1. Timeline Factors May 29th, 2014
Design & Prototyping
In the design and prototyping of the urinalysis test strip the design team consisted of two males and their patent was for a protein test composition device and method. They were Roger Lee Atkinson of Three Rivers MI and Marshall Lloyd Fader of Elkhart IN, laboratory scientists who were assignors to Miles Laboratories, Inc. Although only one gender designed these strips, their view of society was general neutral in the discipline of this product design.
Before production this patent application was a continuation in part of another co-pending application filed October 1, 1964 and then abandoned. In 1969 it was US patent document 3438737 of the United States Patent Office. (Office, 1969).
There was public domain statistics and guidelines on test volume data in 2011 for urinalysis. Even though urinalysis test strips were considered as waived laboratory tests under CLIA (Clinical Laboratory Improvement Amendments) which was made law by Congress in 1988. Only eight waived tests out of nearly 10,000 laboratory tests, and one was the dipstick urine test. (Frankel, 1992)
Microscopic and macroscopic examinations can be done in urinalysis. Macroscopic are called dipsticks. They are counted as one test under CLIA regardless of the number of reagent pads are on the strips. (State of Oregon, 2005)
Reagents are the substances that are used to test for the presence of other substances in urinalysis test strips, causing a chemical reaction to show what may be the pathology. The Centers for Medicare & Medicaid Services (CMS) were a huge source of the test data. They define urinalysis under the Chemistry class, specialty Hematology and subspecialty, urinalysis. (Wians, 2013) .
Manufacturing & Production
In 1956 Clinistix; Ames Co., Elkhart, IN, which is now Bayer Diagnostics, was one of the first reagent strips with a pad for glucose that could be dipped into urine, allowed to react for a minute, and then was read. This eliminated the previous methods of using liquid and tablet reagents, and made testing easier. This began the development of tests used to diagnose kidney function, liver function, urinary tract infections and carbohydrate metabolism. They also manufactured 1957 tests for protein and ketone, pH in 1959, occult blood in 1961, bilirubin and urobilinogen in 1969, nitrite in 1972, specific gravity in 1981, and WBC’s (white blood cells) in 1984. (Pugia, 2000-2002)
POC (Point of Care) testing was done by hospitals from 1999-2001. Their standards were developed by CIC (Connectivity Industry Consortium) and Bayer and Roche were the suppliers. Roche is a Swiss manufacturer. (Robert P. Mappes, 2002)
Automation in urinalysis and evaluation of three urine test strip analyzers was done in Italy in 2000. Precision was found to have good repeat success with all three. Clinitek Auto 2000, again manufactured by the Ames Co. a division of Miles Laboratory in Milano; the Super Auction Analyzer, represented by Italy and the Urotron RL9 in Milano as well. (Bonini, 1988)
Again it was Bayer in the United States and Baer Diagnostics Europe (BDE) for protein detection in a test fluid. The buffer and dye may be absorbed in a test strip of absorbent material. Inventors were two men and a woman in Indiana, filed patent abstract 12/11/2003. (Profitt, 2004) United States Patent 6815210, 2004
Most common Urine Analysis using reagent strips are Multistix SG, Multistix 8SG, Multistix GP and Multistix 10SG. They are all functions of Siemens Healthcare manufactured in Pennsylvania and worldwide. (Wilson, 2005)
The workers in the factories are male or female, and they are made in scientific laboratories in the Unites States and worldwide.
Materials used in most urinalysis test strips are plastic and dry colorimetric reagent pads of paper, membranes or polymers make up the general strips. (Pugia, 2000) Colorimetric analysis is a method of determining the concentration of a chemical element or chemical compound in a solution with the aid of a color reagent.
Siemens Multistix Urinalysis Test Strip
Marketing
The urinalysis test strip is marketed to both genders but mainly to doctors and medical offices. It is not often that you would see advertisements for urinalysis test strips in magazines or periodicals to the general public, but they are marketed in medical journals through advertisements and articles.
Urinalysis Test Strips from Roche “© 2012;”
Sales
Urinalysis test strips are sold in drugstores for home use in the retail market. They are sold in wholesale markets by medical sales to doctors’ offices, clinics and hospitals.
User Support
Manufacturers and medical sales support have customer service and technical support websites and phone numbers on their product instructions for help in support to individuals that buy urinalysis test strips over the counter at the drug store or through a prescription by their doctor. Medical office and hospital employees can also access these same support venues. The patient can also contact their physician for support in the use of the urinalysis test strip, especially if the diagnosis warrants a follow up visit because of concerns or questions in the readings as a result of using it.
Maintenance
In order to maintain the required results, urinalysis test strips need to be used prior to expiration date, stored in their original containers and be used following the instructions of the manufacturer. (Wilson, 2005).
Clinical laboratories and POC’s handle most of the urinalysis testing in hospitals and doctors’ offices, but routine follow up testing can be done by unskilled folks as well. (Ogedegbe, 2007)
In developing countries a pocket-sized colorimetric urine reader has been developed for transfer of analyzed data to other experts off-site. (Lee, 2011)
Recycling & Disposal
The landfill is the only place the actual urinalysis test strips can go. The boxes they arrive in can be recycled. (Delmar Cengage Learning, 2005)
In all first world countries, medical office personnel and self-testing strips are disposed of and their boxes recycled as directed on the package or by the guidelines established by the manufacturer. In developing countries a handheld Lab on a Chip (LOC) would have instructions for proper disposal of the test strips, but depending on its versatility, the analyzer would be recycled or reused again and again. (Lee D. J., 2010)
