 98 8 0 Info 56 ICP-MS 8 58 0 55 50 59 ETAAS-Z 7 9 0 05 6 ICP-MS 5 09 0 8 9 79 DRC/CC-ICP-MS 0 0 97 ICP-MS 9 0 6 00 DRC/CC-ICP-MS 7 0 0 6 0 Info 06 ICP-MS 7 78 00 8 97 9 DRC/CC-ICP-MS 5 8 0 9 8 Info 05 ICP-MS 5 9 09 0 DRC/CC-ICP-MS 6 06 0 6 8 Info 66 ETAAS-Z 59 90 06 7 Info 67 DRC/CC-ICP-MS 60 9 0 Info 0 DRC/CC-ICP-MS 7 08 0 7 Info 0 ETAAS-Z 0 00 96 Info 57 ICP-AES/OES 98 90 0 90 Info Percent satisfactory results for all participants: 9.6 % 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.

DRC/CC-ICP-MS New York State Department of Health Serum Selenium Test Results, 00 Event # STATISTICAL SUMMARY BY METHOD ETAAS-Z ICP-AES/OES ICP-MS All Laboratories Results (µg/l serum) SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 8 5 7.8 8 0 7 8 6 0.8 8 8. 8 05.6 78 98 7 99 8 9. 9 09 50 6. 8 0.9 9 0 7 07 0. 8 0 9 8. 8 5 5.0 6 5 0 7 0 0. 8 5 8.8 8 9 0.6 0 5 90 7 8 8.5 9 9.5 notes: Insufficient data for calculation.

Event #, 00 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 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 6 µg/l (9.5 µmol/l) to 07 µg/l (5.8 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, 88.% of test results reported were judged as satisfactory, with five out of 7 participant laboratories (8.5%) 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 006 0-5.. 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 008 5 89-899. Trace Elements PT Program www.wadsworth.org/testing/lead/index.htm

Serum Zinc Test Results, 00 Event # ROBUST STATISTICAL SUMMARY TARGET VALUE ASSIGNMENT AND STATISTICS Results (µg/l serum) SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 Robust Mean 565 8 6 797 07 Robust Standard Deviation 55 09 5 89 97 Standard Uncertainty 7 6 7 RSD (%) 9.9 8.8 8.7. 8.5 Acceptable Range: Upper Limit: 800 78 97 65 Lower Limit: 0 0 50 678 96 notes: Results reported as less than the method detection limit are excluded from statistical calculations.

Serum Zinc Test Results, 00 Event # PERFORMANCE OF PARTICIPATING LABORATORIES Lab Code Method SE0-06 Results (µg/l serum) SE0-07 SE0-08 SE0-09 SE0-0 Info Only Target Values: 565 8 6 797 07 07 DRC/CC-ICP-MS 567 5 600 79 5 Info 0 ICP-MS 75 0 687 857 ICP-MS 0 50 660 70 50 7 ICP-MS 56 0 596 75 6 Info 56 ICP-MS 88 069 65 8 0 59 ICP-AES/OES 570 0 60 790 70 60 FAAS 0 000 50 660 960 6 ICP-MS 6 0 58 76 00 79 DRC/CC-ICP-MS 700 0 660 80 50 97 ICP-MS 50 0 60 80 90 00 FAAS 77 75 680 88 66 Info 06 ICP-MS 550 70 600 880 80 87 FAAS 00 060 90 670 00 9 ICP-MS 5 6 59 7 89 Info 05 ICP-MS 6 68 78 DRC/CC-ICP-MS 70 96 68 85 9 Info 5 FAAS 50 560 60 880 960 Info 55 ICP-MS 69 9 6 80 57 ICP-MS 60 0 570 700 0 58 ICP-MS 69 87 669 87 0 60 FAAS 60 0 60 780 60 6 ICP-MS 90 00 560 690 000 6 ICP-MS 70 0 660 860 580 66 FAAS 66 0 87 9 8 Info 0 DRC/CC-ICP-MS 765 5 699 86 569 Info 57 ICP-AES/OES 59 6 80 0 Info 58 FAAS 60 70 60 800 90 Percent satisfactory results for all participants: 88. % 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.

DRC/CC-ICP-MS New York State Department of Health Serum Zinc Test Results, 00 Event # STATISTICAL SUMMARY BY METHOD FAAS ICP-AES/OES ICP-MS All Laboratories Results (µg/l serum) SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 686 8 5.0 7 659 96 7.8 555 5 8 6.7 7 59 8. 99 9.8 7 58 9 5. 6 6 8 0 6.7 7 9 0. 66 6.6 7 65 06 7.0 67 9 578 5 6.5 7 607 5 0.6 80 0.7 6 789. 797 9 789 7 9.0 5 796 7 9. 7 95.8 7 7 550 6.0 00 99 50 57 6.7 7 9 500.8 notes: Insufficient data for calculation.

Event #, 00 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 Trace Elements PT Program www.wadsworth.org/testing/lead/index.htm

Serum Additional Elements, 00 Event # Page Serum Arsenic Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 97 DRC/CC-ICP-MS <0 <0 <0 <0 <0 Serum Barium Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 97 ICP-MS <.0 <.0.. <.0 Serum Cadmium Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 97 DRC/CC-ICP-MS <0.5 <0.5 <0.5 <0.5 <0.5 Serum Cobalt Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 79 ICP-MS 0.5 0. 0. 0. 0. 97 ICP-MS <.0 <.0 <.0 <.0 <.0 Serum Chromium Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 7 ICP-MS 0.7 0..5 7.6.7 6 ICP-MS 0 7 79 DRC/CC-ICP-MS 0.8 0..5 6.9.8 97 DRC/CC-ICP-MS <.0 <.0. 5.6. DRC/CC-ICP-MS 0. 0. 0.9 5..7 Arithmetic Mean, n=5 0.7 0.. 6..5 SD 0. 0. 0..0 0.5 Serum Iron Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 57 ICP-AES/OES 75 875 59 0 08

Serum Additional Elements, 00 Event # Page Serum Manganese Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 07 DRC/CC-ICP-MS.7 5..8. 79 DRC/CC-ICP-MS. 5..9.8. 97 DRC/CC-ICP-MS. 5..9.6 05 ICP-MS. 5..9.8. DRC/CC-ICP-MS 5 Arithmetic Mean, n=5.7 5...0. SD 0.7 0. 0.5 0.6 0. Serum Lead Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 97 DRC/CC-ICP-MS <0. <0. <0. <0. <0. Serum Tin Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 97 ICP-MS <5.0 <5.0 <5.0 <5.0 <5.0 Serum Tellurium Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 97 ICP-MS <.0 <.0 <.0 <.0 <.0 Serum Thallium Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 97 ICP-MS.. <.0 <.0 <.0 Serum Vanadium Results (µg/l) Lab Code Method SE0-06 SE0-07 SE0-08 SE0-09 SE0-0 07 DRC/CC-ICP-MS 0. 5.5 0.6 5.. 79 DRC/CC-ICP-MS 0.. 0.7 5.0.

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.