Chapter 1. Understanding Your New Analyzer; Intended Use; Test Principle - SD Biosensor MultiCare 03MA10 User Instruction Manual

CHAPTER 1.
Understanding Your New Analyzer

1. Intended Use

The MultiCare System is a reflectometry immunoassay instrument for the
quantitative measurement in human blood, urine and other specimens. This
system is for in vitro diagnostic use and professional use in hospital and
clinic.

2. Test Principle

The MultiCare System is based on a reflectometry and immunoassay
technology. MultiCare Analyzer is a reflectometry scanning instrument to be
used in conjunction with the various MultiCare Test Kits which are based
on antigen-antibody reaction. MultiCare Analyzer uses the optic sensor
to measure the reflected light from the membrane of the test panel as the
quantity source.
The specimen from human should be processed for the preparation using the
components of the MultiCare Test Kit. When applying the sample mixture to
the test panel, the complex will be formed on the membrane as the result of
the antigen-antibody reaction. The intensity of the reflected light is scanned
and converted into an electric signal which is proportional to the intensity
of reflected light produced on the membrane. The MultiCare Analyzer can
calculate the concentration of the analyte in the clinical specimen based
on a pre-programmed calibration and display the test result on the screen.
Blue Latex
Antigen
Capture antibody
6
Detector antibody
Membrane