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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.
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Ferraro, Simona, Marco Bussetti, Sara Rizzardi, Federica Braga, and Mauro Panteghini. "Verification of Harmonization of Serum Total and Free Prostate-Specific Antigen (PSA) Measurements and Implications for Medical Decisions." Clinical Chemistry, December 2, 2020. http://dx.doi.org/10.1093/clinchem/hvaa268.
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Abstract Background Previous studies have shown that the harmonization of prostate-specific antigen (PSA) assays remained limited even after the introduction of WHO International Standards. This information needs updating for current measuring systems (MS) and reevaluation according to established analytical performance specifications (APS) and the characteristics of antibodies used. Methods Total (tPSA) and free (fPSA) PSA were measured in 135 and 137 native serum samples, respectively, by Abbott Alinity i, Beckman Access Dxl, Roche Cobas e801, and Siemens Atellica IM MSs. Passing–Bablok regression and difference plots were used to compare results from each MS to the all-method median values. Agreement among methods was evaluated against APS for bias derived from biological variation of the 2 measurands. Results The median interassay CV for tPSA MSs (11.5%; 25–75th percentiles, 9.2–13.4) fulfilled the minimum APS goal for intermethod bias (15.9%), while the interassay CV for fPSA did not [20.4% (25–75th percentiles, 18.4–22.7) vs goal 17.6%]. Considering the all-method median value of each sample as reference, all tPSA MSs exhibited a mean percentage bias within the minimum goal. On the other hand, Alinity (+21.3%) and Access (−24.2%) were out of the minimum bias goal for fPSA, the disagreement explained only in minimal part by the heterogeneity of employed antibodies. Conclusions The harmonization among tPSA MSs is acceptable only when minimum APS are applied and necessitates further improvement. The marked disagreement among fPSA MSs questions the use of fPSA as a second-level test for biopsy referral.
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Carobene, Anna, Aasne K. Aarsand, William A. Bartlett, Abdurrahman Coskun, Jorge Diaz-Garzon, Pilar Fernandez-Calle, Elena Guerra, et al. "The European Biological Variation Study (EuBIVAS): a summary report." Clinical Chemistry and Laboratory Medicine (CCLM), May 31, 2021. http://dx.doi.org/10.1515/cclm-2021-0370.
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Abstract Biological variation (BV) data have many important applications in laboratory medicine. Concerns about quality of published BV data led the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) 1st Strategic Conference to indicate need for new studies to generate BV estimates of required quality. In response, the EFLM Working Group on BV delivered the multicenter European Biological Variation Study (EuBIVAS). This review summarises the EuBIVAS and its outcomes. Serum/plasma samples were taken from 91 ostensibly healthy individuals for 10 consecutive weeks at 6 European centres. Analysis was performed by Siemens ADVIA 2400 (clinical chemistry), Cobas Roche 8000, c702 and e801 (proteins and tumor markers/hormones respectively), ACL Top 750 (coagulation parameters), and IDS iSYS or DiaSorin Liaison (bone biomarkers). A strict preanalytical and analytical protocol was applied. To determine BV estimates with 95% CI, CV-ANOVA after analysis of outliers, homogeneity and trend analysis or a Bayesian model was applied. EuBIVAS has so far delivered BV estimates for 80 different measurands. Estimates for 10 measurands (Non-HDL Cholesterol, S100-β protein, neuron-specific enolase, soluble transferrin receptor, intact fibroblast growth-factor-23, uncarboxylated-unphosphorylated matrix-Gla protein, human epididymis protein-4, free, conjugated and %free prostate-specific antigen), prior to EuBIVAS, have not been available. BV data for creatinine and troponin I were obtained using two analytical methods in each case. The EuBIVAS has delivered high-quality BV data for a wide range of measurands. The BV estimates are for many measurands lower than those previously reported, having an impact on the derived analytical performance specifications and reference change values.
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Oakey, Jane, Shonagh Haslam, Andrew Peter Brown, Janet Eglin, Brittany Houghton, and Dawn Singleton. "EXPRESS: Comparison of four high throughput, automated immunoassays for the detection of SARS-CoV-2 antibodies." Annals of Clinical Biochemistry: International Journal of Laboratory Medicine, April 23, 2021, 000456322110157. http://dx.doi.org/10.1177/00045632211015711.
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Background: A number of immunoassays have been developed to measure antibodies specific to SARS-CoV-2. More data is required on their comparability, particularly amongst those with milder infections and in the general practice population. The aim of this study was to compare four high throughput automated anti SARS-CoV-2 assays using samples collected from hospitalised patients and healthcare workers with confirmed SARS-CoV-2 infection. In addition, we collected general practice samples to compare antibody results and determine seroprevalence. Methods: Samples were collected from 57 hospitalised patients and 9 healthcare workers at 14 days and at 28 days following confirmed SARS-CoV-2 infection. Samples were also collected from 225 patients presenting to general practice. Four assays were used: Abbott Architect IgG, Beckman Coulter DxI 800 IgG, Roche Cobas e801 total antibody and Siemens Advia Centaur XPT total antibody. Results: All 4 assays showed concordance at 14 days in 83.9% of hospitalised patients and in 66.7% of healthcare workers. All 4 assays showed concordance at 28 days in 88.4% of hospitalised patients and 77.8% of healthcare workers. The sensitivity to detect recent infection was higher for the IgG assays than the total assays. All 4 assays showed concordance of 95.1% in the general practice population. Seroprevalence ranged from 4.9-5.8% depending on the assay used. Conclusions: All 4 assays showed excellent comparability but it may be possible to obtain a negative result for any of the anti SARS-CoV-2 assays in patients with confirmed previous SARS-CoV-2 infection. An equivocal range would be useful for all anti SARS-CoV-2 assays.
