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
LoSo-Urisub 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 (
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.
Among the currently demonstrated applications for LoSo-UriSub are:
- Urine positive and negative controls
- Urine Substitute for making controls and standards