Product Description
Brand Mindray
Sample Type Serum
Pack Size 2 x 50T, 2 x 100T
CAT No 10500566500, 10500568200
Application Immuno-Assay
Ourchemiluminescence immunoassay reagentshave been specially developed to work with Mindray's CL series automatic chemiluminescence immunoassay analyzers to make a complete system, offering high reliability and accuracy. Mindray uses liquid, ready-to-use reagents which come in two packages, 50 tests and 100 tests, to suit customers with different requirements.
Advanced Assay Principle for Clinical AccuracyThe assay employs a robust two-step indirect chemiluminescence immunoassay (CLIA), offering high sensitivity and specificity for detecting anti-TPO antibodies. This advanced methodology enables precise quantitative analysis and supports the diagnosis and monitoring of thyroid autoimmune disorders. By automating the process on compatible Mindray CLIA platforms, the kit ensures reproducibility and reliability for laboratory professionals.
Seamless Integration with Mindray CLIA AnalyzersDesigned to work seamlessly with Mindray analyzers (CL-1000i, CL-1200i, CL-2000i, and CL-6000i), this kit suits a range of laboratory environments. Its compatibility means consistent performance, straightforward operation, and efficient workflow integration. The reagents are ready-to-use, ensuring minimal preparation and maximized productivity.
Quality Assured and Regulatory CompliantComplying with international clinical laboratory standards, the Mindray Anti-TPO CLIA kit is CE marked and IVD certified. Calibration is traceable to IFCC guidelines, while each kit provides reliable quality controls, helping laboratories meet stringent regulatory and reporting requirements. Reagents remain stable for up to 28 days on the analyzer, facilitating uninterrupted routine testing.
FAQ's of Mindray Antibody to thyroid peroxidase (CLIA):
Q: How does the Mindray Anti-TPO CLIA kit detect thyroid peroxidase antibodies?
A: The kit uses a two-step indirect chemiluminescence immunoassay (CLIA) technique, where anti-TPO antibodies in human serum or plasma bind to captured antigens and are quantified through a light-emitting reaction, providing precise, quantitative results.
Q: What types of samples can be used with this assay?
A: The assay is validated for use with human serum or plasma samples, collected and processed according to standard laboratory procedures for immunoassays.
Q: When should laboratories perform calibration for this kit?
A: Calibration should be performed according to the instructions for use (IFU) provided, or when a new lot of the kit is introduced on the analyzer. Calibration is traceable to international standards as per IFCC guidelines to ensure accuracy.
Q: Where can this kit be used, and on which analyzers is it compatible?
A: The Mindray Anti-TPO CLIA kit is intended for in-vitro diagnostic use in clinical laboratories and is compatible with Mindray CL-1000i, CL-1200i, CL-2000i, and CL-6000i analyzers.
Q: What is the process for running a test with this kit on a Mindray analyzer?
A: Testing is fully automated on compatible Mindray CLIA analyzers. After loading samples and reagents, the analyzer performs the assay and provides quantitative results expressed as IU/mL or equivalent unit.
Q: How should the kits and reagents be stored, and what is their stability?
A: Reagents should be stored at 2-8C and must not be frozen. On-board the analyzer, reagents remain stable for up to 28 days, while the kit's shelf life is usually between 12 and 18 months as indicated on the product label.
Q: What are the main benefits of using the Mindray Anti-TPO CLIA kit in clinical practice?
A: The kit provides high sensitivity and specificity for anti-TPO detection, is ready-to-use, offers reliable quality controls, and is designed for seamless automation, enabling accurate, efficient diagnosis and monitoring of thyroid autoimmunity in a busy laboratory setting.