EZValidation Online Tool. The easy way to apply guidelines. The EZValidation Online Tool. The implementation of new tests

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1 The implementation of new tests The EZValidation Online Tool Since 999, AcroMetrix has provided quality control requires validation or verification studies that meet is a comprehensive tool specifically for assisting in the materials with the very best support possible to our guidelines established by governmental agencies or validation and verification of molecular tests. It provides molecular diagnostics customers. AcroMetrix became international institutions. The interpretation of guidelines, standard guideline choices for the laboratory to follow, part of Life Technologies in 200 and is organized under especially in regards to new testing techniques such as calculates the number of reactions and quality control the Applied Biosystems family of products. molecular diagnostic methods, can be very challenging. materials required, and applies statistical analysis Access to standardized protocols that meet or exceed to generate a final report to support user validation regulations, coupled with the appropriate control materials and verification of molecular tests. Contact your local and software solutions to aid in data analysis, is what sales representative or perform a free test drive of our laboratory managers look for. online tool. Over the coming months, you will notice changes to the AcroMetrix website and product packaging as we migrate to the Applied Biosystems brand. We re confident that this rebranding process will not only help us to continue to grow as a company, but that it will enable us to better assist you. For more information, please go to EZValidation Online Tool The EZValidation Online Tool is a tool intended to assist laboratories in meeting their verification and validation requirements. Each laboratory is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditations requirements. 200 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. Printed in the USA. CO AcroMetrix by Life Technologies 600 Egret Ct. Benicia, CA 9450 USA Phone Toll Free International Sales For our office locations please call the division headquarters or refer to our website at The easy way to apply guidelines

2 The implementation of new tests The EZValidation Online Tool Since 999, AcroMetrix has provided quality control requires validation or verification studies that meet is a comprehensive tool specifically for assisting in the materials with the very best support possible to our guidelines established by governmental agencies or validation and verification of molecular tests. It provides molecular diagnostics customers. AcroMetrix became international institutions. The interpretation of guidelines, standard guideline choices for the laboratory to follow, part of Life Technologies in 200 and is organized under especially in regards to new testing techniques such as calculates the number of reactions and quality control the Applied Biosystems family of products. molecular diagnostic methods, can be very challenging. materials required, and applies statistical analysis Access to standardized protocols that meet or exceed to generate a final report to support user validation regulations, coupled with the appropriate control materials and verification of molecular tests. Contact your local and software solutions to aid in data analysis, is what sales representative or perform a free test drive of our laboratory managers look for. online tool. Over the coming months, you will notice changes to the AcroMetrix website and product packaging as we migrate to the Applied Biosystems brand. We re confident that this rebranding process will not only help us to continue to grow as a company, but that it will enable us to better assist you. For more information, please go to EZValidation Online Tool The EZValidation Online Tool is a tool intended to assist laboratories in meeting their verification and validation requirements. Each laboratory is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditations requirements. 200 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. Printed in the USA. CO AcroMetrix by Life Technologies 600 Egret Ct. Benicia, CA 9450 USA Phone Toll Free International Sales For our office locations please call the division headquarters or refer to our website at The easy way to apply guidelines

3 How much time does validation of a molecular test take? It typically takes 58 working days, on average, to perform validation or verification of a molecular test, according to a recent survey of US laboratory managers and supervisors performing molecular testing. Some of the challenges reported were: The EZValidation Online Tool is designed specifically for Difficulty in determining the requirements necessary for a validation study Relying on software used in other laboratories that does not account for molecular methods Creating statistical analyses in Excel spreadsheets Keeping organized when working with multiple people on a validation The EZValidation Online Tool is the first to provide these molecular assay validation and verification features: Standard and customizable protocol options for the laboratory to follow Automatic calculation of the number of reactions and quality materials required Customizable plate mapping based upon your amplification detection system The ability to upload data for automated statistical analysis Validation or verification protocol and final report for printing or storage as a PDF file molecular diagnostic laboratories performing quantitative validation or verification studies. Days to Perform Molecular Validation Steps 30 Take a free test drive In 4 easy steps, the EZValidation Online Tool will calculate the number of reactions, panels, and standards needed. Visit our site at for a free test drive! Identify guideline (ISO, CLIA, or custom) Enter lab and assay info, calculate reagent needs Set up other users, create and print plate maps Enter and review data Generate reports Figure 3. Drop-down driven choices of packaged assays to choose from. Figure 4. A choice of ISO 589 or CAP/CLIA/NY State guidelines and the list of protocols which can be chosen or de-selected. Figure 5. Confirmation of your instruments, list of controls, and extraction volume needed. Figure 6. Easy-to-read order summary containing the number of total reactions and the standards and controls needed for your validation or verification. Options to save your study (if you log in) and request a quote are provided. Figure 2. Typical molecular assay validation workflow Research Guidelines and Create Protocols Set up Statistical Analysis and Create the Final Validation/ Templates Verification Report Figure. Typical number of working days required to perform different steps during the validation of a molecular test (excluding time to execute protocols). With the EZValidation Online Tool, you have a convenient, intuitive application to guide you through: Translating regulatory guidelines into user-defined validation or verification prot ocols Calculating the amount of reagents and quality materials needed to run the protocol Consolidating studies (i.e., accuracy, precision, LOD) across runs and days to minimize time and reagents Selecting and performing statistical analyses Combining results and data analysis into a single validation report for signature Source: Molecular verification and validation survey of US laboratory managers and supervisors. Performed September 200. Standard guideline choices are just the beginning AcroMetrix is focused on quality control products, services, and systems for molecular diagnostics. The EZValidation Online Tool offers a choice of protocols based on ISO 589 or CAP/CLIA/New York State validation and verification guidelines for setting up your studies. In addition, we ve designed the online tool so that you can create your own protocols. Keep up with changing guidelines As a leader in molecular quality materials, AcroMetrix closely monitors changing requirements for clinical laboratories as new standards emerge. Because the EZValidation Online Tool is webbased, you have access to new protocols as guidelines change. Designed for AcroMetrix, but compatible with any While we encourage the use of AcroMetrix quality materials for your validations and verifications, we realize your need for flexibility to accommodate new tests. The EZValidation Online Tool is designed for use with or without AcroMetrix quality control materials. Year subscriptions or pay per use are available. Inquire with your local sales representative for more information.

