Oral fluid testing has many BENEFITS OVER OTHER DRUG TESTING METHODS such as:

• You can observe collections without having to deal with donor privacy issues associated with urine collection.
• Non-invasive
• Eliminates collection site costs.
• Difficult to adulterate.
• You can have results in as little as 10 minutes.

The MD Saliva Test detects the following drugs:

• Benzodiazepine (BZO) 10 ng/mL
• Buprenorphine (BUP) 5 ng/mL
• Amphetamines (AMP) 50 ng/mL
• Methamphetamine (mAMP) 50 ng/mL
• Cocaine (COC) 20 ng/mL
• Opiates (OPI) 40 ng/mL
• Marijuana (THC) parent THC at 50 ng/mL and THC-COOH at 12 ng/mL
• Methadone (MTD) 30 ng/mL
• Oxycodone (OXY) 20 ng/mL
• Phencyclidine (PCP) 10 ng/mL

MD benefits over other competitor's products:

• MD Saliva Screen test is the most sensitive to Marijuana (THC) with the lowest detection levels in the market.
• This saliva drug test provides results in minutes.
• An oral fluid test provides extra security since it can't be substituted or tampered like a urine test.
• Competitively priced!  MD provides the best oral fluid tests on the market!

INTENDED USE

The Multi-Saliva Drugs of Abuse Rapid Test Cup is a rapid visual immunoassay for the qualitative detection of drugs of abuse in human oral fluid specimens. The test system consists of up to 16 membrane strips mounted in a plastic device. This test detects combinations of the following drugs at the concentrations listed below. Specific combinations will vary according to the test in question:

PRINCIPLE

The Multi-Saliva Drugs of Abuse Rapid Test Cup is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against other respective drug conjugate for binding sites on their specific antibody.

During testing, a portion of the oral fluid specimen migrates upward by capillary action. A drug, if present in the oral fluid specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration in the oral fluid specimen will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region.

A drug-positive oral fluid specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative oral fluid specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occured.

MATERIALS

MATERIALS PROVIDED

• Package Insert.
• Procedure cards.
• Oral Fluid Collection Swabs
• Individually packed screening devices

MATERIALS REQUIRED BUT NOT PROVIDED

• Timer

INTRODUCTION

The Oral Fluid Drug Screen Device For AMP/BAR/BUP/BZO/COC/COT/MET/MDMA/OPI/MTD/OXY/PCP/THC parent/THC metabolites is a rapid oral fluid screening test that cacn be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in human oral fluid.

Amphetamine (AMP 50): Amphetamine is a potent central nervous system stimulant currently prescribed to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and narcolepsy. Acute higher doses induce euphoria, alertness and sense of increased energy and power. Although highly pH dependent, amphetamine is readily present and detectable in saliva; experiments indicate that the saliva/plasma ration of amphetamine is 2,76. The cut-off level of amphetamine assay (50 ng/mL) mirros the saliva screening cut-off proposed by the Department of Health and Human Services (DHHS) for the Federal Drug Free Workplace Program.

Barbiturate (BAR 50): Barbiturates are central nervous system depressants. They are used therapeutically as sedatives, hypnotics, and anticonvulsants. Barbiturates are almost always taken orally as capsules or tablets. The effects resemble those of intoxication with alcohol. Chronic use of Barbiturates leads to tolerance and physical dependence. Short acting Barbiturates taken at 400 mg/day for 2-3 months produce a clinically signifigant degree of physical dependence. Withdrawl symptoms experienced during periods of drug abstinence can be severe enough to cause death.

Benzodiazepines (BZD 10): Benzodiazepines are central nervous system (CNS) depressants commonly prescribed for the short-term treatment of anxiety and insomnia. In general, benzodiazepines act as hypnotics in high doses, as anxiolytics in moderate doses and as sedatives in low doses. The use of benzodiazepines can result in drowsiness and confusion. Psychological and physical dependence on benzodiazepines can develop if high doses of the drug are given over a prolonged period. Benzodiazepines are taken orally or by intramuscular or intravenous injection, and are extensively oxidized in the liver to metabolites. Benzodiazepines can be detected in oral fluid after use.

