中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2009年
1期
97-101
,共5页
彭明婷%艾承锦%李臣宾%谷小林
彭明婷%艾承錦%李臣賓%穀小林
팽명정%애승금%리신빈%곡소림
血红蛋白%参考标准%分光光度法
血紅蛋白%參攷標準%分光光度法
혈홍단백%삼고표준%분광광도법
Themoglobins%Reference standards%Spectrophotometry
目的 研制氰化高铁血红蛋白(HiCN)国家一级标准物质,用作血红蛋白测定结果溯源的标准.方法 参照国际血液学标准化委员会(ICSH)的要求,制备HiCN标准物质;按照ISOGuide 35的要求,评价标准物质的均匀性和稳定性,在二者合乎要求的基础上,由多个实验室使用溯源至美国国家标准技术研究所(NIST)标准滤光片的分光光度计为HiCN标准物质定值;为验证定值结果的可靠性,使用定值仪器测定国际标准物质,将测定结果与WHO参考实验室的定值进行比较,此外,对所研制标准物质和国际标准物质的扫描图形进行了比较.结果 HiCN标准物质均匀性的不确定度为0.000 4 g/L,变异系数(CU)为0.09%;长期稳定性的不确定度为0.000 6 g/L;HiCN标准物质的定值为0.6159 g/L,不确定度为0.000 4 g/L;当扩展因子取2时,标准物质的扩展不确定度为0.001 8 g/L;定值仪器对国际标准物质的测定结果与国际标准物质定值的相对偏差为0.08%.结论 HiCN标准物质均匀性和稳定性良好,定值方法准确、可靠.
目的 研製氰化高鐵血紅蛋白(HiCN)國傢一級標準物質,用作血紅蛋白測定結果溯源的標準.方法 參照國際血液學標準化委員會(ICSH)的要求,製備HiCN標準物質;按照ISOGuide 35的要求,評價標準物質的均勻性和穩定性,在二者閤乎要求的基礎上,由多箇實驗室使用溯源至美國國傢標準技術研究所(NIST)標準濾光片的分光光度計為HiCN標準物質定值;為驗證定值結果的可靠性,使用定值儀器測定國際標準物質,將測定結果與WHO參攷實驗室的定值進行比較,此外,對所研製標準物質和國際標準物質的掃描圖形進行瞭比較.結果 HiCN標準物質均勻性的不確定度為0.000 4 g/L,變異繫數(CU)為0.09%;長期穩定性的不確定度為0.000 6 g/L;HiCN標準物質的定值為0.6159 g/L,不確定度為0.000 4 g/L;噹擴展因子取2時,標準物質的擴展不確定度為0.001 8 g/L;定值儀器對國際標準物質的測定結果與國際標準物質定值的相對偏差為0.08%.結論 HiCN標準物質均勻性和穩定性良好,定值方法準確、可靠.
목적 연제청화고철혈홍단백(HiCN)국가일급표준물질,용작혈홍단백측정결과소원적표준.방법 삼조국제혈액학표준화위원회(ICSH)적요구,제비HiCN표준물질;안조ISOGuide 35적요구,평개표준물질적균균성화은정성,재이자합호요구적기출상,유다개실험실사용소원지미국국가표준기술연구소(NIST)표준려광편적분광광도계위HiCN표준물질정치;위험증정치결과적가고성,사용정치의기측정국제표준물질,장측정결과여WHO삼고실험실적정치진행비교,차외,대소연제표준물질화국제표준물질적소묘도형진행료비교.결과 HiCN표준물질균균성적불학정도위0.000 4 g/L,변이계수(CU)위0.09%;장기은정성적불학정도위0.000 6 g/L;HiCN표준물질적정치위0.6159 g/L,불학정도위0.000 4 g/L;당확전인자취2시,표준물질적확전불학정도위0.001 8 g/L;정치의기대국제표준물질적측정결과여국제표준물질정치적상대편차위0.08%.결론 HiCN표준물질균균성화은정성량호,정치방법준학、가고.
Objective To establish the national standard materials for haemiglobincyanide (HiCN) for the traceability assays of hemoglobin. Methods HiCN national standard materials were established according to the document of International Committee for Standardization in Haematology (ICSH). The standard materials were certificated according to ISO Guide 35, including homogeneity and stability. Then they were characterized by the calibrated spectrophotometer which can be traceable to National Institute of Standards and Technology (NIST). The international reference materials of HiCN were compared with the result of the WHO reference laboratory to confirm the reliability. Results The uncertainty of the HiCN standard materials was 0.000 4 g/L and the variation coefficient (CV) was 0.09%. The uncertainty of long-term stability was 0.000 6 g/L; the certificated value of the standard materials was 0.615 9 g/L with uncertainty of 0.000 4 g/L. The combined uncertainty was 0.000 9 g/L and the expanded uncertainty was 0.001 8 g/L when the cover factor was 2. The relative error was 0.08% between the result of the standard materials and the international certificated value. Conclusion The homogeneity and stability of the standard material is acceptable and the method of characterization is accurate and reliable.
