Laboratory Department, Fifth Medical Center of PLA General Hospital, Beijing, China.
Grade 2022 Postgraduate Class, School of Pharmaceutical Sciences, Shandong University of Traditional Chinese Medicine, Jinan, China.
Microbiol Spectr. 2024 Oct 3;12(10):e0076924. doi: 10.1128/spectrum.00769-24. Epub 2024 Sep 13.
To explore the influence of storage temperature and time on the stability of different concentrations of hepatitis C virus nucleic acid (HCV RNA) samples and to provide data reference for laboratory quality control. Serum samples of 10 patients with HCV RNA detection quantitation of 10-10 IU/mL were collected. The samples of each patient were diluted into three concentrations: high, medium, and low. Then the samples of each concentration were divided into 21, which were divided into three groups according to the storage conditions of -20°C, 4°C, and 25°C, with seven samples in each group. The samples were selected from each group for quantitative detection of HCV RNA on day 0, day 1, day 3, day 5, day 7, day 14, and day 30. The results of each concentration and storage temperature sample remained stable within 5 days. Based on the mixed-effect linear model, the main effects of temperature, time, and concentration were statistically significant ( < 0.01). There was an interaction effect between concentration and time ( = 0.0448), and there was also an interaction effect between temperature and time ( < 0.01). There was no interaction effect between concentration and temperature ( = 0.11) or between concentration, temperature, and time ( = 0.90). The results of serum samples with different concentrations of the HCV RNA remained stable within 5 days. The lower the initial concentration of HCV RNA serum sample, the worse the stability; the higher the storage temperature, the worse the stability. If conditions permit, the laboratory should store such samples at -20°C.
Previously, there were few reports about the influence of different concentrations of sample nucleic acid on the stability of samples at various temperatures and times in various literatures. Therefore, it is necessary to analyze the influence of concentration factors on the stability of samples and test results at different storage times and temperatures. This study took the concentration of hepatitis C virus nucleic acid as the research object to further understand the stability of hepatitis C virus nucleic acid test samples under various storage conditions, to provide data reference for the treatment of hepatitis C virus nucleic acid and RNA test samples before clinical laboratory test, and provide guidance and help for the improvement of laboratory quality control.
探索不同浓度丙型肝炎病毒核酸(HCV RNA)样本在储存温度和时间方面的稳定性,为实验室质量控制提供数据参考。
收集 10 例 HCV RNA 检测定量为 10-10 IU/mL 的患者血清样本。将每位患者的样本稀释为高、中、低 3 个浓度,然后将每个浓度的样本分为 21 份,根据-20°C、4°C 和 25°C 的储存条件分为 3 组,每组 7 份。每天对每组样本进行 HCV RNA 定量检测,检测时间分别为第 0、1、3、5、7、14 和 30 天。
在 5 天内,每个浓度和储存温度样本的结果保持稳定。基于混合效应线性模型,温度、时间和浓度的主要效应均具有统计学意义( < 0.01)。浓度和时间之间存在交互作用( = 0.0448),温度和时间之间也存在交互作用( < 0.01)。浓度和温度之间无交互作用( = 0.11),浓度、温度和时间之间也无交互作用( = 0.90)。
不同浓度 HCV RNA 血清样本结果在 5 天内保持稳定。HCV RNA 血清样本初始浓度越低,稳定性越差;储存温度越高,稳定性越差。如果条件允许,实验室应将此类样本储存在-20°C。