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Journal articles on the topic "Cobas e801"
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Won, Dongju, Younhee Park, Dasom Choi, and Hyon-Suk Kim. "Comparison of High-Throughput Fully Automated Immunoanalyzers for Detecting Hepatitis B Virus Infection." Archives of Pathology & Laboratory Medicine 144, no. 5 (October 19, 2019): 612–19. http://dx.doi.org/10.5858/arpa.2019-0096-oa.
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Context.— High-throughput automated immunoanalyzers for hepatitis B virus serologic markers have been introduced but have not been compared to existing systems. Objective.— To compare hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody analyses between our Architect i2000 platform and newer high-throughput fully automated immunoanalyzers. Design.— From May to June 2018, a total of 932, 914, and 1055 samples tested for hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody, respectively, with the Architect i2000 system for routine testing in our center were tested again with Alinity i, Atellica IM, and Cobas e801 systems. Results.— Total concordance rates among the systems were 98.0%, 89.5%, and 93.0% for hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody, respectively. Cohen's κ values exceeded 0.8. The correlations between serum hepatitis B surface antibody levels quantified by all 4 systems were high (r > 0.85). The hepatitis B surface antibody averages were greater for the Alinity i, Atellica IM, and Cobas e801 than for the Architect i2000 (P < .001). Conclusions.— Alinity i, Atellica IM, and Cobas e801 automated immunoanalyzers performed well when compared with the existing Architect i2000 system with regard to detection of hepatitis B viral infection. However, the new systems have higher titer and positivity rates for hepatitis B surface antibody and are more sensitive. Notably, the Atellica IM has a lower positive rate for total hepatitis B core antibody than does the Architect i2000.
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Cachón-Suárez, I., M. C. Gónzalez-Fernando, J. Ros-Pau, and D. Dot-Bach. "Analytical performance of several tumor markers immunoassays on cobas c8000-e801 analyzer." Clinica Chimica Acta 493 (June 2019): S27. http://dx.doi.org/10.1016/j.cca.2019.03.066.
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Lippi, Giuseppe, Gian Luca Salvagno, Matteo Gelati, Mairi Pucci, Claudia Lo Cascio, Davide Demonte, Diego Faggian, and Mario Plebani. "Two-center comparison of 10 fully-automated commercial procalcitonin (PCT) immunoassays." Clinical Chemistry and Laboratory Medicine (CCLM) 58, no. 1 (December 18, 2019): 77–84. http://dx.doi.org/10.1515/cclm-2019-0888.
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Abstract Background This two-center study was designed to verify comparability of procalcitonin (PCT) values among 10 different commercial immunoassays. Methods A total number of 176 routine lithium-heparin plasma samples were divided in identical aliquots and simultaneously analyzed with 10 different PCT immunoassays, including Kryptor BRAHMS PCT sensitive, Abbott Architect BRAHMS PCT, Beckman Coulter Access PCT (on Access and DXI), BioMérieux Vidas BRAHMS PCT, Diasorin Liaison BRAHMS PCT, Fujirebio Lumipulse G BRAHMS PCT, Roche BRAHMS PCT (on Cobas E801), Diazyme PCT (on Roche Cobas C702) and SNIBE Maglumi PCT. Results Highly significant correlation was always found across multiple comparisons, with correlation coefficients comprised between 0.918 and 0.997 (all p < 0.001). Bland and Altman plots analysis revealed highly variable bias among immunoassays, ranging between ±0.2% and ±38.6%. Diazyme PCT on Roche Cobas C702 and SNIBE Maglumi PCT displayed the larger overestimation, whilst PCT values were underestimated by Cobas BRAHAMS PCT. The agreement was always >80% (all p < 0.001), but varied largely across multiple comparisons, ranging between 90%–99% at 0.1 μg/L, 81%–99% at 0.25 μg/L, 83%–100% at 0.5 μg/L, 94%–100% at 2.0 μg/L and 90%–99% at 10 μg/L, respectively. The larger disagreement was observed comparing Diazyme PCT and Maglumi PCT with the other methods. Conclusions Although we found acceptable correlation among 10 commercial PCT immunoassays, the limited agreement at clinical decision thresholds remains a major issue, especially at lower end of PCT concentration, thus potentially contributing to jeopardize the clinical value of this biomarker.
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Agarwal, Amit, Saphalta Baghmar, Suhail Qureshi, Aseem Khurana, Rasika Setia, Maroof Ahmad Khan, Purabi Barman, et al. "Persistent Antibody Responses to SARS-CoV-2 Infection in Cancer Patients: A Single-Center Retrospective Observational Study." Indian Journal of Medical and Paediatric Oncology 42, no. 02 (April 2021): 123–29. http://dx.doi.org/10.1055/s-0041-1733823.