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Kang, Seok-Jin, and Ga-Hyun Lee. "SAT-453 Delayed TSH Elevation in Small for Gestational Age Infants: A Need for Second Screening?" Journal of the Endocrine Society 4, Supplement_1 (April 2020). http://dx.doi.org/10.1210/jendso/bvaa046.1012.
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Abstract The incidence of CH with a delayed TSH elevation was higher in ELBW and VLBW infants compared with infants weighing ≥1500 grams. Second screening should be considered in preterm neonates, low birth weight (LBW) and very low-birth weight (VLBW) neonates, ill and preterm newborns admitted to NICU, specimen collection within the first 24 hours of life, and multiple births (particularly same-sex twins). Purpose of this study was to determine incidence of delayed TSH elevation with or without congenital hypothyroidism in SGA infants and to Investigate necessity for second screening. Retrospective analysis was performed. 66 SGA newborns with 34-40 weeks’ gestation born at Keimyung University Dongsan Medical Center from 2015 to 2018 were enrolled. Primary screening was performed 48 hours - 7 days after birth. Second screening including venous TSH and venous free T4 at postnatal 8-40 days. Exclusion criteria were infants with congenital hypothyroidism at primary screening (NBS), descendants of mothers with immune thyroid disease, congenital malformations, renal, hepatic, and metabolic diseases, history of steroid or dopamine usage. Initial NBS were collected onto pre-printed filter at the age of 2-7 days by heel prick. (normal TSH < 10 mIU/L). Second sample was obtained at the age of 8-49 days by venous sampling (normal TSH < 5 mIU/L). TSH and free T4 were measured on venous samples with Cobas 8000 e801 (electrochemiluminescence, Roche, Diagnostics, Basel, Switzerland) using standard methods. Incidence of delayed TSH elevation was 27% (18/66). Of them number of transient hyperthyrotropinemia was 13. Mean TSH at initial elevation was 7.56 mIU/L and median age at initial TSH elevation was 18.6 days. Median age at resolution of TSH elevation was 41.5 days. Number of hypothyroidism undergoing l-thyroxine medication was 5. Mean TSH at initial elevation was 22.1 mIU/L. Median age at initial TSH elevation was 14 days. Mean peak TSH was 23.4 mIU/L. The presence of delayed TSH elevation was not related to very low birth weight. SGA infants might be at a risk of delayed TSH elevation. Considering 2nd screening test within 1 month. Further study with more SGA infants are needed. Limitation of this study was relative small number of patients and iodine status was not considered
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Maidana, Patricia Nieves Amelia, Nancy Bravo Briones, Vanesa Aparicio, Delfina Ronconi, Juan Manuel Bonomo, Dario Jacobsen, Natalia Pasqualini, Lucia Singh, Viviana Mesch, and Liliana Maggi. "SAT-002 Does the Age of Women Influence the Evaluation of Ovarian Reserve Through the Determination of Antimullerian Hormone and Follicle Count?" Journal of the Endocrine Society 4, Supplement_1 (April 2020). http://dx.doi.org/10.1210/jendso/bvaa046.1362.
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Abstract INTRODUCTION: Oocyte number and quality are known to decline with age. However, fertility varies significantly even among women of the same age. Given that maternal age has been delayed in recent years, an ovarian biomarker that could reflect follicular activity with precision and accuracy is needed in reproductive medicine. In recent years, two key methods, the concentration of serum antimüllerian hormone (AMH), which reflects the number of small antral follicles and is predictive of ovarian response, and antral follicle count (AFC) performed by ultrasonography, have emerged as preferred methods for assessing ovarian reserve. AIM: To assess the influence of women’s age in the association between AMH serum level and antral follicle count by ultrasonography in the evaluation of ovarian reserve SUBJECTS AND METHODS: 49 women between 25 and 45 years old who attended our laboratory with request for AMH and transvaginal ultrasound in early follicular phase were included in the study. In all of them serum AMH was tested using an electrochemiluminescence immunoassay (ECLIA) on a Roche Diagnostic Cobas e801 analyzer. Transvaginal ultrasonography follicle count was performed in both ovaries by Philips affinity 70 on first days of the menstrual cycle. Statistical analysis was performed through SPSS 23 software. RESULTS: Median and ranges of the variables are the following: AMH: 0.78 (<0.03-9.98) ng/ml and AFC: 6 (1.0-60.0) follicles. AMH and AFC were negatively associated with age (r: -0.302, p< 0.01; r: -0.267 p<0.01, respectively). AMH showed a positive correlation with AFC (r=0.567,p<0.01). We then divided the study population in two subgroups, according to age: Group 1, women <40 years old(n=28) and Group 2, women ≥40 years old (n=21).Considering AMH= 1ng/ml and AFC = 7, the cut-off value used routinely in our institution, we calculated the Kappa coefficient in each group to test the degree of agreement between these two variables, with the following results: Group 1, Kappa= 0.4510, CI 95% [0.1566 – 0.7453], p= 0.0088; Group 2, Kappa= -0.0370, CI 95% [-0.4371 – 0.3630], p=ns. CONCLUSION: despite the positive correlation found between AMH levels and AFC in the whole group, Kappa values show that in women younger than 40 years serum AMH>1 ng/ml is a good predictor of AFC >7, but this agreement is lost in women above this age, with the cut-off values used in this study. These results must be confirmed with a larger group of women.