Buprenorphine (BUP 5): Buprenorphine is a potenet analgesic often used in the treatment of opioid addiction. The drug is sold under the trade names Subutex™, Buprenex™, Tengesic™ and Subozone™, which contain Buprenorphine HCI alone or in combination with Naboxone HCL. Thereapeutically, Buprenorphine is used as a substitution treatment for opioid addicts. Substitution treatment is a form of medical care offered to opiate addicts (primarily heroin addicts) based on a similar or identical substance to the drug normally used. In substitution therapy, Buprenorphine is as effective as Methadone but demonstrates a lower level of physical dependence. Concentrations of free Buprenorphine and Norbuprenorphine in saliva may be less than 1 ng/ml after thereapeutic administration, but can range up to 20 ng/ml in abuse situations. The plasma half-life of Buprenorphine is 2-4 hours. While complete elimination of a single-dose of the drug can take as long as 6 days, the detection window for the parent drug in urine is thought to be approximately 3 days.

Cocaine (COC 20): Cocaine is a potenet central nervous system stimulant and a local anesthetic found in the leaves of the coca plant. The pshchological effects induced by using cocaine are euphoria, confidence and sense of increased energy. These psychological effects are accompanied by increased heart rate, dilation of the pupils, fever, tremors and sweating. Cocaine and its metabolites, benzoylecgonine, and ecgonine methylester, can be detected in oral fluid after use 1,2.

Cotinine (COT 50): Cotinine is the first-stage metabolite of nicotine, a toxic alkaloid that produces stimulation of the autonomic ganglia and central nervous system when in humans. Nicotine is a drug to which virtually every member of a tobacco-making society is exposed wheather through direct contact or second-hand inhalation. In addition to tobacco, nicotine is also commercially available as the active ingredient in smoking replacement therapies such as nicotine gum, transdermal patches and nasal sprays.

Marijuana (Δ9- THC, parent 50): Tetrahydrocannabinol, the active ingredient in the marijuna plant (cannabis sativa), is detectable in saliva shortly after use. When ingested or smoked, it produces euphoric effects. Abusers exhibit central nervous system effects, altered mood and sensory perceptions, loss of coordination, impaired short term memory, anxiety, paranoia, depression, confusion, hallucinations and increased heart rate. THC (delta-9-Tetrahydrocannabinol), is the major psychoactive compound found in marijuana. The detection of the drug in saliva is thought to be primarily due to the direct exposure of the drug to the mouth (oral and smoking administrations). The Δ - THC (parent) saliva test provides a snapshot of drugs immediately following consumption. It detects the Δ9 - THC on the subject of the analytical detection window for Δ9 - THC (parent) in saliva. A window of up to 6 hours in considered realistic due to individual fluctuations in the composition of saliva. The Δ9 - THC (parent) Assay contained within the Oral Fluid Drug Screen Device yields a positive results when the THC concentration exceeds 50 ng/mL.

Marijuana (THC-COOH 12): Tetrahydrocannabinol is generally accepted to be the principle active component in Marijuana. Once in the blood stream, Δ9-THC (parent) is mainly quickly metabolized into THC metabolites in the liver. These psycho inactive THC metabolites are stored in the fatty tissue to some extent and are then discharged in urine over a period of between a few days to several weeks following consumption, where it is detected as THC-COOH (metabolite) in a positive test result. When ingested or smoked, it produces euphoric effects. Abusers exhibit central nervous sytem effects, altered mood and sensory perceptions, loss of coordination, impared short term memory, anxiety, paranoia, depression, confusion, hallucinations and increased heart rate. The THC-COOH-Assay contained within the Oral Fluid Drug Screen Device yields a positive result when the THC-COOH concentration exceeds 12 ng/mL.

Methadone(MTD 30): Methadone is a synthetic analgesic drug originally used for the treatment of narcotic addiction. In addition to use as a narcotic agonist, methadone is being used more frequently as a pain management agent. The psychological effects induced by using methadone are analgesia, sedation, and respiratory depression. Based on the saliva/plasma ratio calculated over salivary pH ranges of 6.4-7.6 for therapeutic or recreational doses of methadone, a cut-off <50 ng/mL is suggested. Due to this recommendation, the cut-off level of the methadone test was calibrated to 30 ng/mL.

