Descrizione Clinica
Diagnostics - diagnostics Screen drug test saliva 6
SCREEN
DRUG TESTING
SALES 6
Rapid screening test for simultaneous determination, amphetamine quality, metamphetamine, cocaine, opioids, marijuana, ecstasy and their metabolites in human saliva.
Precautions
• Product not intended for medical or diagnostic use.
• Do not use beyond the expiry date.
• Store the reactive strip panel in the closed enclosure until use.
• Store in sealed enclosure until use.
• The saliva is not classified as a biological risk substance if it does not result from a dental procedure.
• The collector and card used must be disposed of in accordance with the regulations in force.
Expected use and summary
Scrolling chromatographic immunological test for the qualitative detection of multiple drugs and metabolites in saliva at the following concentrations of limit threshold:
This test only provides preliminary analytical data.
More specific chemical methods must be used as confirmation of analytical result.
Preferential confirmation methods are considered for gaschromatography and mass spectrometry (GC/MS).
Any result for determining the presence of abuse drugs must be related to clinical considerations and professional judgment, especially when the preliminary result is positive.
Quick screening test of urine that does not require the use of special tools.
The test uses antibodies to selectively detect high levels of specific substances in human saliva.
The time of stay is approximate for each substance as they vary according to the frequency of use, body mass, age, state of health, tolerance to drugs.
The product detects the presence of narcotic substances in saliva only after their metabolization.
COCAINE (COC)
Cocaine is a powerful stimulant of the central nervous system as well as local anesthetic derived from the coca plant.
The substance is often self administered by inhalation or intravenous injection or by smoking the base substance.
AMFETAMINA
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, vigile state, appetite reduction, sense of greater energy and strength.
Acute reactions produce anxiety, paranoia, hallucinations and psychotic behavior.
METAMFETAMINA (MET/MDMA)
Metamfetamine is a powerful chemically related stimulant to amphetamine, but with a greater stimulation capacity of the central nervous system.
The substance is often self administered by inhalation, smoking or ingestion.
MARIJUANA (THC)
Tetrahydrocannabinol is the active ingredient of cannabis.
When smoked or taken orally, THC produces euphoria.
Regular consumers have short-term memory damage and learning delay, they can also have transient episodes of confusion and anxiety.
Relatively heavy long-term consumption may be associated with behavior disorders.
OPPIACEI (OPI)
The class of opioids refers to any substance derived from opium poppy, including natural compounds such as morphine, codeine and semisynthetic substances such as heroin.
Opiates act on pain control by depressing the central nervous system.
Astinence symptoms may include sweating, tremors, nausea and irritability.
Opiates can be taken orally or through intravenous, intramuscular and subcutaneous injection.
Consumers may also take the substance intravenously or through inhalation.
ECSTASY (MDMA)
Synthetic drugs, first synthesized in 1914 by a German pharmaceutical company for obesity treatment.
Those who make use of it have side effects such as increased muscle tension and sweating.
MMDMA is not a real stimulant, although it has in common with amphetamines an ability to increase blood pressure and heart rhythm.
MMDMA produces some perceptive variations such as increased light sensitivity, difficulty concentration and misconception in some users.
It is thought that its mechanism of action takes place through the release of serotonin neurotransmitter.
MMDMA can also release dopamine, although it is common opinion that this is a secondary effect of the substance (Nichols and Oberlender, 1990).
The most manifest effect of MMDMA, which occurs potentially in all those who have taken a reasonable dose of substance, is the contraction of jaws.
The MDMA test contained in the product provides a positive result when the MDMA concentration in the saliva exceeds 50 ng/ml.
PRINCIPLE
It is an immunological test based on the principle of competitive bond.
Drugs that can be present in the sample of oral fluid compete against the respective conjugates for binding sites on the specific antibody.
During the test part of the saliva sample migrates upwards by capillary action.
A drug, if present in the sample of oral fluid below the threshold-limit concentration, will not saturate the binding sites of this specific antibody.
The antibody then reacts with the conjugated drug-protection and will appear a colored line visible in the test area for the specific drug tested. The presence of drugs above the limit-limit concentration will saturate all antibody binding sites.
So the colored line will not form in the test area.
A positive oral fluid sample will not generate a colored line in the specific strip test area due to the drug competition, while a negative oral fluid sample for the drug will generate a line in the test area for absence of competition.
For procedural control purposes, a coloured line will always appear in the control area, indicating that a correct sample volume has been poured and that the membrane has been funneled.
REASONS
The test contains membrane strips covered with conjugated drug-protein (purified bovine albumin) on the test line, a polyclonal antibody of goats against conjugated gold-protein on the control line, and a funneled tampon containing gold-necked particles covered with monoclonal antibody of topo specific for Amphetamine, Metamfetamine, Cocaine, Oppiacei.
CONSERVATION AND STABILITY
Store in the original package sealed at 2-30°C.
The test is stable until the expiry date printed on the package.
The test must remain in the sealed packaging until use.
Don't freeze.
Do not use beyond the expiry date.
COMPLETING AND PREPARATION OF CHAMPERS
The oral fluid sample should be collected using the collector provided with the kit.
