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OralScreen4 Product Information

Rapid Collection and Test System for Oral Fluid 

For Forensic Use Only

The ORALscreen System is an easy to use collection and immunoassay system intended for use in the highly sensitive, qualitative analysis for recent use of the following drugs of abuse and their metabolites in human oral fluid: Cannabinoids (code THC), Cocaine (code COC), Opiates (code OPI), Methamphetamine (code MET). The ORALscreen System is designed to be used by trained professionals only, for forensic use only. No special instruments or reagents are required to run the test. The test sample is collected by a device included in the test kit.

The ORALscreen System provides only a preliminary analytical test result. A more specific alternative method must be used in order to obtain a confirmed analytical result. Gas chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Cannabinoids are hallucinogenic agents derived from marijuana, the dried flowers and leaves of the hemp plant, Cannabis sativa. Smoking of marijuana is the primary method of ingestion. However, it is sometimes taken orally after being mixed with food or brewed as tea (1). THC (delta-9-tetrahydrocannabinol, tetrahydrocannabinol) is the major psychoactive compound found in marijuana. Smoking marijuana delivers THC to the body faster and in higher quantities than does ingestion. The maximum psychological effect can last for 4-8 hours (2). Marijuana's effects can include sedation, euphoria, sensory heightening or analgesia, impaired short-term memory/learning/thinking/problemsolving abilities, loss of coordination, distorted perception, increased heart rate, anxiety, panic attacks, and temporal distortion (1, 3). NIDA classifies marijuana as an addictive drug (1). After marijuana use, cannabinoids, including THC, are found in oral fluid (4). A synthetic form of THC is available as a prescription drug (dronabinol, Marinol) to stimulate appetite or to prevent nausea and vomiting (2,3).

Cocaine is a natural product obtained from the leaves of the South American coca plant, Erythroxylon coca. Although cocaine is a local, topical anesthetic, it has limited medical use. Cocaine is usually administered by snorting (nasal insufflation) or intravenous injection or smoked as the free base "crack". Smoking cocaine and intravenous injection delivers cocaine to the body faster and in higher quantities than does snorting (2). Cocaine is one of the most efficacious of the naturally occurring central nervous system (CNS) stimulants. Cocaine's effects can make users feel euphoric, energetic, and talkative. Cocaine may increase mental alertness to sight/sound/touch and may decrease the need for

food and sleep. NIDA classifies cocaine as a powerfully addictive drug. With continued use, tolerance develops, requiring the user to increase dosage and frequency to get the same high (5). The psychological effects of cocaine are intense but, short-lived and the drug is rapidly converted to metabolites. After cocaine use, cocaine and the product of cocaine hydrolysis, benzoylecgonine (BE), are present in oral fluid (4, 6).

Opiates such as morphine, heroin, and codeine are derived from the resin of the opium poppy, Papaver somniferum. This class of drugs is known as CNS depressants. Heroin is processed from morphine. Heroin is usually taken by intravenous or intramuscular injection or by snorting or by smoking. Intravenous injection delivers heroin to the body faster than does intramuscular injection, snorting, or smoking. At therapeutic doses, opiates have an analgesic action which reduces the severity of traumatic pain. At acute higher doses, euphoria, release from anxiety and clouded mental functioning can occur. NIDA classifies heroin as a highly addictive drug. With continued use, tolerance develops, requiring the user to increase dosage to get the same high. Physical dependence and addiction develop (7). Heroin and codeine are both metabolized to morphine (2). After these opiates are used, morphine and its metabolites are present in oral fluid (4, 6). A non-negative result for opiates may indicate the use of heroin, morphine, codeine, and/or prescription medications including hydromorphone, hydrocodone, oxycodone, and oxymorphone.

Methamphetamine (D-methamphetamine) is a psychostimulant derived from amphetamine. It can be synthesized in small labs using over-thecounter ingredients. It has been found to have limited medical use in treatment for obesity, narcolepsy and attention deficit disorder. The central nervous system effects of methamphetamine are greater than those of amphetamine. Different modes of use cause different types of sensations or highs. Smoking and intravenous injection produce an immediate, intense "rush" that usually lasts only a few minutes. Snorting and ingestion produce a euphoric high with a sensation beginning as early as 3-5 minutes or 15-20 minutes, respectively, that lasts for many hours. Users may "binge" on the drug, taking more to achieve that "rush" while a high concentration of drug still remains in the body. Methamphetamine's effects may also include increased energy, decreased appetite, alertness, and a general sense of well-being. NIDA classifies methamphetamine as a powerfully addictive stimulant drug. Tolerance can occur with chronic use, requiring the user to increase dosage or frequency or mode of use to get the same high (8). After methamphetamine is used, methamphetamine and its major metabolite, amphetamine, are present in oral fluid (4).

