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准确度达到 2 代国际 HIV-1 RNA WHO 标准：三种 HIV-1 RNA 核酸扩增检测技术的评估。

Accuracy to 2nd International HIV-1 RNA WHO Standard: assessment of three generations of quantitative HIV-1 RNA nucleic acid amplification tests.

机构信息

Roche Diagnostics Ltd., CH-6343 Rotkreuz, Switzerland.

出版信息

J Clin Virol. 2011 Feb;50(2):119-24. doi: 10.1016/j.jcv.2010.10.017. Epub 2010 Nov 24.

DOI:10.1016/j.jcv.2010.10.017
PMID:21109484
Abstract

BACKGROUND

Standardization of quantitative HIV-1 tests to a global primary standard is required by regulatory authorities to ensure comparability of test results across different assays and platforms of different manufacturers.

OBJECTIVES AND STUDY DESIGN

Three generations of quantitative HIV-1 tests, the COBAS(®) AMPLICOR(®) HIV-1 Monitor Test, v1.5 (HIV-1 Monitor test v1.5); the COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HIV-1 Test (HIV-1 TaqMan(®) test v1.0); and the dual-target-based COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HIV-1 Test, v2.0 (HIV-1 TaqMan(®) test v2.0), were assessed for accuracy to World Health Organization (WHO) 2nd International Standard for human immunodeficiency virus 1 (HIV-1) RNA (NIBSC code 97/650) at concentration levels below 1667 IU/mL including relevant medical decision points.

RESULTS

With the 2nd WHO Standard the mean difference across all concentrations was -0.07 log(10) for the HIV-1 Monitor test v1.5; +0.12 log(10) for the HIV-1 TaqMan(®) test v1.0; and +0.09 log(10) for the HIV-1 TaqMan(®) test v2.0. Linearity, including concentrations below the claimed limit of quantitation, was demonstrated for HIV-1 TaqMan(®) test v2.0. The HIV-1 TaqMan(®) test v1.0 showed a trend towards higher quantitation at very low concentration levels and the HIV-1 Monitor test v1.5 had a tendency towards lower quantitation at low concentration levels.

CONCLUSIONS

All three assays are closely traceable to the primary WHO HIV-1 RNA standard for in vitro diagnostic IVD assays. Compared to the other two assays, the HIV-1 TaqMan(®) test v2.0 showed better linearity around the limit of detection and below.

摘要

背景

为确保不同制造商的不同检测平台和检测方法的检测结果具有可比性，监管机构要求将定量 HIV-1 检测标准化至全球一级标准。

目的和研究设计

我们评估了三代定量 HIV-1 检测方法，即 COBAS(®) AMPLICOR(®) HIV-1 Monitor 检测（HIV-1 Monitor 检测 v1.5）、COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HIV-1 检测（HIV-1 TaqMan(®) 检测 v1.0）和基于双靶标的 COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HIV-1 检测（HIV-1 TaqMan(®) 检测 v2.0），以评估其在低于 1667 IU/ml 浓度水平（包括相关医学决策点）下对世界卫生组织（WHO）第 2 代人类免疫缺陷病毒 1（HIV-1）RNA 国际标准品（NIBSC 编码 97/650）的准确度。

结果

以第 2 代 WHO 标准品为参照，HIV-1 Monitor 检测 v1.5 在所有浓度水平的平均差异为-0.07log10；HIV-1 TaqMan(®) 检测 v1.0 为+0.12log10；HIV-1 TaqMan(®) 检测 v2.0 为+0.09log10。HIV-1 TaqMan(®) 检测 v2.0 表现出良好的线性，包括在定量下限以下的浓度。HIV-1 TaqMan(®) 检测 v1.0 表现出在非常低浓度水平时的高定量趋势，而 HIV-1 Monitor 检测 v1.5 在低浓度水平时表现出低定量趋势。

结论

所有三种检测方法都与用于体外诊断（IVD）检测的一级 WHO HIV-1 RNA 标准具有紧密的溯源性。与其他两种检测方法相比，HIV-1 TaqMan(®) 检测 v2.0 在检测限及以下的线性更好。

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