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.
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.
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
1.
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.
2.
Creatinine: Normal creatinine
levels are between 20 and 350 mg/dL. Under rare conditions,
certain kidney diseases may show dilute urine.
3.
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.
4.
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.
5.
Specific Gravity: Elevated
levels of protein in urine may cause abnormally high specific
gravity values.
6.
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
1.
Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company.
1986, 1734.
2.
Tsai, S.C. et.al., J. Anal. Toxicol. 1998; 22 (6): 474
3.
Cody, J.T., “Specimen Adulteration in drug urinalysis. Forsenic Sci.
Rev., 1990, 2:63.
4.
Mikkelsen, S.L. et.al., Clin. Chem. 1988; 34: 648
5.
Hardman J, Limbird LE (Eds). Goodman & Gilman’s The
Pharmacological Basis of
Therapeutics, 10th Ed.,
McGraw-Hill Publishing. 2001, 1010.