Instructions for use for each combination test of the following drugs: amphetamine, methamphetamine, cocaine, marijuana and opiates.
Single-step test for the simultaneous qualitative determination of drugs and their metabolites in human urine.
PRECAUTIONS Product not intended for medical or diagnostic use.
• Do not use beyond expiration date.
• Store the test strip panel in the closed pouch until ready to use.
• All samples must be considered potentially hazardous and therefore, must be handled with the precautions for use with potentially infectious products.
• After use, the panel must be disposed of in accordance with local regulations.
Store in the closed container at a temperature between 2° and 30°C.
The test strip panel is stable until the expiration date indicated on the package label.
The test strip panel should be stored in the closed pouch until ready to use.
Do not freeze.
Do not use beyond the expiration date.
INTENDED USE AND SUMMARY Screening test for the simultaneous detection of several drugs.
The rapidity and sensitivity of immunoassays have led them to be considered the most accepted urine screening tests for the simultaneous detection of drugs of abuse.
The One Step Test Strip Panel (Urine) is a rapid lateral flow immunochromatographic test for the qualitative determination of the following drugs without the aid of instruments.
| Test |
Calibrator |
Cut-off (ng/ml) |
| Cocaine (COC) |
benzoilecgonina |
300 |
| Amphetamine (AMP) |
D-amfetamine |
1.000 |
| Methamphetamine (mAMP) |
D-Methamphetamine |
1.000 |
| Marijuana (THC) |
11-nor-Δ9-THC-9 COOH |
50 |
| Opiates (OPI) |
morphine |
2.000 |
This test provides preliminary analytical data only. More specific chemical methods must be used to confirm the analytical result.
Gas chromatography and mass spectrometry (GC/MS) are considered preferred confirmatory methods.
Any test result for the presence of drugs of abuse must be related to clinical considerations and professional judgment, particularly when the preliminary result is positive.
Rapid urine screening test that does not require the use of special instruments.
The test uses antibodies to selectively detect elevated levels of specific substances in human urine.
Dwell times are approximate for each substance as they vary based on frequency of use, body mass, age, health status, drug tolerance, and urine pH.
It detects the presence of narcotic substances in urine only after their metabolization.
COCAINE (COC) Cocaine is a potent central nervous system stimulant and local anesthetic derived from the coca plant.
The substance is often self-administered by inhalation or intravenous injection or by smoking the base substance.
AMPHETAMINE (AMP) Amphetamine is a substance also used for therapeutic purposes.
The substance is often self-administered by inhalation or ingestion.
High doses produce enhanced central nervous system stimulation and induce euphoria, alertness, reduced appetite, and a sense of increased energy and strength.
More acute reactions produce anxiety, paranoia, hallucinations, and psychotic behavior.
METHAMPHETAMINE (mAMP) Methamphetamine is a potent stimulant chemically related to amphetamine, but with a greater capacity for central nervous system stimulation.
The substance is often self-administered by inhalation, smoking, or ingestion.
MARIJUANA (THC) Tetrahydrocannabinol is the active ingredient in cannabis.
When smoked or taken orally, THC produces euphoria.
Regular users have short-term memory impairment and learning delays, and may also have transient episodes of confusion and anxiety.
Relatively heavy long-term use may be associated with behavioral disturbances.
OPIOIDS (OPI) The class of opiates refers to any substance derived from the opium poppy, including natural compounds such as morphine, codeine, and semi-synthetic substances such as heroin.
Opiates act on pain control by depressing the central nervous system.
Withdrawal symptoms may include sweating, shaking, nausea, and irritability.
Opioids can be taken orally or by intravenous, intramuscular, and subcutaneous injection.
Consumers can also take the substance intravenously or by inhalation.
PRINCIPLE The One Step Test Strip Panel (Urine) is a rapid immunochromatographic test based on the principle of competitive binding.
Drugs that may be present in the urine sample compete with their conjugate for the same binding sites on the antibody.
During the test, a urine sample migrates by capillary action along the membrane.
A drug, if present in the urine sample, at a concentration lower than its cut-off, will not be able to saturate all the binding sites of the particles bound to the relevant antibodies present in the strip.
