An observational study in EBV Viremia, sponsored by QIAGEN Gaithersburg, Inc. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by QIAGEN Gaithersburg, Inc (part of QIAGEN) · Observational
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.
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.
57 studies on the registry are indexed under Viremia; 12 are open to participants now.
This study's enrollment of 1,070 is above the median of 164 across 11 observational studies indexed under Viremia.
Browse Viremia studies →QIAGEN Gaithersburg, Inc is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
First submitted after QIAGEN Gaithersburg, Inc became part of QIAGEN.
Counted across the registry records on this site, refreshed daily.
Standard of care for transplant patients undergoing immuno suppression
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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%."
Time frame: the primary outcome was assessed a single time after collecting and testing specimens over a 19 month duration
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in Dec 2023, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.