Dublin, May 20, 2024 (GLOBE NEWSWIRE) -- The "In Vitro Diagnostic Quality Control Market 2024-2028" report has been added to ResearchAndMarkets.com's offering.
In vitro diagnostics (IVD) quality control refers to the processes and measures implemented to ensure the accuracy, reliability, and precision of diagnostic tests performed outside of a living organism, typically in a laboratory setting.
These tests are crucial for detecting diseases, monitoring health conditions, and guiding treatment decisions. IVD quality control involves various steps and components:
1. Control Materials: These are materials with known characteristics used to monitor the performance of diagnostic tests. Control materials can mimic patient samples and are used to validate the accuracy and precision of test results. They are typically classified as either independent or dependent controls.
2. Quality Control Procedures: Laboratories establish protocols and procedures for performing quality control tests regularly. This includes running control materials alongside patient samples to ensure that the diagnostic test is functioning correctly. Control results are compared against predefined ranges or criteria to assess the accuracy and reliability of the test.
3. Instrument Calibration: IVD instruments require regular calibration to maintain accuracy. Calibration involves adjusting the instrument to ensure that it produces accurate results within specified tolerances. Calibration procedures should be performed according to manufacturer guidelines and regulatory requirements.
4. Documentation and Record Keeping: Proper documentation of quality control activities is essential for traceability and regulatory compliance. This includes recording control results, instrument calibration records, and any deviations from established procedures. Documentation ensures that laboratory processes are transparent and auditable.
5. Troubleshooting and Corrective Actions: When quality control results fall outside acceptable ranges or when instruments show signs of malfunction, laboratories must implement corrective actions promptly. This may involve troubleshooting the issue, performing maintenance or repairs on instruments, or retesting samples to verify results.
Methodology
This report is based on research conducted over the last four months. Data is derived primarily from executive comments, quarterly reports, and industry association data. While much information is kept confidential by suppliers this report infers revenues based on estimates of individual company activities by channel historically, currently, and as intermittently reported.
This report aggregates supplier revenues and compares these to industry and other sources to arrive at estimates of current and historical market size. Forecasts are firstly based on historical growth rates and the current overall economic growth outlook for specific regions and countries. Secondarily the growth outlook is modified to account for factors specific to the market under study as explained in the Situation Analysis.
Key Topics Covered:
1 Market Guides
1.1 Strategic Situation Analysis
1.2 Guide for Executives, Marketing, Sales and Business Development Staff
1.3 Guide for Management Consultants and Investment Advisors
2 Introduction and Market Definition
2.1 What is IVD Quality Control?
2.2 Defining the Opportunity
2.2.1 Revenue Market Size
2.3 Methodology
2.4 Perspective: Healthcare and the IVD Industry
2.4.1 Global Healthcare Spending
2.4.2 Spending on Diagnostics
2.4.3 Important Role of Insurance for Diagnostics
3 Overview of a Dynamic Market
3.1 Players in a Dynamic Market
3.1.1 Academic Research Lab
3.1.2 Diagnostic Test Developer
3.1.3 Instrumentation Supplier
3.1.4 Chemical/Reagent Supplier
3.1.5 Pathology Supplier
3.1.6 Independent Clinical Laboratory
3.1.7 Public National/regional Laboratory
3.1.8 Hospital Laboratory
3.1.9 Physicians Office Lab (POLS)
3.1.10 Audit Body
3.1.11 Certification Body
3.2 Segmentation - Different Approaches
3.2.1 Traditional Market Segmentation
3.2.2 Laboratory Focus and Segmentation
3.3 Structure of Clinical Testing Industry
3.3.1 The Hospital Lab - Share of the Pie
3.3.2 Key Role for Economies of Scale
3.3.3 Physician Office Lab's are Still Here
3.3.4 Physicians and POCT - Reviving Patient Service in China
3.4 National and Regional Diversity
4 Trends Driving a Changing Market
4.1 Growth Is Pushed from Many Sides
4.1.1 Demographic Impacts on Consumption
4.1.2 Movement to Third Party
4.1.3 Point of Care Testing Makes a Difference
4.1.4 New Laboratory Discipline Impact
4.2 Factors at Work to Shrink the Market
4.2.1 Where are Costs Going?
4.2.2 Management Practices
4.2.3 Cannabilization
4.2.4 Point of Care
4.3 Automation and Laboratory Trends
4.3.1 Traditional Automation and Centralization
4.3.2 The New Automation, Decentralization and Point Of Care
4.3.3 Instruments Key to Market Share
4.3.4 Bioinformatics Plays a Role
4.3.5 PCR Takes Command
4.3.6 Next Generation Sequencing Fuels a Revolution
4.3.7 NGS Impact on Pricing
4.3.8 Whole Genome Sequencing, A Brave New World
4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment
4.3.10 Shifting Role of Diagnostics
5 IVD Quality Control Recent Developments
5.1 Recent Developments - Importance and How to Use This Section
5.1.1 Importance of These Developments
5.1.2 How to Use This Section
5.2 New FDA Quality Regulations Spark Questions
5.3 Waters MassTrak Steroid Serum (IVD) Sets
5.4 Cancer Test Harmonization Efforts Progress
5.5 Bio-Techne Expanding With Ella Immunoassay Instrument
5.6 ZeptoMetrix QC Products Receive IVDR Certification
5.7 Coverage Criteria for Cancer Genetic Tests Creates Alarm
5.8 IVDR Rollout Brings QC Hurdles for Clinical Labs
5.9 LGC Clinical Diagnostics Acquires QC Product Maker Kova International
5.10 FDA Probing Lab Test Quality in Cancer Care
5.11 Sensible Diagnostics to Launch 10-Minute POC PCR System
5.12 Streck Gets FDA Clearance for BioFire Sepsis Panel Control Material
6 Profiles of Key Companies
6.1 Abbott Laboratories
6.2 Alpha-Tec Systems
6.3 Bio-Rad Laboratories
6.4 Bio-Techne
6.5 Danaher Corporation
6.6 Fortress Diagnostics
6.7 Grifols
6.8 Helena Laboratories Corporation
6.9 LGC Limited
6.10 Maine Molecular Quality Controls
6.11 Microbiologics
6.12 Microbix Biosystems
6.13 QuidelOrtho
6.14 Qnostics
6.15 Randox Laboratories
6.16 Seegene
6.17 SERO AS
6.18 Streck
6.19 Sun Diagnostics
6.20 Sysmex
6.21 Thermo Fisher
6.22 ZeptoMetrix
7 The Global Market for IVD Quality Control
7.1 Global Market Overview by Country
7.2 Global Market by Assay Type - Overview
7.3 Global Market by Place - Overview
7.4 Global Market by Product - Overview
8 Global IVD Quality Control Markets - By Assay Type
8.1 Chemistry
8.2 Microbiology
8.3 Hematology
8.4 Anatomic Pathology
8.5 Molecular Diagnostics
8.6 Esoteric
9 Global IVD Quality Control Markets - By Place
9.1 Hospital
9.2 Clinical Laboratory
9.3 Research Laboratory
9.4 Physicians Office Laboratory
9.5 Other Laboratory
10 Global IVD Quality Control Markets - By Product
10.1 Control Material Blood
10.2 Control Material Urine
10.3 Control Material Other
10.4 Data Management Systems
10.5 QC Services and Other
11 Appendices
11.1 United States Medicare System: Clinical Laboratory Fees Schedule
11.2 The Most Used IVD Assays
11.3 The Highest Grossing Assays
For more information about this report visit https://www.researchandmarkets.com/r/n7l9z2
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