Follow the detailed instructions below.
Do not use other collection devices for analysis.
The oral fluid can be collected at any time of the day.
INSTRUMENTS FOR USE
Bring the test, sample and/or ambient temperature control (15-30°C) before the test.
Inform the donor not to enter anything in the mouth, including food, drinks, tires or tobacco, for at least 10 minutes before harvesting.
1. Bring the packaging to room temperature before opening. Remove the test from the sealed package and use it within an hour.
2. Remove the test cap and insert the absorbent pad in the mouth, under the tongue, to collect saliva until the appearance of the control line. Extract the test.
3. Put the test on a clean and flat surface. See illustration below. 4. Read the results after 10 minutes. Do not read the results after 1 hour.
INTERPRETATION OF RESULTS
Negative*: all test bands appear. A coloured line must be in the control area (C), while the other must be adjacent to the test zone (Sustance/T). The negative result indicates that the concentration of the substance is lower than the revealable or absent level.
*The tone in the test zone (Sustance/T) varies, but must be considered negative even if a line with weak color appears
Positive: a single coloured line appears in the control area (C). There is no test band in the test zone (Sustance/T). The positive result indicates that the concentration of the substance is higher than the revealable level.
Not valid: no control line appears. The most probable reasons for the failure of the control line are an insufficient volume of sample or non-correct procedural techniques. Check the procedure and repeat the test using a new card.
If the test was positive, avoid aggressive behaviour and calmly seek dialogue with the person concerned. Please be advised by your doctor, a psychologist or contact the competent service for your territory.
CONTROL QUALITY
A procedural control is included in the test.
The line that appears in the control area (C) is considered an internal procedural control.
It confirms that a sufficient sample volume has been used, an adequate membrane imbibation and a correct procedural technique.
LIMITATIONS
1. The test provides only a qualitative preliminary analytical result. It is necessary to use a secondary analytical method to confirm the result. The recommended confirmation method is mass gaschromatography/spectrometry (GC/MS).
2. A positive result in the test does not indicate the concentration of the substance in the sample or route of administration.
3. A negative result may not necessarily indicate a drug-free sample. You can get negative results when the drug is present below the limit threshold of the test.
4. It is possible that technical or procedural errors, as well as interfering substances present in the saliva sample, can cause incorrect results.
5. This test does not distinguish between drugs from abuse and some drugs.
FORM
• 1 buffer.
• 1 Drug Test Saliva 6.
• illustrative leaflet.
Precautions
• Product not intended for medical or diagnostic use.
• Do not use beyond the expiry date.
• Store the reactive strip panel in the closed enclosure until use.
• Store in sealed enclosure until use.
• The saliva is not classified as a biological risk substance if it does not result from a dental procedure.
• The collector and card used must be disposed of in accordance with the regulations in force.
Expected use and summary
Scrolling chromatographic immunological test for the qualitative detection of multiple drugs and metabolites in saliva at the following concentrations of limit threshold:
| Test | Calibrator | Soil-limit (ng/ml) |
| Amphetamine (AMP) | D-Amphetamine | 40 |
| Metamfetamine (MET) | D-Metamphetamine | 40 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 10 |
| Cocaine (COC) | Benzoilecgoni | 30 |
| Opiates (OPI/MOP) | Morphine | 40 |
| Ecstasy (MDMA) | D,L-methylenedioxytamine | 50 |
This test only provides preliminary analytical data.
More specific chemical methods must be used as confirmation of analytical result.
Preferential confirmation methods are considered for gaschromatography and mass spectrometry (GC/MS).
Any result for determining the presence of abuse drugs must be related to clinical considerations and professional judgment, especially when the preliminary result is positive.
Quick screening test of urine that does not require the use of special tools.
The test uses antibodies to selectively detect high levels of specific substances in human saliva.
The time of stay is approximate for each substance as they vary according to the frequency of use, body mass, age, state of health, tolerance to drugs.
The product detects the presence of narcotic substances in saliva only after their metabolization.
COCAINE (COC)
Cocaine is a powerful stimulant of the central nervous system as well as local anesthetic derived from the coca plant.
The substance is often self administered by inhalation or intravenous injection or by smoking the base substance.
AMFETAMINA
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, vigile state, appetite reduction, sense of greater energy and strength.
Acute reactions produce anxiety, paranoia, hallucinations and psychotic behavior.
METAMFETAMINA (MET/MDMA)
Metamfetamine is a powerful chemically related stimulant to amphetamine, but with a greater stimulation capacity of the central nervous system.
The substance is often self administered by inhalation, smoking or ingestion.
MARIJUANA (THC)
Tetrahydrocannabinol is the active ingredient of cannabis.
When smoked or taken orally, THC produces euphoria.
Regular consumers have short-term memory damage and learning delay, they can also have transient episodes of confusion and anxiety.
Relatively heavy long-term consumption may be associated with behavior disorders.
OPPIACEI (OPI)
The class of opioids refers to any substance derived from opium poppy, including natural compounds such as morphine, codeine and semisynthetic substances such as heroin.
