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INTENDED USE
In case of a positive result (when the specific drug is present in the urine sample INTERPRETATION OF TEST RESULTS
at a concentration above the cut-off level) the binding sites of the gold conjugated mulTcup4 is a one step qualitative immunoassay for the rapid determination
antibodies will be saturated by the drug (or drug metabolites) present in the of specific drugs in human urine specimens. The presence of the drugs and their sample and therefore will not bind to the drug molecules embedded on the Negative Result
metabolites can be detected in urine after only a few minutes. The test is intended membrane. As a result, a pink line will not appear near the indicated drug area.
for professional in vitro diagnostic use only.
A positive urine sample is to be confirmed by GC/MS as indicated.
If after 5-10 minutes 5 pink lines appear in the test result window (oneline at the Control area and one line next to each of 4 indicated drugs) A control line added to the membrane strip indicates that the the result is negative for all drugs (see diagram).
mulTcup4 is a unique product combining the specimen collector and test into
one device - a quick, reliable, easy to use, sensitive immunoassay for multiple drugs of abuse detection. All one needs to do is collect urine into the collection Store at room temperature (2-30°C) in the sealed pouch. Do not freeze.
test cup and within minutes the result appears on the outside of the cup. A color- change temperature strip is attached to the back of the cup in order to ensurethat the urine sample being tested is fresh and has not been exchanged.
The test is a quick screening test and provides a preliminary result. Positive MATERIALS PROVIDED
results must be verified using a more specific confirmatory method such asGC/MS. It is a qualitative assay and does not determine the concentration of the drug or the level of intoxication. The mulTcup4 test is based on the principle
2. mulTcup4 in a hermetically sealed pouch, which should be opened close
of highly specific immuno-chemical reactions of antigens and antibodies, which are used for the analysis of specific compounds in biological fluids. The Drugs Of Abuse Multitest Cup
mulTcup4 is a rapid visual screening test in human urine for the simultaneous,
qualitative detection of specific drugs of abuse at the cut-off levels specified
The meaning of negative result is that drug concentrations above the sensitivity level were not detected. It is possible that the lines PRECAUTIONS
1. For professional in vitro diagnostic use only.
SENSITIVITY
2. Handle all samples according to Good Laboratory Practice (GLP) principles.
3. For single use only.
Positive Result
The presence of drugs and their metabolites in the tested urine samples is detected when the concentration passes a certain minimal sensitivity level (cut-off level) 5. Pouch should remain sealed until ready for use.
If after 5-10 minutes one pink line appears at the Control area and there is no pink line next to the tested indicated drug, the result is positive for this specific drug (see diagrams).
SPECIMEN COLLECTION AND STORAGE
It is preferable to use fresh samples. If testing cannot be carried out on freshspecimens, urine may be refrigerated at 2-8°C without preservatives for 2 days, or frozen at -20°C for a longer period of time. Refrigerated specimens must be brought to room temperature prior to testing. Frozen specimens must be thawed, TEST PRINCIPLE
brought to room temperature, and mixed thoroughly prior to testing.
The mulTcup
4 is an immunochromatographic assay based on the principle of
a competitive antigen-antibody complex and is used for the analysis of specific TEST PROCEDURE
drug compounds in human urine samples.
After the urine sample is placed in the mulTcup4, specific antibodies, conjugated
1. Open the foil pouch and take out the mulTcup4 (discard the desiccant).
with colloidal gold particles, bind to the drug (or drug metabolites) molecules 2. The person tested should urinate into the cup to a level above the indicated if present in the tested sample. The sample then migrates chromatographically line (Approximtely 45ml). The exact volume over the line is not important.
along the membrane and reaches an area with immobilized drug Within seconds a pink color can be seen in the test result window.
molecules, embedded as a line, on the membrane.
The green-coloured lines, added to the membrane to mark where the reactions 3. Observing the test window at eye level, read the results within occur, are washed away as the sample migrates through the membrane.
