# DSB-745-021: Discover significant cost savings from iScreen Oral Fluid Device 4, the oral fluid drug test that delivers results in minutes. iScreen Oral Fluid Device 4 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 iScreen Oral Fluid Device Test. Unlike urine-based tests, iScreen Oral Fluid Device 4 is self contained and 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 (3) 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. The iScreen Oral Fluid Device 4 saliva drug test collection process is much less invasive and embarrassing than urine drug testing. We offer quality saliva oral fluid drug test kits. The iScreen Oral Drug Test is a dynamic saliva drug test kit detecting up to 4 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 iScreen Oral Fluid Device for COC, THC, OPI, mAMP, 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 iScreen Oral Fluid saliva Drug Test 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 iScreen Oral Fluid 4 saliva drug test device specimen should be collected using the collector 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.
INTERPRETATION OF RESULTS
(Please refer to the previous illustration)
NEGATIVE: All test lines appear. One colored line should be in the control region (C), and other
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 or drug free.
*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). Any test line not 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.
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 iScreen Oral 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 iScreen Oral Fluid Drug Test when
tested with concentrations up to 100 ¥ìg/mL.
