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美国疾病预防控制中心的维生素 A 实验室-外部质量评估计划显示,在 10 年期间(2008-2017 年),多个营养生物标志物的实验室性能变化不大。

CDC's Vitamin A Laboratory-External Quality Assessment Program Shows Little Change in Laboratory Performance for Multiple Nutritional Biomarkers over a 10-Year Period (2008-2017).

机构信息

Centers for Disease Control and Prevention, Atlanta, GA, USA.

Centers for Disease Control and Prevention, Atlanta, GA, USA.

出版信息

J Nutr. 2023 Jan;153(1):373-384. doi: 10.1016/j.tjnut.2022.11.001. Epub 2022 Dec 21.

Abstract

BACKGROUND

The Vitamin A Laboratory-External Quality Assessment (VITAL-EQA) program operated by the CDC provides analytical performance assessment to low-resource laboratories conducting serum vitamins A (VIA), D (VID), B-12 (B12), and folate (FOL), as well as ferritin (FER) and CRP measurements for public health studies.

OBJECTIVES

We aimed to describe the long-term performance of VITAL-EQA participants from 2008 to 2017.

METHODS

Participating laboratories received 3 blinded serum samples biannually for duplicate analysis over 3 d. We assessed results (n = 6) for relative difference (%) from the CDC target value and imprecision (% CV) and conducted descriptive statistics on the aggregate 10-year and round-by-round data. Performance criteria were based on biologic variation and deemed acceptable (optimal, desirable, or minimal performance) or unacceptable (less than minimal performance).

RESULTS

Thirty-five countries reported VIA, VID, B12, FOL, FER, and CRP results from 2008-2017. The proportion of laboratories with acceptable performance ranged widely by round: VIA 48%-79% (for difference) and 65%-93% (for imprecision), VID 19%-63% and 33%-100%, B12 0%-92% and 73%-100%, FOL 33%-89% and 78%-100%, FER 69%-100% and 73%-100%, and CRP 57%-92% and 87%-100%. On aggregate, ≥60% of laboratories achieved acceptable differences for VIA, B12, FOL, FER, and CRP (only 44% for VID), and over 75% of laboratories achieved acceptable imprecision for all 6 analytes. Laboratories participating continuously in 4 rounds (2016-2017) showed generally similar performance compared to laboratories participating occasionally.

CONCLUSIONS

Although we observed little change in laboratory performance over time, on aggregate, >50% of the participating laboratories achieved acceptable performance, with acceptable imprecision being achieved more often than acceptable difference. The VITAL-EQA program is a valuable tool for low-resource laboratories to observe the state of the field and track their own performance over time. However, the small number of samples per round and the constant changes in laboratory participants make it difficult to identify long-term improvements.

摘要

背景

由疾病预防控制中心运营的维生素 A 实验室外部质量评估(VITAL-EQA)计划为进行血清维生素 A(VIA)、D(VID)、B-12(B12)和叶酸(FOL)以及铁蛋白(FER)和 C 反应蛋白(CRP)测量的资源匮乏实验室提供分析性能评估,这些测量用于公共卫生研究。

目的

我们旨在描述 2008 年至 2017 年 VITAL-EQA 参与者的长期表现。

方法

参与实验室每两年收到 3 份盲样血清样本,在 3 天内进行两次分析。我们评估了相对于疾病预防控制中心目标值的结果(n=6)的相对差异(%)和不精密度(%CV),并对 10 年和轮次的汇总数据进行了描述性统计分析。性能标准基于生物学变异,并被认为是可接受的(最佳、理想或最小性能)或不可接受的(低于最小性能)。

结果

2008-2017 年,35 个国家报告了 VIA、VID、B12、FOL、FER 和 CRP 的结果。各轮次具有可接受性能的实验室比例差异很大:VIA 为 48%-79%(差异)和 65%-93%(不精密度),VID 为 19%-63%和 33%-100%,B12 为 0%-92%和 73%-100%,FOL 为 33%-89%和 78%-100%,FER 为 69%-100%和 73%-100%,CRP 为 57%-92%和 87%-100%。总体而言,≥60%的实验室在 VIA、B12、FOL、FER 和 CRP 方面达到了可接受的差异(仅 VID 为 44%),超过 75%的实验室在所有 6 种分析物中达到了可接受的不精密度。连续参加 4 轮(2016-2017 年)的实验室与偶尔参加的实验室相比,其性能通常相似。

结论

尽管我们观察到实验室性能随时间的变化很小,但总体而言,超过 50%的参与实验室达到了可接受的性能,可接受的不精密度比可接受的差异更常见。VITAL-EQA 计划是资源匮乏实验室观察该领域状况并跟踪自身随时间变化的性能的有价值工具。然而,每轮样本数量少和实验室参与者的不断变化使得确定长期改进变得困难。

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