a.k.a.
Specimen Validity Test (S.V.T.)
Is a rapid, one step screening test for the simultaneous detection of Creatinine, Nitrite, Glutaraldehyde, pH, Specific Gravity, and Oxidants/Pyridinium Chlorochromate (PCC) in human urine.
For forensic use only.
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INTENDED USE
The One Step S.V.T. is a semi-quantitative, color comparison screen for the detection of creatinine, nitrite, glutaraldehyde, pH, specific gravity, and oxidants / pyridinium chlorochromate (PCC) in human urine.
This test provides a preliminary screen only. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Abnormal results should be sent to a laboratory for confirmation.
SUMMARY
Each of the plastic strips contains six (6) chemically treated reagent pads. One (1) minute following the activation of the reagent pads by the urine sample, the colors that appear on the pads can be compared with the printed color chart on the canister. The color comparison provides a semi-quantitative screen for creatinine, nitrite, glutaraldehyde, pH, specific gravity, and oxidants/pyridinium chlorochromate (PCC) in hum an urine which can help assess the integrity of the urine sample.
PRINCIPLE
The test is based on the color derived from the chemical reaction between the chemical reagent on each test pad and the urine sample.
REAGENTS
Adulteration Pad | Reactive indicator | Buffers and non-reactive ingredients |
---|---|---|
Creatinine | 0.04% | 99.96% |
Nitrite | 0.07% | 99.93% |
Glutaraldehyde | 0.02% | 99.98% |
pH | 0.06% | 99.94% |
Specific Gravity | 0.25% | 99.7% |
Oxidants / PCC | 0.36% | 99.64% |
PRECAUTIONS
- For forensic use only. Do not use after the expiration date.
- The adulteration strips should remain in the sealed canister until use.
- All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
- The used test strip should be discarded according to federal, state and local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed canister at 15-30°C. The test strips must remain sealed in the canister until use. DO NOT FREEZE. Do not use beyond the expiration date. Avoid direct exposure to sunlight.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
The urine specimen must be collected in a clean and dry container. Test urine as soon as possible after collection.
Specimen Storage
For best results, test specimens immediately following collection. Storage of urine specimens should not exceed 2 hours at room temperature or 4 hours refrigerated (2-8°C) prior to testing.
MATERIALS
Materials Provided
- Each canister contains 25 S.V.T. Strips
- Package insert
Materials Required But Not Provided
- Timer
DIRECTIONS FOR USE
- Allow the adulteration strip to equilibrate to room temperature (15-30 C) prior to testing.
- Remove the strip(s) from the canister and recap tightly.
- Dip test strip into the urine specimen and remove immediately.
- Blot the test gently on its side to remove excess urine. NOTE: It is important to blot the test strip for consistent results.
- Read results in one (1) minute by comparing each pad with the color chart printed on the canister. Do not interpret test results after 4 minutes.
- If the test indicates adulteration, refer to your Drug Free Policy for guidelines on handling adulterated specimens.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
Semi Quantitative results are obtained by visually comparing the reacted color blocks on the strip to the printed color blocks on the canister. No instrumentation is required.
Quality Control
Control standards are not supplied with this kit. However, it is recommended that positive and negative specimens or controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.
LIMITATIONS
- The adulteration tests included with this product are meant to aid in the determination of abnormal specimens. While comprehensive, these tests are not meant to be an "all-inclusive" representation of possible adulterants.
- Creatinine: Normal creatinine levels are between 20 and 350 mg/dL. Under rare conditions, certain kidney diseases may show dilute urine.
- Nitrite: Nitrite is not a normal component of human urine. However, nitrite found in urine may indicate urinary tract infections or bacterial infections. Nitrite levels of > 20 mg/dL may produce false positive glutaraldehyde results.
- Glutaraldehyde: Is not normally found in urine. However certain metabolic abnormalities such as ketoacidosis (fasting, uncontrolled diabetes or high-protein diets) may interfere with the test results.
- Specific Gravity: Elevated levels of protein in urine may cause abnormally high specific gravity values.
- Oxidants/PCC: Normal human urine should not contain oxidants or PCC. The presence of high levels of antioxidants in the specimen, such as ascorbic acid, may result in false negative results for the oxidants/PCC pad.
BIBLIOGRAPHY OF SUGGESTED READING
- Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company. 1986, 1734.
- Tsai, S.C. et.al., J. Anal. Toxicol. 1998; 22 (6): 474
- Cody, J.T., Specimen Adulteration in drug urinalysis. Forsenic Sci. Rev., 1990, 2:63.
- Mikkelsen, S.L. et.al., Clin. Chem. 1988; 34: 648
- Hardman J, Limbird LE (Eds). Goodman & Gilman's The Pharmacological Basis of Therapeutics, 10th