(COC,THC,MET,AMP,mAMP,MOP) ,Oral drug of abuse test, Saliva Oral Screen Multi panel Drug Testing

Specifications

 Saliva Drug of Abuse DOA Test

- Instant result and convinient opertation

- Shelf life: 24months

- Specimen:saliva

Oral Fluid Drug Screening Device

It's a rapid, screening test for the simultaneous, qualitative detection of Amphetamine, Methamphetamine,

Cocaine, Opiates, Marijuana, Phencyclidine, Benzodiazepines, Oxycodone, Methadone, Barbiturates,

Buprenorphine and their metabolites in human oral fluid.

 1. List of Common Abused Drugs (DOA)&Abbrs

                       •Amphetamine(AMP); 

                 •Barbiturates(BAR);

                 •Benzodiazepines (BZO);

                 •Buprenorphine (BUP);

                 •Cocaine (COC);

                 •Ketamine (KET);

                 •Marijuana (THC);

                 •Methadone (MTD);

                 •Methamphetamine (mAMP);

                 •Methylenedioxymethamphetamine (MDMA);

                 •Morphine (MOP);

                 •Opiates (OPI);

                 •Oxycodone (OXY);

                 •Phencyclidine (PCP);

                 •Propoxyphene (PPX);

                 •Tricyclic Antidepressants (TCA);

2.The Principle of Clungene® Oral Fluid(saliva) Drug Screen Device (Cylinder)  

The Oral Fluid Drug Screen Device for OPI/ AMP/ m-AMP/ THC/ COC/ PCP 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.

3.Cut off levels of Clungene® Oral Fluid(saliva) Drug Screen Device (Cylinder)

 The Oral Fluid Drug Screen Device for OPI/ AMP/ mAMP/ THC/ COC/ PCP is a lateral flow chromatographic immunoassay for the qualitative detection Amphetamine, Methamphetamine, Cocaine, Opiates, Marijuana, Phencyclidine and their metabolites in human oral fluids at the following cut-off concentrations:

4.The Procedure of Oral Fluid(saliva) Drug Screen Device (Cylinder)

Allow the test device, specimen, and/or controls to reach room temperature (15-30°C or 59-86°F) prior to testing. Do not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection of oral fluid specimen.

1.Specimen Collection

2.Using the provided oral fluid swab, sweep the inside of the mouth for 3 minutes. The sponge will gradually soften as oral fluid is absorbed, and should be completely soft after 3 minutes.

3.Stop sweeping the mouth, and push the moistened swab firmly into the specimen dispenser. Push the collector into the collection chamber and press down firmly to release as much liquid as possible. Be sure that at least 0.5 mL liquid has been collected in order to make re-confirmation test possible, if necessary.

4.Tightly shut the outer cap of the specimen dispenser.

5.Test Procedure

6.Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

7.Unscrew the dispensing tip (not the outer cap) of the specimen dispenser, and transfer 3 drops of fluid (approximately 100 µL) to each specimen well (S) of the device and start the timer.

8.Avoid trapping air bubbles in the specimen wells (S), and do not add any solution to the result areas.

9.As the test begins to work, color will migrate across the membrane.

10.Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Only one colored band appears, in the control region (C). No colored band appears in the test region (T) for the drug in question. A positive result indicates that the drug concentration exceeds the detectable level.

 NEGATIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T) for the drug in question. A negative result indicates that

the drug concentration is below the detectable level.

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.