Conversion to the COBAS AmpliPrep/COBAS TaqMan CMV Test for management of CMV disease in transplant recipients

Pritt, Bobbi S.; Germer, Jeffrey J.; Gomez-Urena, Eric; Bishop, Callie J.; Mandrekar, Jayawant N.; Irish, Cole L.; Yao, Joseph D.

doi:10.1016/j.diagmicrobio.2013.01.014

Cited by 11 publications

(11 citation statements)

References 6 publications

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“…The differences observed between the assays might therefore be attributed to a decline in DNA stability over time. However, previous studies have shown that CMV DNA remains stable for 14 days when stored at 4°C and longer at Ϫ70°C (11,17). Furthermore, the concentration of CMV DNA in wholeblood samples tested after prolonged storage was in many instances higher than the concentration in the corresponding plasma samples (Fig.…”

Section: Discussionmentioning

confidence: 90%

“…The LightCycler CMV ASR (Roche Diagnostics, Indianapolis, IN) consists of a set of primers and probes targeting the CMV UL54 DNA polymerase gene with a performance comparable to that of other available commercial assays (3,(10)(11)(12). However, until recently, no standardized quantitative molecular assay was commercially available for the monitoring of CMV viral loads.…”

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confidence: 99%

“…The assay includes (i) specimen preparation to isolate CMV DNA by the Cobas AmpliPrep extractor and (ii) the simultaneous PCR amplification of target DNA and detection of cleaved dually labeled oligonucleotide detection probes specific to the target by the Cobas TaqMan 48 analyzer. This assay provides an automated, rapid, and highthroughput system for CMV viral load determination (11,13). The Cobas CMV test is currently the only FDA-cleared assay for the monitoring of CMV viral loads.…”

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confidence: 99%

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Monitoring of Cytomegalovirus Viral Loads by Two Molecular Assays in Whole-Blood and Plasma Samples from Hematopoietic Stem Cell Transplant Recipients

et al. 2015

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Cytomegalovirus (CMV) viral loads in hematopoietic stem cell transplant (HSCT) recipients are typically monitored using quantitative molecular assays. The Roche Cobas AmpliPrep/Cobas TaqMan CMV test (Cobas CMV) has recently been cleared by the FDA for the monitoring of CMV viral loads in plasma samples from transplant patients. In this study, we compare and correlate the viral loads obtained by a laboratory-developed test (LC CMV) (using Roche analyte-specific reagents [ASR] on the LightCycler 2.0) on whole-blood specimens with those obtained on corresponding plasma and whole-blood specimens by the Cobas CMV assay. Testing was performed on 773 archived patient specimens. The strength of the agreement was good for the two assays performed on whole blood ( ‫؍‬ 0.6; 95% confidence interval [CI], 0.51 to 0.7) and moderate when the tests were performed on different sample types ( ‫؍‬ 0.54; 95% CI, 0.47 to 0.62 for the LC CMV whole blood [WB] assay versus Cobas plasma [PL], and ‫؍‬ 0.57; 95% CI, 0.5 to 0.65 for the Cobas WB assay versus Cobas PL), although the difference was not statistically significant. Using a combination gold standard (i.e., a true positive was a specimen that was positive by two or more methods), the sensitivity and specificity of the assays were 78.8% and 99.3% for the LC CMV assay, 85.2% and 98.1% for the Cobas CMV WB assay, and 100% and 90.5% for Cobas CMV PL assay, respectively. A comparison of the CMV viral load trends in both plasma and whole blood from a few patients with multiple positive successive samples showed similar slopes, with differences in the slope ranging from 0.01 to 0.22. However, the absolute value for individual viral load differed markedly with wholeblood viral loads, being on average 0.5-to 1.22-log higher than those in plasma. The Cobas CMV assay provides a valid option for the monitoring of viral loads in transplant patients. Due to its increased sensitivity, the detection of CMV DNA in patients with low viral loads (i.e., those below limit of quantification [LOQ]) is increased with the Cobas CMV assay in plasma specimens. Longitudinal prospective studies will be needed to examine the clinical significance of these low-level viral loads. C ytomegalovirus (CMV) is an important cause of morbidity and mortality in transplant patients and is typically monitored using quantitative molecular assays. In hematopoietic stem cell transplant (HSCT) recipients, CMV remains an important opportunistic pathogen during the posttransplant period, with infection incidences of as high as 40% and 80% in adults and children, respectively (1). The clinical management of CMV hinges to a large extent on changes in the magnitude of CMV viral load. Several parameters are known to affect the value of CMV viral load results, including (i) the specimen type used (whole blood or plasma), (ii) the limit of detection and limit of quantification of the particular assay chosen by the clinical laboratory, (iii) the linear range of the assay, and (iv) the reproducibility of the assay within the instituti...

