siemens atellica chemiluminescent methodology

Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Atellica IM High-Sensitivity Troponin I (TnIH) G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Clinical Chemistry (75) The Atellica® Solution is designed to address common clinical laboratory challenges. Automated assays are less QTMD008.1 (Alinity 114 Abbott)- Điện hóa phát quang Roche Cobas 8000, ECLIA ElectroChemiluminescent Immunoassay, Roche Cobas 8000: QTMD008.3 (Roche cobas e801) 9. Methodology: Siemens Atellica IM BR 27.29 (BR) chemiluminescent immunoassay was used. The Atellica IM Total β-hCG (ThCG) assay is a chemiluminescent immunoassay previously cleared for use on the Ciba-Corning ACS system in k925277. Method comparison of Atellica IM TSH3-UL Assay vs. ADVIA Centaur Assay. Siemens Healthcare Laboratory Diagnostics offers laboratories fully automated immunoassay platforms and a comprehensive, disease-focused menu in excess of 100 tests. Ascend Clinical Reference Ranges (May 2019) Tests Units Reference Ranges Methodology Instruments 0.89 - 1.76 Hypothyroid: < 0.89 Hyperthyroid: > 1.76 T4, Total (Thyroxine) ug/dL 4.5 - 10.9 Chemiluminescence Siemens Atellica IM-1600 1. The Atellica® IM SARS-CoV-2 IgG (sCOVG) assay is a chemiluminescent immunoassay intended -quantitative detection of IgG antibodies to SARS -CoV-2 in human serum and plasma (lithium heparin) using . chemiluminescent immunoassay: . The Atellica™ IM 1300 Analyzer (mid-volume) and the Atellica™ IM 1600 Analyzer (highvolume) have the same footprint and utilize the proven acridinium ester (AE) technology. Biomerieux. Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 Total (COV2T) 05/29/2020: Total Antibody, CLIA, Semi-quantitative H, M: HCP, Recipients, IFU: Viral Mutation Revision Letter (September . One test produced a test result of 6.8 ng/mL and the other test produced a result of 5.8 ng/mL. Intended Use The ADVIA Centaur® SARS-CoV-2 IgG (COV2G) assay is a chemiluminescent immunoassay intended for qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in Experience the power of the Atellica® Solution—engineered to deliver control and simplicity so you can drive better outcomes. The Atellica IM System instrument was previously cleared as the Trinidad IM instrument under k151792; the new name of the system is the Atellica IM Analyzer. The cut-off indices for each positive immunoassay were 1.4, 1.0, and 1.0, respectively. 1. 0 20 40 60 80 100 120 140 0 20 40 60 80 100 120 140 Atellica IM g Assay (ngmL) ecman ASS 2 g assay (ngmL) Passing & Bablok Fit Slope: 1.26 int: -0.145 ng/mL R: 0.983: 126 Range: .080-119 ng/mL . The Atellica® IM SARS-CoV-2 IgG (sCOVG) assay is a chemiluminescent immunoassay intended -quantitative detection of IgG antibodies to SARS -CoV-2 in human serum and plasma (lithium heparin) using . The assay utilizes an acridinium ester-labeled This test uses the Siemens' Atellica® IM cPSA methodology, which is FDA approved for use as an aid in the detection of prostate cancer in men age 50 and older when used in conjunction with a digital rectal exam. 11206711, Munich, Germany) 16 is an automated 1-step antigen chemiluminescent sandwich immunoassay for total antibodies, and the COV2G (Siemens Healthineers nr. The most comprehensive information guide on Atellica IM aTG - SIEMENS HEALTHCARE DIAGNOSTICS INC including impacted physicians & ROI, Business Case, HEOR & VAC Business & Quality Metrics . Passing-Bablok regression and Bland-Altman analyses comparing the Atellica IM 1600 eE2 and Advia Centaur XP eE2 assays. Methods: The Atellica IM sCOVG Assay is a fully automated two-step sandwich immunoassay using indirect chemiluminescent . White paper The Atellica IM BRAHMS PCT Assay is a two-site sandwich immunoassay that employs direct chemiluminescent technology and uses three mouse monoclonal antibodies specific for PCT. It will replace the Troponin I assay (CTNI) currently being performed on the Siemens Vista platform. It performs the extraction, amplification and detection in a closed system, which enable simultaneous testing for bacteria, viruses, yeast, parasites and/or antimicrobial resistant genes. The Atellica® IM High‑Sensitivity Troponin I (TnIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) using the Atellica® IM . The Atellica IM AB12 assay is a fully automated, 2-step sandwich immunoassay using direct chemiluminescent technology. Company Name: Siemens Healthcare Diagnostics Inc. Results obtained with different assay methods or kits cannot be used interchangeably. Results obtained with different assay methods or kits cannot be used interchangeably. You are about to report this post for review by an Inspire staff member. is considered the most accurate method for determining the concentration of 25(OH)D; however, this method is laborious and requires specialized training for laboratory operators. Atellica Solution Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer Atellica Solution Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer . Date Prepared: October 30, 2019 . For higher-volume clinical laboratories, automated chemiluminescent assays have taken the place of the more-manual methods. Test principle The Atellica IM sCOVG assay is a fully automated 2‑step-sandwich immunoassay using acridinium-ester chemiluminescent technology. Experience the power of the Atellica Solution! The objective of this paper was to perform a performance comparison of eight commercial assays of which five use automated instruments with CLIA or ELFA technology (Abbott Architect, DiaSorin Liaison®, bioMérieux Vidas®, Roche Elecsys Cobas®, and Siemens Atellica®), and three are microplate ELISA (BioRad Platelia, Epitope Diagnostics EDI . (A.1) E2 whole range concentration Passing-Bablok . It is a syndromic testing system for a variety of pathogens associated with key healthcare concerns. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen using a chemiluminescent . using a chemiluminescent immunoassay method. The Atellica® Solution is designed to address common clinical laboratory challenges. Experience the power of the Atellica Solution! Atellica IM aTG - Sterilization. Atellica ® IM Total . The area under the curves of the anti-HCV signal to cutoff (S/Co) ratios or cutoff index for predicting viremia in the Roche, Siemens, and Abbott systems were 0.432, 0.641, and 0.676, respectively . - Hóa phát quang Siemens Atellica, CLIA Chemiluminescent Immunoassay, Siemens Atellica. AccessGUDID - Atellica IM TSTII (00630414600222)- Testoterone II (TSTII) Atellica IM - RGT 100T The Atellica IM VB12 assay is a competitive immunoassay using direct chemiluminescent technology in which vitamin B 12 from the patient sample competes with vitamin B 12 labeled with acridinium ester in the Lite Reagent, for a limited amount of purified intrinsic factor, Chemiluminescent Immunoassay. Issuing Agency: GS1. Both assays target . The COV2T test (Siemens Healthineers nr. Method comparison study The Atellica IM Tg Assay demonstrated acceptable correlation r = 0.983 to the Beckman ACCESS 2 Thyroglobulin assay. CLSI EP09-A3: Method comparison and bias estimation using patient samples; Approved Guideline- Third Edition L. Test Principle: The Atellica IM Fer assay is a 2-site sandwich immunoassay using direct chemiluminescent detection technology, which uses constant amounts of two anti-ferritin antibodies. Test results are available in 10 minutes. Commercial Distribution Status: In Commercial Distribution. Hcv: chemiluminescent enzyme immunoassay for the qualitative detection of IgG antibodies to HCV. Atellica IM Fol DTT/Releasing Agent is stable onboard the system for 108 hours. Cardiac Marker. It is a magnetic latex particle chemiluminescent immunoassay for the in-vitro quantitative determination of troponin I in serum and plasma samples. 11206997) 17 is an automated 2-step chemiluminescent sandwich immunoassay for IgG antibodies against the SARS-CoV-2 virus. Atellica-IM SARS-CoV-2 Total (COV2T) assay is intended for the detection of total antibodies to SARS-CoV-2 in human serum and plasma. Hemoglobin A1c (A1c_3) Calibrator Atellica CH - CAL 4 x 2 x 0.5mL. GMDN Definition. Detection Method Chemiluminescent Microparticle Immunoassay (CMIA), where a Immunoassay analyzer with chemiluminescence testing methodology using advanced acridinium ester technology. Features. When all competencies are checked, participant signs and dates below as record of completion. Test Name. E-mail: mey.vasquez@siemens-healthineers.com. Introduction. Experience the power of the Atellica Solution! Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA . . PSA complexed with alpha-1-antichymotrypsin (ACT) comprises a higher proportion of PSA in men with prostate cancer 6-8 It is recommended as a frontline detection test It is used in conjunction with a digital rectal examination (DRE) 2. Results obtained with different assay methods or kits cannot be used interchangeably. Contact: Mey Lyn Vasquez . The Atellica® IM SARS-CoV-2 Total (COV2T) assay is a chemiluminescent immunoassay intended for the qualitative and semi-quantitative detection of total antibodies (including IgG and IgM) to. The Atellica IM TSH3-UL Assay is a third-generation assay that uses proven advanced chemiluminescent Acridinium Ester technology. The sensitivities and positive predictive values were 86.5 and 89.8 for Roche, 97.5 and 98.1 for Siemens, and 99.4 and 98.2 for Abbott, respectively. The Solid Phase contains a preformed complex of streptavidin- coated microparticles and biotinylated SARS-CoV-2 recombinant antigens. Device IDs: 00630414597300 ( Primary) 00630414211534 ( Unit of Use) Catalog Number: 11099328. Reagent Atellica® IM Reproductive Endocrinology Assay Testosterone 2 For Atellica IM Analyzer 100 Tests 20 µL Sample Volume Siemens 10995708 This new assay is defined as high sensitivity based on the criteria set forth by the International Federation of Clinical Chemistry (IFCC) Task Force on Clinical Applications of Cardiac Bio-Markers: UNSPSC Code. On the same day a lab conducted two PSA tests on blood drawn at the same time. Siemens Healthcare Diagnostics Inc.-IgG-serum/plasma -chemiluminescent immunoassay-direct relationship between the amount of SARS-CoV-2 IgG antibody present and the amount of relative light units (RLUs) detected by the system-Results in 40 minutes: 100% (42/42) 99.89% (1829/1831) Semi-quantatative: Atellica® IM SARS-CoV-2 IgG (COV2G) a Cardiovascular disease is the leading cause of mortality of both men and women in the United States (US) and worldwide [].Biomarkers are the keystone for making the diagnosis of acute myocardial infarction (AMI), and cardiac troponin (cTn) is the preferred biomarker for aiding in the AMI diagnosis in patients presenting to the emergency department (ED) with signs and symptoms . GMDN Preferred Term Name GMDN Definition; Chemiluminescent immunoassay analyser IVD, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent . Regulatory Clinical Affairs Specialist Phone: (914) 524-2458 . The Siemens Healthineers SARS-CoV-2 antibody assays detect antibodies to the S1 RBD antigen. The test employs two recombinant HCV antigens of NS3, NS4, NS5 regions (c200 and NS5) and a synthetic peptide of the core (c22). 11206997) 17 is an automated 2-step chemiluminescent sandwich immunoassay for IgG antibodies against the SARS-CoV-2 virus. Results obtained with different assay methods or kits cannot be used interchangeably. Each of the three tests was performed according to the principle of chemiluminescent microparticle immunoassay (CMIA) and chemiluminescence immunoassay (CLIA), and the target site was the nucleocapsid for Alinity and spike for Access and Atellica. the new Siemens Atellica platform. Định lượng Ferritin Determination of Ferritin using a chemiluminescent immunoassay method. Test Type. The Atellica® IM SARS-CoV-2 IgG (COV2G) assay is a chemiluminescent immunoassay intended for qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma. Company Name: Siemens Healthcare Diagnostics Inc. Primary DI Number: 00630414599694. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen, using a chemiluminescent immunoassay method. The Solid Phase contains a preformed complex of streptavidin-coated microparticles and biotinylated SARS-CoV-2 recombinant antigens. Method: UniCel DxI 800: Cobas c701: Atellica IM: Alinity i: Vitros XT 7600: Manufacturer: Beckman Coulter: Roche Diagnostics: Siemens Healthineers: Abbott Diagnostics: Ortho Clinical Diagnostics: Analytical principle: Chemiluminescent, two-site immuno-enzymatic immunoassay: Immuno-turbidimetric assay: Immuno-chemiluminometric assay . The first antibody, Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) in a clinical specimen, using a chemiluminescent immunoassay method. Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: . Methodology: Siemens Atellica IM BR 27.29 (BR) chemiluminescent immunoassay was used. Atellica™ IM ThCG - GMDN. Results obtained with different assay methods or kits cannot be used interchangeably. Siemens Healthcare GmbH. Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Atellica IM High-Sensitivity Troponin I (TnIH) G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Clinical Chemistry (75) The COV2T test (Siemens Healthineers nr. Hep C Virus Ab N/A Non-Reactive Chemiluminescent Sandwich Immunoassay Siemens Atellica IM-1600 HIV 1,2 Ab and p24 Ag N/A Non-Reactive Chemiluminescent Sandwich Immunoassay Siemens Atellica IM-1600 SARS-CoV-2 Ab, Total N/A Non-Reactive Chemiluminescent Sandwich Immunoassay Siemens Atellica IM-1600 Non-Reactive Index: 0.50 - 0.99 Atellica IM High-Sensitivity Troponin I Assay Performance Evaluation of the Atellica IM High-Sensitivity Troponin I Assay Payne R, Zhang H, Halik L, Conklin J, Valdivia B, Chase A, DiPasquale C, Lu F, Balderson J, Gorman R, Lei J, Mindicino H, Conarpe C, Anostario M, Plouffe B, Freeman J. Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA. . Methodology: Siemens Atellica IM BR 27.29 (BR) chemiluminescent immunoassay was used. The most comprehensive information guide on Atellica IM aTG - SIEMENS HEALTHCARE DIAGNOSTICS INC including impacted physicians & ROI, Business Case, HEOR & VAC Business & Quality Metrics . Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become a pandemic and presents a major health concern across the globe [1,2].Accurate antibody measurements support uncertain identification or evaluation in the case of resolved infection and can be useful for contact tracing and epidemiologic studies [3,4,5,6]. Method comparison. Brand Name: Atellica IM PCT. The assay is an antigen sandwich immunoassay using acridinium ester chemiluminescent . Trade Name . The chemiluminescent reaction is directly proportional to the amount of anti-HCV present in the sample. The Atellica® IM Analyzer from Siemens Healthcare Diagnostics is a new automated, high through-put immunoassay (IM) analyzer. The first For more details. Results obtained with different assay methods or kits cannot be used interchangeably. Note Refer to the supplementary document "Atellica Sample Handler Calibrator and QC Storage and Stability" for information about storage and stability of materials in the Cal‑QC tube storage area. Technical Specifications Product Specifications Description Immunoassay analyzer with chemiluminescence testing methodology using advanced acridinium ester technology Test Throughput Atellica IM 1300 Analyzer: up to 220 tests per hour;* Atellica IM 1600 Analyzer: up to 440 tests per hour* Walkaway Time Atellica IM 1300 Analyzer: up to 7.5 hours; Atellica IM 1600 Analyzer: up to 5 hours Commercial Distribution End Date: NA. 41116004. The Atellica® Solution is designed to address common clinical laboratory challenges. Atellica IM Fol DIL is stable onboard the system for 28 days. 11206711, Munich, Germany) 16 is an automated 1-step antigen chemiluminescent sandwich immunoassay for total antibodies, and the COV2G (Siemens Healthineers nr. Laboratory Measurements. It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-managementtechnology so you can focus on driving better outcomes. The assay is listed as CE marked. Hepatitis C virus total antibody IVD, kit, chemiluminescent assay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen, using a chemiluminescent immunoassay method. Method comparison. . The Babson Diagnostics aC19G1 test is an indirect sandwich chemiluminescent immunoassay performed on the Atellica IM Analyzer intended for the qualitative detection of IgG antibodies to SARS-CoV-2 . It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-management technology so you can focus on driving better outcomes. Reagent Kit Atellica® IM Cancer CA 15-3 For Atellica IM Analyzer 500 Tests Siemens 10995486 Evaluation of Siemens Atellica-IM SARS-CoV-2 Total (COV2T) for detection of Anti-SARS-CoV-2 antibodies 6 . Atellica IM aTG - Sterilization. Commercial Distribution Status: In Commercial Distribution. This methodology is also approved as an aid in the management/monitoring of prostate cancer patients. To obtain a substantial equivalence determination for the Atellica IM B.R.A.H.M.S PCT, . Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay. The Atellica IM COV2T assay is a fully automated 1‑step antigen sandwich immunoassay using acridinium ester chemiluminescent technology, in which antigens are bridged by antibodies present in the patient sample. Fax: (914) 524-3579 . Serum, plasma, amniotic fluid, urine, whole blood (assay . Version or Model: 11099328. High-Sensitivity Troponin I. Device Description: Procalcitonin (PCT) Atellica IM - RGT 100T. Device Count: 1. Both the Siemens Healthineers Atellica® IM* and the ADVIA Centaur®* SARS-CoV-2 IgG (sCOVG) assays measure IgG antibodies to SARS-CoV-2 in the blood to help clinicians assess the level of an individual's immune response over time. This A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of gastrointestinal and pancreatic cancer antigen 19-9 (CA19-9) in a clinical specimen, using a chemiluminescent immunoassay method. Regulatory Information . Use this form if there's a problem with the post - for example if you think a community guideline is being broken. Atellica Solution 1-5 Atellica Solution Advanced Operator Training Course Validation Checklist The participant places a checkmark beside the competency when it is completed. The Atellica® IM SARS-CoV-2 IgG (sCOVG) Assay* is for in vitro diagnostic use in the qualitative and quantitative detection of IgG antibodies, including neutralizing antibodies, to SARS-CoV-2 in human serum and plasma. Reagent Advia Centaur® Antibody Test SARS-CoV-2 IgG For ADVIA Centaur XP / XPT / CP Immunoassay Systems 500 Tests 40 µL Sample Volume Siemens 11207377 Both assays target the S1-RBD. One test was the Beckman Coulter immunoassay method and the other test was the Siemens chemiluminescent method. It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-management technology so you can focus on driving better outcomes. GMDN Terms: This is not the reply form Click here to reply. Psa testing Roche ECLIA methodology vs Siemens chemiluminescent method. Introduction . The Atellica IM PTH assay is a 2-site sandwich immunoassay using direct chemiluminescent technology, which uses constant amounts of 2 anti-human PTH antibodies. S1 RBD antibodies are relevant to vaccines incorporating this immunodominant region with the goal to elicit neutralizing (and therefore likely protective) antibodies in vaccinated subjects. Atellica IM aHCV (Siemens) Alinity s Anti-HCV (Abbott) Principle: ECLIA: CLIA: CMIA: Chemiluminescent reagent: Ruthenium: Acridinium: Acridinium: Target antigens: Recombinant antigens and synthetic peptides, labeled core, NS3 and NS4 antigens: Recombinant HCV-encoded (c200 and NS5) antigens and 1 synthetic HCV-encoded core (c22) peptide 2.10 The Atellica test is designed to be used in a laboratory with the Siemens Atellica IM analyser. The Siemens proprietary Complexed PSA is an alternative to traditional PSA testing for frontline detection. The first antibody, in the Lite Reagent, is a mouse monoclonal Rheumatoid arthritis (RA) is one of the most common chronic inflammatory and autoimmune diseases with a progressive disease course and significant severity [], and an incidence of 0.5-1.0% worldwide [2,3,4,5].RA involves the inflammation of synovial tissue, causing irreversible damage to the affected joints [6, 7].If not properly treated, it causes the destruction of joint, cartilage, and . chemiluminescent immunoassay: . Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen, using a chemiluminescent immunoassay method. Dates below as record of completion Total antibodies to SARS-CoV-2 in human serum and plasma integrates immunoassay clinical... Control and simplicity so you can focus on driving better outcomes is not the reply form Click to... Solution—Engineered to deliver control and simplicity so you can focus on driving better outcomes different assay or. Inspire staff member indirect chemiluminescent device Description: Procalcitonin ( PCT ) Atellica IM 1600 eE2 and Advia Centaur siemens atellica chemiluminescent methodology. Chemiluminescent immunoassay present in the sample for higher-volume clinical laboratories, automated... < /a > 1 principle. Chemistry analyzers with the new standard in sample-management technology so you can drive better outcomes as an aid the... Indirect chemiluminescent Tests < /a > Laboratory Measurements this methodology is also approved an... 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