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 following drugs:
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
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 band.
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 active.
Reagents and materials provided
1. Test Devices.
and immobilized antigen
in protein matrix with sodium azide.
buffered protein solution with sodium azide.
THC at 150 ng/ml in a buffered solution with sodium azide.
MOR at 1000 ng/ml in a buffered protein solution with sodium
BEG at 1000 ng/ml in a buffered
protein solution with sodium azide.
Materials required but not
Clock or timer.
Specimen collection containers.
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic and
professional use only.
2. Do not
use the test device beyond the expiration date.
specimens may be infectious; properly handle and dispose of all used
reaction devices in a biohazard container.
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
test kit below 28°C;
do not freeze. Refer to the
expiration date for stability.
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.
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.
Positive: A rose-pink band is
visible in each control zone. No color band appearing in the appropriate
test zone indicates a positive result for the corresponding drug of that
specific test zone.
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.
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.
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
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.
Sensitivity. 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.
Specificity. A 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 Table II.
of drug-related compounds showing positive response approximately
equivalent to the cut-off set for the test:
Opiates-related substances yield a positive result for Opiates:
Morphine-3-b-D-Glucuronide 300 ng/ml
The following Marijuana-related substances yield positive results for
Cocaine-related substances yield positive results for Cocaine: