Clinical trial NCT06681025: Clinical Performance Evaluation of the NeuMoDx™ EBV Quant Assay 2.0 in Immunocompromised Transplant Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EBV Viremia
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Standard of care for transplant patients undergoing immuno suppression

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: the primary outcome was assessed a single time after collecting and testing specimens over a 19 month duration
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN Gaithersburg, Inc.
Study officials:
affiliation: QIAGEN Gaithersburg, Inc
name: Sarah Johnson
role: STUDY_DIRECTOR
References: