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the test card, urine specimen and/or controls to equilibrate to room
temperature (15-30°C (59-86°F)) prior to testing. |
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1. |
Remove the test
card from the sealed pouch and use it as soon as possible.
Remove the cap from the end of the test card. With arrows
pointing toward the urine specimen, immerse the strip(s) of the
test card vertically in the urine specimen for at least 10-15
seconds. Immerse the test card to at least the level of the wavy
lines on the strip(s), but not above the arrow(s) on the test
card. |
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2. |
Replace cap and place the test card on a non-absorbent flat
surface. Start the timer and wait for the colored line(s) to
appear. The results should be read at 5 minutes. Results remain
stable for up to four hours after test initiation. |
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Interpretation of Results |
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NEGATIVE*:
Two lines appear. A colored line appears in the Control region (C)
and a colored line appears in the Test region (T). This negative
result means that the concentrations in the urine sample are below
the designated cutoff levels for a particular drug tested. |
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*NOTE: The
shade of the colored lines(s) in the Test region (T) may vary. The
result should be considered negative whenever there is even a faint
line. |
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POSITIVE: A
colored line appears in the Control region (C) and NO line appears
in the Test region (T). The positive result means that the drug
concentration in the urine sample is greater than the designated
cutoff for a specific drug. |
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INVALID: No
line appears in the Control region (C). Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for
Control line failure. Read the directions again and repeat the test
with a new test card. If the result is still invalid, contact your
manufacturer. |
| A
procedural control is included in the test. A line appearing in the
Control region (C) is considered an internal procedural control. It
confirms sufficient specimen volume, adequate membrane wicking and
correct procedural technique. |
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Control standards are not supplied with this kit. However, it is
recommended that positive and negative controls be tested as good
laboratory practice to confirm the test procedure and to verify
proper test performance. |
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The
One Step Drug Screen Test Card provides only a qualitative,
preliminary analytical result. A secondary analytical method must be
used to obtain a confirmed result. Gas chromatography / mass
spectrometry (GC/MS) is the preferred confirmatory method. |
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There
is a possibility that technical or procedural errors, as well as
other interfering substances in the urine specimen may cause
erroneous results. |
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Adulterants, such as bleach and/or alum, in urine specimens may
produce erroneous results regardless of the analytical method used.
If adulteration is suspected, the test should be repeated with
another urine specimen. |
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A
Positive result does not indicate level of intoxication,
administration route or concentration in urine. |
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A
Negative result may not necessarily indicate drug-free urine.
Negative results can be obtained when drug is present but below the
cut-off level of the test. |
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