Exact Diagnostics Molecular Quality Controls for Transplant
Confidence in Transplant Diagnostics
At Bio-Rad, we understand the critical role that reliable diagnostics play in transplant patient care. Our Exact Diagnostics line of quality controls and verification panels are designed with the needs of clinical laboratories in mind, offering high-quality solutions to ensure confidence in every test result. Engineered with the highest quality, our products empower labs to monitor and verify system performance of molecular assays for key transplant-related pathogens, streamline workflows, and meet stringent regulatory standards. With Bio-Rad’s Exact Diagnostics portfolio, you can focus on what matters most—delivering reliable results to support life-changing transplant decisions.
Quality Controls and Verification Panels for Transplant-Associated Pathogens
Our comprehensive portfolio of quality controls and verification panels is tailored to monitor and validate molecular assays for pathogens commonly associated with transplant testing. Each product is meticulously characterized using digital droplet PCR (ddPCR) for absolute, unbiased quantification, ensuring unmatched quality and reliability.
Adenovirus
Controls and panels to monitor the presence and establish points of reference for the measurement of Adenovirus DNA measurement.
BKV
Controls and panels to monitor the presence and establish points of reference for the measurement of polyomavirus BK Virus (BKV) DNA.
CMV
Controls and panels to monitor the presence and establish points of reference for the measurement of Cytomegalovirus (CMV) DNA.
EBV
Controls and panels to monitor the presence and establish points of reference for the measurement of Epstein-Barr Virus (EBV) DNA.
HHV-6
Controls and panels to monitor the presence and establish points of reference for the measurement of human herpesvirus-6 (HHV-6) DNA monitoring.
HSV-1
Controls and panels to monitor the presence and establish points of reference for the measurement of Human Herpes Simplex-1 DNA.
HSV-2
Controls and panels to monitor the presence and establish points of reference for the measurement of Human Herpes Simplex -2 DNA.
JCV
Controls and panels to monitor the presence and establish points of reference for the measurement of Human polyomavirus 2 (JCV) DNA measurement.
Parvovirus B19
Controls and panels to monitor the presence and establish points of reference for the measurement of Parvovirus B19 DNA monitoring.
VZV
Controls and panels to monitor the presence and establish points of reference for the measurement of Varicella Zoster Virus (VZV) DNA.
All controls and panels help labs meet CLIA, CAP and ISO:15189 standards for assay verification and system performance monitoring.
Benefits of Exact Diagnostics
Bio-Rad’s Exact Diagnostics offers a comprehensive transplant-specific portfolio, human-based materials, and seamless platform integration for unmatched reliability and efficiency.
Comprehensive Pathogen Coverage
Controls and bundled panels for nine transplant pathogens (CMV, BKV, Adenovirus, EBV, HHV-6, HSV-1/2, JCV, Parvovirus B19, VZV).
Absolute Quantification using Droplet Digital PCR(ddPCR)
Ensures lot-to-lot consistency
Long Shelf-Life
Minimized crossover studies when new reagent lots are implemented
Whole Organisms
When available alignment to WHO standards is performed to enable commutability
Human-Based Matrix
Human-based materials provide a closer representation of clinical samples, enhancing the accuracy of assay validation and monitoring.
Broad Compatibility
Designed to work seamlessly with multiple test systems, reducing the need for platform-specific controls and simplifying procurement.
Workflow Integration
Ready-to-use verification panels that are compatible with major platforms, and controls integrate seamlessly into the Unity QC Data Management System
Trusted Global Legacy
Backed by Bio-Rad’s 50+ years of quality control innovation
Streamlined Lab Workflow
Exact Diagnostics controls and panels help you optimize laboratory efficiency.
Automate Processes
Barcoded verification panels integrate with automated platforms, eliminating manual dilutions and data entry, reducing errors, and speeding up workflows.
Decrease Turnaround Time
Ready-to-use liquid formats minimize preparation time, allowing labs to focus on testing and analysis.
Reduce Contamination Risk
Ready-to-use liquid controls reduce opportunities for contamination, minimizing errors.
Ensure Consistency
Our consistent, reliable controls help labs detect shifts or trends in assay performance early, preventing costly retests and patient result delays.
Compliance
Exact Diagnostics products are designed to meet industry-wide regulatory standards, verifying assay performance characteristics and helping your lab remain compliant.
- CLIA Compliance: our controls align with CLIA requirements for daily quality control testing, ensuring assay performance is monitored with appropriate positive and negative controls.
- CAP Accreditation: independent controls, as recommended by CAP, ensure unbiased assessment of assay performance. Bio-Rad’s Unity QC Peer Program also provides robust documentation that is well-accepted by CAP inspectors.
- ISO 15189 Standards: our controls meet ISO 15189 requirements for internal quality control systems to verify result reliability. The integration with Unity Real Time™ Software automates data collection and analysis, simplifying compliance with audit trails and peer comparisons.
- WHO Alignment: our controls are aligned to WHO standards to enable commutability where relevant.
By using Exact Diagnostics products, laboratories can demonstrate compliance with confidence, streamline audits, and reduce the risk of reporting erroneous results.
Unity QC Data Management: Elevate Your Molecular Lab Workflow
Unity Real Time Software is the industry-leading solution for managing quality control data. Work faster, smarter, and with greater confidence in your molecular laboratory.
Achieve automated data integration, advanced analytics, real-time monitoring, and peer comparison with labs worldwide.