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

NCT06681025 | Completed

• 1 other identifier: SMF-21-2132-1-001
• Study Type: observational
• Target: 1,070
• Locations: 1 country
• Sites: 1

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.

Conditions

EBV Viremia

Outcome Measures

Primary Outcomes (1)

• 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

  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%."

  the primary outcome was assessed a single time after collecting and testing specimens over a 19 month duration

Interventions

NeuMoDx EBV Quant 2.0 Assay DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Standard of care for transplant patients undergoing immuno suppression

You may qualify if:

• 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:
• ° 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (1)

QIAGEN Gaithersburg, Inc.

Manchester, M130BH, United Kingdom

Location

Related Publications (1)

• Doseeva V, Mostafa HH, Rhoads D, Relich RF, Garner O, Findeisen P, Eigner U, English A, Johnson S. Performance evaluation of the NeuMoDx EBV Quant Assay 2.0 in Comparison with cobas(R) EBV for epstein-barr virus DNA quantification in immunocompromised patients, a multicenter study. Diagn Microbiol Infect Dis. 2025 Nov;113(3):116956. doi: 10.1016/j.diagmicrobio.2025.116956. Epub 2025 Jun 19.

  PMID: 40578123 DERIVED

Study Officials

• Sarah Johnson

  QIAGEN Gaithersburg, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 8, 2024
• Study Start: August 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 15, 2024
• Last Updated: November 8, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)