Product Description
| Brand |
Snibe |
| Sample Type |
Whole Blood |
| Pack Size |
100T |
| CAT No. |
130207003M |
| Application |
Drug Test |
The kit has been designed for the quantitative determination of FK506 in human whole blood. The method can be used for samples over the range of 0-50ng/ml. The test has to be performed on the MAGLUMI chemiluminescence immunoassay (CLIA) fully auto analyzer (Including MAGLUMI 1000, MAGLUMI 2000, MAGLUMI 2000 Plus and new developed models).
Precise Monitoring for Immunosuppressive TherapyThe Snibe MAGLUMI FK506 (CLIA) Reagent Kit enables clinicians to accurately quantify Tacrolimus in whole blood samples. This is vital for optimizing immunosuppressive treatment in transplant patients, assisting in dose adjustments to achieve the best possible patient outcomes while minimizing adverse effects. Automated analysis ensures efficient and reproducible results.
Streamlined Workflow with Advanced CLIA TechnologyRelying on chemiluminescence immunoassay (CLIA), the kit delivers rapid results (approximately 40 minutes) and integrates seamlessly with Snibe MAGLUMI analyzers. Its 2-point calibration and optional level 1 & 2 controls ensure robust quality management and confidence in every measurement, making it an ideal choice for routine laboratory operations.
FAQ's of Snibe MAGLUMI FK506 (CLIA):
Q: How is the Snibe MAGLUMI FK506 (CLIA) kit used in clinical laboratories?
A: The kit is used for the quantitative measurement of FK506 (Tacrolimus) in human whole blood, primarily for monitoring patients undergoing immunosuppressive therapy. Laboratories run the assay on validated Snibe MAGLUMI analyzers, following standard operating procedures for automated and precise results.
Q: What is the process for running the FK506 assay on a MAGLUMI analyzer?
A: First, whole blood samples are prepared according to the Instructions for Use (IFU). The analyzer is loaded with the reagent kit, and a 2-point calibration is performed using the provided calibrators. Samples are then processed automatically, and results are obtained in about 40 minutes.
Q: When should Tacrolimus levels be measured using this kit?
A: Typically, Tacrolimus levels are monitored at regular intervals as determined by clinical protocols, especially in patients who have received organ transplants. Regular testing helps ensure therapeutic drug levels are maintained to prevent organ rejection or drug toxicity.
Q: Where can I find information about the kit's lot number and expiry date?
A: Lot number details are indicated on the package label, while expiry information is available on the outer package or label. Always check these details before use to ensure reagent validity.
Q: What are the key benefits of using this CLIA-based FK506 reagent kit?
A: The kit offers high specificity and sensitivity, automated workflow, and reliable quantification of Tacrolimus, aiding effective patient management. It reduces manual intervention, assures consistent results, and integrates easily with MAGLUMI analyzers for streamlined operations.
Q: Are level 1 and 2 controls included in every kit, and why are they important?
A: Level 1 and 2 controls are available separately, not included in every kit. Running these controls ensures ongoing assay accuracy and reliability, facilitating quality assurance in clinical test results.
Q: What are the recommended storage conditions for the FK506 (CLIA) kit?
A: Store the kit between 2-8C and avoid freezing. Proper storage is crucial to maintain reagent stability and guarantee accurate assay performance throughout the stated shelf life.