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SCREEN DRUG TEST opioids Instructions for use for each combined test of the following drugs: amphetamine, benzodiazepine, cocaine, marijuana, methyldioxymethamphetamine, ketamine, opiates, synthetic marijuana k2/spice. One-step test for the simultaneous qualitative determination of drugs and their metabolites in human urine. Precautions The product is not intended for medical or diagnostic use. Do not use after the expiration date. Keep the test strip panel in the sealed pouch until ready to use. All samples should be considered potentially hazardous and therefore should be handled with the precautions necessary 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 sealed pouch until use. Do not freeze. Do not use after the expiration date. Intended use and summary Screening test for the simultaneous detection of multiple drugs. The speed 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 (Urine) is a rapid lateral flow immunochromatographic assay for the qualitative determination of the following drugs without the aid of instruments: TestCalibratorReduction threshold (ng/ml) Cocaine (COC) Amphetamine (AMP) Methyldioxymethamphetamine (MDMA) Marijuana (THC) Opiates (OPIs) Benzodiazepine (BZO) Ketamine (KET) Synthetic marijuana k2/spice benzolechnogin d-Amphetamine D,L-methyldioxymethamphetamine 11-nor- Δ9 -THC-9COOH morphine Oxazepam ketamine jwh-018 and jwh-073 300 1,000 500 50 2,000 300 1,000 50 This test provides only preliminary analytical data. More specific chemical methods must be used to confirm the analytical result. Gas chromatography/mass spectrometry (GC/MS) are considered the preferred confirmatory methods. Any result for determining the presence of drugs of abuse must be correlated with clinical considerations and professional judgment, especially when the preliminary result is positive. It is a rapid urine screening test that does not require the use of special instruments. The test uses antibodies to selectively detect high levels of specific substances in human urine. Residence times are approximate for each substance as they vary depending on frequency of use, body mass, age, health status, drug tolerance and urine pH. The product detects the presence of narcotic substances in urine only after they are metabolized. COCAINE (COC) Cocaine is a powerful 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 increased stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a feeling of increased energy and strength. More acute reactions produce anxiety, paranoia, hallucinations, and psychotic behavior. METHYLDIOXIMETHAMPHETAMINE (MDMA) Ecstasy is not a stimulant, although it has, along with amphetamines, the ability to increase blood pressure and heart rate. It produces some changes in perception, such as increased sensitivity to light, difficulty focusing, and blurred vision. The effect that occurs in practically everyone who takes this substance is that of jaw clenching. 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 have transient episodes of confusion and anxiety. Relatively heavy, long-term use may be associated with behavioral disorders. OPIOIDS (OPIs) 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 work on pain control by depressing the central nervous system. Withdrawal symptoms may include sweating, tremors, nausea, and irritability. Opioids can be administered orally or by intravenous, intramuscular, and subcutaneous injections. Users can also administer the substance intravenously or by inhalation. BENZODIAZEPINES (BZO) These are commonly prescribed medications for the symptomatic treatment of anxiety, sleep disorders, epileptic seizures, and alcohol withdrawal syndrome. Abrupt discontinuation can cause symptoms such as sleep disturbances, gastrointestinal upset, loss of appetite, sweating, tremors, weakness, anxiety, and changes in perception. KETAMINE (KET) Ketamine is a dissociative anesthetic for human and veterinary use. It is marketed in Italy under the names Ketalar, Ketanest and Ketaset, and in humans it is classified as an H drug and must be used exclusively in a hospital setting by an anesthesiologist-resuscitator. Like all neuro-psychoactive drugs, it can be abused and used for recreational purposes, being prohibited and sanctioned by law as a narcotic substance. SYNTHETIC MARIJUANA K2/SPICE (K2/SPICE) Synthetic marijuana, or K2, is a plant and psychoactive chemical that, when consumed, mimics the effects of marijuana. Better known by the trade names K2 and Spice, both of which are widely used to refer to any synthetic marijuana-based product. Principle The One-Step Test Strip Test (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 reaction threshold, will not be able to saturate all the binding sites of the particles bound to the relevant antibodies present on the strip. The antibody-bound particles will be captured by the immobilized conjugate, and a visible colored band will appear in the test strip region of the relevant strip. The colored line will not form in the relevant region if the drug level is above its cutoff threshold, as all binding sites of the relevant antibodies will be saturated. A urine sample positive for the test drug will not cause the colored line to form due to competition from the drug, while a urine sample negative for the test drug or a sample containing a drug concentration below the threshold 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 was used and that migration onto the membrane has occurred. REAGENTS Each lane of the panel contains particle-bound and corresponding mouse monoclonal antibodies. The One-Step Strip Test (Urine) is a rapid, conjugated lateral flow immunoassay 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 at temperatures below -20°C. Before using frozen samples, they must be thawed and thoroughly homogenized. How to 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. Insert the product vertically, in the direction of the arrows, into the urine sample for at least 10-15 seconds. Insert the product up to the level of the wavy lines on the strips, but not above them. 3. Replace the device cap 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 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 threshold level for that drug. *The color tone in the test region (T) may vary, but should be considered negative whenever a pale 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 threshold level for that drug. Invalid: control band (C) does not appear. The most plausible causes for the lack of a 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 in question. Seek advice from your doctor, a psychologist, or contact the appropriate service in your area. Quality control The test includes an internal control system consisting of the red band that appears 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 absorbance 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. limitation 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) are the preferred confirmatory methods if the test is positive. 2. Technical or procedural errors, as well as interfering substances present in the urine sample, may lead to erroneous results. 3. Adulterants such as bleach and/or alum may be present in the urine sample, which may lead to 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 does not contain a drug. A negative result can occur when the drug is present, but at a concentration below the test threshold. 6. The test cannot distinguish between the drug and a drug containing the same substance. False positive results may be caused by some drugs. Format • 1 urine container. • 1 Cocaine detection test. • the prospectus
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