Saliva 5 Oral-Cube

Five Panel Drug of Abuse Screening using a Saliva Sample.

Price/Order

Oral-Cube 5™ is an oral fluid (saliva) based, point of contact test screen for illicit and prescription drug use or abuse. Simple and discreet drug of abuse testing without the inconvenience, embarrassment or biological hazard risks associated with urine specimen collection and handling. Completely eliminates the possibility of sample contamination, adulteration, substitution or manipulation. Qualitative, visually interpreted results in ten minutes, Easy extraction, syringe type sample collection device. Does not require a highly skilled or specially trained test administrator, monitored sample collection facilities, collection observers, special test accessories or equipment. Direct OEM pricing. Non-diagnostic Forensic Use Only.

THC • COC • AMP/MAMP • OPI • BZD

PRINCIPLE

Incorporating a newly developed, patented collection device for human saliva samples, the SalivaConfirm™5 is a self-contained, ready to use, point of contact drug testing device that detects the five most common drugs (or drug classes) of abuse: Marijuana (THC), Cocaine, Opiates (or all opium based drugs), Amphetamine (and its derivatives Methamphetamine), and Benzodiazepines (sedatives) using the preferred lateral flow immunoassay technology for this method of test screening. The test requires no special training to complete and qualitative yes/no results are visibly obtained at ten minutes.

Note: As with all visually interpreted lateral flow tests, this assay provides only a preliminary analytical test result. A more specific alternative chemical method such as high-pressure liquid chromatography (HPLC) or Gas chromatography/mass spectrometry (GC/MS) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be applied to all test results, particularly when preliminary positive results are indicated.

ORAL FLUID ASSAY SYSTEM FOR DRUGS OF ABUSE

The Oral-Cube 5 forensic drug testing system detects the five most commonly abused illicit and prescription drugs using a saliva sample. Because urine collection is not necessary, there are certain advantages using the Oral-Cube 5 system for on-site drug screening. Sample collection is less hazardous, less embarrassing for the parties, and because there is no need for privacy during sample collection, less prone to corruption by sample substitution or adulteration. Because the test subject is present for the entire sample collection and testing process, the possibility of sample adulteration and/or substitution is eliminated. The Oral-Cube 5 will detect Marijuana (THC), Cocaine (COC), Opiate (OPI), Amphetamine (AMP)/Methamphetamine(MET) and Benzodiazepine (BZD) use at a sensitivity level for saliva concentration* according to the following chart:

* Sensitivity detection levels for oral fluid (saliva) are considerably lower than those for urine tests because the concentration of detectable drug metabolites are significantly less in oral fluids (saliva). The sensitivity cut-off levels above generally correlate with the standards established for forensic urine tests by the NIDA, SAMSHA and WHO. For a technical document on the precision and specificity of saliva drug screens in relationship to urine based tests see the Technical Whitepaper on saliva based drug testing methods.

Additionally, the Oral-Cube 5 drug test will detect the metabolites and chemical derivatives of the class of drugs noted above including all opium derivatives (codeine, heroin, etc.) and Amphetamines (ecstasy, Methamphetamine, etc.) Other features of using the Oral-Cube 5 drug test include:

• Definitive sample source: eliminates sample adulteration or substitution
• Eliminates need for urine collection and handling, no biohazard risk or special disposal
• Does not require a highly skilled or specially trained test administrator, visual interpretation
• Does not require sample collection facilities, collection observers, special test accessories or equipment
• Eliminates completely the possibility of test manipulation through sample adulteration
• Eliminates the potential of cross contamination of samples

PROCEDURE

IMPORTANT: Test devices must be at room temperature (15-30°C) before testing. These are basic procedure descriptions, please refer to the detailed product insert when performing the actual test.

1. Bring the sealed pouch to room temperature before opening. Remove the test device from the pouch and use it as soon as possible. Check the expiration date on the product pouch. Remove the test cap exposing the collection pad wick.
2. Insert the collection pad end of the device into the subject's mouth. Keep the opposite end of the device angled downward to ensure good flow (also refer to the procedure card).
3. Instruct the subject to move the collection pad from top to bottom of the tongue and back again filling the collection pad with saliva. Keep the pad in the subject's mouth for about 1-3 minutes until the collection pad is completely saturated with saliva.
4. When migration of saliva or any pink/burgundy color appears in the result window, remove the device from the subject's mouth and replace the cap onto the collection pad end of the device. Lay the device on a flat surface Total time from the start of the test to the appearance of the C line depends on the saliva production and the viscosity of the saliva of the individual. Start timing once the C line is visible in the test window. Read results 5-7 minutes after the C line appears.

INTERPRETATION OF RESULTS

Wait 5-7 minutes after the control line (C) appears for test results to fully develop. Test results are read by observing and scoring whether red/pink lines develop on the test result panel as present or absent. Complete absence of a test line indicates a positive test. Development of a test line, no matter how faint, indicates a negative result for the labeled drug or drug metabolite. No correlation or assumptions should be drawn on the color or intensity of test lines. Intensity and color will vary line to line in the test panel and this result is both usual and expected. Examples of test results:

NEGATIVE A Negative test result is indicated by pink rose lines adjacent to each target drug label plus a control line.

POSITIVE AMP A Positive test result is indicated by the absence of a pink rose line adjacent to the MET drug label plus a control line.

POSITIVE THC/COC A Positive multiple test result is indicated by the absence of pink rose lines adjacent to each target drug label (THC/COC) plus a control line.

INVALID An invalid test result is indicated by the absence of a control line (C). All other lines are invalid without a control line

INVALID Complete absence of any lines on the test panel usually indicates an insufficient sample was added to the sample well.

A NEGATIVE test result is indicated by the development and presence of a red/pink line adjacent to the labeled target drug.. If there is a visible line, no matter how faint it may be, the test should be considered negative result for the target drug. An extremely faint line could mean that the target drug is near the sensitivity cut-off level for the test however the result is still negative. In such circumstances the test could be repeated at another time or a more quantitative method of laboratory testing be employed.
A POSITIVE test result is indicated by the complete absence of a red/pink line at the position indicated for the drug in the test panel. More than one line may be absent indicating a multiple positive drug screen.
An INVALID test result is indicated by the absence of a red/pink line at the (C) or control position. Complete absence of any lines on the test panel usually indicates an insufficient sample was added to the sample well and the test must redone using another test device. Test cassettes are single use only and cannot be reused.

AVAILABILITY:

The Oral-Cube 5 Saliva Drug Testing System is currently available for point of contact drug of abuse screening in procedure packs of 25, 50, and 150 test packs. Each pack includes complete test instruction and technical specifications of the test For quantities exceeding 300 units please contact us by e-mail at customerservice@craigmedical.com. Each test pack comes with individually sealed test procedures containing one disposable collection syringe and one saliva test cassette. Oral-Cube 5 Saliva Drug Tests are recommended for institutional, professional, judicial, educational and workplace drug testing programs and are intended for non-diagnostic *forensic use only.

*Forensic Use Only. Not intended to be used in the diagnosis, cure, mitigation, treatment, or prevention of a disease or illness. For initial indication of drug presence only. Forensic use only tests are intended for use by legal and law enforcement entities or laboratories testing for those entities. Not intended for home use.