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Abstract Introduction There is limited literature available regarding the prevalence and durability of immune response to infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/coronavirus disease 2019 (COVID-19) in cancer patients. Objective The aim of this study was to analyze the seroconversion rate in cancer patients recovered from SARS-CoV-2 infection. Materials and Methods We retrospectively analyzed antibody levels and seroconversion rates in serum samples from 135 cancer patients who had recovered from SARS-CoV-2 infection. Chemiluminescent immunoassay using Roche Cobas e801 analyzer (Roche Diagnostics, Rotkreuz, Switzerland) was performed to identify Pan Ig antibody against nucleocapsid antigen. Reports of first, third, and sixth month were analyzed. Seroconversion was also compared with health-care workers (HCW) of our institute who had recovered from COVID-19 infection. Results Seroconversion rate in cancer patients was 81.2% at 1 month, 95% at 3 months, and 94.6% at 6 months post reverse transcriptase–polymerase chain reaction positivity. There was no difference in seroconversion rate among different age groups, gender, comorbidities, severity of COVID-19 symptoms, cancer disease status, and treatment with chemotherapy. Seroconversion rate in cancer patients is comparable to HCW (90.4 vs. 96%, p = 0.82) and is durable. Conclusion Humoral response to COVID-19 infection in cancer patients is comparable to general population and sustained. Such responses suggest that cancer patients are likely to benefit from COVID-19 vaccination.
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Lau, C. S., S. P. Hoo, S. F. Yew, S. K. Ong, L. T. Lum, P. Y. Heng, J. G. Tan, M. S. Wong, and T. C. Aw. "Evaluation of an Electrochemiluminescent SARS-CoV-2 Antibody Assay." Journal of Applied Laboratory Medicine 5, no. 6 (July 27, 2020): 1313–23. http://dx.doi.org/10.1093/jalm/jfaa134.
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Abstract Background Little is known about the performance of the Roche novel severe acute respiratory syndrome coronavirus 2 antibody (anti-SARS-CoV-2) assay. We provide an extensive evaluation of this fully automated assay on Cobas e801/e602 immunoassay analyzers. Methods We assessed the linearity, precision, and throughput of the Roche anti-SARS-CoV-2 assay. Sensitivity was calculated from 349 SARS-CoV-2 polymerase chain reaction (PCR) positive samples; specificity was determined from 715 coronavirus disease 2019 (COVID-19)-naive samples. We examined cross-reactivity against other antibody positive samples [syphilis, rheumatoid factor (RF), antinuclear antibody (ANA), double-stranded DNA (ds-DNA), influenza, dengue, hepatitis B (HBV), hepatitis C (HCV)] and the anti-SARS-CoV-2 kinetics. Results The assay cut-off index (COI) was linear up to 90.8. The interassay precision was 2.9% for a negative control (COI = 0.1) and 5.1% for a positive control (COI = 3.0). Assay time is 18 min and results are available 1 min later; throughput for 300 samples was 76 min. Only 1 case positive for HBsAg tested falsely positive; specificity was 99.9%. The assay has a sensitivity of 97.1% 14 days after PCR positivity (POS) and 100% at ≥21 days POS; 48.2% of cases had anti-SARS-CoV-2 within 6 days POS. In 11 patients in whom serum was available prior to a positive antibody signal (COI ≥1.0) the interval between the last negative and first positive COI (time to “seroconversion”) on average is 3 days (range 1–6 days) and 4 more days (range 1–7) for the anti-SARS-CoV-2 to plateau. Conclusion The Roche anti-SARS-CoV-2 assay shows excellent performance with minimal cross-reactivity from other viral and confounding antibodies. Antibody development and seroconversion appears quite early.
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"Roche cobas e801 Immunoassay Analyzer." Biomedical Safety & Standards 49, no. 13 (July 2019): 102. http://dx.doi.org/10.1097/01.bmsas.0000574372.56092.da.
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Bunch, Dustin R., Kyle Firmender, Roa Harb, and Joe M. El-Khoury. "First- and Second-Trimester Reference Intervals for Thyroid Function Testing in a US Population." American Journal of Clinical Pathology, November 19, 2020. http://dx.doi.org/10.1093/ajcp/aqaa165.
