Comparison of ADVIA Centaur ultra-sensitive and high-sensitive assays for troponin I in serum.
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SUBMITTER: Osredkar J
PROVIDER: S-EPMC9289728 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:OBJECTIVES:To evaluate the newly developed Roche MODULAR Analytics E170 Total Vitamin D and the Siemens ADVIA Centaur Vitamin D Total assays. MATERIALS AND METHODS:Assays were evaluated using the Clinical and Laboratory Standards Institute protocols. Split patient samples were compared with LC-MS/MS and DiaSorin LIAISON assays (n=79 including 15 specimens with detectable endogenous 25-OH vitamin D(2)). Assay accuracy was also evaluated using the Vitamin D External Quality Assessment Scheme (DEQAS) samples. RESULTS:The ADVIA Centaur and E170 assays demonstrated maximum total CVs of 14.1% and 5.9%, respectively. Both showed excellent linearity (R(2)>0.99). The ADVIA Centaur assay demonstrated interference with bilirubin at 800 ?mol/L, hemolysis at 1.25 g/L, and triglycerides at 2.8 mmol/L. Compared to LC-MS/MS, the ADVIA Centaur assay demonstrated a R(2) value of 0.893, average bias of -8.8%; the E170 assay an R(2) value of 0.872, average bias of 14.3% with underestimation of 25-OH vitamin D(2). Compared to the LIAISON assay, the ADVIA Centaur assay demonstrated an R(2) value of 0.781, average bias of -17.3%; the E170 assay an R(2) value of 0.823, average bias of 11.4%. The ADVIA Centaur and E170 assays demonstrated a biases of <20% in 10/10 and 8/10 DEQAS samples, respectively. CONCLUSIONS:The ADVIA Centaur and E170 vitamin D assays demonstrated acceptable linearity, imprecision, and accuracy. The E170 assay demonstrated consistent underestimation of 25-OH vitamin D(2) levels. Compared with LC-MS/MS, the ADVIA Centaur assay demonstrated a higher R(2) value and a smaller average bias than the E170 assay.
| S-EPMC4193681 | biostudies-literature
Project description:A significant bias was found when using the Siemens ADVIA Centaur XP system for measurement of 25-hydroxyvitamin D (25OHD) with VACUETTE® tubes with Serum Clot Activator and Gel. Here, we examined whether other commonly used tubes or temperatures affected 25OHD results obtained with the Siemens ADVIA Centaur XP system. Serum was collected into five types of vacuum blood collection tubes from three manufacturers, and 25OHD was analyzed using the Siemens ADVIA Centaur XP system and liquid chromatography tandem mass spectrometry (LC-MS/MS) immediately or after storage at 4°C or -80°C for 48 h. Significantly higher 25OHD values were found when using the Siemens ADVIA Centaur XP system with VACUETTE® tubes with serum clot activator and gel and VACUETTE® tubes with clot activator but no gel compared with VACUETTE® tubes with no additives. The 25OHD values in all of these tubes were not significantly different from those obtained by LC-MS/MS. Moreover, after storage at -80°C for 48 h, the values obtained in IMPROVEVACUTER® tubes with serum clot activator and gel significantly increased, with a mean bias of 74.6% compared with the values before storage, on analysis with the Siemens ADVIA Centaur XP system. VACUETTE® tubes containing additives significantly affect the accuracy of 25OHD results obtained using the Siemens ADVIA Centaur XP system. Additionally, the composition of serum collected in IMPROVEVACUTER® tubes was affected by freezing, resulting in different measurements when using the Siemens 25OHD assay platform.