4 How much time does validation of a molecular test take? It typically takes 58 working days, on average, to perform validation or verification of a molecular test, according to a recent survey of US laboratory managers and supervisors performing molecular testing. Some of the challenges reported were: The EZValidation Online Tool is designed specifically for Difficulty in determining the requirements necessary for a validation study Relying on software used in other laboratories that does not account for molecular methods Creating statistical analyses in Excel spreadsheets Keeping organized when working with multiple people on a validation The EZValidation Online Tool is the first to provide these molecular assay validation and verification features: Standard and customizable protocol options for the laboratory to follow Automatic calculation of the number of reactions and quality materials required Customizable plate mapping based upon your amplification detection system The ability to upload data for automated statistical analysis Validation or verification protocol and final report for printing or storage as a PDF file molecular diagnostic laboratories performing quantitative validation or verification studies. Days to Perform Molecular Validation Steps 30 Take a free test drive In 4 easy steps, the EZValidation Online Tool will calculate the number of reactions, panels, and standards needed. Visit our site at for a free test drive! Identify guideline (ISO, CLIA, or custom) Enter lab and assay info, calculate reagent needs Set up other users, create and print plate maps Enter and review data Generate reports Figure 3. Drop-down driven choices of packaged assays to choose from. Figure 4. A choice of ISO 589 or CAP/CLIA/NY State guidelines and the list of protocols which can be chosen or de-selected. Figure 5. Confirmation of your instruments, list of controls, and extraction volume needed. Figure 6. Easy-to-read order summary containing the number of total reactions and the standards and controls needed for your validation or verification. Options to save your study (if you log in) and request a quote are provided. Figure 2. Typical molecular assay validation workflow Research Guidelines and Create Protocols Set up Statistical Analysis and Create the Final Validation/ Templates Verification Report Figure. Typical number of working days required to perform different steps during the validation of a molecular test (excluding time to execute protocols). With the EZValidation Online Tool, you have a convenient, intuitive application to guide you through: Translating regulatory guidelines into user-defined validation or verification prot ocols Calculating the amount of reagents and quality materials needed to run the protocol Consolidating studies (i.e., accuracy, precision, LOD) across runs and days to minimize time and reagents Selecting and performing statistical analyses Combining results and data analysis into a single validation report for signature Source: Molecular verification and validation survey of US laboratory managers and supervisors. Performed September 200. Standard guideline choices are just the beginning AcroMetrix is focused on quality control products, services, and systems for molecular diagnostics. The EZValidation Online Tool offers a choice of protocols based on ISO 589 or CAP/CLIA/New York State validation and verification guidelines for setting up your studies. In addition, we ve designed the online tool so that you can create your own protocols. Keep up with changing guidelines As a leader in molecular quality materials, AcroMetrix closely monitors changing requirements for clinical laboratories as new standards emerge. Because the EZValidation Online Tool is webbased, you have access to new protocols as guidelines change. Designed for AcroMetrix, but compatible with any While we encourage the use of AcroMetrix quality materials for your validations and verifications, we realize your need for flexibility to accommodate new tests. The EZValidation Online Tool is designed for use with or without AcroMetrix quality control materials. Year subscriptions or pay per use are available. Inquire with your local sales representative for more information.

