Immunoassay - Siemens Healthineers Brand Name: Atellica IM PCT. 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 . Instruments - FAS Diagnostic Trade Name . Method comparison. When all competencies are checked, participant signs and dates below as record of completion. 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 AccessGUDID - DEVICE: Atellica IM 1600 Analyzer ... Experience the power of the Atellica Solution! Test results are available in 10 minutes. UNSPSC Code. Reagent Atellica® IM Reproductive Endocrinology Assay Testosterone 2 For Atellica IM Analyzer 100 Tests 20 µL Sample Volume Siemens 10995708 using a chemiluminescent immunoassay method. The first antibody, 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) The Atellica® IM Analyzer from Siemens Healthcare Diagnostics is a new automated, high through-put immunoassay (IM) analyzer. Results obtained with different assay methods or kits cannot be used interchangeably. Passing-Bablok regression and Bland-Altman analyses comparing the Atellica IM 1600 eE2 and Advia Centaur XP eE2 assays. Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: . The Solid Phase contains a preformed complex of streptavidin- coated microparticles and biotinylated SARS-CoV-2 recombinant antigens. 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 . 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. Experience the power of the Atellica® Solution—engineered to deliver control and simplicity so you can drive better outcomes. 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. . Method comparison study The Atellica IM Tg Assay demonstrated acceptable correlation r = 0.983 to the Beckman ACCESS 2 Thyroglobulin assay. Introduction. This 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. Experience the power of the Atellica Solution! The Solid Phase contains a preformed complex of streptavidin-coated microparticles and biotinylated SARS-CoV-2 recombinant antigens. 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 . 11206997) 17 is an automated 2-step chemiluminescent sandwich immunoassay for IgG antibodies against the SARS-CoV-2 virus. Cardiac Marker. chemiluminescent immunoassay: . Reagent Kit Atellica® IM Cancer CA 15-3 For Atellica IM Analyzer 500 Tests Siemens 10995486 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. 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. 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 . Regulatory Clinical Affairs Specialist Phone: (914) 524-2458 . 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) Results obtained with different assay methods or kits cannot be used interchangeably. The cut-off indices for each positive immunoassay were 1.4, 1.0, and 1.0, respectively. Recommended 99th percentile cut-offs are: Biomerieux. 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 . 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 . Regulatory Information . Atellica IM Fol DTT/Releasing Agent is stable onboard the system for 108 hours. Version or Model: 11099328. 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. Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA . The Siemens Healthineers SARS-CoV-2 antibody assays detect antibodies to the S1 RBD antigen. This is not the reply form Click here to reply. Both assays target the S1-RBD. To obtain a substantial equivalence determination for the Atellica IM B.R.A.H.M.S PCT, . 11206711, Munich, Germany) 16 is an automated 1-step antigen chemiluminescent sandwich immunoassay for total antibodies, and the COV2G (Siemens Healthineers nr. For more details. Methodology: Siemens Atellica IM BR 27.29 (BR) chemiluminescent immunoassay was used. One test produced a test result of 6.8 ng/mL and the other test produced a result of 5.8 ng/mL. It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-management technology so you can focus on driving better outcomes. 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 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. 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) using a chemiluminescent immunoassay method. Description Immunoassay analyzer with chemiluminescence testing methodology using advanced acridinium ester technology Test Throughput Atellica IM 1300 Analyzer: up to 220 tests per hour . It is a magnetic latex particle chemiluminescent immunoassay for the in-vitro quantitative determination of troponin I in serum and plasma samples. It is a syndromic testing system for a variety of pathogens associated with key healthcare concerns. (A.1) E2 whole range concentration Passing-Bablok . For higher-volume clinical laboratories, automated chemiluminescent assays have taken the place of the more-manual methods. Method comparison of Atellica IM TSH3-UL Assay vs. ADVIA Centaur The Atellica IM AB12 assay is a fully automated, 2-step sandwich immunoassay using direct chemiluminescent technology. The assay is listed as CE marked. Test principle The Atellica IM sCOVG assay is a fully automated 2‑step-sandwich immunoassay using acridinium-ester chemiluminescent technology. Assay. Atellica Solution 1-5 Atellica Solution Advanced Operator Training Course Validation Checklist The participant places a checkmark beside the competency when it is completed. Detection Method Chemiluminescent Microparticle Immunoassay (CMIA), where a the new Siemens Atellica platform. 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 . On the same day a lab conducted two PSA tests on blood drawn at the same time. 1. 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. 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. Results obtained with different assay methods or kits cannot be used interchangeably. 2.10 The Atellica test is designed to be used in a laboratory with the Siemens Atellica IM analyser. Fax: (914) 524-3579 . Hemoglobin A1c (A1c_3) Calibrator Atellica CH - CAL 4 x 2 x 0.5mL. Methodology: Siemens Atellica IM BR 27.29 (BR) chemiluminescent immunoassay was used. Test Type. The assay is an antigen sandwich immunoassay using acridinium ester chemiluminescent . Định lượng Ferritin Determination of Ferritin 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. Laboratory Measurements. Both assays target . Use this form if there's a problem with the post - for example if you think a community guideline is being broken. Atellica IM aTG - Sterilization. The Atellica® Solution is designed to address common clinical laboratory challenges. Atellica ® IM Total . Contact: Mey Lyn Vasquez . 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. 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. Atellica IM aTG - Sterilization. Serum, plasma, amniotic fluid, urine, whole blood (assay . 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 . 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 High-Sensitivity Troponin I. Device IDs: 00630414597300 ( Primary) 00630414211534 ( Unit of Use) Catalog Number: 11099328. 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. 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. 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 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, 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. The most comprehensive information guide on Atellica IM aTG - SIEMENS HEALTHCARE DIAGNOSTICS INC including impacted physicians & ROI, Business Case, HEOR & VAC Business & Quality Metrics . 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. 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. 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 Atellica® Solution is designed to address common clinical laboratory challenges. GMDN Terms: GMDN Definition. Introduction . . Commercial Distribution Status: In Commercial Distribution. Commercial Distribution End Date: NA. Method comparison. The first Automated assays are less Introduction. 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 . - Hóa phát quang Siemens Atellica, CLIA Chemiluminescent Immunoassay, Siemens Atellica. Commercial Distribution Status: In Commercial Distribution. The most comprehensive information guide on Atellica IM aTG - SIEMENS HEALTHCARE DIAGNOSTICS INC including impacted physicians & ROI, Business Case, HEOR & VAC Business & Quality Metrics . Company Name: Siemens Healthcare Diagnostics Inc. Device Count: 1. Results obtained with different assay methods or kits cannot be used interchangeably. It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-management technology so you can focus on driving better outcomes. 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. It will replace the Troponin I assay (CTNI) currently being performed on the Siemens Vista platform. The COV2T test (Siemens Healthineers nr. Psa testing Roche ECLIA methodology vs Siemens chemiluminescent method. . (A.1) E2 whole range concentration Passing-Bablok . 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. 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 Methodology: Siemens Atellica IM BR 27.29 (BR) chemiluminescent immunoassay was used. The test employs two recombinant HCV antigens of NS3, NS4, NS5 regions (c200 and NS5) and a synthetic peptide of the core (c22). 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. 11206997) 17 is an automated 2-step chemiluminescent sandwich immunoassay for IgG antibodies against the SARS-CoV-2 virus. Company Name: Siemens Healthcare Diagnostics Inc. Primary DI Number: 00630414599694. Experience the power of the Atellica Solution! You are about to report this post for review by an Inspire staff member. 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 . 2. 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: Siemens Healthcare Laboratory Diagnostics offers laboratories fully automated immunoassay platforms and a comprehensive, disease-focused menu in excess of 100 tests. This methodology is also approved as an aid in the management/monitoring of prostate cancer patients. 11206711, Munich, Germany) 16 is an automated 1-step antigen chemiluminescent sandwich immunoassay for total antibodies, and the COV2G (Siemens Healthineers nr. Device Description: Procalcitonin (PCT) Atellica IM - RGT 100T. One test was the Beckman Coulter immunoassay method and the other test was the Siemens chemiluminescent method. Chemiluminescent Immunoassay. Siemens Healthcare GmbH. 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 . 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 E-mail: mey.vasquez@siemens-healthineers.com. Passing-Bablok regression and Bland-Altman analyses comparing the Atellica IM 1600 eE2 and Advia Centaur XP eE2 assays. The Atellica® Solution is designed to address common clinical laboratory challenges. The Siemens proprietary Complexed PSA is an alternative to traditional PSA testing for frontline detection. QTMD008.1 (Alinity 114 Abbott)- Điện hóa phát quang Roche Cobas 8000, ECLIA ElectroChemiluminescent Immunoassay, Roche Cobas 8000: QTMD008.3 (Roche cobas e801) 9. It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-managementtechnology so you can focus on driving better outcomes. 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. The Atellica IM TSH3-UL Assay is a third-generation assay that uses proven advanced chemiluminescent Acridinium Ester technology. The chemiluminescent reaction is directly proportional to the amount of anti-HCV present in the sample. The first antibody, in the Lite Reagent, is a mouse monoclonal The COV2T test (Siemens Healthineers nr. Issuing Agency: GS1. 6 The spike protein and particularly the RBD are the most . Evaluation of Siemens Atellica-IM SARS-CoV-2 Total (COV2T) for detection of Anti-SARS-CoV-2 antibodies 6 . Hcv: chemiluminescent enzyme immunoassay for the qualitative detection of IgG antibodies to HCV. 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 Test Name. Methods: The Atellica IM sCOVG Assay is a fully automated two-step sandwich immunoassay using indirect chemiluminescent . Features. 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]. Results obtained with different assay methods or kits cannot be used interchangeably. 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. Immunoassay analyzer with chemiluminescence testing methodology using advanced acridinium ester technology. 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. 41116004. chemiluminescent immunoassay: . 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 . AccessGUDID - Atellica IM TSTII (00630414600222)- Testoterone II (TSTII) Atellica IM - RGT 100T 1. Results obtained with different assay methods or kits cannot be used interchangeably. The Atellica IM Total β-hCG (ThCG) assay is a chemiluminescent immunoassay previously cleared for use on the Ciba-Corning ACS system in k925277. Date Prepared: October 30, 2019 . Atellica Solution Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer Atellica Solution Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer . Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay. The assay utilizes an acridinium ester-labeled 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. Atellica™ IM ThCG - GMDN. Atellica IM Fol DIL is stable onboard the system for 28 days. Im Fol DTT/Releasing Agent is stable onboard the system for a variety of pathogens associated with key Healthcare.. Troponin I assay ( CTNI ) currently being performed on the Siemens method. Affairs Specialist Phone: ( 914 ) 524-2458 SARS-CoV-2 virus company Name: Siemens Healthcare Inc.... Standard in sample-management technology so you can focus on driving better outcomes particle chemiluminescent immunoassay IgG... Regulatory clinical Affairs Specialist Phone: ( 914 ) 524-2458 were 1.4, 1.0, respectively was. 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