定量的巨细胞病毒(CMV)DNA载量的标本,而不是血液,如支气管肺泡灌洗,肠道活检,或尿液已成为诊断CMV肺炎的辅助工具,肠道疾病,或者先天性感染,分别。然而,大多数市售CMVPCR平台尚未在这些样本类型中进行CMVDNA检测。在这项研究中,评估了基于AlinitymCMV(“AlinityLDT”)的实验室开发测试。使用加标支气管抽吸物(BAS)或尿液样本进行的重复性评估显示出低标准偏差为0.08和0.27LogIU/mL,分别。与基于RealTimeCMV(“RealTimeLDT”)的实验室开发的测试相比,评估AlinityLDT的临床表现在包括呼吸道标本在内的200个临床标本中显示出良好的一致性,肠道活检,尿液,和凳子。高皮尔逊相关系数r=0.92,低平均偏差-0.12LogIU/mL,90%的定性一致性,并且观察到Cohen的kappa值为0.76(实质一致)。在对样品类型BAS的单独分析中,气管抽吸物,支气管肺泡灌洗,活检,和尿液,测定结果在两个平台之间相关性良好,r值在0.88和0.99之间,偏倚<0.5LogIU/mL。总的来说,完全自动化,连续,随机访问AlinityLDT产生了良好的重现性,高度一致,与呼吸中的实时LDT具有良好的相关性,胃肠,和尿液样本,并可以通过快速的结果报告来增强患者管理。重要移植受者,发病和死亡的主要原因是由呼吸道或胃肠道的原发性或继发性CMV感染引起的终末器官疾病。此外,感觉神经性听力损失和神经发育异常是新生儿先天性CMV感染的常见后遗症。血浆和全血标本中CMVDNA负载的高灵敏度检测和定量的护理标准是实时PCR测试。除此之外,需要定量测定呼吸道中的CMVDNA水平,胃肠,使用高度自动化的尿路标本,具有短周转时间的随机访问CMVPCR检测,以实现早期诊断和治疗。在本研究中,与目前的RealTimeLDT检测相比,在8种不同的标签外样本类型中评估了全自动Alinitym分析仪的临床性能.
Quantitation of cytomegalovirus (CMV) DNA load in specimens other than blood such as bronchoalveolar lavages, intestinal biopsies, or urine has become a common practice as an ancillary tool for the diagnosis of CMV pneumonitis, intestinal disease, or congenital infection, respectively. Nevertheless, most commercially available CMV PCR platforms have not been validated for CMV DNA detection in these specimen types. In this study, a laboratory-developed test based on Alinity m CMV (\"Alinity LDT\") was evaluated. Reproducibility assessment using spiked bronchial aspirate (BAS) or urine samples showed low standard deviations of 0.08 and 0.27 Log IU/mL, respectively. Evaluating the clinical performance of Alinity LDT in comparison to a laboratory-developed test based on RealTime CMV (\"RealTime LDT\") showed good concordance across 200 clinical specimens including respiratory specimens, intestinal biopsies, urine, and stool. A high Pearson\'s correlation coefficient of r = 0.92, a low mean bias of -0.12 Log IU/mL, a good qualitative agreement of 90%, and a Cohen\'s kappa value of 0.76 (substantial agreement) were observed. In separate analyses of the sample types BAS, tracheal aspirates, bronchoalveolar lavage, biopsies, and urine, the assay results correlated well between the two platforms with r values between 0.88 and 0.99 and a bias <0.5 Log IU/mL. Overall, the fully automated, continuous, random access Alinity LDT yielded good reproducibility, high concordance, and good correlation to RealTime LDT in respiratory, gastrointestinal, and urine samples and may enhance patient management with rapid result reporting.IMPORTANCEIn transplant recipients, a major cause for morbidity and mortality is end-organ disease by primary or secondary CMV infection of the respiratory or gastrointestinal tract. In addition, sensorineural hearing loss and neurodevelopmental abnormalities are frequent sequelae of congenital CMV infections in newborns. Standard of care for highly sensitive detection and quantitation of the CMV DNA load in plasma and whole blood specimens is real-time PCR testing. Beyond that, there is a need for quantitative determination of CMV DNA levels in respiratory, gastrointestinal, and urinary tract specimens using a highly automated, random access CMV PCR assay with a short turnaround time to enable early diagnosis and treatment. In the present study, clinical performance of the fully automated Alinity m analyzer in comparison to the current RealTime LDT assay was evaluated in eight different off-label sample types.