© Pro Advantage by NDC. All rights reserved
PS-733 Rev 00-3/10
21/23
Appendix 3: Analyzer Summary & Policy
Intended Use of Analyzer
The Pro Advantage Urine Analyzer is for
in vitro diagnostic use
only:
• The analyzer reports results semi-quantitatively for leukocytes, nitrite, urobilinogen, protein, pH, specific gravity,
blood, ketone, bilirubin, and glucose in urine samples.
Optical System Explanation
The TC-101 can determine the intensity of different colors on the reagent strip test area. It does this by irradiating the test
area with light and detecting the reflectance of different wavelengths using an integrated sphere photo-detector. This
photo-detector is filtered to measured wavelengths of 550nm, 620nm, and 720nm using the integrated sphere. 720nm is
the reference wavelength and the combination of 550nm and 620nm light is used to differentiate between the different
color combinations used in the urine strips. Results are calculated by a reflection rate (R%) which is a percentage of the
total reflectance of the testing wavelength and are printed automatically. If the intensity of color on the strip is high then
the reflectance will be low conversely if the intensity of the color is low then the reflectance will be high.
Apart from there being strip blocks for each test there is also a reference block (blank) on the strips. Its function is to
rectify any error that may be caused by the color or the urine itself. The formula for reflectance is:
R: Reflectance
Tm: The intensity of reflected radiation of the strip block to testing wavelength
Ts: The intensity of reflected radiation of the strip block to reference wavelength
Cm: The intensity of reflected radiation of the reference block to testing wavelength
Cs: The intensity of reflected radiation of the reference block to reference wavelength
Internal Checks Explanation
When the user first turns on the Pro Advantage Urine Analyzer, the analyzer performs a series of electronic checks. Each
time a test is read with the analyzer, the instrument ensures each test is positioned correctly on the strip bed. The
analyzer then pulls the strip bed and strip into the analyzer, taking a reference reading from the reference block on the
strip. After the initial reference block reading the analyzer begins to read all the test pads at all 4 wavelengths, The test
and reference results are then used to determine whether there is a presence and/or amount of each component in the
urine sample and the results are used to calculate the sample results.
Human Eye vs. Instrumental Optics
The human eye is inherently different in the colors that it perceives compared to those detected by an optical system. The
human eye is capable of determine differences in shade and color by the minute, whereas the optical system cannot.
However, optical systems can detect specific colors that are hidden or masked by other colors apparent to the human
eye.
Since there are slight difference between the human eye vs an optical system, an exact agreement between the two
options may be hard to find. Yet, agreement between the two can be found visually, if the user reports a value within one
visual color block compared to the optical system reading.
