SCREEN DRUG TEST 7 DRUGS ON SOLID SURFACES OR DUSTS SCREEN ITALIA

Instructions for use for each test combination to test for any combination of the following drugs: Cocaine, Marijuana/THC, Methamphetamine, Amphetamine, Ketamine, MDMA/Ecstasy, Morphine.

PRECAUTIONS
• Product not intended for diagnostic use.
• Do not use beyond expiration date.
• Keep the test 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 package at a temperature between 2° and 30°C.
The test is stable until the expiration date indicated on the package label.
The test must be kept in the closed pouch until ready for use.
Do not freeze.
Do not use beyond expiration date.

INTENDED USE AND SUMMARY
Rapid chromatographic immunoassay for the qualitative detection of multiple drugs and metabolites on surfaces and solids at the following cut-off concentrations:

Test	Calibrator	Cutoff (ng/mL)
Amphetamine (AMP)	D-Amphetamine	1.000
Cocaine (COC)	Benzoylecgonine	300
Marijuana (THC)	11-nor-Δ9-THC-9 COOH	50
Methamphetamine (MET)	D-Methamphetamine	1.000
Methylenedioxymethamphetamine (MDMA)	D,L-Methylenedioxymethamphetamine	500
Morphine (MOP)	Morphine	300
Ketamine (KET)	Ketamine	1.000

Product not intended for diagnostic medical use.
This test provides only a preliminary analytical result.
A more specific alternative chemical method will be needed to obtain a confirmatory analytical result.
Medical judgment and professional opinion will be necessary in evaluating any drug of abuse test, particularly when it indicates preliminary positive results.

SUMMARY
The Screen Drug Test Rapid Test is a rapid test of surfaces or solids that can be performed without the use of instrumentation.
The test uses monoclonal antibodies to selectively detect elevated levels of specific drugs on surfaces and solids.

Amphetamine (AMP)
Amphetamine is a US DEA Schedule II substance sold by prescription (Dexedrine) and also available illegally on the market. Amphetamines are a class of potent sympathomimetic agents with therapeutic functions. They are chemically related to two catecholamines naturally produced by the human body: epinephrine and norepinephrine. High acute doses induce central nervous system stimulation and cause euphoria, alertness, decreased appetite, and a sense of increased energy and power. Cardiovascular reactions to amphetamines include increased blood pressure and cardiac arrhythmias. More acute reactions cause anxiety, paranoia, hallucinations, and psychotic behavior.

Cocaine (COC)
Cocaine is a powerful central nervous system stimulant and local anesthetic. It initially causes extreme energy and restlessness, but gradually progresses to tremors, hypersensitivity, and spasms.
Cocaine, taken in high doses, causes fever, loss of sensation, difficulty breathing and loss of consciousness.
Cocaine is often self-administered by nasal snorting, intravenous injection, and free-base smoking.

Marijuana (THC)
THC (Δ9-tetrahydrocannabinol) is the main active ingredient in cannabis (marijuana).
When smoked or administered orally, THC produces euphoria.
Users experience damage to short-term memory and slow learning.
You may also experience transient episodes of confusion and anxiety.
Relatively heavy and long-term use may be associated with behavioral disturbances.
The peak effect of smoked marijuana occurs within 20-30 minutes and lasts 90-120 minutes after a cigarette.

Methamphetamine (MET)
Methamphetamine is a stimulant drug that vigorously activates certain brain systems.
Methamphetamine is very similar chemically to Amphetamine, but its effects on the central nervous system are greater.
Methamphetamine is produced in illegal laboratories and has a high potential for abuse and addiction.
The drug can be taken orally, injected or inhaled.
High acute doses induce excessive stimulation of the central nervous system, euphoria, lucidity, reduced appetite, and a sense of increased energy and power.
Cardiovascular reactions to Methamphetamine include increased blood pressure and cardiac arrhythmias.
More severe reactions cause anxiety, paranoia, hallucinations, psychotic behavior, and eventually depression and exhaustion.

Ecstasy (MDMA)
Methylenedioxymethamphetamine (ecstasy) is a synthetic drug first synthesized in 1914 by a German pharmaceutical company for the treatment of obesity.
Those who take it frequently have experienced side effects, such as increased muscle tension and sweating.
MDMA is clearly not a stimulant, although it shares with amphetamine the ability to increase blood pressure and heart rate.
MDMA produces some changes in perception, increasing sensitivity to light, difficulty concentrating, and blurry vision in some individuals. Its mechanism of action is thought to be through the neurotransmitter serotonin.
MDMA can also release dopamine, although the general opinion is that this is a secondary effect of the drug (Nichols and Oberlender, 1990).
The main effect of MDMA, which is likely to occur in anyone who has taken a reasonable dose, is to produce a clenching of the jaw.

Morphine (MOP)
The term Opiate refers to any substance derived from the opium poppy, including natural products, morphine, codeine, and semi-synthetic drugs such as heroin.
The term Opioid is more generic and refers to any drug that acts as an opioid receptor.
Opioid analgesics include a large group of substances that control pain by sedating the central nervous system.
High doses of Morphine can produce high levels of tolerance, physiological dependence and may lead to substance abuse.
Morphine is eliminated without being metabolized and is also the major metabolic product of codeine and heroin.

