Oral Fluid Summary

Oral Fluid Drug Screen Device Package Insert for the AMP/MAMP/COC/OPI/THC/PCP Test for Oral Fluids

A rapid, screening test for the simultaneous, qualitative detection of amphetamine, methamphetamine, cocaine, opiates, THC and PCP and their metabolites in human oral fluid.

The Oral Fluid Drug Screen Device for AMP/MAMP/COC/OPI/THC/PCP is a lateral flow chromatographic immunoassay for the qualitative detection of amphetamine, methamphetamine, cocaine, opiates, THC, PCP and their metabolites in oral fluids at the following cut-off concentrations:

          Test                                     Calibrator                                  Cut-off 

Amphetamine (AMP)                  d-Amphetamine                                50 ng/mL

Methamphetamine (MAMP)        d-Methamphetamine                          50 ng/mL

Marijuana (THC)                         THC-COOH                                      12 ng/mL

Phencyclidine (PCP)                   Phencyclidine                                  10 ng/mL

Cocaine (COC)                           Benzoylecgonine                              20 ng/mL

Opiates (OPI)                             Morphine                                         40 ng/mL

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) and gas chromatography/tandem mass spectrometry (GC/MS/MS) are the preferred confirmatory methods. Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

SUMMARY

The Oral Fluid Drug Screen Device for AMP/MAMP/COC/OPI/THC/PCP and their metabolites is a rapid, oral fluid screening test that can 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)

Amphetamine is a sympathomimetic amine with therapeutic indications. The drug is often selfadministered by nasal inhalation or oral ingestion. Depending on the route of administration, amphetamine can be detected in oral fluid as early as 5-10 minutes following use1. Amphetamine can be detected in oral fluids for up to 72 hours after use1. The amphetamine assay contained within the Oral Fluid Drug Screen Device yields a positive result when the amphetamine concentration in oral fluid exceeds 50 ng/mL.

Methamphetamine (MAMP)

Methamphetamine is a potent stimulant chemically related to amphetamine but with greater CNS stimulation properties. The drug is often self-administered by nasal inhalation, smoking or oral ingestion. Depending on the route of administration, methamphetamine can be detected in oral fluid as early as 5- 10 minutes following use1. Methamphetamine can be detected in oral fluids for up to 72 hours after use1. The Methamphetamine assay contained within the Oral Fluid Drug Screen Device yields a positive result when the methamphetamine concentration in oral fluid exceeds 50 ng/mL.

Cocaine (COC)

Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic derived from the coca plant (erythroxylum coca). The drug is often self-administered by nasal inhalation, intravenous injection and free-base smoking. Depending on the route of administration, cocaine and metabolites benzoylecgonine and ecgonine methyl ester can be detected in oral fluid as early as 5-10 minutes following use1. Cocaine and benzoylecgonine can be detected in oral fluids for up to 24 hours after use1. The cocaine assay contained within the Oral Fluid Drug Screen Device for cocaine and opiates yields a positive result when the cocaine metabolite in oral fluid exceeds 20 ng/mL.

Opiates (OPI)

The drug class opiates refers to any drug that is derived from the opium poppy, including naturally occurring compounds such as morphine and codeine and semi-synthetic drugs such as heroin. Opiates act to control pain by depressing the central nervous system. The drugs demonstrate addictive properties when used for sustained periods of time; symptoms of withdrawal may include sweating, shaking, nausea and irritability. Opiates can be taken orally or by injection routes including intravenous, intramuscular and subcutaneous; illegal users may also take the intravenously or by nasal inhalation. Using an immunoassay cutoff level of 40 ng/mL, codeine can be detected in the oral fluid within 1 hour following a single oral dose and can remain detectable for 7-21 hours after the dose2. Heroin metabolite 6-monoacetylmorphine (6-MAM) is found more prevalently in excreted unmetabolized, and is also the major metabolic product of codeine and heroin. Morphine is detectable in the urine for several days after an opiate dose. The Oral Fluid Drug Screen Device yields a positive result when the concentration of opiates in the specimen exceeds the 40 ng/mL cut-off level.

