Description

Product Overview

The Vitamin B12 Test Kit is a fluorescence immunoassay designed for quantitative determination of Vitamin B12 in human serum samples. Vitamin B12 is an essential water-soluble vitamin involved in red blood cell formation, neurological function and DNA synthesis.

Measurement of Vitamin B12 levels helps clinicians diagnose vitamin deficiency disorders and monitor nutritional status. This assay is suitable for hospital laboratories and diagnostic centers using immunofluorescence analyzers.

Intended Use

The Vitamin B12 Fast Test Kit is intended for in vitro quantitative determination of Vitamin B12 in serum samples. The test is used as an aid in the diagnosis of Vitamin B12 deficiency related diseases and nutritional disorders.

Clinical Significance

Vitamin B12 plays an important role in:

• red blood cell formation
• neurological function
• DNA synthesis
• metabolism of fatty acids and amino acids

Vitamin B12 deficiency may cause:

• megaloblastic anemia
• neurological disorders
• memory impairment
• fatigue and weakness
• developmental delay in infants

Early detection of Vitamin B12 deficiency helps clinicians provide appropriate treatment and prevent complications.

Test Principle

The Vitamin B12 test is a competitive fluorescence immunoassay. When the serum sample is applied to the test strip, fluorescence-labelled intrinsic factor binds with Vitamin B12 in the sample.

The bound complex is captured by antibodies on the test strip. The fluorescence signal generated is measured by the analyzer and is inversely proportional to the concentration of Vitamin B12 in the sample.

Sample Type: Serum

Hemolyzed samples should not be used.

Sample Volume

Test Time

15 minutes

The result is displayed automatically on the analyzer screen.

Measuring Range:100 – 2000 pg/mL

Technology

Compatible Analyzers

Kit Contents

Each kit contains:

• Vitamin B12 test cards
• Sample diluent
• Disposable pipettes
• SD card (for calibration)
• User manual

Storage and Stability

• Store at 4–30°C
• Shelf life 24 months
• Use test card within 1 hour after opening foil pouch

Applications

This test kit is suitable for:

• Hospital laboratories
• Diagnostic centers
• Nutritional deficiency testing
• Vitamin deficiency screening