The urine specimen must be collected in a clean and dry
container. Urine collected at any time of the day may be used.
Urine specimens exhibiting visible precipitates should be
centrifuged, filtered, or allowed to settle to obtain a clear
specimen for testing.
Urine specimens may be stored at 2-8°C (36-46°F) for up to 48
hours prior to testing. For prolonged storage, specimens may be
frozen and stored below -20°C (-4°F). Frozen specimens should be
thawed and mixed well before testing.
Allow the
test card, urine specimen and/or controls to equilibrate to room
temperature (15-30°C (59-86°F)) prior to testing.
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.
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.
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.
*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.
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.
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.
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.
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.
·
There is a
possibility that technical or procedural errors, as well as other
interfering substances in the urine specimen may cause erroneous
results.
·
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.
·
A Positive
result does not indicate level of intoxication, administration route or
concentration in urine.
·
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.
Drugs of Abuse
Information includes synonyms, street names, trade names for
prescription drugs, therapeutic drugs class, drug description, and
drug/metabolite excretion information. The following specific drugs are
discussed:
