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

NCT06681025 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1070

Last updated 2024-11-08

No results posted yet for this study

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.

Conditions

  • EBV Viremia

Interventions

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.

Sponsors & Collaborators

  • QIAGEN Gaithersburg, Inc

    lead INDUSTRY

Principal Investigators

  • Sarah Johnson · QIAGEN Gaithersburg, Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-12-31
Completion
2024-03-15

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06681025 on ClinicalTrials.gov