化学性能规范综合比较
标准化还是标准化?协调还是协调?我们似乎正在走向性能规范的分裂，而不是达成共识。这是目前化学分析全球性能规格的比较。
化学(和毒理学)性能规范的综合比较
斯滕·韦斯特加德，硕士
根据巴西标准于2022年10月10日更新。俄罗斯标准被淘汰。
更新于2022年7月24日，根据CLIA 2024提出的能力测试标准
2022年6月12日更新EFLM最低质量建议
更新于2022年2月17日，2021年RIQAS最先进的目标
更新于2022年1月21日
与过去相比，现在生成的性能规范越来越多。所有这些目标的激增可能导致质量缺乏一致性。2014年米兰会议引发了性能规范的重大变化之一(该会议为我们提供了2015年的共识声明)，“Ricos目标”的权威从西班牙EQA协会转移到EFLM组织，在那里他们被更严格地分析和组织。EuBIVAC检查表促进了生物变异研究的标准方案，已经催生了一系列新的论文，这些论文显著地重申了生物变异衍生的分析性能规范。虽然其中一些研究专门计算了允许的分析总误差，但其他研究没有。因此，下表提供了别处没有转载的新资料。
[全部学分必须支付给西班牙检验医学学会(SEQC)的分析质量委员会(CCA)毫升)，它代表了与EFLM和IFCC联合的西班牙专业人员对实验室医学质量项目的正式愿景。如果没有他们的努力，从1999年到2015年，生物变异数据库永远不会启动。你可以在EFLM通讯最近的采访中看到他们历史的简短个人回顾:https://www.eflm.eu/upload/newsletters/2022-May-Jun-EuroLabNews.pdf］
我们选择使用来自EuBIVAS研究的数据以及EFLM数据库性能规范来获得理想的和最低的质量。
| 常规化学性能规范(允许总分析误差，TEa) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 测试或分析物 | 推荐选择 | CLIA | CLIA“2024”[h] | 2021年RIQAS |
2014年的 “rico目标” |
EFLM / |
Rilibak | RCPA高山 | 巴西 |
中国WS/T 403-2012 |
2015 “西班牙分钟。” |
| alpha -抗胰蛋白酶 | ±20% | ±20% | ±9.6% | ±9.2% | ±6.2% [f] ±9.3% [g] |
||||||
| 酸性磷酸酶 | ±10.3% | ±10.3% | |||||||||
| Adinoponectin | ±43.7% | ±29.1% [f] ±43.7% [g] |
|||||||||
| 丙氨酸转氨酶(ALT) | ±15%或 ±6u / l |
±20% | ±15%或±6u /L | ±15.1% | ±27.5% | ±14.4%(一个) ±16.1% [f] ±24.1% [g] |
±21% | ±5u /L或12% | ±40% | ±16% | ±23% |
| 白蛋白 | ±10% | ±10% | ±10% | ±9% | ±4.1% | ±3.4% [f] ±5.2% [g] |
±20% | ±2.0 g/L或6% | ±30% | ±6% | ±14% |
| 碱性磷酸酶 | ±20.0% | ±30% | ±20% | ±18.5% | ±12.0% | ±10.7%(一个) ±14.5% [f] (骨) ±21.7% [g] (骨) ±10.5% [f](肝脏) ±15.8% [g] (肝) |
±21% | ±15u /L或12% | ±50% | ±18% | ±31% |
| 淀粉酶 | ±20% |
±30% | ±20% | ±20.3% | ±14.6% | ±13.7%(一个) |
±10u /L或15% | ±50% | ±14.6% | ±35% | |
| 载脂蛋白A1 | ±11.3% | ±9.1% | ±7.6% [f] ±11.3% [g] |
±0.2 g/L或10% | |||||||
| 载脂蛋白B | ±17.2% | ±11.6% | ±11.5% [f] ±17.2% [g] |
±0.2 g/L或10% | |||||||
| 谷草转氨酶(AST) | ±15%或 ±6u / l |
±20% | ±15%或±6u /L | ±14.8% | ±16.7% | ±13.4%(一个) ±13.6% [f] ±20.5% [g] |
±21% | ±5u /L或12% | ±30% | ±15% | ±21% |
| 胆红素、直接 | ±44.5% | ±25.8% | ±44.5% | ±33.4% [b] | ±3umol /L或20% | ||||||