| S-EPMC5104342 | biostudies-literature
Project description:BackgroundThe instant, single-sampling rule-out of acute myocardial infarction (AMI) is still an unmet clinical need. We aimed at testing and comparing diagnostic performance and prognostic value of two different single-sampling biomarker strategies for the instant rule-out of AMI.MethodsFrom the Biomarkers in Acute Cardiac Care (BACC) cohort, we recruited consecutive patients with acute chest pain and suspected AMI presenting to the Emergency Department of the University Medical Center Hamburg-Eppendorf, Hamburg, Germany. We compared safety, effectiveness and 12-month incidence of the composite endpoint of all-cause death and myocardial infarction between (i) a single-sampling, dual-marker pathway combining high-sensitivity cardiac troponin I (hs-cTnI) and ultra-sensitive copeptin (us-Cop) at presentation (hs-cTnI ≤ 27 ng/L, us-Cop < 10 pmol/L and low-risk ECG) and (ii) a single-sampling pathway based on one-off hs-cTnI determination at presentation (hs-cTnI < 5 ng/L and low-risk ECG). As a comparator, we used the European Society of Cardiology (ESC) 0/1-h dual-sampling algorithm.ResultsWe enrolled 1,136 patients (male gender 65%) with median age of 64 years (interquartile range, 51-75). Overall, 228 (20%) patients received a final diagnosis of AMI. The two single-sampling instant rule-out pathways yielded similar negative predictive value (NPV): 97.4% (95%CI: 95.4-98.7) and 98.7% (95%CI: 96.9-99.6) for dual-marker and single hs-cTnI algorithms, respectively (P = 0.11). Both strategies were comparably safe as the ESC 0/1-h dual-sampling algorithm and this was consistent across subgroups of early-comers, low-intermediate risk (GRACE-score < 140) and renal dysfunction. Despite a numerically higher rate of false-negative results, the dual-marker strategy ruled-out a slightly but significantly higher percentage of patients compared with single hs-cTnI determination (37.4% versus 32.9%; P < 0.001). There were no significant between-group differences in 12-month composite outcome.ConclusionsInstant rule-out pathways based on one-off determination of hs-cTnI alone or in combination with us-Cop are comparably safe as the ESC 0/1 h algorithm for the instant rule-out of AMI, yielding similar prognostic information. Instant rule-out strategies are safe alternatives to the ESC 0/1 h algorithm and allow the rapid and effective triage of suspected AMI in patients with low-risk ECG. However, adding copeptin to hs-cTn does not improve the safety of instant rule-out compared with the single rule-out hs-cTn at very low cut-off concentrations.
| S-EPMC9395923 | biostudies-literature
Project description:An electrochemical immunosensor based on a nanohybrid film of carboxylated polypyrrole and amine nanoclay was developed for label-free detection of the human cardiac troponin T (cTnT). The nanohybrid film was formed in situ on the surface of the glassy carbon electrode, followed by the covalent immobilization of anti-troponin T antibodies by glutaraldehyde. Morphological and chemical characterizations of the nanohybrid film were performed by scanning electron microscopy and Fourier-transform infrared spectroscopy. Under the optimized conditions, a calibration curve for cTnT in spiked serum was obtained by square wave voltammetry, and a low limit of detection and quantification was achieved (0.35 and 1.05 pg mL-1, respectively). This was the first time that this type of nanohybrid film was used in the development of an immunosensor for cTnT that proved to be a simple and efficient strategy for the manufacture of a label-free electrochemical device that could be applied in the diagnosis of acute myocardial infarction.
| S-EPMC9313248 | biostudies-literature
Project description:Leprosy urgently needs a precise and early diagnostic tool. The sensitivity of the direct (bacilli staining, Mycobacterium leprae DNA) and indirect (antibody levels, T cell assays) diagnostics methods vary based on the clinical form. Recently, PCR-based M. leprae DNA detection has been shown to differentially diagnose leprosy from other dermatological conditions. However, accuracy can still be improved, especially for use with less invasive clinical samples. We tested different commercial DNA extraction kits: DNeasy Blood & Tissue, QIAamp DNA Microbiome, Maxwell 16 DNA Purification, PowerSoil DNA Isolation; as well as in-house phenol-chloroform and Trizol/FastPrep methods. Extraction was performed on M. leprae-infected mouse footpads and different clinical samples of leprosy patients (skin biopsies and scrapings, lesion, oral and nasal swabs, body hair, blood on FTA cards, peripheral whole blood). We observed that the Microbiome kit was able to enrich for mycobacterial DNA, most likely due the enzymatic digestion cocktail along with mechanical disruption involved in this method. Consequently, we had a significant increase in sensitivity in skin biopsies from paucibacillary leprosy patients using a duplex qPCR targeting 16S rRNA (M. leprae) and 18S rRNA (mammal) in the StepOnePlus system. Our data showed that the presence of M. leprae DNA was best detected in skin biopsies and skin scrapings, independent of the extraction method or the clinical form. For multibacillary patients, detection of M. leprae DNA in nasal swabs indicates the possibility of having a much less invasive sample that can be used for the purposes of DNA sequencing for relapse analysis and drug resistance monitoring. Overall, DNA extracted with the Microbiome kit presented the best bacilli detection rate for paucibacillary cases, indicating that investments in extraction methods with mechanical and DNA digestion should be made.