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Abstract Objectives Thyroid dysfunction in pregnancy is associated with increased risk of adverse outcomes to mother and child. Trimester-specific reference intervals for thyroid function tests are not routinely provided by clinical laboratories. In this study, we present first- and second-trimester-specific reference intervals in a US population for thyroid-stimulating hormone (TSH), free thyroxine (FT4), total thyroxine (T4), and total triiodothyronine (T3) measured on Roche analyzers. Methods We used patient samples from first- and second-trimester prenatal screening. Samples were limited to singleton pregnancies and negative screening results for thyroid peroxidase and thyroglobulin antibodies. Analytes (TSH, FT4, T4, and T3) were measured on a Roche Modular e170 then verified on a Roche cobas e801. Results The reference intervals established on the e170 and verified on the e801 for the first trimester were 0.11 to 3.48 mIU/L for TSH, 11.2 to 19.0 pmol/L for FT4, 51.1 to 185.6 nmol/L for T4, and 1.4 to 3.5 nmol/L for T3. The reference intervals for the second trimester were 0.31 to 3.85 mIU/L for TSH, 9.4 to 16.5 pmol/L for FT4, 55.1 to 174.0 nmol/L for T4, and 1.5 to 3.7 nmol/L for T3. Conclusions This is the first report of trimester-specific reference intervals for thyroid function tests on Roche analyzers in the United States, and it is consistent with worldwide reports.
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Dupuy, Anne Marie, Anne Sophie Bargnoux, François Roubille, and Jean Paul Cristol. "Letter in reply to the letter to the editor of Geerts N and Schanhorst V with the title “Roche Troponin T hs-STAT meets all expert opinion analytical laboratory practice recommendations for the use of the differential diagnosis of acute coronary syndrome”." Clinical Chemistry and Laboratory Medicine (CCLM), August 1, 2020. http://dx.doi.org/10.1515/cclm-2020-0469.
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AbstractOver the period from December 3rd, 2019 to March 13th, 2020, after the urgent field safety notice reported by Roche, we performed double determinations of all troponins from the same tube in parallel and in the same run. We used the same Elecsys troponin T hs reagent (ref 08469873190), first result was obtained with the current hs-cTnT application (18 min) and the second measurement was with the STAT application (9 min). On the 11,388 results in the range from 3 to 500 ng/L, we observed 4.18% discordant results (above 18.8% RCV). Overall, we observed an overestimation of the hs-cTnT STAT assay. The Elecsys Troponin T hs STAT assay demonstrated good analytical performances on Cobas e801 analyzer. However, its use according to the ESC recommendations for the 0 h/1 h algorithm should be carefully evaluated and requires further studies with serial cTn testing.
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Bashir, Bilal, Moulinath Banerjee, Harnovdeep Singh Bharaj, Simmi Krishnan, Atir Khan, Carolyn Williams, and Ambar Basu. "MON-480 Isolated Hyperthyroxinemia - Does Everyone Needs Treatment?" Journal of the Endocrine Society 4, Supplement_1 (April 2020). http://dx.doi.org/10.1210/jendso/bvaa046.1418.
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Abstract Background: Raised free thyroxine (T4) with normal thyroid stimulating hormone (TSH) levels should be identified and interpreted with caution. Some of these conditions do not need treatment. We present three cases with similar biochemical abnormalities from three different causes. Case 1: A 62-year-old clinically asymptomatic lady was referred to us with Free T4 34.9 pmol/L (10.0 – 24.0 pmol/L), TSH 0.81 mU/L (0.2 – 5.0 mu/L) and negative TSH receptor antibodies (<0.9 IU/L). She was trialled on antithyroid drugs for 6 months. Her Free T4 stayed elevated between 29.0 – 35.0 pmol/L with normal TSH. We worked up for assay interference by running tests on two analysers, Roche Cobas e801 and Siemens ADIVA Centaur CP, both yielded similar results. Alpha1 glycoprotein subunits and SHBG were normal with clinical euthyroid status making TSHoma less likely. Serum protein electrophoresis did not detect any abnormal albumin. We were unable to perform equilibrium dialysis due to non-availability of facility at our centre. Due to strong clinical suspicion and family history of thyroid dysfunction that never needed a treatment, we tested her genetically for familial dysalbumineic hyperthyroxinemia (FDH) using mutation surveyor and fluorescent sequence analysis showed her to be heterozygous for c.725G>A ALB variant confirming diagnosis of FDH. Case 2: A 65-year-old clinically asymptomatic lady, was referred to us with Free T4 28.8 pmol/L (10.0 – 24.0 pmol/L) and TSH 2.50 mU/L (0.2 – 5.0 mu/L). Given inappropriately normal TSH levels, we repeated her TFTs using 3 different analysers, Roche cobas e801, Siemens ADIVA centaur CP and Abbot ARCHITECT i1000SR. Roche and Siemens assays yielded similar results, however Abbot assay showed normal thyroid function tests with TSH 1.01 mu/L (0.4-5.0 mu/L) and free T4 18.7pmol/L (9.0-19.0 pmol/L), confirming assay interference. As Siemens and Roche uses streptavidin-biotin immobilizing system while Abbot uses a magnetic bead-based capture system, the abnormal results could be due to biotin interference. Case 3: A 65-year-old lady, clinically asymptomatic was referred to us with Free T4 29.2 pmol/L (10.0 – 24.0 pmol/L) and TSH 1.59 mU/L (0.2 – 5.0 mu/L), 3 months after stopping amiodarone, which she took for 3 weeks for atrial fibrillation. This was thought to be due to amiodarone, owing to its long half-life of 58 days. We repeated thyroid function tests in 3 months from first clinical encounter i.e. 6 months after stopping amiodarone that showed Free T4 24.2pmol/L and TSH 2.30 mU/L and repeated further 3 months later that were normal, confirming amiodarone induced abnormal biochemical profile requiring no treatment. Conclusion: Hyperthyroxinaemia with normal TSH need to be interpreted with caution as illustrated above. Some of them do not need treatment and inappropriate interpretation can potentially cause anxiety for the patient and harm due to unnecessary treatment.