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Section: Discussionmentioning

confidence: 90%

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confidence: 99%

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confidence: 99%

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Monitoring of Cytomegalovirus Viral Loads by Two Molecular Assays in Whole-Blood and Plasma Samples from Hematopoietic Stem Cell Transplant Recipients

et al. 2015

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“…Beim derzeitigen Wissenstand ist keine Präferenz für eine Methode sicher belegbar [135]. Nach Verfügbarkeit des WHO-Standards für HCMV-DNA, kommerzieller Assays und Ringversuche ist eine höhere Standardisierbarkeit und Vergleichbarkeit der NAT-Methoden gegeben [136][137][138].…”

Section: Bekanntmachungen -Amtliche Mitteilungenunclassified

Humanes Cytomegalievirus (HCMV)

2017

Bundesgesundheitsbl

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“…Plasma CMV VL was measured via QPCR with a laboratory-developed assay, as previously described. [11][12][13] The VL was reported as copies per milliliter. The lower limit of detection was 2000 copies/mL.…”

Section: Infectionmentioning

confidence: 99%

Risk factors for cytomegalovirus reactivation after liver transplantation: Can pre‐transplant cytomegalovirus antibody titers predict outcome?

et al. 2015

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Despite preexisting cytomegalovirus (CMV) immunity, CMV-seropositive liver transplantation (LT) patients remain at risk of CMV infection. We hypothesized that the pre-transplant CMV antibody titer correlates with the risk of CMV reactivation. We conducted a retrospective study of CMV-seropositive LT recipients who did not receive anti-CMV prophylaxis from 2007 to 2013. The pre-transplant CMV immunoglobulin G (IgG) titer, which was measured with an enzyme-linked fluorescent immunoassay, was assessed as a risk factor for CMV reactivation with multivariate Cox proportional hazards models. The population consisted of 225 CMV-seropositive LT patients with a median age of 57 years (interquartile range, 47-62 years). The CMV titer distributions were as follows: <60 (40%) and 60 AU/mL (arbitrary unit per milliliter) (60%). The Kaplan-Meier estimates for CMV infection were 17% at 3 months, 18% at 6 months, and 19% at 12 months after transplantation. In a univariate analysis, a marginally significant increased risk of CMV infection was seen in LT recipients with a pre-transplant CMV IgG titer < 60 AU/mL versus 60 AU/mL [hazard ratio (HR), 1.79; 95% confidence interval (CI), 0.98-3.28 (P 5 0.06)]. This risk was statistically significant in the subgroup of recipients who received allografts from CMV-seropositive donors [HR, 2.21; 95% CI, 1.15-4.26 (P 5 0.02)]. In a multivariate analysis, a pre-transplant CMV IgG titer < 60 AU/mL was significantly associated with CMV infection [HR, 3.11; 95% CI, 1.60-6.03 (P < 0.001)]. The other risk factors were high body mass index, donor CMV seropositivity, prolonged cold ischemic time, use of an interleukin-2 receptor antagonist for induction therapy, and high numbers of post-transplant infections. A lower pre-transplant CMV antibody titer is significantly associated with CMV infection after LT. Quantitative measurement of CMV-specific humoral immunity may have a potential role in improving the CMV prevention strategy in CMV-seropositive LT recipients.

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Conversion to the COBAS AmpliPrep/COBAS TaqMan CMV Test for management of CMV disease in transplant recipients

Cited by 11 publications

References 6 publications

Monitoring of Cytomegalovirus Viral Loads by Two Molecular Assays in Whole-Blood and Plasma Samples from Hematopoietic Stem Cell Transplant Recipients

Monitoring of Cytomegalovirus Viral Loads by Two Molecular Assays in Whole-Blood and Plasma Samples from Hematopoietic Stem Cell Transplant Recipients

Humanes Cytomegalievirus (HCMV)

Risk factors for cytomegalovirus reactivation after liver transplantation: Can pre‐transplant cytomegalovirus antibody titers predict outcome?

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