Marijuana (THC)

Tetrahydrocannabinol, the active ingredient in the marijuana plant (cannabis sativa), is detectable in saliva shortly after use. The detection of the drug is thought to be primarily due to the direct exposure of the drug to the mouth (oral and smoking administrations) and the subsequent sequestering of the drug in the buccal cavity3. Historical studies have shown a window of detection for THC in saliva of up to 14 hours after drug use3. The THC assay contained within the Oral Fluid Drug Screen Device yields a positive result when the THCCOOH concentration exceeds 12 ng/mL.

Phencyclidine (PCP)

Phencyclidine, the hallucinogen commonly referred to as Angel Dust, can be detected in saliva as a result of the exchange of the drug between the circulatory system and the oral cavity. In a paired serum and saliva sample collection of 100 patients in an Emergency Department, PCP was detected in the saliva of 79 patients at levels as low as 2 ng/mL and as high as 600 ng/mL4. The PCP assay contained within the Oral Fluid Drug Screen Device yields a positive result when the PCP concentration in oral fluids exceeds 10 ng/mL.

ASSAY PRINCIPLE

The Oral Fluid Drug Screen Device for AMP/MAMP/COC/OPI/THC/PCP is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their 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 occurred.

REAGENTS

The test contains membrane strips coated with drug-protein conjugates (purified bovine albumin) on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody specific to Amphetamine, Methamphetamine, Benzoylecgonine, Morphine, THC-COOH and PCP.

PRECAUTIONS

• For forensic use only.

• Do not use after the expiration date.

• The Oral Fluid test device should remain in the sealed pouch until use.

• Saliva is not classified as biological hazard unless derived from a dental procedure.

• The used collector and device should be discarded according to federal, state and local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at 2-30°C. The test is stable through the expiration date printed on the sealed pouch. The test devices must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

SPECIMEN COLLECTION AND PREPARATION

The oral fluid specimen should be collected using the collector provided with the kit. Follow the detailed Directions for Use below. No other collection devices should be used with this assay. Oral fluid collected at any time of the day may be used.

MATERIALS

Materials Provided

• Test devices • Collectors • Collection chambers • Security seals • Package insert • Procedure Card

Materials Required but Not Provided

• Timer

DIRECTIONS FOR USE

Allow the test device, specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test from the sealed pouch and use it as soon as possible.

2. Remove the collector from the sealed pouch and insert the sponge end of the collector into the mouth. Actively swab the inside of the mouth and tongue to collect oral fluid for a total of 3 minutes until the sponge becomes fully saturated. Gentle pressing the sponge between the tongue and teeth will assist saturation. No hard spots should be felt on the sponge when saturated.

3. Remove the collector from the mouth. Place saturated oral fluid collector into chamber and press sponge fully against the strainer to collect oral fluid. Discard the collector. Snap the cap shut on the collection chamber.

4. Place the test device on a clean and level surface. Unscrew cap cover from the collection chamber. Invert the collection chamber and transfer 3 drops of oral fluid (approximately 100 µL) into each specimen well of the test device and start the timer. Avoid trapping air bubbles in the specimen well. Place screw cap on the collection chamber. See illustration below.

5. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not read results after 1 hour.

6. Apply the security seal over screw cap and send to the laboratory for confirmation if necessary.

INTERPRETATION OF RESULTS 

NEGATIVE:* Two lines appear. One red line should be in the control region (C), and another apparent red or pink line adjacent should be in the test region (Drug/T). This negative result indicates that the drug concentration is below the detectable level. *NOTE: The shade of red in the test line region (Drug/T) will vary, but it should be considered negative whenever there is even a faint pink line.

POSITIVE: One red line appears in the control region (C). No line appears in the test region (Drug/T). This positive result indicates that the drug concentration is above the detectable level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact the manufacturer.

QUALITY CONTROL

A procedural control is included in the test. A red line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

LIMITATIONS

1. The Oral Fluid Drug Screen Device for cocaine and opiates provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) or gas chromatography/tandem mass spectrometry (GC/MS/MS) is preferred confirmatory methods.

2. A positive test result does not indicate the concentration of drug in the specimen or the route of administration.

3. A negative result may not necessarily indicate a drug-free specimen. Drug may be present in the specimen below the cutoff level of the assay.