The meaning of positive result is that drug concentrations were detected In case of a negative result, the binding sites of the gold conjugated antibodies 4. Do not interpret results appearing after 10 minutes.
above the sensitivity level of the test for each tested drug.
will not be saturated and therefore will bind to the drug molecules embedded on the membrane, forming a pink line near the indicated drug area.
mulTcup4 is a quick screening urine test and provides a preliminary
Ingestion of foods containing poppy seeds may cause a positive test result. The “poppy seed 2. Negative: Compounds that do not interfere with the test at the following concentrations
morphine”, when present in sufficient quantity, is detectable by all chemical and result only. Positive results must be verified, in a qualified laboratory, Compound
Compound
SPECIFICITY
using a more specific method to obtain a confirmed result. Gas mulTcup4 test for THC (cannabinoids) is very specific. The cannabinoids compounds showed
chromatography and mass spectrometry (GC/MS) is a preferred significant different cross reactivities in the test. Related compounds such as cannabidiol, cannabinol, 11-hydroxy-delta-9-THC, and delta-9-tetrahydrocannabinol at concentrations of 25, 50, 100 and 200 ng/ml produced negative results. Only the following compounds at the indicated concentration levels resulted as positive in this test. 11-nor-delta-9-tetrahydrocannabinol- SPECIFICITY
9-carboxylic acid at >50 ng/ml, 11-nor-delta-8-tetrahydrocannabinol-9-carboxylic acid at Invalid result
mulTcup4 detects benzoylecgonine in the urine. Urine samples with a pH between
>50 ng/ml, and 11-OH delta-9-THC at a concentration above 200 ng/ml. Urine samples with 4.6 to 8.0 showed no interference in either negative or positive (~150 ng/ml) test results.
a pH between 4.6 to 8.0 showed no interference in either negative or positive (~150 ng/ml) test results. Other compounds studied at concentrations as indicated showed to have no If no line appears at the control area, the test may not have been carried 1. Compounds that will produce a positive result
out according to instructions and no conclusion may be reached.
Compound
Concentration (ng/ml)
1. Compounds showed no interference with the test
The test should be repeated with a new device.
Compound
Concentration (mg/ml)
2. Compounds that will not interfere with negative or positive (1000 ng/ml of
benzoylecgonine) test results at concentrations indicated
Limitations
Substance
Concentration Levels
1. mulTcup
4 is a qualitative assay and does not determine the
In Positive Test
In Positive Test
In negative Test
concentration of the drug or the level of intoxication.
2. There is a possibility that technical errors or incorrect test procedure, REFERENCES
as well as interfering substances in the urine sample may cause 1. E. J. Cone, Anal. Toxicol., 1993, 17:156-164.
2. R.C. Baselt and R.H. Cravey, Disposition of Toxic Drugs and Chemicals in Man, 3. A negative result may not necessarily indicate drug-free urine. The 3rd ed, Year Book Medical Publ., Davis, U.S., 1989, pp. 208-213, 516-519, 575-579, 661- drug may be present below the cut-off level of the test.
3. Dept. of Health and Human Services; Alcohol, Drug Abuse and Mental Health Administration; 4. Clinical considerations and professional judgement should be applied Mandatory Guidelines for Federal Workplace Drug Testing Program, Federal Register, 2. Compounds that do not interfere with the test at a concentration of 100 µg/ml
4. A.J. McBay, Clin. Chem. 1987, 33: 33B-40B.
5. Handle all samples according to good laboratory practice.
5. Norbert W. Tietz, Textbook of Chemistry, W.B. Saunders Company, 1986, p. 1735.
6. Urine Testing for Drugs of Abuse, NIDA, Research Monograph, 1986, p. 73.
7. S.L. Kanter and L.E. Hollister, Res. Comm. Chem. Path. Pharm. 1977, 17: 421-431.
PERFORMANCE CHARACTERISTICS
MORPHINE
3. Compounds added to human urine at listed quantity showed no interference with the
SPECIFICITY
test results for the negative (0 ng/ml), or positive urine controls (at about 120 ng/ml)
muTcup4 detects morphine and morphine glucuronide (the major metabolite of heroin) in
the urine. The assay also detects codeine, hydromorphine, and levorphanol. The analgesic mepiridine and the narcotic antagonist nalorphine are not detected at high concentrations.
Urine samples with pH between 4.5 to 8.0 showed no interference in either negative or positive 1. Cross-reactive substances (compound detected)
Compound
Concentration (ng/ml)
METHAMPHETAMINE
SPECIFICITY
The following compounds will produce either positive or negative readings for 2. Compounds that do not interfere with Morphine at a concentration of 100 µg/ml
Methamphetamine with the mulTcup4 test.
1. Positive: Interference substances (compound detected)
Concentration µg/ml
3. Compounds added to human urine at the listed quantity showed no interference
with the test results

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