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简短通讯:用于测量HIV发病率的Maxim和Sedia限量抗原检测性能比较

Short Communication: Comparison of Maxim and Sedia Limiting Antigen Assay Performance for Measuring HIV Incidence.

作者信息

Schlusser Katherine E, Konikoff Jacob, Kirkpatrick Allison R, Morrison Charles, Chipato Tsungai, Chen Pai-Lien, Munjoma Marshall, Eshleman Susan H, Laeyendecker Oliver

机构信息

1 Department of Medicine, Johns Hopkins University , Baltimore, Maryland.

2 Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health , Baltimore, Maryland.

出版信息

AIDS Res Hum Retroviruses. 2017 Jun;33(6):555-557. doi: 10.1089/aid.2016.0245. Epub 2017 Mar 20.

Abstract

Accurate methods for cross-sectional incidence estimation are needed for HIV prevention research. The Limiting Antigen Avidity (LAg-Avidity) assay has been marketed by two vendors, Maxim Biomedical and Sedia BioSciences Corporation. Performance differences between the two versions of the assay are unknown. We tested a total 1,410 treatment-naive samples with both versions of the assay. The samples came from 176 seroconverters from the Zimbabwe Hormonal Contraception and HIV Study. The correlation between the two versions of the assay was 0.93 for the optical density (OD) and 0.86 for the normalized OD. As the difference was more pronounced for the normalized OD, the difference in assays can be attributed to the calibrators. The mean duration of recent infection (MDRI), the average time individuals infected <2 years appear recently infected, was determined for both versions using an assay cutoff of 1.5 OD-n alone or in combination with a viral load cutoff of >1,000 copies/ml. The MDRI was 137 days for Sedia and 157 days for Maxim, with a difference of 20 days (95% CI 11-30). The MDRIs decreased to 102 and 120 days with the inclusion of a viral load cutoff of >1,000 copies/ml. These results imply that use of the Sedia LAg-Avidity will result in estimates of incidence ∼13% lower than those using the Maxim LAg-Avidity.

摘要

艾滋病预防研究需要准确的横断面发病率估算方法。有限抗原亲和力(LAg-Avidity)检测已由两家供应商推向市场,分别是Maxim Biomedical和Sedia BioSciences Corporation。两种版本检测的性能差异尚不清楚。我们用两种版本的检测方法对总共1410份未接受过治疗的样本进行了检测。这些样本来自津巴布韦激素避孕与艾滋病研究中的176名血清转化者。两种版本检测的光密度(OD)相关性为0.93,标准化OD相关性为0.86。由于标准化OD的差异更为明显,检测方法的差异可归因于校准物。使用单独的1.5 OD-n检测临界值或结合病毒载量临界值>1000拷贝/毫升,为两种版本测定了近期感染的平均持续时间(MDRI),即感染<2年的个体近期出现感染的平均时间。Sedia版本的MDRI为137天,Maxim版本为157天,相差20天(95%可信区间11 - 30)。纳入病毒载量临界值>1000拷贝/毫升后,MDRI分别降至102天和120天。这些结果表明,使用Sedia LAg-Avidity检测得出的发病率估计值比使用Maxim LAg-Avidity检测低约13%。

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