New dip-and-read test for determining leukocytes in urine

Area of Science:

• Clinical Chemistry
• Urinalysis
• Diagnostic Reagents

Background:

• Leukocyte detection in urine is crucial for diagnosing urinary tract infections.
• Existing methods for leukocyte determination can be time-consuming or require specialized equipment.

Purpose of the Study:

• To describe and evaluate the performance of a new reagent strip, LEUKOSTIX, for the determination of leukocytes in urine.
• To compare the efficacy of LEUKOSTIX with a standard method (sediment microscopy) and another commercially available test (CHEMSTRIP LN).

Main Methods:

• The LEUKOSTIX test utilizes the esterase activity present in leukocytes to produce a color change.
• A clinical study involving 867 urine specimens across eight sites was conducted.
• Results were compared to urine sediment microscopy, with ≥5 cells/high-power field considered positive.

Main Results:

• The LEUKOSTIX reagent strip demonstrated a sensitivity of 76.3% and a specificity of 80.8%.
• Performance was found to be comparable to the CHEMSTRIP LN leukocyte test.
• The test relies on visual comparison of the strip's color change to a provided chart.

Conclusions:

• LEUKOSTIX offers a viable method for detecting leukocytes in urine based on esterase activity.
• The reagent strip provides a convenient and accessible option for urinalysis.
• Further studies may be warranted to optimize sensitivity and specificity for clinical applications.