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NCT06681025
Clinical Performance Evaluation of the NeuMoDx™ EBV Quant Assay 2.0 in Immunocompromised Transplant Patients
trial testing NeuMoDx EBV Quant 2.0 Assay in EBV Viremia in 1,070 participants. Completed in 15 March 2024.
31 December 2023
Quick facts
| Lead sponsor | QIAGEN Gaithersburg, Inc |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,070 |
| Start date | 31 August 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 15 March 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- NeuMoDx EBV Quant 2.0 Assay
Conditions studied
- EBV Viremia — all drugs for EBV Viremia →
Sponsor
QIAGEN Gaithersburg, Inc — full company profile →
Who can join
18 and older, any sex, with EBV Viremia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Performance evaluation of the NeuMoDx™ EBV Quant Assay 2.0 in Comparison with cobas® EBV for epstein-barr virus DNA quantification in immunocompromised patients, a multicenter study.
Doseeva V, Mostafa HH, Rhoads D, Relich RF, et al · · 2025 · PMID 40578123 · DOI 10.1016/j.diagmicrobio.2025.116956
Verify or expand the search:
- PubMed search for NCT06681025
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other QIAGEN Gaithersburg, Inc trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06681025 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by QIAGEN Gaithersburg, Inc
- Last refreshed: 8 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06681025.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing