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Microsoft word - urinecheck-7 102010.doc

TECO DIAGNOSTICS
UrineCheck 7
Drug Adulteration
Test Strip

For in vitro use only. Read all instructions, precautions, and
method that gives distinguishable colors over wide pH range. limitations before performing this test. The colors range from orange (low pH) to yellow and green to INTENDED USE
Teco UrineCheck 7 is a fast dip-and-read test for the Specific Gravity: Testing for sample dilution. This test is
determination of diluted or adulterated urine specimens. It is an based on the apparent pKa change of certain pretreated important pre-screening test for any drug-testing program. polyelectrolytes in relation to the ionic concentration. In the presence of an indicator, the colors range from dark blue or SUMMARY AND EXPLANATION
blue-green in urine of low ionic concentration to green and UrineCheck 7 drug adulteration tests are firm plastic strips to yellow in urine of higher ionic concentration. which seven different reagent areas are affixed. UrineCheck 7 test strips are ready-to-use and disposable. No equipment is Bleach: Testing for the presence of bleach in urine. In this test,
required for its use. Only fresh and uncentrifuged urine the presence of bleach forms a blue-green color complex. samples without preservatives are to be used. Pyridium Chlorochromate: Testing for the presence of
UrineCheck 7 provides tests for Creatinine, Nitrite, pH, chromate in urine. In this test, the presence of chromate forms a Specific Gravity, Glutaraldehyde, Bleach, and Pyridium Chlorochromate in urine. Test results may be useful for assessing the integrity of the urine sample prior to REAGENTS (Based on dried weight at time of impregnation)
Drugs-of-Abuse testing. For example, whether the sample is Creatinine:
possibly diluted with water or other liquids as indicated by the 44.6% w/w Lithium Hydroxide Monohydrate; 18.2% w/w creatinine and specific gravity tests. UrineCheck 7 detects 3.5-Dinitrobenzoic Acid; 37.2% w/w nonreactive ingredients. whether the sample contains commercially available adulterants including nitrite, glutaraldehyde, bleach, Glutaraldehyde:
pyridinium chlorochromate and other oxidizing agents. 2.4% w/w Sodium Hydrosulfite; 0.016% w/w Pararosaniline; UrineCheck 7 can also assess whether the sample is possibly contaminated by acidic (vinegar) or basic (ammonia solution) adulterants as indicated by the pH test. Nitrite:
1.4% w/w p-arsanilic acid, 98.6% w/w nonreactive ingredients. TEST PRINCIPLE
In general, all seven tests are based on the chemical reactions of the indicator reagents on the pads with components in the urine 1.4% w/w Bromothymol Blue; 0.4% w/w bromocresol blue; sample effecting color changes. Results are obtained by 0.5% w/w Thymol Blue; 0.02% w/w Bromophenol Blue; comparing the color on each of the test pads with the corresponding pad on the container color chart label. Specific Gravity:
Creatinine: Testing for sample dilution. In this assay,
4.2% w/w Bromothymol Blue; 95.8% w/w nonreactive creatinine reacts with a creatinine indicator in an alkaline condition to form a purplish-brown color complex. The concentration of creatinine is directly proportional to the color 0.65% w/w Peroxidase; 6.75% w/w Tetramethylbenzidine. 2HCl; 92.6% w/w nonreactive ingredients. Glutaraldehyde: Testing for the presence of exogenous
aldehyde. In this assay, the aldehyde group on the Pyridium Chlorochromate:
glutaraldehyde reacts with an indicator to form a pink/purple 0.7% w/w Peroxidase; 6.8% w/w Tetramethylbenzidine. 2HCl; Nitrite: Testing for the presence of exogenous nitrite. Nitrite
reacts with an aromatic amine to form a diazonium compound 1. Store at room temperature between 15 oC – 30 oC. in an acid medium. The diazonium compound in turn couples 2. All test strips should be stored in the original container. with an indicator to produce a pink-red/purple color. pH: Testing for the presence of acidic or alkaline adulterant.
4. Remove only as many strips required for testing and This test is based on the well-known double pH indicator immediately recap the container tightly. LIMITATIONS
Comparison to the color chart is dependent on the interpretation PRECAUTIONS
of the individual. It is therefore, recommended that all UrineCheck 7 test strips are for in vitro diagnostic use. Do not 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 SPECIMEN COLLECTION
based on any single test result or method. 1. Collect urine in a clean glass or plastic container. 2. Test urine sample as soon as possible after collection. Some compounds or physical properties that may affect the test Refrigerate urine sample immediately if the sample cannot result are listed below. Medications that discolor the urine may be tested within one hour. Bring refrigerated sample to also cause abnormal results due to masking of the reactions of room temperature and mix thoroughly before testing. 3. Do not centrifuge or add preservatives to the urine sample. 4. Handle the urine sample as if it is potentially infectious. EXPECTED VALUES
5. Aliquot a small portion of the urine sample into another Creatinine: Daily creatinine excretion, related to muscle mass
container for testing in order to avoid contamination of the of the human body, is usually constant6. The DOT guideline1 whole urine sample. Do not dip UrineCheck 7 directly into 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 PROCEDURE
distribution2, sample with creatinine level of lower than 20 1. Remove from the bottle only enough strips for immediate 2. Completely immerse reagent areas of the strip in fresh, Glutaraldehyde: Glutaraldehyde is not a natural component
well-mixed urine. Remove the strip immediately to avoid of human urine and it should not be present in normal urine. The presence of glutaraldehyde in the urine sample indicates 3. While removing, touch the side of the strip against the rim the possibility of adulteration. However, false positive may of the urine container to remove excess urine. Blot the result when ketone bodies are presence in urine. Ketone bodies lengthwise edge of the strip on an absorbent paper towel to may appear in urine when a person is in ketoacidosis, starvation further remove excess urine and avoid running over (contamination from adjacent reagent pads.) 4. Compare each reagent area to its corresponding color Nitrite: Although nitrite is not a normal component of urine,
blocks on the color chart and read at the times specified. nitrite levels of up to 3.6 mg/dl may be found in some urine Proper read time is critical for optimal results. specimens due to urinary tract infections, bacterial 5. Obtain results by direct color chart comparison. contamination or improper storage. In the UrineCheck 7, nitrite level above 7.5 mg/dl is considered abnormal.
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 Note: All reagent areas may be read between 1 - 2 minutes for obtained in the presence of moderate quantities of protein. screening positive urine from negative urine. Changes in color DOT guidelines1 state that a urine specimen with specific after 2 minutes are of no diagnostic value. gravity level of less than 1.003 is an indication of adulteration. Specific gravity and creatinine values should be considered INTERPRETATION OF RESULTS
together to provide a better picture of whether the sample is 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. Bleach: The presence of any bleach in urine is indicative of
adulteration as bleach is not a normal constituent of urine. QUALITY CONTROL
For best results, performance of reagent strips should be Pyridium Chlorochromate: The presence of any chromate in
confirmed by testing known negative and positive specimens or urine is indicative of adulteration as chromate is not a normal controls whenever a new test is performed or whenever a new bottle is first opened. Each laboratory should establish its own goals for adequate standard of performance, and should question handling and testing procedures if these standards are REFERENCES
1. U.S. Department of Transportation, Drug Testing 2. Young, D.S.et al, Clinical Chemistry, 21 (9), 1975. 3. Friedman, R.B. et.al. Clinical Chemistry: 26 (4), 1980. 4. Tietz, N.W. Clinical Guide to Laboratory Tests, Third Edition, W.B. Saunders Company, p566, 1995. 5. Chu, S.Y. and Sparks. Clinical Chemistry, 17, 1984. 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 Laboratory Methods, 16th Ed. Philadelphia: Saunders; (1979).
D700: 04/2008

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