EBV ViremiaNCT06681025
Clinical Performance Evaluation of the NeuMoDx™ EBV Quant Assay 2.0 in Immunocompromised Transplant Patients
An observational study of EBV Viremia, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EBV Viremia
- What is being tested?
- NeuMoDx EBV Quant 2.0 Assay
- How many people
- 1,070 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2022to 15 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Standard of care for transplant patients undergoing immuno suppression
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- EBV Viremia
- Being tested
- NeuMoDx EBV Quant 2.0 Assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuMoDx EBV Quant 2.0 AssayDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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%."
Measured: the primary outcome was assessed a single time after collecting and testing specimens over a 19 month duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start31 Aug 2022
- Primary completion31 Dec 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EBV ViremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,070 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Study director, QIAGEN Gaithersburg, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681025
- Sponsor's protocol ID
- SMF-21-2132-1-001
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40578123
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06681025
- Acronym / sponsor ID
- SMF-21-2132-1-001
- Conditions
- EBV Viremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Standard of care for transplant patients undergoing immuno suppression
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuMoDx EBV Quant 2.0 AssayThe 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. | Diagnostic test | – |
Primary outcome
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
Time frame: the primary outcome was assessed a single time after collecting and testing specimens over a 19 month duration
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%."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 40578123Doseeva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Johnson study director
QIAGEN Gaithersburg, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EBV Viremia, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: the primary outcome was assessed a single time after collecting and testing specimens over a 19 month duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06681025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.