Clinical Performance Evaluation of the NeuMoDx™ EBV Quant Assay 2.0 in Immunocompromised Transplant Patients
NCT ID: NCT06681025
Last Updated: 2024-11-08
Study Results
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Basic Information
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COMPLETED
1070 participants
OBSERVATIONAL
2022-08-31
2024-03-15
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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QIAGEN Gaithersburg, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Johnson
Role: STUDY_DIRECTOR
QIAGEN Gaithersburg, Inc
Locations
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QIAGEN Gaithersburg, Inc.
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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SMF-21-2132-1-001
Identifier Type: -
Identifier Source: org_study_id
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