Unlocking the Power of Molecular Quality Control in Infectious Disease Testing
Hecin Scientific, Inc.
Expert in Respiratory Disease Diagnostics/PCR Kits/PCR Quality Control/Molecular Enzyme.
In recent years, there has been a significant surge in the use of molecular testing for diagnosing infectious diseases. This advancement brings with it an increased need for meticulous quality control (QC) measures to ensure the accuracy and reliability of test results. As primary point-of-care diagnostics (POCT) gain popularity, tests are often conducted by non-laboratory personnel, making QC indispensable in guaranteeing precise outcomes.
Laboratories are witnessing a transformation with the adoption of automated and commercially available tests. In this evolving landscape, QC emerges as a vital component for ensuring test compliance and meeting the performance standards set by manufacturers. Moreover, there is a growing emphasis on traceability and standardization of results, mandated by accreditation bodies. The implementation of robust QC protocols not only ensures result accuracy but also helps in curbing costs by minimizing repetitive and expensive testing due to errors.
However, navigating the realm of molecular testing poses its own set of challenges, primarily due to the multitude of in vitro diagnostic manufacturers and the wide array of available tests. This diversity underscores the critical importance of quality control in detecting potential errors early on. For instance, the market boasts over 200 commercial molecular tests designed for detecting human papillomavirus (HPV) alone. Moreover, the heterogeneous nature of equipment used for molecular diagnostics further complicates the standardization process.
Enter independent, third-party quality controls from external sources. These controls offer a reliable means to monitor the entire assay process, encompassing extraction, amplification, and detection. To ensure optimal performance, QC should be integrated at every stage of the assay process, including method validation, performance verification, and implementation.
The use of third-party QC products is indispensable across various scenarios:
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1. External Process QC: Frequency defined by the laboratory.
2. Reagent Lot Change: Whenever a reagent lot is changed.
3. New Batch of Reagents: Upon the arrival of a new batch of reagents.
4. System Maintenance: Following system maintenance, partial replacement, or software updates.
5. Addressing Performance Issues: When performance issues need to be addressed.
6. Staff Training: Utilized as a staff training tool.
Hecin offers nucleic acid quality control products in the field of infectious disease testing. The product line covers hundreds of pathogens such as viruses, bacteria, or fungi. The products contain complete pathogens and can be used for performance validation of reagents for nucleic acid testing (e.g. PCR, LAMP, etc.) and laboratory quality control.
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