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- For in vitro diagnostic and professional use only.
- Do not use the test device beyond the expiration date.
- Urine specimens may be infectious; properly handle and
dispose of all used reaction devices in a biohazard container.
- Visually inspect the foil package to insure it is intact.
If the package is not intact, the integrity of DrugCheck 5 TM
might be compromised.
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Store test kit below 28°C (83°F); do not freeze. If stored
at 2°-8°C (36°-46°F), allow the test kit to reach room temperature (15°-28°;
59°-83°F) before performing the test. Refer to the expiration date for stability.
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Fresh urine specimens should be collected directly into
the cup and do not require any special handling or pretreatment. No additives
or preservatives are required. Note: Urine specimens can be transferred from
a urine collection container into DrugCheck 5 TM,
if necessary.
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- Do not break the seal of the pouch until ready to begin
testing.
- Remove DrugCheck 5 TMfrom
the foil pouch.
- Collect a urine specimen directly into DrugCheck 5 TM.
Ensure the sample is no less than 1/2 oz and does not exceed 2 oz., as indicated
by the graduations on the side of DrugCheck 5 TM.
- Read the results at 5 minutes. Note:
The result must be interpreted at five minutes. Waiting more than five
minutes may cause the reading to be inaccurate.
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Confirm: A rose-pink band is visible in each control zone. No color
band appearing in the appropriate test zone indicates a preliminary
positive result for the corresponding drug of that specific test
zone. Send urine specimen to a certified laboratory for confirmation.
Negative: A rose-pink band is visible in each
control zone and the appropriate test zone, indicating that the
concentration of the corresponding drug of that specific test zone
is below the detection limit of the test.
Retest: If a color band is not visible in each
of the control zones, the test is invalid. Another test should be
run to re-evaluate the specimen.
Note: There is no meaning
attributed to line color intensity or width.
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An internal procedure control has been incorporated
into the test to ensure proper kit performance and reliability.
The use of an external control is recommended
to verify proper kit performance. Quality control samples should
be tested according to quality control requirements established
by the testing laboratory.
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- This product is designed to be used for the
detection of drugs of abuse and their metabolites in human urine
only.
- Although the test is very accurate, there
is the possibility false results will occur due to the presence
of interfering substances in the specimen sample.
- The test is a qualitative screening assay
and is not suggested for quantitative determination of drug levels
in urine, or the level of intoxication.
- Adulterants such as bleach or other strong
oxidizing agents, when added to urine specimens, can cause erroneous
test results regardless of the analysis method used. If adulteration
is suspected, obtain another urine specimen.
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1 (Table of Contents) - 2-3-4-5-6
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