Product Description
| Brand |
Snibe |
| Sample Type |
Serum |
| Pack Size |
100T |
| CAT No. |
130203001M |
| Application |
Thyroid Marker |
The kit has been designed for the quantitative determination of Thyroid-Stimulating Hormone (TSH) in human serum. The method can be used for samples over the range of 0.01-100.0 IU/ml.
The test has to be performed on the Fully-auto chemiluminescence immunoassay (CLIA) analyzer MAGLUMI (Including Maglumi 600,Maglumi 1000,Maglumi 1000 Plus, Maglumi 2000,Maglumi 2000 Plus,Maglumi 3000 and Maglumi 4000).
Fully Automated TSH TestingThe MAGLUMI TSH (CLIA) kit is engineered for seamless integration with MAGLUMI series analyzers, providing fully automated operation for routine and emergency diagnostic needs. Its easy-to-use format and minimal sample volume requirement optimize workflow efficiency in busy clinical environments.
Reliable Results and Quality ControlEvery kit comes with 6-point calibration and built-in quality controls, supporting consistent and reproducible results. With CE-mark and IVD certification, laboratories can trust in the assay's accuracy, while lot-specific certificates of analysis offer added assurance for regulatory compliance.
Convenient and Versatile ApplicationSuitable for human serum or plasma samples, the MAGLUMI TSH (CLIA) kit can handle both low and high test volumes, depending on laboratory demands. Its rapid turnaround time and wide measurement range make it invaluable for diagnosing and monitoring thyroid disorders effectively.
FAQ's of Snibe MAGLUMI TSH (CLIA):
Q: How is the Snibe MAGLUMI TSH (CLIA) test performed in a laboratory setting?
A: The test is conducted by loading the sample-either human serum or plasma-into a MAGLUMI series analyzer along with the provided reagents, calibrators, and controls. The analyzer automates the entire two-step chemiluminescent sandwich immunoassay process, generating quantitative TSH results.
Q: What are the primary benefits of using this TSH CLIA kit in a clinical laboratory?
A: This kit provides high sensitivity and specificity, swift results (typically under 30 minutes), and integrates seamlessly with automated analyzers for high-throughput processing. Its included calibration and controls ensure reliable, reproducible readings suitable for routine and urgent testing.
Q: When should the Snibe MAGLUMI TSH (CLIA) kit be used?
A: The kit is best utilized whenever a quantitative assessment of TSH is needed-such as in routine thyroid function screening, diagnosis of thyroid disorders, or monitoring of ongoing thyroid treatment in clinical laboratories, hospitals, or specialized diagnostic centers.
Q: Where can the MAGLUMI TSH (CLIA) kit be employed, and who are its intended users?
A: The kit is designed for use in clinical laboratories, hospitals, and diagnostic centers where compatible MAGLUMI series analyzers are installed. It is intended for professional use by trained laboratory personnel.
Q: What are the storage and handling requirements for this TSH immunoassay kit?
A: The kit should be stored at 2C - 8C, ensuring it is not frozen. Each package contains reagents, calibrators, controls, and user instructions, and should be used before the printed expiration date to guarantee optimal performance.
Q: How does the kit ensure quality control and calibration for accurate results?
A: A 6-point calibration is performed with manufacturer-provided calibrators, and each lot is supplied with a Certificate of Analysis. Controls included in the kit must be run for quality assurance, thus maintaining high accuracy and reproducibility.