Product Description
| Brand |
Snibe |
| Sample Type |
Serum |
| Pack Size |
100T |
| CAT No. |
130201010M |
| Application |
Cancer Marker |
The kit has been designed for the quantitative determination of Cancer Antigen 15-3 (CA 15-3) in human serum. The method can be used for samples over the range of 1.6-1,000 U/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).
Precision and Efficiency in Tumor Marker TestingWith its chemiluminescence immunoassay (CLIA) technology, the Snibe MAGLUMI CA 15-3 kit delivers rapid, high-throughput testing-up to 180 tests per hour depending on the analyzer. Its high sensitivity, wide measurement range (1.0-300.0 U/mL), and automated operations enable consistent, dependable CA 15-3 quantification, crucial for oncology diagnostics and patient monitoring.
Designed for Convenience and ReliabilityEach reagent kit includes all necessary components-reagent cartridges, calibrators, and product inserts-allowing for smooth integration into existing laboratory workflows. The ready-to-use liquid reagents reduce prep time, and the kit is optimized for performance stability with a 12-month shelf life and up to 4-week calibration validity. Lot and expiry information on every box ensures complete traceability.
FAQ's of Snibe MAGLUMI CA 15-3 (CLIA):
Q: How does the Snibe MAGLUMI CA 15-3 (CLIA) test operate?
A: The test employs a sandwich immunoassay principle with chemiluminescent detection. When a serum or plasma sample containing CA 15-3 is introduced, it binds to specific antibodies on the assay, generating a light signal (Relative Light Units) that the MAGLUMI analyzer converts to concentration values.
Q: What sample types and minimum volume are required for testing?
A: The kit is designed for use with serum or plasma samples collected in EDTA, heparin, or citrate tubes. A minimum sample volume of 50 L is recommended, although requirements may vary slightly depending on the compatible analyzer model.
Q: When should calibration and quality controls be performed?
A: Calibration is recommended every 4 weeks or as advised by the analyzer's software program. Two control levels (low and high) should be used to verify assay performance routinely and after reagent changes for consistent, accurate results.
Q: Where is the Snibe MAGLUMI CA 15-3 (CLIA) kit used?
A: This kit is intended for laboratory diagnostic use in clinical laboratories, hospitals, and diagnostic centers equipped with compatible MAGLUMI 800, 1000, 2000, or 4000 analyzers.
Q: What process ensures lot traceability and regulatory compliance?
A: Each kit box is clearly labeled with the lot number and expiry date for streamlined inventory management. The kit is CE marked and IVD certified, ensuring adherence to international quality and regulatory standards.
Q: How can laboratories benefit from using this CA 15-3 assay kit?
A: Labs benefit from automated, high-throughput operation, robust sensitivity (0.5 U/mL detection limit), a broad measurement range, and minimal hands-on preparation due to ready-to-use reagents. This results in efficient, reliable quantitative tumor marker results for enhanced patient management.