Instructions for use for each test combination of the following drugs: methamphetamine methadone, amphetamine barbiturates, tricyclic antidepressants phencyclidine, cocaine, marijuana, opiates, benzodiazepines.
One-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 for use.
• All samples must be considered potentially dangerous and therefore must be handled with the precautions for use relating to potentially infectious products.
• After use, the panel must be disposed of according to local regulations in force.
Store in the closed packaging at a temperature between 2 ° and 30 ° C.
The test strip panel is stable until the expiration date printed on the package label.
The test strip panel should be stored in the closed pouch until ready for use.
Do not freeze.
Do not use beyond the expiration date.
Intended Use and Summary Screening test for the simultaneous determination of several drugs.
The speed and sensitivity of immunological tests have led them to be considered the most accepted as urine screening tests for the simultaneous detection of drugs of abuse.
The One Step Test Strip Panel (Urine) is a lateral flow immunochromatographic rapid test for the qualitative determination of the following drugs without the aid of tools:
Test | Calibrator | Cut-off (ng / ml) |
Methamphetamine (MET / MDMA) | d-Methamphetamine | 1000 |
Methadone (MTD) | Methadone | 300 |
Amphetamine (AMP) | d-Amphetamine | 1000 |
Barbiturates (BAR) | Secobarbital | 300 |
Tricyclic Antidepressants (TCAs) | Nortriptyline | 1000 |
Phencyclidine (PCP) | Phencyclidine | 25 |
Cocaine (COC) | Benzoylecgonine | 300 |
Marijuana (THC) | 11-nor-Δ9 -THC-9 COOH | 50 |
Opiates (OPI) | Morphine | 2000 |
Benzodiazepines (BZO) | Oxazepam | 300 |
This test provides preliminary analytical data only.
More specific chemical methods should be used as confirmation of the analytical result.
Gas chromatography and mass spectrometry (GC / MS) are considered to be preferred confirmatory methods.
Any drug of abuse finding should 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 tools.
The test uses antibodies to selectively detect high levels of specific substances in human urine.
The residence times are approximate for each substance as they vary according to the frequency of use, body mass, age, state of health, tolerance to drugs and the pH of the urine.
The product detects the presence of narcotic substances in the urine only after their metabolization.
COCAINE (COC) Cocaine is a powerful central nervous system stimulant as well as a 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, decreased appetite, a sense of increased energy and strength.
More acute reactions produce anxiety, paranoia, hallucinations and psychotic behavior.
METAMPHETAMINE (MET / MDMA) Methamphetamine is a potent stimulant chemically linked to amphetamine, but with an increased ability to stimulate the central nervous system.
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 delay, they may also have transient episodes of confusion and anxiety.
Relatively heavy long-term consumption may be associated with behavioral disturbances.
OPIASES (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 can include sweating, tremors, nausea, and irritability.
Opiates can be taken orally or by intravenous, intramuscular and subcutaneous injection.
Consumers can also take the substance intravenously or by inhalation.
METHADONE (MTD) Methadone is a narcotic analgesic prescribed for the treatment of severe to moderate pain and for the treatment of opiate addiction (heroin, Vicodin, Percocet, Morphine).
Methadone is a long-acting pain reliever that produces effects that last twelve to forty-eight hours.
BARBITURICS (BAR) Barbiturates are used in medicine as sedatives, hypnotics and anticonvulsants.
Barbiturates are almost always taken orally in capsule or tablet form.
The effects resemble those of alcohol intoxication.
Chronic use of barbiturates leads to tolerance and physical dependence.
BENZODIAZEPINE (BZO) Benzodiazepines are frequently prescribed medications for the symptomatic treatment of anxiety and sleep disturbances.
They produce their effects via specific receptors involving a neurochemical called gamma aminobutyric acid (GABA).
Due to their increased safety and efficacy, benzodiazepines have replaced barbiturates in the treatment of anxiety and insomnia.
Benzodiazepines are also used as sedatives before surgery and medical procedures and for the treatment of seizures and alcohol withdrawal.
FENCYCLIDINE (PCP) Phencyclidine, also known as PCP or Angel Dust, is a hallucinogen used in powder, capsule and tablet form.
The powder is inhaled or smoked after mixing it with marijuana or plant substances.
PCP is commonly administered by inhalation but can also be used intravenously, intranasally, and orally.
Following small doses, users think and act quickly and experience mood swings from euphoria to depression.
Self-destructive behavior is one of the effects of PCP.
TRICYCLIC ANTIDEPRESSANTS (TCAs) TCAs (tricyclic antidepressants) are commonly used for the treatment of depressive disorders.
Overdoses of TCA can cause profound depression, cardiotoxicity, and anticholinergic effects.
Overdose of TCA is the leading cause of drug-related death.
TCAs are taken orally or sometimes by injection.
PRINCIPLE The One Step Test Strip Panel (Urine) is an immunochromatographic rapid test based on the principle of competitive binding.
Drugs that may be present in the urine specimen compete with their conjugate for the same binding sites as the antibody.
During the test, a urine sample migrates by capillarity along the membrane.
A drug, if present in the urine sample, at a concentration below its cut-off, will not be able to saturate all the binding sites of the particles bound to the relative antibodies present in the strip.
The particles bound to the antibodies will be captured by the immobilized conjugate and a visible colored band will appear in the test band area of the relevant strip.
The colored band will not form in the relevant area if the drug level is above its cut-off, as all related antibody binding sites will be saturated.
A urine specimen positive for the test drug will not cause the colored band to form due to drug competition, while a urine specimen negative for the test drug or a specimen containing a drug concentration below the cut-off will cause the formation of the colored band in the specific test area.
As a control of the procedure, a colored band will appear in the relevant area, indicating that a correct amount of sample has been used and that the migration on the membrane has taken place.
REAGENTS Each strip of the panel contains mouse monoclonal antibodies bound to the particles and to the corresponding one.
The One Step Test Strip Panel (Urine) is a conjugated lateral flow immunochromatographic rapid test 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 specimens with evident precipitate should be centrifuged, filtered, or allowed to settle in order to obtain a clear specimen for testing.
Urine samples can be stored at a temperature of 2-8 ° C for a maximum of 48 hours.
For extended storage, samples can be frozen and stored below -20 ° C.
Before using frozen samples, they must be thawed and homogenized thoroughly.
PROCEDURE OF USE 1. Before opening the package, bring it to room temperature.
Take the product out of 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, in 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. Put the cap back on the device and lay 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 band appears in the control region (C) and a second one in the test region (T) for each drug indicating a negative result.
This negative result indicates that the concentration of the target drug in urine is below the detectable cut-off level for that specific drug.
* the color tone in the reactive zone (T) can vary, but it must be considered negative whenever a faint colored band appears. Positive: A colored band appears in the control region (C) but not in the test region (T) for each drug indicating a positive result.
This positive result indicates that the concentration of the target drug in 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 missing control line may be insufficient sample volume or incorrect analytical procedure.
Check the procedure again 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 competent 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 sufficient sample volume, that the membrane absorption was adequate and the procedure was correct.
Standard controls are not supplied 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 correct characteristics.
LIMITS 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 absorption was adequate and the procedure was correct.
Standard controls are not supplied 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 correct characteristics.
FORMAT Kit containing:
• 1 urine container.
• 1 Urine Test Drug 10.
• 1 package insert.