DRUGLAB ORAL FLUID 6

One Step Multi-Line Screen Test Device (Oral Fluid)

A rapid, screening test for the simultaneous, qualitative detection of multiple drugs and metabolites in human oral fluid. For medical and other professional in vitro diagnostic use only.

INTENDED USE & SUMMARY

The DRUGLAB ORAL FLUID 6 is a lateral flow chromatographic immunoassay for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Opiate, and Phencyclidine and their metabolites in oral fluid at the following cut-off concentrations. The detection window, when drugs can be detected in oral fluid specimens using this test, is also indicated.

Test Calibrator Cut-off (ng/mL) Detection Time

Amphetamine (AMP) D-Amphetamine 50 10 min – 72 hrs

Cocaine (COC) Benzoylecgonine 2010 min – 24 hrs

Marijuana (THC) 11-nor-_9-THC-9 COOH 12 Up to 14 hrs

Methamphetamine (MET) D-Methamphetamine 50 10 min – 72 hrs

Opiate (OPI) Morphine 40 1 hr – several days*

Phencyclidine (PCP) Phencyclidine 10 -

This test will detect other related compounds, please refer to the Analytical Specificity table in the package insert.

AMP: Amphetamine is a sympathomimetic amine with therapeutic indications. The drug is often self-administered by nasal inhalation or oral ingestion.1

COC: Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic derived from the coca plant (erythroxylum coca).1

THC: Tetrahydrocannabinol, the active ingredient in the marijuana plant (cannabis sativa), is detectable in oral fluid 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 cavity.2

MET: 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.1

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 control pain by depressing the CNS, and demonstrate addictive properties when used for sustained periods of time. 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.3 *The window of detection varies for different opiates. Codeine can be detected within one hour and up to 7-21 hours after a single oral dose. Morphine is detectable for several days after a dose.

PCP: Phencyclidine is a hallucinogen and, can be detected in oral fluid as a result of the exchange of the drug between the circulatory system and the oral cavity.

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.

PRINCIPLE

The DRUGLAB ORAL FLUID 6 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 device contains drug protein conjugates and mouse monoclonal antibody-coupled particles specific to each drug coated on the membrane. A goat antibody is employed in each control line.

PRECAUTIONS

For medical and other professional in vitro diagnostic use only. Do not use after the expiration date. • The test device should remain in the sealed pouch until use.

• All specimens should be considered potentially biohazardous and handled in the same manner as an infectious agent.

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

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device 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 test. Oral fluid collected at any time of the day may be used. If specimen cannot be tested immediately, it is recommended that specimen be stored at 2-8°C or -20°C for up to 72 hours. Specimen may also be stored at room temperature for up to 48 hours. For ideal shipment conditions, transport specimen using ice packs (2-8°C).

MATERIALS

Materials Provided

• Test devices

• Collectors

• Collection tubes

• Security seals

• Package insert Materials

Required but not Provided

• Timer