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3 Panel Urine Drug Test Kit
The Multi-Drug InstaStrip
Test is an immunochromatographic assay for rapid,
qualitative detection of drugs and their principal
metabolites in urine at specified cut-off
concentrations. A combination is composed from any the
COCAINE/BENZOYLECGONINE 300 ng/ml
Note: The test provides
only preliminary data, which should be confirmed by
other methods such as gas chromatography/mass
spectrometry (GC/MS). Clinical considerations and
professional judgment should be applied to any drug of
abuse test result, particularly when preliminary
positive results are indicated.
Summary and explanation of the test
Multi-drug InstaStrip Test is an easy, fast,
qualitative, visually read competitive binding
immunoassay method for screening without the need of
instrumentation. The method employs unique mixture of
monoclonal and polyclonal antibodies to selectively
identify the drugs of abuse and their metabolites in
test samples with a high degree of sensitivity.
Drug abuse remains a growing social and economical concern in many developed and developing countries throughout the world. The above stated drugs are among the most frequently abused illicit drugs, according to the U.S. Substance Abuse and Mental Health Services Administration. Opiates are among a class of heavily abused prescription drugs.
The sensitivity of the
Multi-drug InstaStrip Test is set as required for the
screening immunoassays of these drugs in the reference
guidelines set by the National Institute on Drug Abuse (NIDA)
and the U.S. Department of Health and Human Services.
Principle of the test
Multi-drug InstaStrip Test is a competitive binding
immunoassay in which drug and drug metabolites in a
urine sample compete with immobilized drug conjugate for
limited labeled antibody binding sites. By utilizing
antibodies that are specific to different drug classes,
the test permits independent, simultaneous detection of
three drugs from a single sample. The approximate run
time is 5 minutes.
In the assay procedure,
urine mixes with labeled antibody-dye conjugate and
migrates along a porous membrane. When the concentration
of a given drug is below the detection limit of the
test, unbound antibody-dye conjugate binds to antigen
conjugate immobilized on the membrane, producing a
rose-pink color band in the appropriate Test Zone for
that drug. Conversely, when the drug level is at or
above the detection limit, free drug competes with the
immobilized antigen conjugate on the membrane by binding
to antibody-dye conjugate, forming an antigen- antibody
complex, preventing the development of a rose-pink color
Regardless of the drug
levels in the sample, a rose-pink color band is produced
in each Control Zone (marked “C”) by a parallel
immunochemical reaction. These bands serve as built-in
quality control measures by demonstrating antibody
recognition, verifying that the reagents are chemically
Reagents and materials provided
1. Test Devices. Contains dye-conjugated antibody and immobilized antigen in protein matrix with sodium azide.
Materials required but not provided
Clock or timer.
2. Specimen collection
WARNINGS AND PRECAUTIONS
1. For in vitro
diagnostic and professional use only.
2. Do not use the test
device beyond the expiration date.
3. 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
the device might be compromised.
Storage and and stability
Store test kit below 28°C;
do not freeze. Refer to the expiration date for
1. Bring a urine sample
and a foil test pouch to room temperature (15°-28°C).
2. Do not break the
seal of the pouch until ready to begin testing.
3. Remove a Test Device
from the foil pouch.
4. Remove the
protective cap and place the revealed strips into the
urine sample for 10 seconds. Do not allow the urine
level to touch the plastic device.
5. Read the results at 5 minutes.
The result must be interpreted
at five minutes. Waiting more than five minutes may
cause the reading to be inaccurate. To avoid confusion,
discard the test device after interpreting the result.
INTERPRETATION OF RESULTS
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.
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.
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
Limitations of the test
1. This product is
designed to be used for the detection of drugs of abuse
and their metabolites in human urine only.
2. 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.
3. The test is a
qualitative screening assay and is not suggested for
quantitative determination of drug levels in urine, or
the level of intoxication.
4. 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.
The Multi-drug InstaStrip Testdetects drugs of abuse and
their major metabolites in urine at concentrations equal
to or greater than the cut-off level for the specific
drug, which is suggested by the National Institute on
Drug Abuse (NIDA) for the immunoassay method.
study was conducted with the Multi-drug InstaStrip Test
to determine the cross-reactivity of drug-related
compounds with the test. Substances listed in Table I
produced results approximately equivalent to the cutoff
levels. A separate study was conducted to determine the
cross-reactivity of non-related compounds with the test
at concentrations much higher than normally found in the
urine of people using or abusing them. No cross
reactivity was detected with the substances listed in
Concentrations of drug-related compounds showing
positive response approximately equivalent to the
cut-off set for the test:
The following Opiates-related substances yield a positive result for Opiates:
The following Marijuana-related substances yield positive results for Marijuana:
The following Cocaine-related substances yield positive
results for Cocaine:
Cocaine 300 ng/ml
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