The OrAlert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/BZO is an immunoassay based on the principle of competitive binding. A rapid, screening test for the simultaneous, qualitative detection of drugs and their metabolites in human oral fluid. The Oralert 6 Tests for the Parent Drug THC and can detect THC for up to 24 hours. The OrAlert Oral Fluid Drug Screen Device is a lateral flow chromatographic immunoassay for the qualitative detection of drugs and their metabolites in oral fluids. The OrAlert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/BZO 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.
Discover significant cost savings from OrAlert 6 Oral Fluid Drug Screen Device, the oral fluid drug test that delivers results in minutes. OrAlert 6 Oral Fluid Drug Screen Device provides a faster, easier saliva drug test with dramatic cost savings over your current method. Save thousands of dollars in collection fees and lost labor time with OrAlert 6 Oral Fluid Drug Screen Device Test. Unlike urine-based tests OrAlert 6 Oral Fluid Drug Screen Device is ready to use anytime, in any location and anyone can be trained to use the test in minutes. No Waiting For Lab Results. Results In (10) Minutes - Built In Confirmation Chamber. Bathrooms Not Required.
Detecting drug use with a saliva drug test is a clean and easy drug screening technique. Saliva specimens are collected while the donor is under observation, which makes it harder for the donor to tamper with the results. OrAlert 6 Oral Fluid Drug Screen Device saliva drug test collection process is much less invasive and embarrassing than urine drug testing. We offer quality saliva oral fluid drug test kits. OrAlert 6 Oral Fluid Drug Screen Device is a dynamic saliva drug test kit detecting up to 5 drugs. Our saliva drug test kit detects traces of drugs (or drug metabolites) in oral fluids from the donor. Since drugs and drug metabolites (residues) do not remain in oral fluids as long as they do in urine, this method shows more promise in determining current use and impairment.
ASSAY PRINCIPLE
The OrAlert 6 Oral Fluid Drug Screen Device 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 conjugates 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 OrAlert 6 Oral Fluid Drug Screen Device contains membrane strips coated with drug-protein conjugates on the test line, polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with antibody specific to the drugs being tested.
SPECIMEN COLLECTION AND PREPARATION
The OrAlert 6 Oral Fluid Drug Screen Device saliva drug test specimen should be collected using the collecting swab provided with the kit, following the detailed instructions under Directions for Use. No other collection devices should be used with this assay. Oral fluid collected at any time of the day may be used.
DIRECTIONS FOR USE
Allow the OrAlert 6 Oral Fluid saliva Drug test to come to room temperature (59-86¨F) prior to testing. Instruct the donor not to place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.
1. Bring the OrAlert 6 Oral Fluid saliva Drug Screen pouch to room temperature before opening it. Remove the test and Cap from the sealed pouch and use the test as soon as possible.
2. Remove the OrAlert 6 Oral Fluid saliva Drug Screen Device Sample Collector Cap from the collection Swab. Instruct the donor to insert the Swab end of the collector into the mouth and actively swab the inside of the mouth and the top of the tongue. As soon as the Swab softens slightly, the donor should gently press the Swab between the tongue and teeth to ensure complete saturation.
3. The Swab is saturated when no hard spots can be felt. Collect for a total of at least three (3) minutes before removing the Swab. Remove the collector from the mouth
4. Align the Red Arrow on the OrAlert 6 Oral Fluid Drug Screen Device with one of the White Marks on the Cap. Insert the collector vertically into the Cap and press down firmly. Twist the Cap clockwise 180 degrees until the Red Arrow lines up with the other White Mark.
5. Place the test device horizontally on a clean and level surface with facing up.
6. Read results at 10 minutes. Do not read results after 1 hour.
7. If positive results are observed, secure Cap with security seal and send the OrAlert 6 Oral Fluid Drug Screen Device to a laboratory for confirmation. The laboratory can access the reservoir through the Sample Port.
How to Read Results
NEGATIVE: Two lines appear.
One colored line should be in the control region (C), and another apparent colored line should be adjacent in the test region (Drug/T). This negative result indicates that the drug concentration is below the detectable level.
NOTE: The shade of color in the test region (Drug/T) will vary, but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored 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. A procedural control is included in the test. A colored 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 OrAlert 6 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) are 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.
Cross-Reactivity
A study was conducted to determine the cross-reactivity of the test with compounds spiked into drug-free PBS stock. The compounds demonstrated no false positive results on the OrAlert 6 when tested with concentrations up to 100 mL.
