LoSo-UriSub™
Liquid, Particulate-Free Odorless Stable Synthetic Urine
With Low Electrolytes For Use in Manufacturing of Urine Controls, Reference Standards for
Clinical Chemistry And
Immunological Procedures
INTRODUCTION AND BACKGROUND
Urine is a liquid waste product of the body. A healthy person’s urine is amber
colored and slightly acid. Normal urine has a specific gravity of 1.022. The major
components of the urine are water, urea, creatinine, uric acid, and inorganic salts. The
inorganic salts include, sodium, potassium, ammonia, calcium and magnesium.
The condition of urine is often an indication of a person’s health and
electrolytes are an important part of diagnosis.
Urine analysis is very popular in determining the concentration of electrolytes.
Urinalysis is preferred by doctors in lieu of blood samples. This created a problem for
the manufacturer when he had to obtain large quantities of urine to make controls,
standards and calibrants to assure the accuracy of the results.
Most manufacturers of urine assay kits depend on their employees to donate urine
samples. These urine samples are then combined to make a large pool, which then has to be
treated before controls can be manufactured.
Obtaining a large pool of consistent quality is difficult primarily because the
majority of donors are either coffee drinkers, on medication, or take vitamins, and/or
other commonly used drugs such as aspirin.
Urine also has a bad connotation and the odor makes it a component that most chemists
do not like to work with.
To solve the problem of obtaining a consistent quality of low electrolytes urine and
also odorless, CST has developed a patented product, LoSo-UriSub™.
LoSo-UriSub™, a newly developed synthetic urine, has all the characteristics of
urine, but is low in electrolytes. In addition, it is stable at room temperature for at
least 3 years. This offers the manufacturer of urine assay kits for making low electrolyte
controls the optimal alternate solution to problems and matrix compatibility.
FORMULATIONS AND PROPERTIES
LoSO-UriSub™ is a synthetic buffered solution which is physically equivalent to
normal urine except it is low in sodium and potassium (<15 mmole of Na < 3 mmole K).
Unlike normal urine, it has no odor.
REGULATORY COMPLIANCE
LoSo-UriSub™ is a synthetic urine for use as a component in preparing standards
and controls for in-vitro diagnostic tests. LoSo-UriSub™ should be treated as any
other component or ingredient that has to be qualified prior to use. LoSo-UriSub™,
when used in this manner, does not require FDA approval for its use. A Device Master File
for LoSo-UriSub™ is pending. LoSo-UriSub™ is manufactured under the strictest
quality control guidelines to ensure quality and lot to lot uniformity.
USER’S GUIDELINES
Among the currently demonstrated applications for LoSo-UriSub are:
- Urine positive and negative controls
- Calibrators
- Urine Substitute for making controls and standards
RATIONALE |
Human Urine |
|
LoSo-UriSub™ |
YES |
Lot to lot variability |
NO |
YES |
Unpleasant odor |
NO |
YES |
Costly processing, column purification prior to use |
NO |
YES |
Unpredictable availability |
NO |
YES |
Refrigeration |
NO |
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