MDMA (methylenedioxymethamphetamine, Ecstasy) is a synthetic psychoactive drug with a structure similar to methampetamine. MDMA should be detected by ORALscreen. L-methamphetamine is used in some non-prescription inhalers as a decongestant (2). Normal therapeutic doses of L-methamphetamine should not be detected by ORALscreen.

The ORAIscreenr System utilizes a lateral flow membrane immunoassay technique that provides the accuracy of an immunoassay without the need for any laboratory equipment. The test detects THC, cocaine, opiates, methamphetamine, and their metabolites in human oral fluid with high sensitivity.

The ORALscreen System is based on the principle of antigen/antibody complexation and competition (9). The drug or drug metabolite in the sample competes with a drug conjugate immobilized on a porous membrane support for limited antibody sites on red colored microspheres. This membrane is housed in a plastic device. The sample is loaded into a sample well on the device. No other reagents are necessary to run the test.

The drug conjugates and control reference lines are marked with a green dye on the test membrane. After the sample is applied, the green dye will be washed away and the test reaction will take place on the lines. A sample of oral fluid is loaded in the sample well and is automatically wicked along the membrane by capillary action. The sample also serves to mobilize the red microspheres coated with the antibody specific to the drug. In the absence of the drug in the oral fluid, the red microspheres attach to the drug conjugate, forming a red line as the antibody complexes with the drug conjugate. Therefore, the formation of a red line occurs when the oral fluid is negative for the drug. When the drug (or drug metabolite) is present in the oral fluid sample, the drug competes for the limited antibody sites on the red microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the red microspheres to the drug conjugate on the membrane. Therefore, a positive oral fluid sample will not form a red line. A control line with a different antigen/antibody reaction is included in the test device to indicate that the test is valid. This control line should always be seen. Thus, a negative oral fluid sample will produce five red lines and an oral fluid sample positive for only one drug will produce only four red lines, etc. See examples under INTERPRETATION OF RESULTS.

Each ORALscreen Test Device is housed in a single plastic device. Each device contains a membrane strip with a defined amount of microspheres coated with anti-drug or drug metabolite antibody. A secondary antibody is used to form a control line. Drug conjugates and animal serum are also adsorbed onto the membrane. The entire membrane is then dried before assembly and used in the dry form. All necessary reagents for performing the test are included in the ORALscreen Test Devices. No additional reagents are required. In addition, an ORALscreen Oral Fluid Collector is provided and must be used for the test system to meet the claims in this insert.

Each ORALscreenm, System dispenser includes: 

1. One package insert

2. One instruction sheet

3. 20 sealed pouches each containing a Test Device sealed in a foil pouch plus an ORALscreen Oral Fluid Collector

A timer and disposable gloves are recommended but not included. 

ADDITIONAL MATERIALS

ORALconfirm Collection Kit Part Number OC01-0 ORALscreen Oral Fluid Collectors

(Collector only) Part Number OS03-1

Result Reporting Forms Part Number P417-080A

Chain of Custody Forms Part Number G417-075A

Powder Free Vinyl Gloves Part Number PF934L

The components of this kit are stable until the marked expiration date when stored in the sealed pouch at 2° - 30° C (36° - 86° F).

Extreme temperatures could affect performance.

The test device must be brought to room temperature prior to use.

1. Use a new ORALscreen Oral Fluid Collector for each oral fluid sample.

2. If the test device foil pouch is torn or perforated, the test device should not be used.

3. Do not use the kit beyond the expiration date indicated on the kit.

4. Bring the pouch to room temperature and open immediately prior to loading sample.

5. Always perform the ORALscreen test on a flat, level surface.

6. Never move the ORALscreen test after adding the sample and while running the test.

7. Always interpret test results using adequate lighting 

SPECIMEN COLLECTION AND HANDLING

The ORALscreen System is formulated for use with oral fluid specimens. Oral fluid specimens arc to be collected using the ORALscreen Oral Fluid Collector contained in the kit. The collector is an integral part of the test system and must be used to collect oral fluid and to apply oral fluid to the test device. Do not collect oral fluid by another means. Do not apply oral fluid to the test device by another means. Sufficient volume is collected using this collection device and no preservatives or additives are present in the collection device. Collect the oral fluid specimen and immediately perform the testing. The oral fluid specimens do not require any special pretreatment. The sample should be free from gross debris (i.e., food debris).

1. The ORALscreen System is formulated for use with oral fluid specimens. Bring the pouch to room temperature. Make sure that the person being tested has had nothing in their mouth for at least 5 minutes .before sample collection. Directly observe the person during sample collection.

NOTE: If the person being tested is experiencing dry mouth prior to sample collection, have them drink a glass of water, wait 5 minutes, then start the collection process.

2. Collect the oral fluid sample by removing the collector from the package, sliding the plastic hood back, and exposing the foam.