Ketamine (KET)
Ketamine is a dissociative anesthetic developed in 1963 to replace PCP (Phencyclidine).
While Ketamine is still used in human and veterinary anesthesia, it is increasingly being abused as a drug.
Ketamine is molecularly similar to PCP and thus creates similar effects including numbness, loss of coordination, a sense of invulnerability, muscle rigidity, aggressive/violent behavior, slurred speech or aphasia, an exaggerated sense of strength, and a vacant stare.
There is depression of respiratory function but not of the central nervous system and cardiovascular function is maintained.

PRINCIPLE
During the test the sample migrates upwards by capillary action.
A drug, if present in the sample below the cut-off concentration, will not saturate the binding sites of this specific antibody.
The antibody will then react with the drug-protein conjugate and a visible colored line will appear in the test region for the specific drug being tested.
The presence of the drug above the cut-off concentration will saturate all binding sites on the antibody.
So the colored line will not form in the test area.
A positive sample will not generate a colored line in the specific test region of the strip due to drug competition, while a drug-negative sample will generate a line in the test region due to the absence of competition.
For procedural control purposes, a colored line will always appear in the control region, indicating that the correct volume of sample has been added and the membrane has been saturated.

REAGENTS
Each test line contains a guinea pig monoclonal antibody to the drug and its corresponding drug-protein conjugates.
The control line contains goat anti-rabbit IgG and rabbit IgG polyclonal antibodies.

PRECAUTIONS
• Disposable.
• Do not touch the free ends of the strips to avoid contamination.
• Do not immerse the media beyond the maximum level indicated.
• Immerse the test in the buffer until one or two red lines appear in the reaction zone (~15 seconds).
• Do not pour samples into the reaction zone.
• Specimens may be potentially infectious. Establish appropriate disposal and handling methods.
• Do not use the Multi Drug device beyond the expiration date.
• Do not use the test if the package is damaged.
• Use the test immediately after opening.
• Please take into account specificity and cross-reactivity for the evaluation.
• Always store and transport the test device at 2-30°C.

CONSERVATION AND STABILITY
Store in the original sealed container at 2-30°C.
The test is stable until the expiration date printed on the package.
The test must remain in the sealed package until use.
Do not freeze.
Do not use beyond expiration date.

MATERIALS PROVIDED
• Device.
• Package leaflet.
• Buffers.

MATERIALS REQUIRED BUT NOT PROVIDED
• Sample collection container.
• Timer.

INSTRUCTIONS FOR USE
The test device (in sealed packages), specimens and controls should be brought to room temperature (15-30°C) before testing.
Do not open the packages until you are ready to perform the test.

FOR SURFACES
1. Pass the strips over the surface to be tested.
2. Remove the cap from the supplied bottle.
3. Pour all the buffer from the bottle into the protective lid.
4. Insert the Multi Test slowly and carefully into the lid with the buffer.
5. Wait for lines to appear on the membrane and read the results after 5 minutes. Do not interpret the results after 10 minutes.

FOR SOLIDS
1. Open the bottle and insert the solid into the buffer.
2. Close the bottle with dropper and cap. Shake it briefly. Wait 30 seconds.
3. Remove the cap from the bottle;
4. Pour all the buffer with the dissolved substances into the protective lid.
5. Insert the Multi Test slowly and carefully into the protective cover with the buffer.
6. Wait for lines to appear on the membrane and read the results after 5 minutes. Do not interpret the results after 10 minutes.

INTERPRETATION OF RESULTS
Negative*: A colored line appears in the Control region (C) and a colored line appears in the Test region (T). This negative result indicates that the concentrations in the sample are below the cut-off levels established for a particular drug tested.
*The shade of the colored line(s) in the test region (T) may vary. The result should be considered negative whenever even a faint line appears. Positive: A colored line appears in the Control region (C) and no line appears in the Test region (T). A positive result indicates that the drug concentration in the sample is greater than the cut-off threshold established for a specific drug.
Invalid: No line appears in the Control region (C). The most likely reasons for the lack of a Control line are insufficient specimen volume or incorrect procedural techniques. Reread the instructions and repeat the test. If the result is still invalid, contact the manufacturer.

QUALITY CONTROL
A procedural control is included in the test.
The line appearing in the control region (C) is considered an internal procedural control.
Confirm that sufficient sample volume, adequate membrane wetting, and correct procedural technique were used.
Control standards are not supplied with this kit.
However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and its correct functioning.

LIMITATIONS
1. The Rapid Screen Drug Test provides only a preliminary qualitative analytical result. A secondary analytical method must be used to confirm the result. The recommended confirmatory method is gas chromatography/mass spectrometry (GC/MS).
2. A negative result may not necessarily indicate a drug-free sample. Negative results may occur when the drug is present below the cut-off threshold of the test.
3. This test does not distinguish between drugs of abuse and some medications.

EXPECTED VALUES
A negative result indicates that the drug concentration is below the detection level.
A positive result indicates that the drug concentration is above the detection level.

FORMAT
• 1 bottle.
• 1 Drug Test Surface Dust.
• 1 leaflet.