Handy Immunofluorescent Analyzer

Model: PhiSure-201

Intended use:

The PhiSure-201 Handy Immunofluorescent Analyzer is used in conjunction with the fluorescence immunochromatography reagent cassette produced by Guangzhou PHICON Biotech Co., Ltd. to quantitatively detect the concentration of the analyte in human samples.

Working principle:

During test, the test substance is combined with a specific fluorescent marker after immunochromatography to form an immunoconjugate, which is fixed on the test area and the control area on the test strip; due to the specificity of the fluorescent marker, when the test area and  control area on the strip are illuminated by a specific LED excitation light source (365nm), the immune conjugate scatters emission light (610nm) due to excitation, and the emitted light is collected by the photoelectric sensor and converted from an analog signal to a digital signal. It is transmitted to the system to automatically calculate the concentration of the sample.

Performance:

Accuracy: When test the  samples whose fluorescence intensity is within 1000AU±100AU concentration, the relative deviation should not exceed ±15%.

Reproducibility: For samples with high, medium and low levels of fluorescence in the range of [500AU, 4000AU], the coefficient of variation (CV) ≤15%.

Linearity: For samples with five levels of concentration within the range of [500AU, 4000AU] for testing the fluorescence intensity, the linear correlation coefficient (r) should ≥ 0.975.

Stability: Test the samples with high, medium and low concentrations of fluorescence intensity in the range of [500AU, 4000AU], the measurement results at the 4th and 8th hours after the start-up is in a stable state and the measurement results at the beginning of the stable working state relative deviation should not exceed ±10%.