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Bottani, Michela, Aasne K. Aarsand, Giuseppe Banfi, Massimo Locatelli, Abdurrahman Coşkun, Jorge Díaz-Garzón, Pilar Fernandez-Calle, Sverre Sandberg, Ferruccio Ceriotti, and Anna Carobene. "European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates for serum thyroid biomarkers based on weekly samplings from 91 healthy participants." Clinical Chemistry and Laboratory Medicine (CCLM), February 9, 2021. http://dx.doi.org/10.1515/cclm-2020-1885.
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Abstract Objectives Thyroid biomarkers are fundamental for the diagnosis of thyroid disorders and for the monitoring and treatment of patients with these diseases. The knowledge of biological variation (BV) is important to define analytical performance specifications (APS) and reference change values (RCV). The aim of this study was to deliver BV estimates for thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3), thyroglobulin (TG), and calcitonin (CT). Methods Analyses were performed on serum samples obtained from the European Biological Variation Study population (91 healthy individuals from six European laboratories; 21–69 years) on the Roche Cobas e801 at the San Raffaele Hospital (Milan, Italy). All samples from each individual were evaluated in duplicate within a single run. The BV estimates with 95% CIs were obtained by CV-ANOVA, after analysis of variance homogeneity and outliers. Results The within-subject (CV I ) BV estimates were for TSH 17.7%, FT3 5.0%, FT4 4.8%, TG 10.3, and CT 13.0%, all significantly lower than those reported in the literature. No significant differences were observed for BV estimates between men and women. Conclusions The availability of updated, in the case of CT not previously published, BV estimates for thyroid markers based on the large scale EuBIVAS study allows for refined APS and associated RCV applicable in the diagnosis and management of thyroid and related diseases.
Dissertations / Theses on the topic "Cobas e801"
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Karlsson, Kristin. "S-Kalcidiol : En metodjämförelse mellan IDS-iSYS och Cobas E801 vid analys av S-Kalcidiol." Thesis, Linnéuniversitetet, Institutionen för kemi och biomedicin (KOB), 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-105003.
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Vitamin D är den sammanlagda koncentrationen för metaboliterna vitamin D2 och vitamin D3 och är en tillförlitlig indikator gällande vitamin D-statusen i kroppen. Den huvudsakliga källan till vitamin D är bildandet av metaboliten vitamin D3 i huden med hjälp av ultraviolett B-ljus och vitaminet har bland annat en viktig roll för skelettets utveckling. Koncentrationen kalcidiol (25(OH) vitamin D) kan bestämmas till exempel med hjälp av elektrokemiluminiscens med kompetitiv inbindning. Mätprincipen har flera likheter med kemiluminiscens med den huvudsakliga skillnaden att elektrisk spänning används för att starta reaktionen. När en analys ska flyttas från ett instrument till ett annat är det viktigt att verifiera att de är överensstämmande gällande bland annat precision. Syftet med projektet var att genomföra en metodjämförelse för analys av kalcidiol i serum (S-Kalcidiol) mellan instrumenten IDS-iSYS och Cobas E801 samt att genomföra en jämförelse av kontroller från företagen Roche Diagnostics och ThermoFisher Scientific och utifrån de erhållna resultaten avgöra vilka som var mest lämpliga att använda vid analys med Cobas E801. Kontrollerna från Roche Diagnostics är optimerade för analysen, men det vore fördelaktigt att kunna använda kontrollerna från ThermoFisher Scientific eftersom de även kan användas för flera andra analyser. Metodjämförelsen gjordes med hjälp av en inomserie- och totalimprecisionsstudie med en låg och en hög kontrollnivå från företagen Roche Diagnostics och ThermoFisher Scientific samt en korrelationsstudie med 20 stycken patientprover bestående av serum. Inomserie- och totalimprecisionen resulterade i att Cobas E801 hade likvärdig precision med IDS-iSYS. Gällande kontrollerna var endast kontrollerna från Roche Diagnostics inom acceptansintervallen och är därmed lämpligast att använda. Korrelationsstudien resulterade i determinationskoefficienten 0,942, vilket tyder på ett tydligt linjärt samband. Studien visar dock att Cobas E801 har en större spridning när koncentrationen kalcidiol överstiger 50 nmol/L. Utifrån de erhållna resultaten kan en flytt av analysen från IDS-iSYS till Cobas E801 genomföras för att effektivisera arbetsflödet.
