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尼日利亚用于艾滋病毒病毒载量检测的血浆制备管使用情况评估。

Evaluation of the Use of Plasma Preparation Tubes for HIV Viral Load Testing in Nigeria.

作者信息

Okwuraiwe Azuka Patrick, Adeniyi Anthony, Babaleye Oluwasegun Adesina, Osuolale Kazeem, Audu Rosemary Ajuma

机构信息

Centre for Human Virology and Genomics, Microbiology Department, Nigerian Institute of Medical Research Yaba, Lagos, Nigeria.

出版信息

J Appl Lab Med. 2025 Jul 1;10(4):843-851. doi: 10.1093/jalm/jfaf053.

Abstract

BACKGROUND

Routine viral load (VL) monitoring of persons living with HIV (PLWH) on antiretroviral therapy (ART) is imperative for improving the long-term success of treatment. Due to a limited number of PCR laboratories, VL testing is centralized, requiring cold chain storage while transporting samples from remote healthcare centers to referral PCR laboratories, which is a major challenge. The Becton Dickinson (BD) Vacutainer® Plasma Preparation Tube (PPT) was designed to mitigate cold chain transport needs and secondary tube storage of plasma.

METHODS

This cross-sectional study assessed the suitability of PPTs for sample transportation in remote settings, in place of EDTA non-gel Vacutainers, eliminating the need for cold chain storage. Venous blood was collected from 115 PLWH into 3 Vacutainer tubes (1 EDTA and 2 PPT). The plasma obtained from the first PPT was assayed for HIV VL along with the plasma obtained from EDTA non-gel Vacutainer within 6 h on the COBAS 6800 (Roche Diagnostics) instrument. Samples from the second PPT were stored at room temperature (20 to 28°C) for 24 h before testing on the same instrument.

RESULTS

The Wilcoxon signed rank test and W statistic (P value 0.91) showed that VL results obtained from the EDTA were comparable to the PPT on the collection day, and after 24 h at room temperature. Sensitivity and specificity for same-day and 24-hour testing were both 100%.

CONCLUSIONS

The BD Vacutainer PPT was shown to have similar VL results to the EDTA non-gel Vacutainer, and can therefore be deployed to remote settings for sample collection and transportation to PCR referral laboratories.

摘要

背景

对接受抗逆转录病毒疗法(ART)的艾滋病毒感染者(PLWH)进行常规病毒载量(VL)监测对于提高治疗的长期成功率至关重要。由于PCR实验室数量有限,VL检测集中进行,在将样本从偏远医疗中心运送到转诊PCR实验室的过程中需要冷链储存,这是一个重大挑战。贝克顿·迪金森(BD)Vacutainer®血浆制备管(PPT)旨在减少冷链运输需求和血浆的二次试管储存。

方法

这项横断面研究评估了PPT在偏远地区用于样本运输的适用性,以取代乙二胺四乙酸(EDTA)非凝胶真空采血管,从而无需冷链储存。从115名PLWH中采集静脉血,分别注入3个真空采血管(1个EDTA管和2个PPT管)。在COBAS 6800(罗氏诊断)仪器上,在6小时内对从第一个PPT管获得的血浆以及从EDTA非凝胶真空采血管获得的血浆进行HIV VL检测。来自第二个PPT管的样本在室温(20至28°C)下储存24小时后,在同一仪器上进行检测。

结果

威尔科克森符号秩检验和W统计量(P值0.91)表明,在采集当天以及在室温下放置24小时后,从EDTA管获得的VL结果与PPT管的结果相当。同日和24小时检测的敏感性和特异性均为100%。

结论

BD Vacutainer PPT显示出与EDTA非凝胶真空采血管相似的VL结果,因此可部署到偏远地区用于样本采集并运输到PCR转诊实验室。

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