| S-EPMC7274454 | biostudies-literature
Project description:Rare tumor-specific mutations in patient samples serve as excellent markers to monitor the course of malignant disease and responses to therapy in clinical routine, and improved assay techniques are needed for broad adoption. We describe herein a highly sensitive and selective molecule amplification technology - superRCA assays - for rapid and highly specific detection of DNA sequence variants present at very low frequencies in DNA samples. Using a standard flow cytometer we demonstrate precise, ultra-sensitive detection of single-nucleotide mutant sequences from malignant cells against up to a 100,000-fold excess of DNA from normal cells in either bone marrow or peripheral blood, to follow the course of patients treated for acute myeloid leukemia (AML). We also demonstrate that sequence variants located in a high-GC region may be sensitively detected, and we illustrate the potential of the technology for early detection of disease recurrence as a basis for prompt change of therapy.
| S-EPMC9276831 | biostudies-literature
Project description:BackgroundUse of high-sensitivity troponin (hs-Tn) assays can detect small levels of myocardial damage previously undetectable with conventional troponin (c-Tn) assays. However, prognostic utility of these hs-Tn assays in prediction of mortality remains unclear in the presence of nonelevated c-Tn levels on admission. A systematic review and meta-analysis was performed to assess mortality risk of patients with hs-Tn elevations in the setting of normal c-Tn levels.HypothesisPatients with hs-Tn elevations with normal c-Tn levels on admission blood samples, drawn to rule out acute coronary syndrome (ACS), have a higher mortality risk than those without hs-Tn or c-Tn elevations.MethodsA search was made of the PubMed, CENTRAL, EMBASE, CINAHL, EBSCO, and Web of Science databases. Studies evaluating patients with suspected ACS that reported mortality rates for those with elevated hs-Tn levels but normal c-Tn levels on admission were included. A random-effects model was used to pool event rates, and data were reported in odds ratios (95% confidence interval).ResultsFour studies (N = 2033, mean age 64-75 years, 49%-70% male) revealed that nearly 32% of suspected ACS patients with normal c-Tn levels on admission had elevated hs-Tn levels. Elevated hs-Tn levels conferred a significantly higher risk of all-cause mortality vs normal hs-Tn levels (odds ratio: 4.35, 95% confidence interval: 2.81-6.73, P < 0.01), with negligible heterogeneity (I(2) = 0%).ConclusionsElevation of hs-Tn levels predicted a higher risk of mortality in patients with suspected ACS and may aid in the early identification of higher-risk patients in this setting. Future studies are needed to investigate further optimal management strategies.
| S-EPMC6649604 | biostudies-literature
Project description:ObjectivesCardiac troponin T, measured using a high-sensitive assay (hs-cTnT), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) are associated with increased stroke risk and perhaps with cognitive decline. However, few well-designed prospective studies with extended follow-up have been conducted. We aimed to estimate the association of hs-cTnT and NT-proBNP with 15-year cognitive change in the Atherosclerosis Risk in Communities (ARIC) study.DesignProspective cohort study.SettingFour US communities.ParticipantsA total of 9114 and 9108 participants from the Atherosclerosis Risk in Communities study for analyses of hs-cTnT and NT-proBNP, respectively.MeasurementsWe examined association of hs-cTnT and NT-proBNP with 15-year change (1996-1998 to 2011-2013) in three cognitive tests of executive function (Digit Symbol Substitution Test), verbal learning memory (Delayed Word Recall Test), and semantic fluency (Word Fluency Test), and an overall score combining the three tests using multivariable linear mixed effect models. We conducted several sensitivity analyses including multiple imputations to address bias due to missing data and attrition, and we compared associations within groups combining hs-cTnT and NT-proBNP into a three-level categorical variable.ResultsAt baseline (1996-1998), mean age was 63.4 (standard deviation [SD] = 5.7) years; 56.4% were women, and 17.5% were black. The hs-cTnT at baseline was not associated with cognitive change in any measure. Some evidence indicated accelerated decline in verbal learning and memory when comparing those in the highest with the lowest NT-proBNP quintiles; however, this association was not replicated when considering clinically relevant cutoffs or deciles of exposure in survivors. Sensitivity analyses were consistent with our primary analyses. There was little evidence to support effect modification by any considered factors. People with highest levels of both biomarkers had excessive decline in global z scores vs people with lowest levels (-.34; 95% confidence interval = -.63 to -.04).ConclusionMarkers of myocardial injury and stretch were not associated with cognitive decline following 15 years among survivors, but when combined together they were suggestive in post hoc analysis. Whether this represents targets of intervention should be examined in the future. J Am Geriatr Soc 67:2353-2361, 2019.
