Detects the presence of up to six different drugs in saliva...

The iScreen OFD is a top quality oral fluid drug test that is easy to use and conduct. The test takes a matter of minutes and there is no need to use a bathroom. The iScreen OFD kit is less invasive and embarrassing than urine drug testing. Oral fluid screening is useful in determining current use and impairment, since drugs and drug metabolites (residues) do not remain in oral fluids as long as they do in urine.

Detecting drug use with a saliva drug test kit is clean, quick and easy. Specimens are collected while the donor is under observation, which makes tampering with the specimen more difficult.

The Benefits of the iScreen include:

• Low Cost
• Simple to use and read
• Can be performed at remote locations
• Non invasive
• Proven laboratory accuracy
• Smaller, Compact Design
• 99.9% Accurate
• Results in Seconds
• 18 month shelf life
• Is CE marked and FDA approved
• No technical training required
• No clinical personnel required

Assay Principal

The iScreen OFD is an immunoassay based on the principle of competitive binding. drugs that maybe present in the oral fluid specimen compete against there respective drug conjugates for binding sites on there specific antibody.

During testing, a portion of 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 upwardly by capillary action. A drug if present in the oral fluid specimen below its cut of concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug protein conjugate and a viable colored line will show up in the test line region of the spefic 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.

The iScreen OFD will detect the following metabolites:

Drug Name:	Abbr:	Cutoff:
Amphetamine	AMP	50ng/mL
Methamphetamine	mAMP	50ng/mL
Marijuana	THC	12ng/mL
Phencyclidine	PCP	10ng/mL
Cocaine	COC	20ng/mL
Opiates	OPI	40ng/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. Professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Instructions

	Section I: Sample Collection   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. Remove Sample Collector Protector.
Insert Sponge end of collector into mouth. Actively swab the inside of the mouth and tongue with Sponge. As soon as the Sponge softens slightly, gently press the Sponge between the tongue and teeth to ensure complete saturation. The Sponge is saturated when no hard spots can be felt. Collect for at least three (3) minutes before removing Sponge. Hand the saturated collector over to the tester.
Section II: Testing   A. Align the Red Arrow on the device with either one of the White Marks on the Cap. Insert the collector vertically into the Cap and press down firmly until the Cap reaches the thread. B. Twist the Handle clockwise 180° to tighten the Cap until the Red Arrow lines up with the other White Mark. C. Place the test device horizontally on a clean and level surface with result window facing up.
Read results at five (5) minutes. Results stable up to sixty (60) minutes.   * All positive results are presumptive and should be confirmed by an alternative method. The preferred confirmation method is GC/MS or GC/MS/MS.	If results are positive, secure Cap with Security Seal and send to laboratory for confirmation.