Snibe MAGLUMI CA 19-9 (CLIA)

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Product Details:

Usage Type Clinical Laboratory / Hospital
Instruments Type Snibe MAGLUMI Series Immunoassay Analyzer
Accuracy 10% CV (Within-run and Between-run)
Shelf Life 12 Months (unopened)
Display Type Analyzer-dependent
Measurement Range 0.5 to 1000 U/mL
Features High specificity and sensitivity, ready-to-use reagents, traceable calibrators, and controls
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Snibe MAGLUMI CA 19-9 (CLIA) Price And Quantity

Reagent Format Liquid, ready to use
Quality Control Internal QC included
Barcode System Automated reagent identification
Throughput High, as per analyzer capacity
Result Type Quantitative
Compatibility MAGLUMI series analyzers
Sample Type Human serum
Calibration Interval Defined by standard calibration procedure
Kit Components Includes reagents, calibrators, and controls
Expiry Date Printed on label
Intended Use In vitro diagnostic use for cancer (pancreatic, gastrointestinal) monitoring
Test Principle Two-step Chemiluminescent Immunoassay
Package Size 100 tests/kit
Lot Traceability Lot number on all reagent vials

Snibe MAGLUMI CA 19-9 (CLIA) Product Specifications

Dimension (L*W*H) Kit Size: Refer to packaging
Operating Type Automatic (compatible with MAGLUMI platforms)
Usage Type Clinical Laboratory / Hospital
Technology Chemiluminescence Immunoassay (CLIA)
Accuracy 10% CV (Within-run and Between-run)
Material Diagnostic Grade Reagents (ready-to-use)
Instruments Type Snibe MAGLUMI Series Immunoassay Analyzer
Weight Kit Weight: Refer to packaging
Condition New
Use In vitro quantitative determination of CA 19-9 in human serum/plasma
Shelf Life 12 Months (unopened)
Power Source External (Analyzer-dependent)
Real-Time Operation Yes
Storage Instructions Store at 2C to 8C, avoid freezing
Features High specificity and sensitivity, ready-to-use reagents, traceable calibrators, and controls
Noise Level Minimal
Display Type Analyzer-dependent
Measurement Range 0.5 to 1000 U/mL
Power Consumption Analyzer-dependent
Color Kit/Box: White/Blue Labelled
Portable No
Function CA 19-9 detection and quantification for diagnostic and monitoring purposes
Voltage Analyzer-dependent
Wall Mounted No
Equipment Type Immunoassay Analyzer Reagent Kit

Reagent Format Liquid, ready to use
Quality Control Internal QC included
Barcode System Automated reagent identification
Throughput High, as per analyzer capacity
Result Type Quantitative
Compatibility MAGLUMI series analyzers
Sample Type Human serum
Calibration Interval Defined by standard calibration procedure
Kit Components Includes reagents, calibrators, and controls
Expiry Date Printed on label
Intended Use In vitro diagnostic use for cancer (pancreatic, gastrointestinal) monitoring
Test Principle Two-step Chemiluminescent Immunoassay
Package Size 100 tests/kit
Lot Traceability Lot number on all reagent vials

Product Description

Brand	Snibe
Sample Type	Serum
Pack Size	100T
CAT No.	130201011M
Application	Cancer Marker

The kit has been designed for the quantitative determination of Cancer Antigen 19-9 (CA19-9) in human serum. The method can be used for samples over the range of 1.0-1,000 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).

High Sensitivity and Specificity for Clinical Monitoring

The MAGLUMI CA 19-9 (CLIA) kit provides laboratories with high specificity and sensitivity in detecting and quantifying CA 19-9, a vital tumor marker for pancreatic and gastrointestinal cancer. Its precise chemiluminescent technology enables reliable monitoring and aids early disease detection and effective treatment assessment.

Efficient Workflow and Easy Integration

Ready-to-use liquid reagents and an automated barcode system simplify preparation and traceability, reducing hands-on time for laboratory staff. The kit supports high throughput and is compatible with all Snibe MAGLUMI series analyzers, ensuring seamless integration into routine clinical laboratory operations without compromising accuracy or productivity.

FAQs of Snibe MAGLUMI CA 19-9 (CLIA):

Q: How is the Snibe MAGLUMI CA 19-9 (CLIA) kit typically used in clinical laboratories?

A: This kit is used for the in vitro quantitative determination of the CA 19-9 tumor marker in human serum or plasma. It is primarily utilized to monitor and manage patients with pancreatic and gastrointestinal cancers, providing critical information for disease progression and therapeutic response.

Q: What is the principle behind the test, and how does it ensure accurate results?

A: The assay operates on a two-step Chemiluminescent Immunoassay (CLIA) principle, offering high sensitivity and specificity. Internal quality control, traceable calibrators, and automated reagent identification help maintain reliable and accurate quantitative results.

Q: When should the reagents and controls be calibrated and quality checked?

A: Calibration should be performed as defined by the standard calibration procedure for your laboratorys MAGLUMI analyzer. Internal quality control is included to monitor assay performance with every run, ensuring continual result integrity.

Q: Where can this kit be used, and on which equipment is it compatible?

A: It is intended for use in clinical laboratories and hospitals. The kit is specifically compatible with Snibe MAGLUMI series Immunoassay Analyzers, ensuring optimal performance and workflow automation.

Q: What benefits does the MAGLUMI CA 19-9 (CLIA) kit offer laboratory professionals?

A: Laboratory professionals benefit from ready-to-use reagents, high-throughput capability, automated barcode-based reagent identification, and a measurement range of 0.5 to 1000 U/mL, all contributing to streamlined workflows and dependable results.

Q: How should the kit and its reagents be stored, and what is the shelf life?

A: Reagents and kit components should be stored at 28C, strictly avoiding freezing. When unopened and properly stored, the shelf life is 12 months, as indicated on the product label.

Q: What traceability and documentation features are included in the kit?

A: Each reagent vial features a lot number for full traceability, and calibrators and controls are reference-traceable, supporting regulatory compliance and consistent quality assurance.

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