Cytomegalovirus Viral Load in Transplanted Patients Using the NeuMoDx™ (Qiagen) Automated System: A 1-Month Experience Feedback

Abstract

Cytomegalovirus (CMV) reactivations represent a significant morbidity and mortality problem in transplant patients. Reliable and rapid measurement of CMV viral load is a key issue for optimal patient management. We report here the evaluation of NeuMoDx™ (Qiagen) in a routine hospital setting (University Hospitals of Marseille, France) in comparison with our classical reference technique R-GENE. During one month, 719 CMV viral loads from 507 patients were measured in parallel in both techniques. Using the ROC (receiver operating characteristic) curve and our biological experience we suggest that values <52 IU/mL (geometric mean) correspond to negative samples, values >140 IU/mL (Fowlkes–Mallows index) correspond to quantifiable positive results and values ranging from 52 to 140 IU/mL represent non-quantifiable positive results. Follow-up of 15 transplant patients who developed CMV reactivation during the study showed that NeuMoDx™ provided higher viral load measurement during the first two weeks of follow-up for three patients. These important intra-individual variations resulted in a significant median increase considering the whole data set (6.7 points of difference expressed as a percentage of the initial viral load). However, no difference between the two techniques was noticeable after two weeks of treatment. Subsequent to this first study we conclude that NeuMoDx™, used with optimized logistics and an adapted threshold, allows a rapid CMV viral load measurement and that its use does not lead to any difference in patient management compared to the reference technique R-GENE®.

Performance Evaluation of the Fully Automated NeuMoDx RT-PCR Platform for the Quantification of CMV and EBV DNA in EDTA Plasma: Implications for Clinical Management and Establishment of a Conversion Formula

“…In implementing the MeuMoDx platform in routine clinical laboratory practice, we found that time to result improved, especially due to the possibility of continuous loading. This is also reported by Luciani et al ( 28 ).…”

“…In concordance with both Luciani et al ( 28 ), who evaluated the NeuMoDx platform and assay for CMV, and Mourik and colleagues ( 29 ), who evaluated NeuMoDx for both CMV and EBV, qualitative agreement with previously established tests was good. However, while Luciani et al ( 28 ) found the NeuMoDx CMV assay too sensitive clinically, the sensitivity is in excellent concordance with our previous routine test (Abbott m2000 and RealTime CMV assay). In contrast to Mourik and colleagues ( 29 ), we found a good quantitative agreement for both NeuMoDx assays.…”

Analytical and Clinical Performance of the NeuMoDx™ Platform for Cytomegalovirus and Epstein–Barr Virus Viral Load Testing

“…However, in whole blood samples, this was not noticeable after 2 weeks of treatment. While that study is not directly comparable to the present study, as it pertained to different sample inputs (plasma versus whole blood), the authors concluded that use of the NeuMoDx assay would not result in differences in the clinical treatment of CMV infections in transplanted patients [30]. However, it was noted that the random-access properties of the NeuMoDx platform could offer significant advantages versus the R-GENE in a hospital setting, such as a shorter time to result (<4 h versus 12-24 h with the R-GENE), allowing medical staff to receive the result the same day (during duty hours) [30].…”