| 胆红素、总 | ±0.4 mg/dL 或±20% |
±0.4 mg/dL 或±20% |
±0.4 mg/dL 或±20% |
±15.9% | ±27% | ±24.8% [f] ±37.3% [g] |
±22% | ±3umol /L或12% | ±0.4 mg/dL 或±20% |
±15% | ±24% |
| 血气p02 | ±15mm Hg 或±15% |
±3sd | ±15mm Hg 或±15% |
||||||||
碳酸氢 |
±20% |
±5mmhg 或±8% |
±20% | ±17.3% | ±4.86% | ±4.9% [f] ±7.3% [g] |
±2.0 mmol/L或10% | ||||
| 血气pH值 | ±0.04 | ±0.04 | ±3.9% | ||||||||
| c反应蛋白(CRP) | ±1mg /dL或30%(秒) | ±1mg /dL或 30% (hs) |
±8.8% | ±56.6% | ±50.7% [f] ±72.9% hs [f] ±76.1% [g] ±109.4% hs [g] |
±0.8 mg/L或20% | |||||
| 钙、总 | ±1.0 mg/dL | ±1.0 mg/dL | ±1.0 mg/dL | ±8.3% | ±2.5% | ±2.3% [f] ±3.4% [g] |
±10% | ±0.10 mmol/L或4% | ±15% | ±5% | ±11% |
| 卡马西平 | ±1.0微克/分升或20% | ±25% | ±20%或±1.0微克/分升 | ±11.1% | ±20% | ||||||
| 氯 | ±5% | ±5% | ±5% | ±4.6% | ±1.5% | ±1.2% [b] ±1.3% [f] ±2.0% [g] |
±8% | ±3.0 mmol/L或4% | ±13% | ±4% | ±9% |
| 胆固醇、总 | ±10% | ±10% | ±10% | ±8.6% | ±9.0% | ±9.3% [d] ±8.7% [f] ±13.0% [g] |
±13% | ±0.30 mmol/L或6% | ±15% | ±9% | ±11% |
| 胆固醇、高密度脂蛋白 | ±20%或±6mg /dL | ±30% | ±20%或±6mg /dL | ±21.1% | ±11.6% | ±11.1% [d] ±11.1% [f] ±16.6% [g] |
±0.10 mmol/L或12% | ±30% | ±33% | ||
| 胆固醇、低密度脂蛋白 |
±20% | ±20% | ±20.6% | ±11.9% | ±11.3% [d] ±13.7% [f] ±20.5% [g] |
±0.2 mmol/L或10% | |||||
| Cholesterinase | ±9.8% | ±13.3% | ±9.8% | ±500u /L或10% | |||||||
| 补体C3 | ±15% | ±15% | ±7.9% | ±8.4% | ±7.8% [f] ±11.6% [g] |
||||||
| 补体C4 | ±5毫克/分升 或±20% |
±5mg /dL或±20% | ±9% | ±16% | ±12.1% [f] ±18.1% [g] |
||||||
| 皮质醇 | ±20% | ±25% | ±20% | ±13.5% | ±22.8% | ±26.3% [f] ±39.4% [g] |
±15nmol /L或15% | ±25% | |||
| 肌酸激酶 | ±20% | ±30% | ±20% | ±11.3% | ±30.3% | ±20.4%(一个) ±22.6% [f] ±33.8% [g] |
±40% | ±15% | ±24% | ||
| 肌酸激酶同工酶 | ±3 ng/mL 或±25% |
MB升高 (出席或缺席)或 ±3 SD肌酐 |
±25%或±3ng /mL(更大 MB升高(存在或不存在) |
||||||||
| 肌酸酐 | ±0.2 mg/dL或±10% | ±0.3 mg/dL或±15% | ±0.2 mg/dL或±10% | ±12.6% | ±8.9% | ±6.4% [c] ±7.4% [f] ±11.1% [g] |
±20% | ±8.0 umol/L或±8% | ±0.4 mg/dL或±20% | ±12% | ±20% |
| 地高辛 | ±0.2 ng/L或±15% | ±0.2 ng/L或±20% | ±15%或±0.2 ng/mL | ±14.9% | ±20% | ||||||
| GGT | ±5u /L或 ±15% |
±5u /L或±15% | ±17.9% | ±22.1% | ±16.2%(一个) ±18.9% [f] ±28.3% [g] |
