Oral Fluid Multi-Panel Drug Test Cup

TEST PROCEDURE

Allow the test device, specimen and/or control to reach room temperature [15-30°C (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. 1. Open the sealed pouch, then remove the saliva collector from the sealed plastic bag.
2. 2. Insert the sponge into the mouth, actively swab the inside of the mouth and tongue to collect oral fluid for approximately 3 minutes until the sponge becomes soft and fully saturated. The sponge will be free from hard spots when fully saturated.
3. 3. Remove the test tube from the pouch, put the tube on a flat surface. Remove the collector from the mouth and put the saturated oral fluid collector into the strainer of the tube (on thecentral of the bottom).
4. 4. Keep the tube upright, push the Cap into the tube vertically and start the timer.
5. 5. Wait for the colored line(s) to appear. Read the results of drug tests at 5 to 10 minutes, read the alcohol test result at 2 to 5 minutes. DO not read the results of drug tests after 1hour, do not read the alcohol test result after 5 minutes.

6. INTERPRETATION OF RESULTS

   Positive: One colored line appears in the Control zone (C). No line appears in the Test Zone (T). The absence of a line in the test region (T line) indicates a positive result. The positive result indicates that the drug level is above the detectable level.

   Note: The samples with positive results should be confirmed with more specific method.

   Negative: One colored line appears in the Control zone, and another colored line appears in the Test zone. The negative result indicates the drug or its metabolite level is below the detectable level.

   Invalid: No line appears in the Control zone. If no C line or no C line and T line develop within 5 to 10 minutes, the test is invalid. The test should be repeated with a new test device. Insufficient specimen volume or the incorrect procedural techniques are the most likely reasons for invalid result. Review the procedure and repeat the test using a new test strip or device. If the problem persists, discontinue using the current lot and contact your suppliers.

   Alcohol Test Results

   Alcohol Negative Result: The alcohol pad shows no color change (remains white or cream color), it should be interpreted as a negative result (no alcohol present). A result where the outer edges of the alcohol pad produces a slight color but the majority of the pad remains colorless should be repeated to ensure complete saturation of the alcohol pad

   with oral fluid. If the second result is the same, the results should be interpreted as negative (no alcohol present).

   Alcohol Presumptive Positive Result: The Alcohol test produces a color change to green to blue in the presence of salivary alcohol 0.02 % B.A.C. or higher. At higher alcohol concentration near 0.30% B.A.C., the color may change to a dark blue-gray.

   
   

   LIMITATIONS

   1. The Oral Fluid Multi-Panel Drug Test Cupprovides 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) is 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.
   4. There is a possibility that technical or procedural errors, as well as other interfering substances in the specimen may cause erroneous results.

   5.The test results can be used to provide evidence and basis for therapy and treatment plans of drug dependence and toxic psychosis. For laboratory professional in vitro diagnostic use only.

   6.The test should only be performed by health professionals in a clinical/hospital setting to aid in screening of drug of abuse to determine the follow-up treatment measures in combination of clinical symptoms.