5 How much time does validation of a molecular test take? It typically takes 58 working days, on average, to perform validation or verification of a molecular test, according to a recent survey of US laboratory managers and supervisors performing molecular testing. Some of the challenges reported were: The EZValidation Online Tool is designed specifically for Difficulty in determining the requirements necessary for a validation study Relying on software used in other laboratories that does not account for molecular methods Creating statistical analyses in Excel spreadsheets Keeping organized when working with multiple people on a validation The EZValidation Online Tool is the first to provide these molecular assay validation and verification features: Standard and customizable protocol options for the laboratory to follow Automatic calculation of the number of reactions and quality materials required Customizable plate mapping based upon your amplification detection system The ability to upload data for automated statistical analysis Validation or verification protocol and final report for printing or storage as a PDF file molecular diagnostic laboratories performing quantitative validation or verification studies. Days to Perform Molecular Validation Steps 30 Take a free test drive In 4 easy steps, the EZValidation Online Tool will calculate the number of reactions, panels, and standards needed. Visit our site at for a free test drive! Identify guideline (ISO, CLIA, or custom) Enter lab and assay info, calculate reagent needs Set up other users, create and print plate maps Enter and review data Generate reports Figure 3. Drop-down driven choices of packaged assays to choose from. Figure 4. A choice of ISO 589 or CAP/CLIA/NY State guidelines and the list of protocols which can be chosen or de-selected. Figure 5. Confirmation of your instruments, list of controls, and extraction volume needed. Figure 6. Easy-to-read order summary containing the number of total reactions and the standards and controls needed for your validation or verification. Options to save your study (if you log in) and request a quote are provided. Figure 2. Typical molecular assay validation workflow Research Guidelines and Create Protocols Set up Statistical Analysis and Create the Final Validation/ Templates Verification Report Figure. Typical number of working days required to perform different steps during the validation of a molecular test (excluding time to execute protocols). With the EZValidation Online Tool, you have a convenient, intuitive application to guide you through: Translating regulatory guidelines into user-defined validation or verification prot ocols Calculating the amount of reagents and quality materials needed to run the protocol Consolidating studies (i.e., accuracy, precision, LOD) across runs and days to minimize time and reagents Selecting and performing statistical analyses Combining results and data analysis into a single validation report for signature Source: Molecular verification and validation survey of US laboratory managers and supervisors. Performed September 200. Standard guideline choices are just the beginning AcroMetrix is focused on quality control products, services, and systems for molecular diagnostics. The EZValidation Online Tool offers a choice of protocols based on ISO 589 or CAP/CLIA/New York State validation and verification guidelines for setting up your studies. In addition, we ve designed the online tool so that you can create your own protocols. Keep up with changing guidelines As a leader in molecular quality materials, AcroMetrix closely monitors changing requirements for clinical laboratories as new standards emerge. Because the EZValidation Online Tool is webbased, you have access to new protocols as guidelines change. Designed for AcroMetrix, but compatible with any While we encourage the use of AcroMetrix quality materials for your validations and verifications, we realize your need for flexibility to accommodate new tests. The EZValidation Online Tool is designed for use with or without AcroMetrix quality control materials. Year subscriptions or pay per use are available. Inquire with your local sales representative for more information.

6 The implementation of new tests The EZValidation Online Tool Since 999, AcroMetrix has provided quality control requires validation or verification studies that meet is a comprehensive tool specifically for assisting in the materials with the very best support possible to our guidelines established by governmental agencies or validation and verification of molecular tests. It provides molecular diagnostics customers. AcroMetrix became international institutions. The interpretation of guidelines, standard guideline choices for the laboratory to follow, part of Life Technologies in 200 and is organized under especially in regards to new testing techniques such as calculates the number of reactions and quality control the Applied Biosystems family of products. molecular diagnostic methods, can be very challenging. materials required, and applies statistical analysis Access to standardized protocols that meet or exceed to generate a final report to support user validation regulations, coupled with the appropriate control materials and verification of molecular tests. Contact your local and software solutions to aid in data analysis, is what sales representative or perform a free test drive of our laboratory managers look for. online tool. Over the coming months, you will notice changes to the AcroMetrix website and product packaging as we migrate to the Applied Biosystems brand. We re confident that this rebranding process will not only help us to continue to grow as a company, but that it will enable us to better assist you. For more information, please go to EZValidation Online Tool The EZValidation Online Tool is a tool intended to assist laboratories in meeting their verification and validation requirements. Each laboratory is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditations requirements. 200 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. Printed in the USA. CO AcroMetrix by Life Technologies 600 Egret Ct. Benicia, CA 9450 USA Phone Toll Free International Sales For our office locations please call the division headquarters or refer to our website at The easy way to apply guidelines