PDF(Pubmed)
Abstract：
UNASSIGNED: Cytomegalovirus (CMV) serostatus is a major determinant of CMV infection, disease risk, and transplant outcomes. Current clinical serology assays are limited by relatively slow turnaround time, design for batched testing, need for trained personnel, and/or specialized equipment. Rapid diagnostic assays in development have a role in emerging settings, such as critically ill patients, but have not been systematically evaluated.
UNASSIGNED: We assessed the performance of 3 rapid lateral flow assays (LFAs) for the detection of CMV immunoglobulin (Ig)G antibodies compared with a reference commercially available CMV IgG enzyme-linked immunosorbent assay in residual serum samples from 200 consecutive adults who underwent clinical CMV serology testing. Samples with discrepant results between the LFA and reference assay were tested by a second reference assay. A subset of serum samples was assessed for interoperator variability. Operating characteristics of the QooLabs LFA were separately assessed in plasma samples.
UNASSIGNED: The sensitivity and specificity of the individual LFA assays using serum varied significantly: 86%/83%, 99/93%, and 57/97%, for Healgen, QNow automated reader, and nanoComposix, respectively, compared with the reference assay. Results for the QNow assay were comparable between automated and manual reads. Among a subset of 10 serum samples assessed by 5 individual operators, 44 of 50 (88%) results were concordant. Among 50 plasma samples assessed by the QooLabs LFA, the sensitivity and specificity were 72% and 96%.
UNASSIGNED: The ease of performance, rapid turnaround time, and good operating characteristics provide the rationale for further evaluation of the Qoolabs QNow LFA in specialized settings where rapid assessment of CMV serostatus would be advantageous.
UNASSIGNED: We assessed the performance of 3 rapid lateral flow assays (LFAs) for the detection of CMV immunoglobulin (Ig)G antibodies compared with a reference commercially available CMV IgG enzyme-linked immunosorbent assay in residual serum samples from 200 consecutive adults who underwent clinical CMV serology testing. Samples with discrepant results between the LFA and reference assay were tested by a second reference assay. A subset of serum samples was assessed for interoperator variability. Operating characteristics of the QooLabs LFA were separately assessed in plasma samples.
UNASSIGNED: The sensitivity and specificity of the individual LFA assays using serum varied significantly: 86%/83%, 99/93%, and 57/97%, for Healgen, QNow automated reader, and nanoComposix, respectively, compared with the reference assay. Results for the QNow assay were comparable between automated and manual reads. Among a subset of 10 serum samples assessed by 5 individual operators, 44 of 50 (88%) results were concordant. Among 50 plasma samples assessed by the QooLabs LFA, the sensitivity and specificity were 72% and 96%.
UNASSIGNED: The ease of performance, rapid turnaround time, and good operating characteristics provide the rationale for further evaluation of the Qoolabs QNow LFA in specialized settings where rapid assessment of CMV serostatus would be advantageous.
摘要：
■巨细胞病毒（CMV）血清状态是CMV感染的主要决定因素，疾病风险,和移植结果。当前的临床血清学测定受到相对较慢的周转时间的限制。批量测试的设计，需要训练有素的人员，和/或专用设备。开发中的快速诊断测定法在新兴环境中发挥作用，如危重病人，但尚未进行系统评估。
■我们评估了3种快速侧流测定（LFA）检测CMV免疫球蛋白（Ig）G抗体的性能，与参考的市售CMVIgG酶联免疫吸附测定相比来自200例接受临床CMV血清学检测的连续成年人的残余血清样品。通过第二参考测定测试在LFA和参考测定之间具有不同结果的样品。评估血清样品的子集的操作者间变异性。在血浆样品中单独评估QooLabsLFA的操作特征。
■使用血清进行的单个LFA测定的灵敏度和特异性差异显着：86％/83％，99/93%,和57/97％，对于Healgen来说,QNow自动阅读器，和nanoComposix，分别,与参考测定相比。QNow测定的结果在自动和手动读取之间是可比较的。在5名个体操作员评估的10份血清样本中，50个结果中有44个(88%)是一致的。在QooLabsLFA评估的50份血浆样本中，敏感性和特异性分别为72%和96%.
■性能的简便性，快速的周转时间，良好的操作特性为在快速评估CMV血清状态将是有利的特殊环境中进一步评估QoolabsQNowLFA提供了理论基础。
■我们评估了3种快速侧流测定（LFA）检测CMV免疫球蛋白（Ig）G抗体的性能，与参考的市售CMVIgG酶联免疫吸附测定相比来自200例接受临床CMV血清学检测的连续成年人的残余血清样品。通过第二参考测定测试在LFA和参考测定之间具有不同结果的样品。评估血清样品的子集的操作者间变异性。在血浆样品中单独评估QooLabsLFA的操作特征。
■使用血清进行的单个LFA测定的灵敏度和特异性差异显着：86％/83％，99/93%,和57/97％，对于Healgen来说,QNow自动阅读器，和nanoComposix，分别,与参考测定相比。QNow测定的结果在自动和手动读取之间是可比较的。在5名个体操作员评估的10份血清样本中，50个结果中有44个(88%)是一致的。在QooLabsLFA评估的50份血浆样本中，敏感性和特异性分别为72%和96%.
■性能的简便性，快速的周转时间，良好的操作特性为在快速评估CMV血清状态将是有利的特殊环境中进一步评估QoolabsQNowLFA提供了理论基础。