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Taira, Takayasu. "MO827ASSESSMENT OF SARS-COV-2 ANTIBODIES IN PATIENTS ON HEMODIALYSIS." Nephrology Dialysis Transplantation 36, Supplement_1 (May 1, 2021). http://dx.doi.org/10.1093/ndt/gfab098.0019.
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Abstract Background and Aims Strategies to minimize the risk of transmission of coronavirus disease 2019 (COVID-19) infection in hemodialysis (HD) patients have been rapidly implemented worldwide (Nature 16: 311, 2020). Serological testing of 356 HD patients revealed that 129 (36.2%) patients were positive for SARS-CoV-2 antibodies. Out of these 129 patients, 52 (40.3%) patients were asymptomatic (JASN 31:1969, 2020). In this study, we investigated the seroprevalence of SARS-CoV-2 antibodies in HD patients who were managed per Japanese Society for Dialysis-Therapy guidelines in the context of COVID-19. Method Study (1): A total of, 55 patients that underwent HD (41 males, 14 females; mean age: 66.3±12.8 years, HD duration: 72.2±68.4 months) between August 1 and December 14, 2020, were included. We measured SARS-CoV-2 antibodies with a fully automated cobas e801 analyzer using an Elecsys® Anti-SARS-CoV-2 electrochemiluminescence immunoassay (Roche Diagnostics) to qualitatively detect SARS-CoV-2 antibodies in human plasma. The Elecsys® assay uses a modified double-antigen sandwich immunoassay with recombinant nucleocapsid protein (N), which is geared towards the detection of late, mature, high-affinity antibodies independent of the subclass. Study (2): We tested the plasma of 8,982 adult with normal renal function for SARS-CoV-2 antibodies between July 1 and November 18, 2020. Results Study (1): Using serological testing, only 2 out of 55 (3.64%) HD patients tested positive for SARS-CoV-2 antibodies. In total 54 patients were asymptomatic during the study period and did not have a polymerase chain reaction (PCR) test. Only 1 out of the 54 (1.85%) patients that were asymptomatic had SARS-CoV-2 antibodies. Case 1 was an 89-year-old, male who had undergone HD for 53 months because of end stage kidney disease (ESKD) secondary to diabetic nephropathy. His blood type was O Rh (+). This patient tested positive for SARS-CoV-2 antibodies on August 11, 2020. Serological testing showed that this patient had an asymptomatic disease. Case 2 was a 74-year-old, male that had undergone HD for 62 months due to ESKD secondary to diabetic nephropathy. He was hospitalized because of bradycardia-tachycardia syndrome on November 14, 2020. On that day, his PCR test was negative. He underwent surgery to insert a cardiac pacemaker on November 18, and had a fever (37.7°C) on November 24. A chest CT scan revealed that he had bilateral lung pneumonia. On that day, his PCR test was positive. Blood tests showed that his white blood cell count was 4300/μL (lymphocyte 30.4%), and C-reactive protein (CRP) levels was 2.8 mg/dL. He was not treated with antiviral medication, the PCR test was repeated and was positive on December 4,7, and 9. However, his PCR test was negative on December 13. This patient tested positive for SARS-CoV-2 antibodies on December 14. He recovered from a COVID-19 infection 21 days after the onset of the disease. Study (2): Using serological testing, 47 out of 8,982 (0.52%) adults tested positive for SARS-CoV-2 antibodies. In Japan, the population of Kanagawa prefecture is 9,216,009. The number of PCR-confirmed patients with COVID-19 infection was 13,340 (0.14%) on December 6, 2020. The estimated number of asymptomatic SARS-CoV-2 infection was 47,923 (0.52%). The total estimated number of patients with COVID-19 infection was 61,263. In study 1, more than 90% of HD patients wear face masks, wash their hands, and maintain social distance of 2 m in dialysis facilities. Almost all patients avoided the three Cs (closed spaces with poor ventilation, crowded places with nearby people, close-contact settings, such as close-range conversations). Conclusion We found that Japanese patients on HD had a lower prevalence of SARS-CoV-2 antibodies compared to those in the United Kingdom. Serological testing identified HD patients with asymptomatic disease. Avoiding the ‘three Cs’ is very important in minimizing the risk of COVID-19 among HD patients.