Methamphetamine (MET 50): Methamphetamine is a potent central nervous system stimulant. Acute higher doses induce euphorira, alertness, and a sense of increased energy and power. More acute responses produce anxiety, paranoia, psychotic behaviour, and cardiac dysrhythmias. Depending on the route of administration, amphetamine or methamphetamine can be detected in oral fluid as early as 5-10 minutes after use and can be detected in oral fluid for up to 72 hours after use.

Exstasy (MDMA 50): MDMA is an abbreviation for the chemical Methylenedioxymethamphetamine MDMA. It has street many name including Ecstasy, X, XTC, E, Love Doves, Clarity, Adam, Disco Biscuits and Shamrocks, etc. It is a stimulant with hallucinogenic tendencies, described as an empathogen as it releases mood-altering chemicals, such as cartooning and L-dopa, in the brain and may generate feelings of love and friendliness. MDMA is a Class A drug, in the same category as heroin and cocaine. The adverse effects of MDMA use include elevated blood pressure, hyperthermia, anxiety, paranoia, and insomnia. Overdoses of MDMA can be fatal, often resulting in heart failure or heart stroke. MDMA belongs to a family of man-made drugs, its relatives include MDA (methylenedioxy MDMA), the parent drug of MDMA, and MDEA (methylenedioxyethyl MDMA), also known as EVE. They all share the MDMA-like effects. MDMA is administered either by oral ingestion or intravenous injection. MDMA tablets come in different sizes and colors, and often have logos such as doves on them. Its clinical dose is 50-100mg; the threshold toxic dose is 500mg. The effects of MDMA begin 30 minutes after intake. They peak in an hour and last for 2-3 hours. IT is detectible in the saliva for up to 3 days after use.

Opiates (OPI 40): Opiates such as heroin, morphine, and codeine, are central nervous system (CNS) depressants. The use of opiates at high doses produces euphoria and release from anxiety. Physical dependence is apparent in users and leads to depressed coordination, disrupted decision making, decreased respiration, hypothermia and coma. After opiates are used, morphine and its metabolites are present in oral fluid 2,3.

Oxycodone (OXY 20): Oxycodone is a semi-synthetic opioid with a structural similarity to codeine. The drug is manufactured by modifying thebaine, an alkaloid found in the opium poppy. Oxycodone, like all opiate agonists, provides pain relief by acting on opioid receptors in the spinal cord, brain and possibly directly in the affected tissues. Oxycodone is presvribed for the relief of moderate to high pain under the well-known pharmaceutical trade name of OxyContin®, Tylox®, Percodan® and Percocet®. While Tylox®, Percodan® and Percocet® contain only small doses of oxycodone hydrochloride combined with other analgesics such as acetaminophen or aspirin, OxyContin consists solely of oxycodone hydrochloride in a time-release form. Oxycodone is known to metabloize by demethylation into oxymorphone and noroxycodone.

Phencyclidine (PCP 10): Phencyclidine is an arylcyclohexylamine that was originally used as an anesthetic agent and a veterinary tranquilizer. Phencyclidine can produce hallucinations, lethargy, disorientation, loss of coordination, trance-like estatic states, a sense of euphoria and visual distortions. It has many street names, such as "angel dust" and "crystal cyclone" etc. Phencyclidine can be administered orally, by nasal ingestion, smoking, or intraveneous injection. It is metabolized in the liver and excreted through the kidneys.

PRECAUTIONS

• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissaible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., to not ingest or inhale).
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in the area where specimens are kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded in accordance with local regulations.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

STORAGE AND STABILITY

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Do not freeze.
• Kits should be kept out of direct sunlight.
• Care should be taken to protect the componenets of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

SPECIMEN COLLECTION AND STORAGE

• The Multi-Saliva Drugs of Abuse Rapid test Cup is intended for use with human oral fluid specimens only.
• Oral fluid specimens must be collected according to the directions in the Prcedure section of this package inserrt.
• Perform testing immediately after specimen collection.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for trasnportation of etiological agents.

PROCEDURE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use. Donors should avaoid placing anything (including food, drink, gum and tobacco products) in their mouth for at least 10 minutes prior to specimen collection.

