Evaluation of matrix effects and prolonged storage on Trypanosoma cruzi serology in blood donor specimens.
Evaluation of matrix effects and prolonged storage on Trypanosoma cruzi serology in blood donor specimens.
复制标题
DOI：
10.1111/trf.15736
复制
发表时间：
2020-06
期刊：
影响因子：
2.9
通讯作者：
Stramer SL
中科院分区：
文献类型：
--
作者：
Whitman JD;Townsend RL;Bern C;Stramer SL
为研究方案适当储存的血液制品为临床研究收集大量样本提供了宝贵的资源，特别是对于低流行性疾病，如恰加斯病。我们评估了 500 份献血血浆成分 (PC) 样本的血清学结果，根据 FDA 推荐的算法确认为克氏锥虫血清阳性。使用 Ortho T. cruzi ELISA 和 Abbott PRISM Chagas 检测重新测试子集。还对具有匹配结果的真空采血管血清 (VS) 和 PC 标本的初步结果进行了比较。在初始测试中，通过 ELISA 观察到 VS 和 PC 之间的基质效应，证明 PC 的平均变化为 -0.39 S/CO (p<0.0001)，PRISM 的平均变化为 +0.35 S/CO (p=0.008)。在当前（重新测试）与初始测试结果之间的匹配 PC 样本中，ELISA 和 PRISM 的平均 S/CO 分别降低了 -0.76 (p<0.0001) 和 -0.90 (p<0.0001)。当分析匹配 PC 样本的 S/CO 变化随时间变化时，PRISM 显示 S/CO 没有显着下降（Y=−0.002941*X–0.6250，p=0.20；R2=0.005），而 ELISA 显示最近采集的样本中 S/CO 显着下降（Y=0.007183*X-1.516，p<0.0001；R2=0.005）。 R2=0.06）。虽然克氏锥虫血清学结果显示初始 VS 和 PC 测试值之间的基质效应存在微小但显着的差异，并且随着时间的推移 PC 测试值发生微小变化，但我们的数据验证了使用 PC 样本进行头对头测试性能比较研究，但需要注意的是，需要评估这些限制以进行适当的研究设计。
Blood products appropriately stored for research protocols provide an invaluable resource for amassing large numbers of specimens for clinical research, especially for low-prevalence diseases, such as Chagas disease. We evaluated serologic results of 500 blood donation plasma component (PC) specimens confirmed as T. cruzi seropositive by FDA-recommended algorithms. Subsets were retested using the Ortho T. cruzi ELISA and Abbott PRISM Chagas assays. Initial results for vacutainer-derived serum (VS) and PC specimens with matching results were also compared. On initial testing, matrix effects between VS and PC were observed with ELISA demonstrating a mean change in the PC of −0.39 S/CO (p<0.0001) and PRISM of +0.35 S/CO (p=0.008). In matched PC specimens between current (retest) versus initial test results, both ELISA and PRISM had a decrease in mean S/COs of −0.76 (p<0.0001) and −0.90 (p<0.0001), respectively. When the change in S/CO for matched PC specimens was analyzed as a function of time, PRISM showed no significant S/CO decrease (Y=−0.002941*X–0.6250, p=0.20; R2=0.005), whereas the ELISA showed a significant S/CO decrease in more recently collected specimens (Y=0.007183*X-1.516, p<0.0001; R2=0.06). While T. cruzi serology results showed minor, but significant differences in matrix effects between initial VS and PC testing values, and minor changes in PC test values over time, our data validate the use of PC specimens for head-to-head test performance comparison studies with the caveat that these limitations are assessed for appropriate study design.
登录
查看更多内容
DOI：
10.1093/cid/cix064
发表时间：
2017-05-01
期刊：
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子：
--
作者：
Meymandi SK;Forsyth CJ;Soverow J;Hernandez S;Sanchez D;Montgomery SP;Traina M
通讯作者：
Traina M
影响因子：
2.9
作者：
Chang, Chi-Deu;Cheng, Kevin Y.;Shah, Dinesh O.
通讯作者：
Shah, Dinesh O.
影响因子：
2.9
作者：
Gorlin, Jed;Rossmann, Susan;Warren, Harold
通讯作者：
Warren, Harold
影响因子：
3.2
作者：
通讯作者：
--
影响因子：
9.4
作者：
Whitman, Jeffrey D.;Bulman, Christina A.;Bern, Caryn
通讯作者：
Bern, Caryn