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首页> 外文期刊>Journal of Clinical Microbiology >Deterioration of detectable human immunodeficiency virus serum p24 antigen in samples stored for batch testing.
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Deterioration of detectable human immunodeficiency virus serum p24 antigen in samples stored for batch testing.

机译：储存用于分批测试的样品中可检测的人类免疫缺陷病毒血清p24抗原的变质。

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Virologic measurements are becoming important surrogate markers for therapeutic efficacy in clinical trials with human immunodeficiency virus (HIV)-infected subjects. One such marker which is inexpensive and easily evaluated is the HIV p-24 antigen. To determine the storage stability of p24 antigen assayed by enzyme-linked immunosorbent assay of serum collected during clinical trials, a retrospective analysis was performed. The p24 antigen results were available from four Adult or Pediatric AIDS Clinical Trials Group protocols: studies 047, 050, 128, and 213. Paired samples (n = 930) which were assayed by ELISA for p24 antigen both in real time and in batch were analyzed for agreement. Batch and real-time values were correlated; however, there was a lack of agreement which increased with prolonged storage time of batched samples and greater p24 antigen levels. The p24 antigen values were significantly lower in the batched samples, which had a maximum storage time of 1,548 days. The degradation rate of p24 antigen per year was 0.052 log10 for samples with less than 30 pg/ml, 0.197 log10 for those with 30 to 100 pg/ml, and 0.245 log10 for those with > 100 pg/ml. Due to degradation over time, use of p24 antigen values from batch assays with long-term storage could bias study results toward a lack of treatment effect. On the basis of these results we make the following recommendations. (i) Samples should be assayed either in real time by laboratories undergoing quality assurance or in batch with short-term storage (less than 1 year). (ii) When real-time assays are to be performed, the serum samples should not be stored at 4 degrees C, but should be frozen immediately after processing and stored frozen until tested.
机译：在人免疫缺陷病毒（HIV）感染的受试者的临床试验中，病毒学测量已成为治疗功效的重要替代指标。一种廉价且易于评估的标记物是HIV p-24抗原。为了确定通过临床试验中收集的血清的酶联免疫吸附测定法测定的p24抗原的储存稳定性，进行了回顾性分析。 p24抗原的结果可从四个成人或儿童AIDS临床试验组协议中获得：研究047、050、128和213。配对样品（n = 930）通过ELISA实时和分批检测了p24抗原。分析达成协议。批处理值和实时值相关;但是，缺乏一致性，随着批量样品的储存时间延长和p24抗原水平升高而增加。在分批样品中，p24抗原值明显较低，最长存储时间为1,548天。小于30 pg / ml的样品每年p24抗原的降解速率为0.052 log10，具有30至100 pg / ml的样品每年降解为0.197 log10，大于100 pg / ml的样品每年为0.245 log10。由于随着时间的推移会降解，使用批次分析中的p24抗原值并长期保存可能会使研究结果偏向缺乏治疗效果。基于这些结果，我们提出以下建议。 （i）样品应由接受质量保证的实验室实时分析，或分批短期保存（少于一年）。 （ii）当要进行实时测定时，血清样品不应在4摄氏度下保存，而应在处理后立即冷冻并冷冻保存直至进行测试。

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