Review Related Literature

Reagent strip

The history of the urinary test papers does not being in the post-war period. As early as

the 1880's some practitioners and pharmacists tried to replace the complicated wet-

chemical procedures and apparatus by "dry chemistry." The first popular test paper for

sugar and albumin originated in England in 1883. Dry reagents for proving hematuria

have been available since the beginning of this century. Until the 1930s a wide palette of

commercial urine tests with "modern" brand names was established. A methodological

breakthrough was created by the spot test chemistry inaugurated by the Austrian, Fritz

Feigl, about 1920. Using the capillary properties of filter paper in enhancing color

reactions he founded a new area of analytical chemistry. Many of the pioneers were

recruited from Jewish scientists. In this lecture is proposed that their emigration and

banishment as well as the Second World War have stopped the development of urinary

diagnostics on the European continent. In the post-war period the American industry

succeeded to the leading position in the researching and marketing of test papers. In

1956, the triumphal progress of the "stick tests" began with the "Clinistix" (Ames

Company, today Bayer Diagnostic). (Voswinckel,1994)

The diagnostic reagent strip, with 1 or more reagent pads adhered to a plastic handle, is

one of the most common testing technologies in routine clinical use. The key reason for

its acceptance is ease of use. One of the first reagent strips contained a reagent pad for

glucose (Clinistix; Ames Co, Elkhart, IN; 1956) that could be dipped into urine, was

allowed to react for a minute, and read.This diagnostic method eliminated the necessity

of preparing liquid reagents and was easier to use than tablet reagents. The routine
urinalysis panel used today tests for glucose (1956), protein (1957), ketone (1957), pH

(1959), occult blood (1961), bilirubin (1969), urobilinogen (1969), nitrite (1972), specific

gravity (1981), and WBCs (1984). (Bayer Diagnostics, Elkhart, IN; 1984)

In the 1980s, reagent strip design began to include multiple reagent layers to measure 1

analyte. This allowed chemical reagent systems to be placed in distinct reagent layers

and provided for reaction separation steps such as chromatography and filtration.

Immunochromatography strips are constructed so that chemical reactions occur in distinct

areas of reagents (Bayer Diagnostics, Elkhart, IN; 1984)

The first urine strip instrument was the Clinilab (Bayer), introduced in 1972. Today

analyzers range from high throughput, fully automated systems (Clinitek Atlas; Bayer;

1994) to single urine strip analyzers for use in the physician’s office (Clinitek 50, Bayer,

1996; Urilux S, Boehringer Mannheim, 1998). Microscopic analyzers have also made use

of reagent strips (Bayer Diagnostics, Elkhart, IN; 1984)

Reagent strips currently provide a simple, rapid means for performing medically

significant chemical analysis of urine, including pH, protein, glucose, ketones, blood,

bilirubin, urobilinogen, nitrite, leukocytes, and specific gravity. The two major types of

reagent strips are manufactured under the trade names Multistix (Siemens Healthcare

Diagnostics, Deerfield, IN) and Chemstrip (Roche Diagnostics, Indianapolis, IN).

(Strasinger, 2008)

Reagent strips consist of chemical-impregnated absorbent pads attached to a plastic

strip. A color-producing chemical reaction takes place when the absorbent pad comes in

contact with urine. The reactions are interpreted by comparing the color produced on the
pad within the required time frame with a chart supplied by the manufacturer. Several

colors or intensities of a color for each substance being tested appear on the chart. By

careful comparison of the colors on the chart and the strip, a semiquantitative value of

trace, 1+, 2+, 3+, or 4+ can be reported. An estimate of the milligrams per deciliter present

is available for appropriate testing areas. Automated reagentstrip readers also provide

Système International units. (Strasinger, 2008)

According to Elkhart (1984), Reagent strip technology has been used to provide either

threshold or quantitative results for many analytes. Both applications are well described

for many clinical uses. Threshold tests are applied to analytes with well-established

clinical decision limits, based on large outcomes studies (eg, albuminuria, hCG), and have

well-defined differences between positive and negative test results. Quantitative tests are

more often applied to analytes that require measuring of the specific levels present over

a continuous range of values (eg, glucose or therapeutic drug monitoring) or do not have

well-established clinical outcomes or have smaller differences between decision levels

(eg, cholesterol risk assessment).