Opiates act on pain control by depressing the central nervous system.
Astinence symptoms may include sweating, tremors, nausea and irritability.
Opiates can be taken orally or through intravenous, intramuscular and subcutaneous injection.
Consumers may also take the substance intravenously or through inhalation.
ECSTASY (MDMA)
Synthetic drugs, first synthesized in 1914 by a German pharmaceutical company for obesity treatment.
Those who make use of it have side effects such as increased muscle tension and sweating.
MMDMA is not a real stimulant, although it has in common with amphetamines an ability to increase blood pressure and heart rhythm.
MMDMA produces some perceptive variations such as increased light sensitivity, difficulty concentration and misconception in some users.
It is thought that its mechanism of action takes place through the release of serotonin neurotransmitter.
MMDMA can also release dopamine, although it is common opinion that this is a secondary effect of the substance (Nichols and Oberlender, 1990).
The most manifest effect of MMDMA, which occurs potentially in all those who have taken a reasonable dose of substance, is the contraction of jaws.
The MDMA test contained in the product provides a positive result when the MDMA concentration in the saliva exceeds 50 ng/ml.
PRINCIPLE
It is an immunological test based on the principle of competitive bond.
Drugs that can be present in the sample of oral fluid compete against the respective conjugates for binding sites on the specific antibody.
During the test part of the saliva sample migrates upwards by capillary action.
A drug, if present in the sample of oral fluid below the threshold-limit concentration, will not saturate the binding sites of this specific antibody.
The antibody then reacts with the conjugated drug-protection and will appear a colored line visible in the test area for the specific drug tested. The presence of drugs above the limit-limit concentration will saturate all antibody binding sites.
So the colored line will not form in the test area.
A positive oral fluid sample will not generate a colored line in the specific strip test area due to the drug competition, while a negative oral fluid sample for the drug will generate a line in the test area for absence of competition.
For procedural control purposes, a coloured line will always appear in the control area, indicating that a correct sample volume has been poured and that the membrane has been funneled.
REASONS
The test contains membrane strips covered with conjugated drug-protein (purified bovine albumin) on the test line, a polyclonal antibody of goats against conjugated gold-protein on the control line, and a funneled tampon containing gold-necked particles covered with monoclonal antibody of topo specific for Amphetamine, Metamfetamine, Cocaine, Oppiacei.
CONSERVATION AND STABILITY
Store in the original package sealed at 2-30°C.
The test is stable until the expiry date printed on the package.
The test must remain in the sealed packaging until use.
Don't freeze.
Do not use beyond the expiry date.
COMPLETING AND PREPARATION OF CHAMPERS
The oral fluid sample should be collected using the collector provided with the kit.
Follow the detailed instructions below.
Do not use other collection devices for analysis.
The oral fluid can be collected at any time of the day.
INSTRUMENTS FOR USE
Bring the test, sample and/or ambient temperature control (15-30°C) before the test.
Inform the donor not to enter anything in the mouth, including food, drinks, tires or tobacco, for at least 10 minutes before harvesting.
1. Bring the packaging to room temperature before opening. Remove the test from the sealed package and use it within an hour.
2. Remove the test cap and insert the absorbent pad in the mouth, under the tongue, to collect saliva until the appearance of the control line. Extract the test.
3. Put the test on a clean and flat surface. See illustration below. 4. Read the results after 10 minutes. Do not read the results after 1 hour.
INTERPRETATION OF RESULTS
Negative*: all test bands appear. A coloured line must be in the control area (C), while the other must be adjacent to the test zone (Sustance/T). The negative result indicates that the concentration of the substance is lower than the revealable or absent level.
*The tone in the test zone (Sustance/T) varies, but must be considered negative even if a line with weak color appears
Positive: a single coloured line appears in the control area (C). There is no test band in the test zone (Sustance/T). The positive result indicates that the concentration of the substance is higher than the revealable level.
Not valid: no control line appears. The most probable reasons for the failure of the control line are an insufficient volume of sample or non-correct procedural techniques. Check the procedure and repeat the test using a new card.
If the test was positive, avoid aggressive behaviour and calmly seek dialogue with the person concerned. Please be advised by your doctor, a psychologist or contact the competent service for your territory.
CONTROL QUALITY
A procedural control is included in the test.
The line that appears in the control area (C) is considered an internal procedural control.
It confirms that a sufficient sample volume has been used, an adequate membrane imbibation and a correct procedural technique.
LIMITATIONS
1. The test provides only a qualitative preliminary analytical result. It is necessary to use a secondary analytical method to confirm the result. The recommended confirmation method is mass gaschromatography/spectrometry (GC/MS).
2. A positive result in the test does not indicate the concentration of the substance in the sample or route of administration.
3. A negative result may not necessarily indicate a drug-free sample. You can get negative results when the drug is present below the limit threshold of the test.
4. It is possible that technical or procedural errors, as well as interfering substances present in the saliva sample, can cause incorrect results.
5. This test does not distinguish between drugs from abuse and some drugs.
FORM
• 1 buffer.
• 1 Drug Test Saliva 6.
• illustrative leaflet.