 

3. Have the person pucker their mouth and accumulate oral fluid before inserting collector. Place the foam end in the mouth and move it around gently for at least 2 minutes to allow the oral fluid to enter the foam. Pressing gently with one's tongue may help the oral fluid to enter the collector foam. Do not chew or suck on the collector.

4. Remove the collector and hold it in a slightly upright position (not straight up). Slide the hood forward gently until the foam is completely surrounded by the hood.

NOTE: The foam piece should swell in size after sample collection. If you suspect an insufficient amount of sample was collected prior to loading the sample, simply reinsert the collector into the person's mouth for additional time, or use a new collector and start the collection process over again. (Additional collectors are available through Avitar Customer Service.)

 

TEST PROCEDURE

5. Remove the test device from the foil pouch immediately prior to loading the sample. Complete the specimen ID section on the test device label. Note the presence of green indicator lines in the result window before sample is added.

6. With one hand, hold the hood in place over the foam. Firmly squeeze and hold the foam and the middle of the hood between your index finger and your thumb. This will dispense the oral fluid from the foam toward the end of the hood.

7, Carefully tip the collector downwards and add one individual drop of oral fluid into the sample well.

NOTE: Continue to squeeze and hold the foam, keeping the collector level in order to prevent the oral fluid from absorbing back into the foam.

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8. After loading the first drop, wait 10 seconds and then add an additional drop of oral fluid.

9. Repeat this process until a total of 4 drops of oral fluid have been added, making sure that you wait 10 seconds between each additional drop.

NOTE: If insufficient or excess oral fluid is added then the device and collector should be discarded and another package opened and the process repeated.

10. The test results are determined by the presence or absence of red lines.

It is possible that line intensity may vary for each drug line. Do not compare line intensities when interpreting results. ORALscreen is a qualitative test. Variations in line intensity do not reflect drug concentration.

A drug negative interpretation may be made once a red line is clearly visible at the control position and at the position indicated for the drug.

A non-negative interpretation must be made at 15 minutes after sample addition.

Do not read results beyond 15 minutes after sample addition.

Diagrams of possible test results are shown below where the black lines are meant to represent the red lines on the test device.

A NEGATIVE test result for all four drugs is indicated by the presence of five red lines.

A NON-NEGATIVE test result is indicated by the absence of a red line at the position indicated for the drug. More than one line may be absent indicating a multiple non-negative.

In order to be VALID, all test results must have a red Control line present. If there is no red Control line, the test is INVALID and the device and collector should be discarded. Open another package and repeat the process.

The assay is designed for use with human oral fluid only. A non-negative result from the test only indicates the presence of a drug or drug metabolite. However, scientific studies such as those by Cone have shown that the presence of cocaine in oral fluid "can reasonably be interpreted as an indication of both recent use and a high likelihood that the subject was experiencing pharmacological effects when the sample was obtained (10)". There is a possibility that other substances and/or factors not listed (e.g. technical or procedural errors) may interfere with the test and cause false results.

REFERENCES

1. NIDA Infofax Marijuana 13551. Last updated 02/04/00. Printed from web 02/10/00.

2. Baselt, R.C. and Cravey, R.H. Disposition of Toxic Drugs and Chemicals in Man, 5th ed., p. 205-210, p. 407-412, p. 527-531, p. 812-817. Biomedical Publ., Davis, CA, 1999.

3. Hart, C. Marijuana: From evil weed to wonder drugs? Modern Drug Discovery. November/December; 39-40,43,45 (1999).

4. Kidwell, D.A., Holland, J.C., Athanaselis, S. Testing for Drugs of Abuse in Saliva and Sweat. J. Chrom. B. 713: 111-135 (1998).

5. NIDA Research Report. Cocaine Abuse and Addiction. NIH Publication No. 99-4342, printed May, 1999. Printed from web 02/10/00.

6. Jenkins, AJ., Oyler, J.M. and Cone, EJ. Comparison of Heroin and Cocaine Concentrations in Saliva with Concentrations in Blood and Plasma. J. Anal. Toxicology. 19: 359-374 (1995).

7. NIDA Research Report. Heroin Abuse and Addiction. NIH Publication No. 97-4165. Printed from web 02/10/00.

8. NIDA Research Report. Methamphetamine Abuse and Addiction. NIH Publication No. 98-4210, printed April, 1998. Printed from web 02/10/00.

9. Sun, M. and Pfeiffer, FR. "Analytical Test Devices for Competition Assay for Drugs of Non-Protein Antigens Using Immunochromatographic Techniques," U.S. Patent #5,238,652.

10. Cone, EJ. Saliva Testing for Drugs of Abuse. Malamud, D., Tabak, L., eds. Saliva as a Diagnostic Fluid. Annals NY Acad Sci. 694: 91127(1993).

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