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Hoberg, Emilia. "Metodverifiering av reagens med förhöjt tröskelvärde för biotininterferens för biomarkörerna NT-proBNP, prokalcitonin och prostataspecifikt antigen på Roche Cobas® e801." Thesis, Linnéuniversitetet, Institutionen för kemi och biomedicin (KOB), 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-96861.
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Biotin är ett vitamin som finns naturligt i livsmedel och det dagliga intaget nås via födan. Höga doser biotintillskott samt höga doser biotin i läkemedel, kan leda till biotininterferens i kliniska immunokemiska analyser. Roche Diagnostics® vill införa nya reagens med högre tröskel för biotininterferens för att minska risken för biotininterferens vid analys av patientplasma. Därför var syftet med studien att metodverifiera fyra nya reagens från Roche Diagnostics® som används vid diagnostisering och behandling av hjärtsvikt, sepsis, och prostatacancer. De fyra reagensen, Elecsys® proBNP II, Elecsys® BRAHMS PCT, Elecsys® total PSA samt Elecsys® free PSA metodverifierades för att användas på Cobas® e801. Studiematerialet bestod av 20 patientprover av litiumheparinplasma per reagens (totalt 80 patientprover). Resultatet av verifieringen av Elecsys® proBNP II visade en korrelation till det befintliga reagenset på r = 0,9998 och Bland-Altman analys visade en spridning av resultaten på < 10 %; inomserieprecisionsstudien gav CV 1,56 %. Elecsys® BRAHMS PCT hade en korrelation på r = 0,9997 och Bland-Altman analysen visade en spridning på > 10 %; inomserieprecisionsstudien gav CV 1,70 %. För Elecsys® total PSA och free PSA fanns korrelationen till det befintliga reagenset på r = 1 respektive 0,9997 och Bland- Altman analysen visade en spridning på < 10 % hos båda reagensen. Inomserieprecisionsstudien gav CV 0,44 % respektive CV 2,67 %. Resultaten för samtliga reagens uppvisar god korrelation till det befintliga reagenset och en hög mätnoggrannhet vilket talar för att de fyra nya reagensen kan tas i bruk.Biotin is naturally found in foods, and we obtain this vitamin through our daily diet. Biotin supplements as well as high doses of biotin in drugs can lead to biotin interference in clinical immunochemical analyzes. Therefore, the purpose of this study was to methodically verify four new reagents from Roche Diagnostics® with a higher threshold for biotin interference, used in the diagnosis and treatment of heart faliure, sepsis and prostate cancer. The four reagents, Elecsys® proBNP II, Elecsys® BRAHMS PCT, Elecsys® total PSA and Elecsys® free PSA were method-verified for use on Cobas® e801. The study material consisted of 20 patient samples of lithium heparin plasma per reagent. In total 80 samples were analyzed.The result of the verification of Elecsys® proBNP II showed a correlation to the existing reagent of r = 0.9998 and Bland-Altman analysis showed a distribution of the results of <10 %. The withinseries precision study yielded CV 1.56 %. Elecsys® BRAHMS PCT had a correlation of r = 0.9997 and the Bland-Altman analysis showed a distribution of > 10 %. The withinseries precision study gave CV 1.70 %. For Elecsys® total PSA and free PSA, the correlation to the existing reagent was r = 1 and 0.9997, respectively, and the Bland-Altman analysis showed a distribution of <10 % in both reagents. The withinseries precision study yielded CV 0.44 % and CV 2.67 % respectively.The results for all reagents show a good correlation to the existing reagent and a high accuracy of measurement, which indicates that the four new reagents can be used.