| S-EPMC6861618 | biostudies-literature
Project description:Mammalian HtrA3 (high temperature requirement A3) is a serine protease of the HtrA family. It has two isoforms [long (HtrA3-L) and short (HtrA3-S)] and is important for placental development and cancer progression. Recently, HtrA3 was identified as a potential diagnostic marker for early detection of preeclampsia, a life-threatening pregnancy-specific disorder. Currently there are no high-throughput assays available to detect HtrA3 in human serum. In this study we generated and fully tested a panel of five HtrA3 mouse monoclonal antibodies (mAbs). Three mAbs recognised both HtrA3-L and HtrA3-S and the other two detected HtrA3-L only. All five mAbs were highly specific to HtrA3 and applicable in western blotting and immunohistochemical analysis of endogenous HtrA3 proteins in the mouse and human tissues. Amplified luminescent proximity homogeneous assays-linked immunosorbent assays (AlphaLISAs), were developed to detect HtrA3 isoforms in picomolar levels in serum. The HtrA3 AlphaLISA detected significantly higher serum levels of HtrA3 in women at 13-14 weeks of gestation who subsequently developed preeclampsia compared to gestational-age matched controls. These HtrA3 mAbs are valuable for the development of immunoassays and characterisation of HtrA3 isoform-specific biology. The newly developed HtrA3 AlphaLISA assays are suitable for large scale screening of human serum.
| S-EPMC3457993 | biostudies-literature
Project description:BackgroundHigh-sensitivity cardiac troponin (hs-cTn) assays have different analytic characteristics.ObjectivesThe goal of this study was to quantify differences between assays for common analytical benchmarks and to determine whether they may result in differences in the management of patients with suspected acute coronary syndrome (ACS).MethodsThe authors included patients with suspected ACS enrolled in the ROMICAT (Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography) I and II trials, with blood samples taken at emergency department presentation (ROMICAT-I and -II) or at 2 and 4 h thereafter (ROMICAT-II). hs-cTn concentrations were measured using 3 assays (Roche Diagnostics, Elecsys 2010 platform; Abbott Diagnostics, ARCHITECT i2000SR; Siemens Diagnostics, HsVista). Per blood sample, we determined concordance across analytic benchmarks (99th percentile). Per-patient, the authors determined concordance of management recommendations (rule-out/observe/rule-in) per the 0/2-h algorithm, and their association with diagnostic test findings (coronary artery stenosis >50% on coronary computed tomography angiography or inducible ischemia on perfusion imaging) and ACS.ResultsAmong 1,027 samples from 624 patients (52.8 ± 10.0 years; 39.4% women), samples were classified as <LOD (56.3% vs. 10.4% vs. 41.2%; p < 0.001), LOD-99th percentile (36.5% vs. 83.5% vs. 52.6; p < 0.001), >99th percentile (7.2% vs. 6.0% vs. 6.2%) by Roche, Abbott, and Siemens, respectively. A total of 37.4% (n = 384 of 1,027) of blood samples were classified into the same analytical benchmark category, with low concordance across benchmarks (<LOD 11.1%; LOD-99th percentile 29.3%; >99th percentile 43.6%). Serial samples were available in 242 patients (40.1% women; mean age: 52.8 ± 8.0 years). The concordance of management recommendations across assays was 74.8% (n = 181 of 242) considering serial hs-cTn measurements. Of patients who were recommended to discharge, 19.6% to 21.1% had positive diagnostic test findings and 2.8% to 4.3% had ACS at presentation.ConclusionsCaregivers should be aware that there are significant differences between hs-cTn assays in stratifying individual samples and patients with intermediate likelihood of ACS according to analytical benchmarks that may result in different management recommendations. (Rule Out Myocardial Infarction by Computer Assisted Tomography [ROMICAT]; NCT00990262) (Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography [ROMICAT-II]; NCT01084239).
| S-EPMC8040768 | biostudies-literature