±21% | ±5u /L或±12% | ±40% | ±11% | ±22% | |
| 庆大霉素 | ±25% | ±25% | ±25% | ±13.3% | ±15% | ||||||
| 葡萄糖 | ±6mg /dL 或±8% |
±6mg /dL 或±10% |
±6mg /dL或±8% | ±8.5% | ±7% | ±6.3% [e] ±6.5% [f] ±9.8% [g] |
±15 | ±0.4 mmol/L 或±8% |
±13% | ±7% | ±11% |
| 糖化血红蛋白(NGSP) | ±8.0%(NGSP) | ±8.0% | ±2.8% [e] |
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| 糖化血红蛋白(IFCC) | ±3.1%(IFCC) | ±3.1% [f] ±4.7% [g] |
|||||||||
| 结合珠蛋白 | ±25.6% | ±7.9% | ±27.3% | ±17.1% [f] ±25.6% [g] |
|||||||
| IgA | ±20% | ±20% | ±7.9% | ±13.5% | ±9.8% [f] ±14.7% [g] |
±25% | ±21% | ||||
| IgE | ±20% | ±20% | |||||||||
| 免疫球蛋白 | ±20% | ±20% | ±7.9% | ±8% | ±7.3% [f] ±10.9% [f] |
±25% | ±16% | ||||
| IgM | ±20% | ±20% | ±7.9% | ±16.8% | ±17.1% [f] ±25.6% [g] |
±25% | ±28% | ||||
| 铁、总 | ±15% | ±20% | ±15% | ±10% | ±30.7% | ±26.7% [f] ±40.0% [g] |
±30% | ±29% | ±15% | ±24% | |
| 乳酸 | ±30.4% | ±9.1% | ±30.4% | ±36.2% [e] | ±0.2 mmol/L | ||||||
| 乳酸脱氢酶(LDH) | ±15.0% | ±20% | ±15.0% | ±12.8% | ±11.4% | ±7.7% [f] ±11.5% [g] |
±18% | ±40% | ±22% | ±11% | ±26% |
| LDH同功酶 | LDH1/LDH2(+或-) |
||||||||||
| 脂肪酶 | ±21.3% | ±25.7% | ±37.9% | ±12.6%(一个) ±14.2% [f] ±21.3% [g] |
±25% | ||||||
| 脂蛋白(a) | ±24.1% | ±9.6% [f] ±14.4% [g] |
|||||||||
| 锂 | ±0.3 mmol/L或±15% | ±0.3 mmol/L 或20% |
±0.3 mmol/L或15% | ±11.7% | ±0.3 mmol/L 或30% |
±18% | |||||
| 镁 | ±15% | ±25% | ±15.0% | ±11% | ±4.8% | ±4% [b] ±4.0 [f] ±6.0% [g] |
±15% | ±25% | ±13% | ±15% | |
| 骨钙素 | ±15.7% | ±15.7 [f] ±23.6% [g] |
|||||||||
| 苯巴比妥 | ±2微克/毫升 或±15% |
±20% | ±2微克/毫升或±15% | ±13.7% | ±20% | ±15% | |||||
| 苯妥英 | ±2微克/分升 或15% |
±25% | ±2微克/分升 或15% |
±14.6% | ±20% | ±13% | |||||
| 磷 | ±0.3 mg/dL 或10% |
±0.3 mg/dL 或10% |
±10.1 | ±9.7% [f] ±14.6% [g] |
±20% | ±17% | |||||
| 钾 | ±0.3 mmol/L | ±0.5 mmol/L | ±0.3 mmol/L | ±5.6% | ±5.6% | ±4.6% [b] ±4.8% [f] ±7.3% [g] |
±8% | ±0.5 mmol/L |
±9% | ±6% | ±8% |
| 前白蛋白 | ±14.5% | ±9.4% | ±14.5% | ||||||||
| 催乳激素 | ±37.4% | ±37.4% [f] ±56.1% [g] |
±20% | ||||||||
| 钙结合蛋白B | ±17.0% | ±17.0% [f] ±25.5% [g] |
