Collaborative national multicenter for the identification of conversion factors from copies/mL to international units/mL for the normalization of HCMV DNA load

Sidoti, Francesca; Piralla, Antonio; Costa, Cristina; Scarasciulli, M.L.; Calvario, Agata; Conaldi, Pier Giulio; Paba, Pierpaolo; Perno, Carlo Federico; Gaeta, Aurelia; Antonelli, Guido; Sodano, Giuseppe; Santangelo, Rosaria; Sanguinetti, Maurizio; Vatteroni, Maria Linda; Barzon, Luisa; Palù, Giorgio; Abbate, Isabella; Capobianchi, Maria Rosaria; Piccirilli, Giulia; Lazzarotto, Tiziana; Baldanti, Fausto; Cavallo, Rossana

doi:10.1016/j.diagmicrobio.2019.05.012

Cited by 11 publications

(7 citation statements)

References 18 publications

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“…Our system (ELITe InGenius R ) is completely automatic and thus can optimally reduce the bias eventually associated with manual manipulation of blood samples. The next step will be the expression of CMV DNA in IU instead of copies/ml, by applying a conversion factor, with the aim to abolish any inter-laboratory variation (Sidoti et al, 2019). This process is ongoing in our center and in the GITMO scientific society, in the context of a multicentric study.…”

Section: Discussionmentioning

confidence: 99%

Advances in CMV Management: A Single Center Real-Life Experience

Malagola

Pollara

Polverelli

et al. 2020

Front. Cell Dev. Biol.

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CMV infection is a major challenge in allogeneic stem cell transplantation (allo-SCT). The changing landscape in CMV management includes the introduction of letermovir in prophylaxis of high-risk patients and the source of CMV DNA monitoring (plasma-PL vs. whole blood-WB), for pre-emptive therapy (PET) initiation. We report here how our real-life experience in CMV management evolved, following letermovir registration. We focus on: (i) the effects of systematic use of letermovir for CMV prophylaxis in high-risk patients, (ii) the results of a longitudinal comparison of CMV DNAemia monitoring in PL and WB. From December 2018 to April 2020, 60 allo-SCTs have been performed in our center (LET ERA), of whom 45 received letermovir in prophylaxis from day 0 to day + 100, because of recipient positivity of anti CMV IgG. These patients were compared with a cohort of 41 allo-SCTs performed between November 2017 and November 2018 (NO LET ERA). Firstly, the incidence of CMV clinically significant infections, CMV disease, bacterial infections, proven/probable fungal infections, hospital re-admissions after allo-SCT by day + 100 in the two ERA were 8 vs. 44% (p = 0.0006), 2 vs. 12% (p = 0.02), 37 vs. 56% (p = 0.05), 8 vs. 19% (p = 0.09), and 23 vs. 39% (p = 0.09), respectively. By day + 180 these differences were 17 vs. 68% (p < 0.00001), 2 vs. 12% (p = 0.02), 45 vs. 78% (p = 0.09), 8 vs. 22% (p = 0.05), and 40 vs. 66% (p = 0.01), respectively. Secondly, from February to May 2019, we comparatively measured CMV DNA from WB and PL and we confirmed that there is a linear correlation between CMV DNA level in WB and PL (Spearman's test r = 0.86). Moreover, CMV DNAemia at the time of PET in the 12 patients with a clinically significant CMV infection was higher in WB vs. PL (5.202 vs. 4.981 copies/ml, p = 0.1). Our real-life experience confirms that: (i) letermovir is highly effective, leading to a significant drop in CMV clinically significant infections and CMV-related complications by day + 100 and + 180 after allo-SCT; (ii) WB may be an effective alternative to PL as a source for CMV DNA monitoring, as a linear correlation of DNAemia was confirmed between WB and PL, even if the CMV DNAemia at PET initiation was comparable in the two sources.

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Section: Discussionmentioning

confidence: 99%

Advances in CMV Management: A Single Center Real-Life Experience

Malagola

Pollara

Polverelli

et al. 2020

Front. Cell Dev. Biol.

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“…According to approved therapeutic protocol, prophylaxis was started by 28th day after transplant and lasted for 100 days. All the patients were monitored twice a week for the first month and then weekly for the following period of prophylaxis for the quantification of HCMV DNAemia in whole blood and, in case of positive results, in plasma using standardized methods 10,11 …”

Section: Methodsmentioning

confidence: 99%

Positive HCMV DNAemia in stem cell recipients undergoing letermovir prophylaxis is expression of abortive infection

Cassaniti

Colombo

Bernasconi

et al. 2021

American Journal of Transplantation

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Letermovir (LMV) inhibits HCMV replication by binding to components of the HCMV‐terminase complex showing a potential role in prevention of HCMV‐related complications in allogenic hematopoietic stem cell transplant recipients (allo‐HSCTRs). However, little is known about breakthrough HCMV infection and the relevance of HCMV DNAemia during prophylaxis. We reported the results of a multicenter prospective study involving five Italian centers in the management of HCMV DNAemia in 75 adult HCMV‐seropositive allo‐HSCTRs undergoing LMV prophylaxis. The aim of the present study was to characterize the presence of real HCMV reactivation during LMV prophylaxis. Then, the presence of circulating infectious HCMV particles was determined by virus isolation and degradation of free‐floating viral DNA. This report provides the first evidence that during LMV prophylaxis the clinical relevance of HCMV DNAemia should be critically considered.

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“…The World Health Organization (WHO) international standard for CMV nucleic acid amplification techniques was developed in October 2010 [ 34 ]. Implementation of the WHO international standard for calibration has significantly improved the degree of agreement of viral load values between different assays and allows results to be reported in units of IU/mL [ 27 , 35 ]. A multicenter study for intraassay harmonization of the CMV QNAT on plasma samples has been conducted, but clinically relevant differences in viral load values have been reported between the various assays [ 36 ].…”

Section: Assays Of Virus Detectionmentioning

confidence: 99%

Laboratory diagnostic testing for cytomegalovirus infection in solid organ transplant patients

Lee

2022

Korean J Transplant

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Human cytomegalovirus (CMV) infection, which is one of the most common complications in transplant recipients, increases the risk of graft loss and rejection. Laboratory strategies for diagnosing CMV infection rely on the measurement of viral DNAemia and CMV-specific cell-mediated immunity (CMV-CMI). The CMV quantitative nucleic acid amplification test (QNAT) enabled the spread of preemptive therapy and prompted recommendations for surveillance, diagnosis, and monitoring. Despite the implementation of the World Health Organization international standard for calibration, variability of QNAT persists due to technical issues. CMV immunoglobulin G serology is the standard method for CMV immune screening of transplant candidates and donors. Assays for CMV-CMI play an important role in helping to predict the risk and to develop an individualized CMV management plan. Genotypic testing for resistance is needed when drug-resistant CMV infection is suspected. Here, we review the state of the art of laboratory tests for CMV infection in solid organ transplantation.

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Collaborative national multicenter for the identification of conversion factors from copies/mL to international units/mL for the normalization of HCMV DNA load

Cited by 11 publications

References 18 publications

Advances in CMV Management: A Single Center Real-Life Experience

Advances in CMV Management: A Single Center Real-Life Experience

Positive HCMV DNAemia in stem cell recipients undergoing letermovir prophylaxis is expression of abortive infection

Laboratory diagnostic testing for cytomegalovirus infection in solid organ transplant patients

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