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HID Validation Services
Cat. No. / ID: 9245629
Comprehensive customized validation service for forensic or HID testing
The Validation Support Services for Human Identification and Forensics is intended for molecular biology applications in forensic, human identity, and paternity testing. This product is not intended for diagnosis, prevention, or treatment of a disease.
✓ 24/7 automatic processing of online orders
✓ Knowledgeable and professional Product & Technical Support
✓ Fast and reliable (re)-ordering
Features
- Supports the validation process of new methods
- Supports the validation process of new instruments
- Aims to cut validation time by up to 50%
- Individualized approach ensures customer satisfaction
Product Details
Validation of new equipment or methods is an important part of any forensic quality assurance system. When a new technique is introduced, an internal validation study must always be conducted to demonstrate that the procedure is robust, reliable and reproducible, that it ensures personnel safety, and adheres to all local and national regulatory standards. QIAGEN offers a consultative Validation Service to human identity (HID) and forensic laboratories supporting the validation process of new technology and application implementation. Our comprehensive service offers complete internal validation of your purification systems, assays and automated workflows in forensic or HID testing.
Want to discuss your laboratory validation requirements with one of our specialists? Please select Inquire to learn more about Customized Validation Planning.
Performance
All our validation studies meet or exceed the requirements of these standards:
- ISO/IEC 17025:2005
- ENFSI Recommended Minimum Criteria for the Validation of Various Aspects of the DNA Profiling Process (2010)
- FBI Quality Assurance Standards for Forensic DNA Testing Laboratories (2020)
Principle
Customized Validation Planning
QIAGEN offers an individualized approach to every validation ensuring complete customer satisfaction. Working with each laboratory, a defined scope of work will be agreed choosing from these options:
- Validation planning
- Execute validation
- Data analysis and report writing
- Validation report
- Validation teach-back
Procedure
Inclusive services
| Validation service* | Extraction | Quantification | STR amplification: Casework | STR amplification: Database |
| Consultative validation planning | Yes | Yes | Yes | Yes |
| Scope of work agreement | Yes | Yes | Yes | Yes |
| Comprehensive validation plan | Yes | Yes | Yes | Yes |
| Onsite support to execute validation | Yes | Yes | Yes | Yes |
| Comprehensive data analysis | Yes | Yes | Yes | Yes |
| Validation report | Yes | Yes | Yes | Yes |
| Validation teach-back | Yes | Yes | Yes | Yes |
* Actual studies subject to local regulations and customer requirements.
Configurable services
| Validation service | Extraction | Quantification | STR amplification: Casework | STR amplification: Database |
| Sensitivity study | Yes | Yes | Yes | Yes |
| Reproducibility study | Yes | Yes | Yes | Yes |
| Precision study | Yes | Yes | Yes | |
| Contamination evaluation | Yes | Yes | Yes | Yes |
| Mixture study | Yes | Yes | Yes | |
| Stutter assessment | Yes | Yes | ||
| Concordance study (NIST**) | Yes | Yes | Yes | |
| Known and non-probative sample study | Yes | Yes | Yes | Yes |
| Analytical threshold | Yes | Yes | ||
| Stochastic evaluation | Yes | Yes |
** Dependent on availability.
Applications
You get a workflow to suit the needs of your laboratory. Our highly qualified Application Specialists are experts from the forensic field, each with multiple years’ experience through senior roles in forensic DNA analysis. They combine molecular biology expertise with extensive technical experience, and understand your systems and their possible applications.
Resources
Brochures & Guides (1)
Safety Data Sheets (1)
Certificates of Analysis (1)