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Gyrolab ImmunoAssays
Gyrolab ImmunoAssays
說明
Gyrolab® xPand 和 Gyrolab xplore™ 儀器提供預裝軟體,針對生產力進行了優化:
Gyrolab Manager 可在家裡、辦公桌或實驗室規劃和設置運行;
Gyrolab Control可控制整合的自動化工作流和
Gyrolab Evaluator 讓您能夠分析資料和生成報告。
所有軟體程式都專為 21 CFR Part 11 合規性而設計。
直觀的Gyrolab軟體有助於加快檢測開發、簡單運行整個系統並輕鬆分析數據。Gyrolab 平臺的軟體模組專為21 CFR Part 11合規性而設計,因此您可以從研究到受監管的 GxP 環境。
另外Gyrolab亦有針對專門的試驗撰寫專用的分析模組
Gyrolab ADA Software
Gyrolab ADA software將引導您順利通過標準的物抗體(Anti-drug antibody, ADA)免疫分析工作流程。該軟體確保無故障檢測開發和驗證、ADA 篩選和確認分析。您可以定義首選切點公式,並根據預定義的驗收標準和切點查看結果。該軟體將幫助您的確認分析,顯示結果根據您的驗收標準和確認點,並突出顯示超過正常範圍的資料點。
Gyrolab Affinity Software
Gyrolab Affinity Software模組有助於解決方案內關聯性實驗的設計和評估。相關性設計類型模組指導您設置相關性實驗,其中涉及定義相關性系列,即交互對的數量及其濃度序列。一旦親和力樣本達到平衡,自動陀螺儀相關性分析運行將測量每個樣本中未綁定相互作用的回應。相關性評估器軟體根據所選的交互模型從運行結果生成相關性曲線。相關性摘要頁顯示擬合曲線、KD 值、固定或可變相互作用器的計算(活動)濃度及其置信區間。
相關性曲線可用於比較源自不同交互對或測定變體的親和力序列。可以分析一個交互對中的多個曲線,以獲得全域擬合參數。
Gyrolab Control Report
Gyrolab Control Report在每次執行後生成21 CFR Part 11相容、不可編輯的原始數據報告,並以電子方式儲存結果以説明您滿足法規要求。
Gyrolab LIMS interface
LIMS介面模組能夠完全將Gyrolab系統整合到實驗室資訊管理系統(LIMS)中,符合GxP要求。該模組實現了一個完全自動化的過程,其中整個設置由 LIMS 控制,LIMS 透過 Web 介面與Gyrolab儀器通信。或者,Gyrolab LIMS 介面提供使用 LIMS 序列檔將範例資訊從 LIMS 傳輸到 Gyrolab 的選項,包括從 LIMS 直接傳輸到 Gyrolab 資料庫。
Gyrolab Manager 可在家裡、辦公桌或實驗室規劃和設置運行;
Gyrolab Control可控制整合的自動化工作流和
Gyrolab Evaluator 讓您能夠分析資料和生成報告。
所有軟體程式都專為 21 CFR Part 11 合規性而設計。
直觀的Gyrolab軟體有助於加快檢測開發、簡單運行整個系統並輕鬆分析數據。Gyrolab 平臺的軟體模組專為21 CFR Part 11合規性而設計,因此您可以從研究到受監管的 GxP 環境。
另外Gyrolab亦有針對專門的試驗撰寫專用的分析模組
Gyrolab ADA Software
Gyrolab ADA software將引導您順利通過標準的物抗體(Anti-drug antibody, ADA)免疫分析工作流程。該軟體確保無故障檢測開發和驗證、ADA 篩選和確認分析。您可以定義首選切點公式,並根據預定義的驗收標準和切點查看結果。該軟體將幫助您的確認分析,顯示結果根據您的驗收標準和確認點,並突出顯示超過正常範圍的資料點。
Gyrolab Affinity Software
Gyrolab Affinity Software模組有助於解決方案內關聯性實驗的設計和評估。相關性設計類型模組指導您設置相關性實驗,其中涉及定義相關性系列,即交互對的數量及其濃度序列。一旦親和力樣本達到平衡,自動陀螺儀相關性分析運行將測量每個樣本中未綁定相互作用的回應。相關性評估器軟體根據所選的交互模型從運行結果生成相關性曲線。相關性摘要頁顯示擬合曲線、KD 值、固定或可變相互作用器的計算(活動)濃度及其置信區間。
相關性曲線可用於比較源自不同交互對或測定變體的親和力序列。可以分析一個交互對中的多個曲線,以獲得全域擬合參數。
Gyrolab Control Report
Gyrolab Control Report在每次執行後生成21 CFR Part 11相容、不可編輯的原始數據報告,並以電子方式儲存結果以説明您滿足法規要求。
Gyrolab LIMS interface
LIMS介面模組能夠完全將Gyrolab系統整合到實驗室資訊管理系統(LIMS)中,符合GxP要求。該模組實現了一個完全自動化的過程,其中整個設置由 LIMS 控制,LIMS 透過 Web 介面與Gyrolab儀器通信。或者,Gyrolab LIMS 介面提供使用 LIMS 序列檔將範例資訊從 LIMS 傳輸到 Gyrolab 的選項,包括從 LIMS 直接傳輸到 Gyrolab 資料庫。
Description
Gyrolab Software
Gyrolab® xPand and Gyrolab xPlore™ instruments are delivered with pre-installed software, optimized for productivity: Gyrolab Manager to plan and set up runs at home, at your desk, or in the lab; Gyrolab Control to control integrated, automated workflows and Gyrolab Evaluator to give you the power to analyze data and generate reports. All software programs are designed for 21 CFR Part 11 compliance.
Gyrolab Manager
Gyrolab Manager maximizes productivity while working at your desk or remote. Plan experiments utilizing different assay formats while away from the lab and run assays any combination, from performing five CD runs with one assay and many samples to running different assays on different CDs, all in one operation. Run designs are stored in user-defined folders, allowing the organization of information according to your needs. The advanced Dilution/Spike functionality provides a high level of flexibility and enables you to perform advanced analyte concentration determinations, for example when testing assay accuracy and sensitivity by spike recovery studies or analyzing sample dilution linearity.
