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Validation of Dried Tube Sample Format Quality Controls for the Monitoring of Viral Load and Blood Screening Assays.
Journal of Virological Methods ( IF 3.1 ) Pub Date : 2020-08-14 , DOI: 10.1016/j.jviromet.2020.113957
Wayne Dimech 1 , Giuseppe Vincini 1 , Kylie Davies 1 , Marina Karakaltsas 1 , Natasha Dubois van Cauwalaert 2 , Emilande Guichet 2 , Marco Koppelman 3 , Liza Cabuang 1
Affiliation  

HIV viral load (VL) and donor screening assays experience variation and require quaity assurance (QA). NRL sought to confirm a dried tube sample format (HIVDTS) sample type for use in quality control (QC) programs for HIV molecular testing.

50 μL of HIV supernatant at 1 × 105 copies per millilitre (copies/mL)) was dried for 48 hours at room temperature. Post-production and shipped integrity studies were undertaken. Dried HIVDTS was reconstituted in PBS buffer and tested in HIV VL (six participants) or blood screening assays (four participants). Results were entered into NRL’s QC monitoring software (EDCNet™) for analysis.

The mean of 224 VL results when HIVDTS QCs were tested in Biocentric HIV GENERIC Charge Virale assay was 4.54 log10 copies/mL, with the percentage coefficient of variation (CV%) ranging from 1.75 to 13.20%. The mean Ct value for HIVDTS QCs tested on Roche Cobas MPX assay results was 28.71 (range 28.33 to 29.14), with CV% ranging from 1.56 to 3.98%.

The study confirms HIVDTS QCs can effectively monitor the performance of HIV molecular testing and offers a cheaper alternative to commercial QC samples that require cold-chain shipping on dry ice and UN3373 conditions.



中文翻译:

用于监测病毒载量和血液筛查分析的干管样品格式质量控制的验证。

HIV病毒载量(VL)和供体筛选测定法会发生变化,并需要质量保证(QA)。NRL试图确认干管样本格式(HIVDTS)样本类型,以用于HIV分子测试的质量控制(QC)程序。

将50μLHIV上清液(每毫升1×10 5份(副本/ mL))在室温下干燥48小时。进行了后期制作和运输完整性研究。将干燥的HIVDTS在PBS缓冲液中重建,并在HIV VL(六名参与者)或血液筛查分析(四名参与者)中进行测试。将结果输入NRL的QC监控软件(EDCNet™)中进行分析。

在以生物为中心的HIV GENERIC电荷病毒分析中测试HIVDTS QC时,平均224 VL结果为4.54 log 10个拷贝/ mL,变异百分率(CV%)为1.75至13.20%。在Roche Cobas MPX分析结果上测试的HIVDTS QC的平均Ct值为28.71(范围为28.33至29.14),CV%范围为1.56至3.98%。

该研究证实,HIVDTS质控品可以有效监测HIV分子检测的性能,并为需要在干冰和UN3373条件下进行冷链运输的商业质控品提供了更便宜的替代品。

更新日期:2020-08-20
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