An Observational, Multi-center, Prospective and Retrospective Clinical Study to Evaluate the Performance of the NeuMoDx™ EBV Quant Assay 2.0 on the NeuMoDx™ Molecular Systems in Immunocompromised Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,070
- 试验地点
- 1
- 主要终点
- Demonstration that the NeuMoDx™ EBV Quant Assay 2.0 achieves its intended performance during normal conditions of use by the intended user in the intended environment
研究概览
简要总结
The NeuMoDx EBV Quant Assay 2.0 study is a multi-center, observational clinical investigation designed to evaluate the performance of the NeuMoDx EBV Quant Assay 2.0 in quantifying Epstein-Barr virus (EBV) DNA levels in plasma samples from immunocompromised transplant patients. The study compares the NeuMoDx EBV assay's performance against an FDA-cleared comparator assay under routine clinical use conditions, utilizing both the NeuMoDx™ 96 and NeuMoDx™ 288 Molecular Systems. The aim is to demonstrate the quantitative concordance and clinical utility of the assay in monitoring EBV DNA levels as part of patient management.
详细描述
This study is an observational, multi-center, open-labeled, prospective, and retrospective clinical evaluation aimed at assessing the performance of the NeuMoDx EBV Quant Assay 2.0 on the NeuMoDx™ 96 and NeuMoDx™ 288 Molecular Systems. Plasma samples are collected from immunocompromised patients undergoing solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT) who are at risk of EBV infection or reactivation. The study includes both fresh and frozen plasma specimens obtained as part of routine clinical care.
The primary objective is to demonstrate the quantitative concordance of the NeuMoDx EBV assay when compared to the cobas® EBV assay (Roche Diagnostics Corporation) using a predefined set of performance criteria. The study also assesses the equivalence of performance between the two NeuMoDx systems (NeuMoDx™ 96 and NeuMoDx™ 288) in quantifying EBV DNA levels across a range of clinical specimens. Secondary objectives include evaluating the assay's performance across different viral load concentrations and subgroups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunocompromised transplant patients (Solid Organ Transplant (SOT) or Hematopoietic Stem Cell Transplant (HSCT)).
- •Fresh and frozen plasma specimens derived from whole blood collected with EDTA as an anticoagulant.
- •Residual fresh or frozen EDTA plasma specimens obtained from routine testing, including specimens collected from the same subject at different timepoints.
- •Sufficient sample volume 1.6- 2.0 ml for testing with 2 assays plus discordant testing.
- •EDTA plasma samples have been stored under the following conditions:
- •2-8° C up to 7 days and/or -20° C +/- 2° C or colder for up to 6 months following the separation of plasma from whole blood. Or fresh EDTA plasma samples that have not been stored loaded onto the NeuMoDx™ system immediately after they have been separated from whole blood.
- •Frozen samples have not gone through more than two freeze/thaw cycles.
排除标准
- •Specimens not collected according to the manufacturer's instructions or study protocol.
- •Lack of clear subject identification or label on a residual plasma sample
- •Unable to obtain required medical chart information.
- •Obvious physical damage to the residual sample.
- •Specimens that have remained onboard the NeuMoDx System for longer than 8 hours prior to processing.
结局指标
主要结局
Demonstration that the NeuMoDx™ EBV Quant Assay 2.0 achieves its intended performance during normal conditions of use by the intended user in the intended environment
时间窗: the primary outcome was assessed a single time after collecting and testing specimens over a 19 month duration
The concordance of the NeuMoDx™ EBV Quant Assay 2.0 to a comparator's test shall meet these performance metrics with EBV-positive samples within the linear range of the NeuMoDx™ EBV Quant Assay 2.0: * Slope (m): 0.9 ≤ m ≤1.1 * R2 ≥ 0.90, or p-value ≥ 0.05 Due to the variance in EBV qPCR assays, the Intercept (b) of the linearity fit will be characterized with an anticipated range of -1.0 to +1.0 Log10(IU/mL). Percent agreement above the threshold (\>LoD/LLoQ) of the reference method shall be \> 95%, with the lower confidence interval to be \> 80%. Percent agreement below the threshold (\<LoD/LLoQ) of the reference method shall be \> 95%, with the lower confidence interval to be \> 90%."
次要结局
未报告次要终点