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目的评估一次性尿液采集器保存的尿液样本,用于艾滋病病毒(HIV)抗体检测的可行性。方法利用尿液酶联免疫吸附试验,比较了普通样品管和采集器对尿液HIV-1抗体检出的影响;进一步检测了不同温度和储存时间下,采集器对尿液HIV-1抗体保存的均一性、稳定性以及邮寄前后的影响。结果与普通样品管比较,采集器保存的尿液,对HIV-1抗体检测无明显影响(P=0.24);在不同温度下,采集器可稳定保存尿液的时间:采集器尿液在-20℃和4℃保存1年,在常温保存1个月,在37℃保存9天。均一性:批间和批内变异系数(CV)均<15%(P>0.05);邮寄前后尿液HIV-1抗体无显著变化,Kappa值为0.957。结论一次性尿液采集器可用于检测HIV-1抗体尿液样本的采集、贮存与运输。
Objective To evaluate the feasibility of urine samples from disposable urine collectors for the detection of HIV antibodies. Methods Urine ELISA was used to compare the detection of HIV-1 antibody in urine with ordinary sample tubes and collectors. The urine samples were collected and stored at different temperatures and storage times The homogeneity, stability and impact before and after mailing. Results Compared with ordinary sample tube, the urine collected by the collector had no significant effect on the detection of HIV-1 antibody (P = 0.24). At different temperatures, the collector could keep the urine stably: Store at 20 ° C and 4 ° C for 1 year, store at room temperature for 1 month and at 37 ° C for 9 days. Homogeneity: Inter-assay and intra-assay coefficient of variation (CV) were <15% (P> 0.05). There was no significant change in urinary HIV-1 antibody before and after post-delivery, with a Kappa value of 0.957. Conclusion The disposable urine collector can be used to detect HIV-1 antibody urine sample collection, storage and transportation.