|||||||||
| 水杨酸 | ±2微克/分升 或15% |
±15%或±2微克/分升 | |||||||||
| 钠 | ±4 mmol/L | ±4 mmol/L | ±4 mmol/L | ±3.6% | ±0.7% | ±0.7% [f] ±1.0% [g] |
±5% | ±8mmol /L | ±4% | ±4% | ±5% |
| 茶碱 | ±20% | ±25% | ±20% | ±9.9% | ±25% | ||||||
| 妥布霉素 | ±20% | ±25% | ±20% | ±9.4% | ±25% | ||||||
| 血清总蛋白 | ±8% | ±10% | ±8.0% | ±8.7% | ±3.6% | ±3.4% [b] ±3.5% [f] ±5.2% [g] |
±10% | ±12% | ±9% | ±5% | ±12% |
| 转铁蛋白 | ±12% | ±7.9% | ±3.8% | ±6.8% [f] ±10.2% [f] |
±12% | ||||||
| 甘油三酸酯 | ±15% | ±25% | ±15% | ±15.4% | ±26% | ±28% [d] ±27.0% [f] ±40.6% [g] |
±16% | ±16% | ±33% | ±14% | ±18% |
| 尿素氮 | ±2mg /dL 或±9% |
±2mg /dL 或±9% |
±2mg /dL 或±9% |
±12.5% | ±15.5% | ±16.1% [b] ±17.8% [f] ±26.6% [g] |
±21% | ±18% | ±22% | ±8% | ±19% |
| 尿酸 | ±10% | ±17% | ±10% | ±10.6% | ±12% | ±10.6% [b] ±12.8% [f] ±19.2% [g] |
±13% | ±15% | ±18% | ±12% | ±17% |
| 丙戊酸 | ±20% | ±25% | ±20% | ±12.1% | ±20% | ||||||
| 万古霉素 | ±2微克/分升或±15% | ±2微克/分升或15% | ±16.2% | ±25% | |||||||
| 25-羟基维生素D | ±25% | ±22.4% | ±12.4% [f] |
±5 ng/mL 或25% |
±25% | ||||||
这并不是一个详尽的目标清单。事实上，RCPA目标和其他受欢迎的目标可以在网站的其他页面上找到。但这让我们对全球范围的目标有了一个概念。存在一些很大的差异，我们将在2019年的剩余时间里探索这些差异的含义，以及如果我们采用所有新的EFLM规范，实验室性能将面临的挑战。
以下是EuBIVAS研究的参考文献:
一个。91名健康受试者血清中9种酶的生物学变异估计王晓明，王晓明，王晓明，等。中国生物医学工程杂志，30(3):326 - 326。2018.
b。EuBIVAS:电解质、脂质、尿素、尿酸、总蛋白、总胆红素、直接胆红素和葡萄糖的受试者内部和受试者之间生物变异数据，陈建军，陈建军，陈建军，等。中国生物医学工程杂志，2017,34 (4):391 - 391
c。EuBIVAS项目:使用酶和碱性苦味酸方法测定血清肌酐的受试者内部和受试者之间的生物变异数据及其监测意义王晓明，王晓明，王晓明，等。中国生物医学工程学报(英文版)。2017年使用的酶法估算值。
d。脂质心血管风险评估生物标志物的生物变异数据。应用生物变异数据关键评价清单(BIVAC)的系统评价陈晓明，陈晓明，陈晓明，等。中国临床医学杂志[J](2019年8月):467-475。
e。糖尿病相关分析物生物学变异数据的系统综述，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚，龚龚。
f. EFLM数据库，最初访问日期为2020年1月13日。最近更新与SIMED协助22年1月20日https://biologicalvariation.eu/meta_calculations
g. EFLM数据库，最初访问日期为2020年1月13日。最近更新了新的最低质量建议，6/12/22https://biologicalvariation.eu/meta_calculations
h. CLIA 2024能力测试标准，引自联邦公报第87卷，第131号，2022年7月11日。详情请参阅//www.chin-gon.com/2024-clia-requirements.htm
[感谢Randox RIQAS分享他们每月EQA计划的最新技术(SOTA)目标]
[特别感谢Vladimir Procenko，提供了俄罗斯GOST目标的非正式英文翻译，附件A列在这里，它代表了单次测量的最大允许分析误差。]