The antibody-bound particles will be captured by the immobilized conjugate and a visible colored band will appear in the test band region of the appropriate strip.
The colored line will not form in the relevant area if the drug level is above its cut-off, as all the binding sites of the relevant antibodies will be saturated.
A urine specimen positive for the drug being tested will not cause the formation of the colored line due to competition from the drug, while a urine specimen negative for the drug being tested or a specimen containing a concentration of the drug below the cut-off will cause the formation of the colored line in the specific test region.
As a procedural control, a colored band will appear in the test region, indicating that the correct amount of sample has been used and that migration onto the membrane has occurred.
REAGENTS Each strip of the panel contains mouse monoclonal antibodies bound to the particles and the corresponding.
The One Step Test Strip Panel (Urine) is a rapid lateral flow immunochromatographic test conjugated for each drug.
Goat antibodies are used for the control band.
SAMPLE COLLECTION AND PREPARATION Collect the urine sample in a clean, dry container.
Urine samples collected at any time of the day can be used.
Urine samples with obvious precipitate should be centrifuged, filtered, or allowed to settle to obtain a clear sample for testing.
Urine samples can be stored at 2-8°C for up to 48 hours.
For long-term storage, samples can be frozen and stored below -20°C.
Before using frozen samples, they must be thawed and thoroughly homogenized.
PROCEDURE FOR USE 1. Before opening the package, bring it to room temperature.
Remove the product from the package and use it as soon as possible.
2. Remove the cap from the strips. Immerse the product vertically, in the direction of the arrows, into the urine sample for at least 10/15 seconds. Dip the product up to the level of the wavy lines on the strips but not above them.
3. Replace the cap on the device and place the product horizontally on a flat, non-absorbent surface. Read the result after 5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS Negative*: One colored line appears in the control region (C) and a second in the test region (T) for each drug indicating a negative result. A negative result indicates that the concentration of the drug in question in the urine is below the detectable cut-off level for that specific drug.
*The color tone in the test region (T) may vary, but should be considered negative whenever a faint colored band appears. Positive: A colored line appears in the control region (C) but not in the test region (T) for each drug indicating a positive result. A positive result indicates that the concentration of the drug in question in the urine is above the detectable cut-off level for that specific drug.
Invalid: the control band (C) does not appear. The most plausible causes for the failure to appear of the control band could be an insufficient sample volume or an incorrect analytical procedure.
Recheck the procedure and repeat the test using a new panel. If the problem persists, stop using the kit immediately and contact your local distributor.
If the test is positive, avoid aggressive behavior and calmly seek a dialogue with the person concerned.
Get advice from your doctor, a psychologist or contact the service that is competent for your area.
QUALITY CONTROL The test includes an internal control system consisting of the red band appearing in the control region (C).
The appearance of this band confirms that the test was performed correctly with sufficient sample volume, that the membrane absorbency was adequate and that the procedure was correct.
Standard controls are not provided with the kit; however, it is recommended to test positive and negative controls, as a good laboratory practice, to confirm the test procedure and verify its correct performance.
LIMITS 1. The One Step Test Strip Panel (Urine) provides only a preliminary qualitative analytical result. It is necessary to adopt a second analytical method. Gas chromatography/mass spectrometry (GC/MS) are considered the preferred confirmatory methods if the test is positive.
2. It is possible that technical or procedural errors, as well as interfering substances present in the urine sample, may cause erroneous results.
3. Adulterants, such as bleach and/or alum, may be present in the urine specimen and may cause erroneous results regardless of the analytical method used. If the presence of such substances is suspected, the test must be repeated with another urine sample.
4. A positive result indicates the presence of the drug or its metabolites but not the level of intoxication, route of administration or concentration in urine.
5. A negative result does not necessarily mean that the urine sample is drug-free. A negative result may be obtained when the drug is present but at a concentration below the test cut-off level.
6. The test cannot distinguish between the drug and a medicine containing the same substance. False positives may be caused by some medicines.
FORMAT • 1 urine container.
• 1 Droga Test Urina 5.
• 1 leaflet.