• The oral fluid specimen should be collected using the collector provided with the kit. No other collection devices should be used with this assay.
• Instruct the donor to not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.
• Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
• Using the provided collection swab, have donor sweep inside of mouth (cheek, gums, tongue) several times, then hold swab in mouth until color on the saturation indicator strip appears in the indicator window of collection swab. Important: Do not bite, suck or chew on the sponge.
• NOTE: If after 7 minutes, color on the saturation indicator has not appeared in the indicator window, proceed with the test below.
• Remove collection swab from mouth and insert the sponge into the screening device until it touches the bottom. Push cap until the cap locks in place in the bottom of the device.
• Test device upright on flat surface and keep upright while test is running. Wait for the colored bands to appear in test results area. Read results at 10 minutes.
• NOTE: Once the collection swab locks in place, the device is airtight, tamper evident, and ready to be disposed or sent to the lab for confirmation (on presumptive positive result).

INTERPRETATION OF RESULTS

POSITIVE:

One colored band appears, in the control region (C). No colored band appears in the test region (T) for the drug in question. A positive result indicates that the drug concentration exceeds the detectable level.

NEGATIVE:

Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T) for the drug in question. A negative result indicates that the drug concentration is below the detectable level.

INVALID:

Control band fails to appear. Results from any test which has not produced a control band at the specified reat time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region (T) should be considered negative. Please note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

QUALITY CONTROL

• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

LIMITATIONS OF THE TEST

1. The Multi-Saliva Drugs of Abuse Rapid test Cup is for professional in vitro diagnostic use, and should be only used for the qualitative detection of drugs of abuse in oral fluid.
2. This assay provides a preliminary analytical test result only. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgement should be applied to any test result, particularly when preliminary positive results are indicated.
3. There is a possibility that technical or procedural erros as well as other substances and factors may interfere with the test and cause false results.
4. A positive result indicates the presence of a drug/metabolite only, and does not indicate or measure intoxication.
5. A negative result does not at any time rule out the presence of drugs/metabolites in urine, as they may be present below the minimum detection level of the test.
6. This test does not distinguish between drugs of abuse and certain medications.

PERFORMANCE CHARACTERISTICS

1. Sensitivity

A phosphate-buffered saline (PBS) pool was spiked with drugs to target concentrations of ± 50% cut-off and tested with The Multi-Saliva Drugs of Abuse Rapid Test Cup. The results are summarized below.

2. Specificity

The following table lists the concentration of compounds (ng/Ml) above which The Multi-Saliva Drugs of Abuse Rapid Test Cup identified positive results at 10 minutes.

A study was conducted to determine the cross-reactivity of the test with compounds spiked into drug-free PBS stock. The following compounds demonstrated no false positive results on The Multi-Saliva Drugs of Abuse Rapid Test Cup when tested at concentrations up to 100 ng/mL.

BIBLIOGRAPHY

1. Moolchan, E., et al, "Saliva and Plasma Testing for Drugs of Abuse: Comparison of the Disposition and Pharmacological Effects of Cocaine", Addiction Research Center, IRP, NIDA, NIH, Baltimore, MD. As presented at the SOFT-TIAFT meeting October 1998.
2. Jenkins, A.J., Oyler. J.M. and Cone, E.J. Comparison of Heroin and Cocaine Concentrations in Saliva with Concentrations in Blood and Plasma. J. Anal. Toxicology. 19: 359-374 (1995).
3. Kidwell, D.A., Holland, J.C., Athannaselis. S. Testing for Drugs of Abuse in Saliva and Sweat. J. Chrom. B. 713: 111-135 (1998)
4. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd ed. Davis: Biomedical Publications: 1982.
5. Hawks RL, Chiang CN, eds. Urine Testing for Drugs of Abuse. Rockville: Department of Health and Human Services, National Institute of Drug Abuse; 1986.
6. Substance Abuse and Mental Health Services Administration. Mandatory Guidelines for Federal Workplace Drug Testing Programs. 53 Federal Register; 1988.
7. McBay AJ. Drug-analysis technology-pitfalls and problems of drug testing. Clin Chem. 1987 Oct; 33 (11 Suppl):33B-40B
8. Gilman AG, Goodman LS, Gilman A, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan:1980.