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Urine Drug Adulteration Test Strip

For in vitro use only. Read all instructions, precautions, and
limitations before performing this test. Specific Gravity: Testing for sample dilution. This test is
based on the apparent pKa change of certain pretreated INTENDED USE
polyelectrolytes in relation to the ionic concentration. In the Clarity Urine Drug Adulteration test strips are a fast presence of an indicator, the colors range from dark blue or dip-and-read test for the determination of diluted or adulterated blue-green in urine of low ionic concentration to green and urine specimens. It is an important pre-screening test for any yellow in urine of higher ionic concentration. Bleach: Testing for the presence of bleach in urine. In this test,
SUMMARY AND EXPLANATION
the presence of bleach forms a blue-green color complex. Clarity Urine drug adulteration tests are firm plastic strips to which seven different reagent areas are affixed. Clarity Urine Pyridium Chlorochromate: Testing for the presence of
test strips are ready-to-use and disposable. No equipment is chromate in urine. In this test, the presence of chromate forms required for its use. Only fresh and uncentrifuged urine samples Clarity Urine Drug Adulteration test strips provides tests for 1. Store at room temperature between 15 oC – 30 oC. Creatinine, Nitrite, pH, Specific Gravity, Glutaraldehyde, 2. All test strips should be stored in the original container. Do Oxidants, and Pyridium Chlorochromate in urine. Test results may be useful for assessing the integrity of the urine sample prior to Drugs-of-Abuse testing; for example, whether the 4. Remove only as many strips required for testing and sample is possibly diluted with water or other liquids as immediately recap the container tightly. indicated by the creatinine and specific gravity tests. Clarity Urine Adulteration Test strips detects whether the sample contains commercially available adulterants including nitrite, PRECAUTIONS
glutaraldehyde, bleach, pyridinium chlorochromate and other oxidizing agents. Clarity Urine Adulteration test strips can also assess whether the sample is possibly contaminated by acidic SPECIMEN COLLECTION
(vinegar) or basic (ammonia solution) adulterants as indicated 1. Collect urine in a clean glass or plastic container. 2. Test urine sample as soon as possible after collection. Refrigerate urine sample immediately if the sample cannot TEST PRINCIPLE
be tested within one hour. Bring refrigerated sample to In general, all seven tests are based on the chemical reactions room temperature and mix thoroughly before testing. of the indicator reagents on the pads with components in the 3. Do not centrifuge or add preservatives to the urine sample. urine sample effecting color changes. Results are obtained by 4. Handle the urine sample as if it is potentially infectious. comparing the color on each of the test pads with the 5. Aliquot a small portion of the urine sample into another corresponding pad on the container color chart label. container for testing in order to avoid contamination of the whole urine sample. Do not dip Clarity Urine directly into Creatinine: Testing for sample dilution. In this assay,
creatinine reacts with a creatinine indicator in an alkaline condition to form a purplish-brown color complex. The PROCEDURE
concentration of creatinine is directly proportional to the color 1. Remove from the bottle only enough strips for immediate 2. Completely immerse reagent areas of the strip in fresh, Glutaraldehyde: Testing for the presence of exogenous
well-mixed urine. Remove the strip immediately to avoid aldehyde. In this assay, the aldehyde group on the glutaraldehyde reacts with an indicator to form a pink/purple 3. While removing, touch the side of the strip against the rim of the urine container to remove excess urine. Blot the lengthwise edge of the strip on an absorbent paper towel to Nitrite: Testing for the presence of exogenous nitrite. Nitrite
further remove excess urine and avoid running over reacts with an aromatic amine to form a diazonium compound in (contamination from adjacent reagent pads.) an acid medium. The diazonium compound in turn couples with 4. Compare each reagent area to its corresponding color an indicator to produce a pink-red/purple color. blocks on the color chart and read at the times specified. Proper read time is critical for optimal results. Oxidants: Testing for presence of oxidizing reagents. In this
5. Obtain results by direct color chart comparison. reaction, a color indicator reacts with oxidants such as hydrogen peroxide, ferricyanide, persulfate, or pyridinium chlorochromate
to form a blue color complex. Other colors may indicate the
presence of other oxidants.
pH: Testing for the presence of acidic or alkaline adulterant.
This test is based on the well-known double pH indicator
method that gives distinguishable colors over wide pH range.
The colors range from orange (low pH) to yellow and green to
blue (high pH).
Note: All reagent areas may be read between 1 - 2 minutes for gravity and creatinine values should be considered together to screening positive urine from negative urine. Changes in color provide a better picture of whether the sample is adulterated. after 2 minutes are of no diagnostic value. Pyridium Chlorochromate: The presence of any chromate in
INTERPRETATION OF RESULTS
urine is indicative of adulteration as chromate is not a normal Semi-quantitative results are obtained by visually comparing the color of each pad with the corresponding test color block pictured on the container label. No equipment is required. REFERENCES
1. U.S. Department of Transportation, Drug Testing QUALITY CONTROL
For best results, performance of reagent strips should be 2. Young, D.S.et al, Clinical Chemistry, 21 (9), 1975. confirmed by testing known negative and positive specimens or 3. Friedman, R.B. et.al. Clinical Chemistry: 26 (4), 1980. controls whenever a new test is performed or whenever a new 4. Tietz, N.W. Clinical Guide to Laboratory Tests, Third bottle is first opened. Each laboratory should establish its own Edition, W.B. Saunders Company, p566, 1995. goals for adequate standard of performance, and should 5. Chu, S.Y. and Sparks. Clinical Chemistry, 17, 1984. question handling and testing procedures if these standards are 6. Tingsrud, K.M. and Linne, J.J., Urinalysis and body Fluids A color Test and Atlas, Mosby-Year Book, Inc., 1995. 7. Henry, J.B. et al.: Clinical Diagnosis and Management by LIMITATIONS
Laboratory Methods, 16th Ed. Philadelphia: Saunders; Comparison to the color chart is dependent on the interpretation of the individual. It is therefore, recommended that all laboratory personnel interpreting the results of these strips be tested for color blindness. As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any Diagnostic Test Group LLC
33 SE 8th Street, Boca Raton-33432
Tech Support: 1-877-485-7877
Some compounds or physical properties that may affect the test result are listed below. Medications that discolor the urine may Email:techsupport@claritydiagnostics.com
also cause abnormal results due to masking of the reactions of EXPECTED VALUES
Creatinine: Daily creatinine excretion, related to muscle mass
of the human body, is usually constant6. The DOT guideline1 Rev: 0111242010
states that urine specimens with creatinine levels of less than 20 mg/dl are indications of adulteration. Although these ranges are affected by age, sex, diet, muscle mass and local population distribution2, sample with creatinine level of lower than 20 mg/dl
should be considered adulterated.

Glutaraldehyde:
Glutaraldehyde is not a natural component of
human urine and it should not be present in normal urine. The
presence of glutaraldehyde in the urine sample indicates the
possibility of adulteration. However, false positive may result
when ketone bodies are presence in urine. Ketone bodies may
appear in urine when a person is in ketoacidosis, starvation or
other metabolic abnormalities.

Nitrite
: Although nitrite is not a normal component of urine,
nitrite levels of up to 3.6 mg/dl may be found in some urine
specimens
contamination or improper storage.
Oxidants: The presence of oxidizing reagents in the urine is
indicative of adulteration since oxidizing reagents are not
normal constituents of urine. Oxidizing reagents include
Hydrogen Peroxide, Ferricyanide, Persulfate, and Pyridinium
Chlorochromate…etc.
pH: Normal urine pH ranges from 4.5 to 8.0. Values below pH
4.0 or above pH 9.0 are indicative of adulteration.
Specific Gravity: Random urine may vary in specific gravity
from 1.003 - 1.030. Normal adults with normal diets and normal
fluid intake will have an average urine specific gravity of 1.016 -
1.0227. Elevated urine specific gravity value may be obtained in
the presence of moderate quantities of protein. DOT
guidelines1 state that a urine specimen with specific gravity level
of less than 1.003 is an indication of adulteration. Specific

Source: http://www.claritydiagnostics.com/files/inserts/DTG-ADUSTP%20PI.pdf

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