Appendix E: System Overview & Principles - Bayer HealthCare Clinitek Status Operator's Manual

10
Appendices
Appendix E: System Overview & Principles
Appendix E: System Overview & Principles
Intended Use of Analyzer
The Clinitek Status
in vitro diagnostic use in:
• the semi-quantitative
detection of albumin,
bilirubin, blood (occult),
creatinine, glucose, ketone
(acetoacetic acid),
leukocytes, nitrite, pH,
protein, specific gravity and
urobilinogen in urine
samples. The tests
reported depend on the
type of Bayer urinalysis
strip used.
• the semi-quantitative
calculation of albumin-to-
creatinine and protein-to-
creatinine ratios in urine
samples, when certain
strips are used.
• the detection of human
Chorionic Gonadotropin
(hCG) in urine samples,
when Clinitest
Cassette Tests are used.
Description of Optical System
The optical system consists of six
light emitting diodes, a light guide,
a mirror, a lens and a detector.
10-14
® analyzer is for
®
hCG
Light from the LEDs travels along
the light guide and is reflected off
the calibration bar, strip or cassette
onto the mirror. It is then directed
through an aperture on the lens,
from where it is focused onto the
detector. The light intensity
detected is converted into electrical
impulses, which are processed by
the instrument's microprocessor
and converted into clinically
meaningful results.
When carrying out analysis on a
urinalysis strip, the test table
positions strip pads in the "read
area". The light reflected at specific
wavelengths (470 nm, 525 nm,
565 nm, 625 nm, 660 nm and
845 nm) from the test pad is
dependent upon the degree of color
change in the pad and is directly
related to the concentration of the
particular constituent in the urine.
The analyzer's optical system
images the entire strip (i.e., all
reagent pads at once).
When using a Clinitest immunoassay
cassette, the detector will scan the
"read area" for the test, reference
and control lines that form after
urine has been applied. The
reference and control lines will
132387 Rev. B, 2004-10