Rush Medical College, Department of Immunology and Microbiology, Chicago, Illinois, USA
Biogen, Inc., Cambridge, Massachusetts, USA.
J Clin Microbiol. 2018 May 25;56(6). doi: 10.1128/JCM.00120-18. Print 2018 Jun.
The National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Group (ACTG) stores specimens from its clinical trials in a biorepository and permits the use of these specimens for nonprotocol exploratory studies, once the studies for the original protocol are concluded. We sought to assess the comparability of the data generated from real-time HIV-1 RNA testing during two clinical trials with the data generated from the retesting of different aliquots of the same samples after years of storage at -80°C. Overall, there was 92% agreement in the data generated for 1,570 paired samples (kappa statistic = 0.757; 95% confidence interval [CI], 0.716 to 0.797), where samples were tested in one laboratory using the microwell plate (MWP) version of the Roche HIV-1 Monitor test within 1 to 37 days of collection and retested in another laboratory using the Cobas version of the assay after a median of 6.7 years of storage (range, 5.7 to 8.6 years). Historical external quality control data submitted to the NIAID Virology Quality Assurance program (VQA) by client laboratories using the same two versions of the Monitor assay were used to differentiate between systematic differences in the assays to evaluate the stability of HIV-1 RNA in the stored samples. No significant loss of RNA was noted in samples containing either a low concentration (<50 copies/ml) or a high concentration (≥50 copies/ml) of HIV-1 RNA ( = 0.10 and = 0.90, respectively) regardless of the time in storage. These data confirm the quality of the plasma samples in the ACTG biorepository following long-term storage.
美国国家过敏和传染病研究所 (NIAID) 艾滋病临床试验组 (ACTG) 在生物库中存储其临床试验标本，并允许在原始方案研究完成后，使用这些标本进行非方案探索性研究。我们旨在评估在两项临床试验中使用实时 HIV-1 RNA 检测生成的数据与经过多年 -80°C 储存后重新检测同一批样本不同等分样本所生成的数据的可比性。在对 1570 对配对样本进行检测时，数据之间有 92%的一致性（kappa 统计量=0.757；95%置信区间[CI]，0.716 至 0.797），其中样本在收集后 1 至 37 天内在一个实验室使用微孔板（MWP）版本的罗氏 HIV-1 Monitor 检测进行检测，并在中位数为 6.7 年（范围为 5.7 至 8.6 年）后在另一个实验室使用该检测的 Cobas 版本重新检测。使用同一两种 Monitor 检测版本的客户实验室向 NIAID 病毒学质量保证计划 (VQA) 提交的历史外部质量控制数据用于区分检测中的系统差异，以评估储存样本中 HIV-1 RNA 的稳定性。无论储存时间如何，在含有低浓度（<50 拷贝/ml）或高浓度（≥50 拷贝/ml）HIV-1 RNA 的样本中均未观察到 RNA 明显丢失（ = 0.10 和 = 0.90，分别）。这些数据证实了 ACTG 生物库中血浆样本在长期储存后的质量。
