SCREEN DRUG TEST URINE 5 Instructions for use for each combination test for 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 the expiration date. • Keep 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 kept in the closed pouch until ready to use. Do not freeze. Do not use after the expiration date. INTENDED USE AND SUMMARY Screening test for the simultaneous detection of several drugs. The speed and sensitivity of immunological tests 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, instrument-free detection of the following drugs. TestCalibratorCut-off (ng/ml) Cocaine (COC) benzoylecgonine 300 Amphetamine (AMP) D-amphetamine 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 should be used to confirm the analytical result. Gas chromatography and mass spectrometry (GC/MS) are considered preferred confirmatory methods. Any result for the determination of 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 stimulation of the central nervous system 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 through inhalation, smoking, or ingestion. MARIJUANA (THC) Tetrahydrocannabinol is the active ingredient in cannabis. When smoked or taken orally, THC produces euphoria. Regular users experience short-term memory impairment and learning delays, and may also experience 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. Opioids 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 relevant strip. The colored line will not form in the relevant region 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 colored line to form due to competition from the drug, while a urine specimen negative for the drug being tested or a specimen containing a drug concentration below the cut-off will cause the colored line to form in the specific test region. As a procedural control, a colored band will appear in the appropriate 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 immunoassay 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. Immerse 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 THE RESULTS Negative*: One colored line appears in the control region (C) and a second colored line appears 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 line 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 likely causes for the control band not appearing are insufficient sample volume or incorrect analytical procedure. Recheck the procedure and repeat the test using a new panel. If the problem persists, discontinue use of 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. Seek advice from your doctor, a psychologist, or contact the appropriate service 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 a 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 that positive and negative controls be tested, as 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. A second analytical method is required. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for positive results. 2. 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 sample and may cause erroneous results regardless of the analytical method used. If the presence of such substances is suspected, the test should 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 occur when the drug is present but at a concentration below the test cutoff level. 6. The test cannot distinguish between the drug and a medicine containing the same substance. False positives can be caused by some drugs. FORMAT • 1 urine container. • 1 Urine Drug Test 5. • 1 leaflet