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五种盐碘含量分析定量快速检测试剂盒的比较验证:实验室性能、用户友好性和现场适用性

Comparative Validation of Five Quantitative Rapid Test Kits for the Analysis of Salt Iodine Content: Laboratory Performance, User- and Field-Friendliness.

作者信息

Rohner Fabian, Kangambèga Marcelline O, Khan Noor, Kargougou Robert, Garnier Denis, Sanou Ibrahima, Ouaro Bertine D, Petry Nicolai, Wirth James P, Jooste Pieter

机构信息

GroundWork LLC, Crans-près-Céligny, Switzerland.

Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso.

出版信息

PLoS One. 2015 Sep 24;10(9):e0138530. doi: 10.1371/journal.pone.0138530. eCollection 2015.

Abstract

BACKGROUND

Iodine deficiency has important health and development consequences and the introduction of iodized salt as national programs has been a great public health success in the past decades. To render national salt iodization programs sustainable and ensure adequate iodization levels, simple methods to quantitatively assess whether salt is adequately iodized are required. Several methods claim to be simple and reliable, and are available on the market or are in development.

OBJECTIVE

This work has validated the currently available quantitative rapid test kits (quantRTK) in a comparative manner for both their laboratory performance and ease of use in field settings.

METHODS

Laboratory performance parameters (linearity, detection and quantification limit, intra- and inter-assay imprecision) were conducted on 5 quantRTK. We assessed inter-operator imprecision using salt of different quality along with the comparison of 59 salt samples from across the globe; measurements were made both in a laboratory and a field setting by technicians and non-technicians. Results from the quantRTK were compared against iodometric titration for validity. An 'ease-of-use' rating system was developed to identify the most suitable quantRTK for a given task.

RESULTS

Most of the devices showed acceptable laboratory performance, but for some of the devices, use by non-technicians revealed poorer performance when working in a routine manner. Of the quantRTK tested, the iCheck® and I-Reader® showed most consistent performance and ease of use, and a newly developed paper-based method (saltPAD) holds promise if further developed.

CONCLUSIONS

User- and field-friendly devices are now available and the most appropriate quantRTK can be selected depending on the number of samples and the budget available.

摘要

背景

碘缺乏会对健康和发育产生重要影响,在过去几十年里,将碘盐引入国家计划是一项巨大的公共卫生成就。为使国家碘盐计划可持续并确保足够的碘添加水平,需要简单的方法来定量评估盐是否添加了足够的碘。有几种方法声称简单可靠,有的已投放市场,有的仍在研发中。

目的

以比较的方式验证目前可用的定量快速检测试剂盒(quantRTK)在实验室性能和现场使用便利性方面的情况。

方法

对5种quantRTK进行了实验室性能参数测试(线性、检测限和定量限、批内和批间不精密度)。我们使用不同质量的盐评估了不同操作人员之间的不精密度,并比较了来自全球的59个盐样本;技术人员和非技术人员在实验室和现场环境中都进行了测量。将quantRTK的结果与碘量滴定法进行比较以验证其有效性。开发了一个“使用便利性”评级系统,以确定最适合特定任务的quantRTK。

结果

大多数设备在实验室性能方面表现可接受,但对于一些设备,非技术人员按常规操作时表现较差。在所测试的quantRTK中,iCheck®和I-Reader®表现出最一致的性能和易用性,一种新开发的基于纸张的方法(saltPAD)如果进一步开发有望取得良好效果。

结论

现在已有用户友好型和现场友好型设备,可根据样本数量和可用预算选择最合适的quantRTK。

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