Gyrolab Control
An easy-to-use template controls all steps in the immunoassay workflow, including sample and reagent transfer, wash and incubation, spinning of Gyrolab CD and fluorescence detection for each type of CD. All instrument and software actions are logged within an audit trail.
For users working with validation and analysis of preclinical and clinical samples, the software can be integrated with your LIMS through the Gyrolab LIMS interface software module. Users analyzing raw data through their LIMS systems are advised to acquire a license for the Gyrolab Control report module to automatically generate non-editable, raw data reports after each run.
Gyrolab Evaluator
Gyrolab Evaluator enables samples from different experiments within a single run to be analyzed and quantified in one step so that data can be compared within and between runs. All sample and run details, data and analyses can be stored in specified project folders. Analytical parameters, such as curve-fitting options and acceptance criteria, can be locked by an administrator to ensure consistency between different users during data evaluation.
All software actions, such as changes in acceptance criteria or exclusion of data points, are logged within an audit trail.
The intuitive Gyrolab software helps to speed up assay development, run the entire system simply and analyze data with ease. The software modules for Gyrolab platforms are designed for 21 CFR Part 11 compliance, so you can use them from research through to regulated GxP environments, transferring assays between laboratories with confidence.
Gyrolab Viewer software
Gyrolab Viewer visualizes the binding response of each data point. Accessed from within Gyrolab Evaluator, the binding profile is displayed together with sample and run data. You can compare binding profiles and compare samples run under the same conditions on different CDs. You can quality-control data by investigating outliers and troubleshoot during development or routine analysis.
Gyrolab ADA Software
Gyrolab ADA software module leads you smoothly through a standard ADA immunoassay workflow. The software ensures trouble-free assay development and validation, ADA screening, and confirmatory analysis. You can define the preferred cut point formula and view results according to predefined acceptance criteria and cut point. The software will help your confirmatory analysis by displaying results according to your acceptance criteria and confirmatory cut point, and highlight any samples that fall outside.
Gyrolab Affinity Software
Gyrolab Affinity SoftwareGyrolab Affinity Software module facilitates the design and evaluation of in-solution affinity experiments. The Affinity Design Type module guides you in setting up the affinity experiment which involves defining the Affinity Series i.e. the number of interacting pairs and their concentration series. Once the affinity samples have reached equilibrium, an automated Gyrolab Affinity analysis run measures the response of unbound interactant in each sample. The Affinity Evaluator Software generates affinity curves from the run results which are fitted according to a selected interaction model. The affinity summary page presents fitted curves, KD values, calculated (active) concentrations of fixed or variable interactants, and their confidence intervals.
