Okwuraiwe Azuka Patrick, Adeniyi Anthony, Babaleye Oluwasegun Adesina, Osuolale Kazeem, Audu Rosemary Ajuma
Centre for Human Virology and Genomics, Microbiology Department, Nigerian Institute of Medical Research Yaba, Lagos, Nigeria.
J Appl Lab Med. 2025 Jul 1;10(4):843-851. doi: 10.1093/jalm/jfaf053.
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.
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.
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%.
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.
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。
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。
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%。
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。