Absolute CD4+ cell count using a plastic microchip and a microscopic cell counter.

Area of Science:

• Biotechnology
• Immunology
• Medical Diagnostics

Background:

• Accurate CD4(+) T-cell counts are crucial for monitoring immune status, particularly in HIV-infected individuals.
• Existing methods for CD4(+) T-cell enumeration can be complex, costly, and time-consuming.
• There is a need for simple, rapid, and affordable diagnostic tools for cell counting.

Purpose of the Study:

• To design and evaluate a novel, low-cost microchip-based system for quantifying CD4(+) T-cells.
• To assess the precision, linearity, and diagnostic accuracy of the new CD4(+) counting method.
• To explore the potential applicability of this technology for other cell-based diagnostic assays.

Main Methods:

• Development of a "no-lyse, no-wash," volumetric single platform assay utilizing plastic microchips.
• Determination of absolute CD4(+) T-cell counts using a microscopic scanning cell counter.
• Validation against established single and dual platform flow cytometry reference assays using 123 clinical samples.

Main Results:

• The new microchip method demonstrated high correlation (r = 0.98) with reference assays for clinical samples.
• Dilution tests showed excellent linearity (r >= 0.99) and low coefficients of variation (<=7.6%).
• The system proved to be precise, rapid, and cost-effective for CD4(+) T-cell enumeration.

Conclusions:

• The developed microchip-based CD4(+) T-cell counting system is a simple, rapid, and affordable diagnostic tool.
• The assay exhibits high accuracy and precision, comparable to established flow cytometry methods.
• This technology holds potential for broader applications in quantifying cellular antigens or other biomarkers.