NCT06681025

Clinical Performance Evaluation of the NeuMoDx™ EBV Quant Assay 2.0 in Immunocompromised Transplant Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,070 (actual)
• Sponsor: QIAGEN Gaithersburg, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• EBV Viremia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NeuMoDx EBV Quant 2.0 Assay	The NeuMoDx™ EBV Quant Assay 2.0 is an automated in vitro nucleic acid amplification test for the quantification of Epstein-Barr virus (EBV) DNA in EDTA plasma from immunocompromised transplant patients. Transplant patients are screened for EBV viral load as part of their standard of care. The remaining samples from these in vitro diagnostic nucleic acid amplification tests (NAAT) will be analyzed using the NeuMoDx EBV Quant Assay 2.0 to quantify EBV DNA in EDTA plasma. That result will be compared to a comparator in vitro diagnostic assay to evaluate the performance of the NeuMoDx EBV Quant 2.0 assay.

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-12-31
• Completion: 2024-03-15
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

1 site across 1 country: United Kingdom