This product provides a preliminary result. For in vitro
diagnostic use only. A quantitative analytical method is needed to obtain a
confirmed result.
Instructions:
Reagents: The test contains a membrane strip coated with drug-protein conujugates
(purified bovine albumin) on the test line, a goat polyclonal antibody
against gold-protein conjugate at the control line, and a dye pad which
contains colloidal gold particles coated with mouse monoclonal antibody
specific to Amphetamine, Barbiturates, benzodiazepines, Cocaine, Marijuana,
Methadone, Methamphetamine, Methylenedioxy-methamphetamine, Morphine,
Oxycodone, Phencyclidine, Propoxyphene or Tricyclic Antidepressants.
Precautions:
For healthcare professionals including professionals at
point of care sites.
For in vitro diagnostic use only. Do not use after
the expiration date.
The test card should remain in the sealed pouch until use.
All specimens should be considered potentially hazardous
and handled in the same manner as an infectious agent.
The used test card should be discarded according to
federal, state, and local regulations.
Specimen Collection and Preparation: Urine Assay: 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. Specimen Storage: Urine specimens may be stored at 2-8°C for up to 48
hours prior to testing. For prolonged storage, specimens may be frozen and
stored below -20°C. Frozen specimens should be thawed and mixed well before
testing.
Materials Provided: One step drug screen test card
Package Insert
Materials Required but not Provided: Specimen collection container
Timer
External controls
Directions for Use:
Allow the test card, urine specimen,
and/or controls to equilibrate to room temperature (15-30°C) prior to
testing.
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. See
Illustration below:
Replace cap and place the test card on
a non-absorbent flat surface. Start the timer. Read the adulteration
strips between 3-5 minutes (when applicable) compare the colors on the
adulteration pads to the enclosed color chart. If the specimen indicates
adulteration, refer to your Drug Free Policy for guidelines on
adulterated specimens. We recommend not to interpret the drug test
results and either retest the urine or collect another specimen.
The drug strip results should be read
at 5 minutes.
Interpretation of Results: (please refer to
illustration above)
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 cut-off levels for a particular drug tested.
NOTE: The shade of the colored line(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 cut-off 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.
Limitations:
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.
Test does not distinguish between drugs of abuse and
certain medications.
* The products and the claims made about specific products on or through this
site have not been evaluated by
Maximum Nutrientsand are not approved to diagnose, treat, cure or prevent disease.
The information provided on this site is for informational purposes only and is
not intended as a substitute for advice from your physician or other health care
professional or any information contained on or in any product label or
packaging. You should not use the information on this site for diagnosis or
treatment of any health problem or for prescription of any medication or other
treatment. You should consult with a healthcare professional before starting any
diet, exercise or supplementation program, before taking any medication, or if
you have or suspect you might have a health problem. Please view our full
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