Affinity curves can be used to compare affinity series originating from different interaction pairs or assay variants. Multiple curves from one interaction pair can be analyzed to obtain globally fitted parameters.
Gyrolab Control Report
Gyrolab Control Report generates 21 CFR Part 11 compliant, non-editable raw data reports after each run, and stores results electronically to help you meet regulatory requirements.
Gyrolab® xPand and Gyrolab xPlore™ instruments are delivered with pre-installed software, optimized for productivity: Gyrolab Manager to plan and set up runs at home, at your desk, or in the lab; Gyrolab Control to control integrated, automated workflows and Gyrolab Evaluator to give you the power to analyze data and generate reports. All software programs are designed for 21 CFR Part 11 compliance.
Gyrolab Manager
Gyrolab Manager maximizes productivity while working at your desk or remote. Plan experiments utilizing different assay formats while away from the lab and run assays any combination, from performing five CD runs with one assay and many samples to running different assays on different CDs, all in one operation. Run designs are stored in user-defined folders, allowing the organization of information according to your needs. The advanced Dilution/Spike functionality provides a high level of flexibility and enables you to perform advanced analyte concentration determinations, for example when testing assay accuracy and sensitivity by spike recovery studies or analyzing sample dilution linearity.
Gyrolab Control
An easy-to-use template controls all steps in the immunoassay workflow, including sample and reagent transfer, wash and incubation, spinning of Gyrolab CD and fluorescence detection for each type of CD. All instrument and software actions are logged within an audit trail.
For users working with validation and analysis of preclinical and clinical samples, the software can be integrated with your LIMS through the Gyrolab LIMS interface software module. Users analyzing raw data through their LIMS systems are advised to acquire a license for the Gyrolab Control report module to automatically generate non-editable, raw data reports after each run.
Gyrolab Evaluator
Gyrolab Evaluator enables samples from different experiments within a single run to be analyzed and quantified in one step so that data can be compared within and between runs. All sample and run details, data and analyses can be stored in specified project folders. Analytical parameters, such as curve-fitting options and acceptance criteria, can be locked by an administrator to ensure consistency between different users during data evaluation.
All software actions, such as changes in acceptance criteria or exclusion of data points, are logged within an audit trail.
The intuitive Gyrolab software helps to speed up assay development, run the entire system simply and analyze data with ease. The software modules for Gyrolab platforms are designed for 21 CFR Part 11 compliance, so you can use them from research through to regulated GxP environments, transferring assays between laboratories with confidence.
Gyrolab Viewer software
Gyrolab Viewer visualizes the binding response of each data point. Accessed from within Gyrolab Evaluator, the binding profile is displayed together with sample and run data. You can compare binding profiles and compare samples run under the same conditions on different CDs. You can quality-control data by investigating outliers and troubleshoot during development or routine analysis.
Gyrolab ADA Software
Gyrolab ADA software module leads you smoothly through a standard ADA immunoassay workflow. The software ensures trouble-free assay development and validation, ADA screening, and confirmatory analysis. You can define the preferred cut point formula and view results according to predefined acceptance criteria and cut point. The software will help your confirmatory analysis by displaying results according to your acceptance criteria and confirmatory cut point, and highlight any samples that fall outside.
Gyrolab Affinity Software
Gyrolab Affinity SoftwareGyrolab Affinity Software module facilitates the design and evaluation of in-solution affinity experiments. The Affinity Design Type module guides you in setting up the affinity experiment which involves defining the Affinity Series i.e. the number of interacting pairs and their concentration series. Once the affinity samples have reached equilibrium, an automated Gyrolab Affinity analysis run measures the response of unbound interactant in each sample. The Affinity Evaluator Software generates affinity curves from the run results which are fitted according to a selected interaction model. The affinity summary page presents fitted curves, KD values, calculated (active) concentrations of fixed or variable interactants, and their confidence intervals.
Affinity curves can be used to compare affinity series originating from different interaction pairs or assay variants. Multiple curves from one interaction pair can be analyzed to obtain globally fitted parameters.
Gyrolab Control Report
Gyrolab Control Report generates 21 CFR Part 11 compliant, non-editable raw data reports after each run, and stores results electronically to help you meet regulatory requirements.
