Wholesale Multi-Drug Test Panel (Urine) manufacturers and supplier

The Multi-Drug Test Panel (Urine) is a rapid urine test panel for the quantitative detection of drugs in human urine specimen, integrated with multiple combination from 1 to 15 drug test strips of the following drugs: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, EDDP, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiate, Oxycodone, Phencyclidine, Tricyclic Antidepressants.

PRINCIPLE

The Multi-Drug Test Panel (Urine) is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below the cut-off value, will not saturate the binding sites of the antibody coated particles in the test strip. The antibody coated particles will then be captured by immobilized drug conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the drug level exceeds the cut-off value because it will saturate all the binding sites of antibodies.

A drug-positive urine specimen will not generate a colored line in the test line region, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. 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.

MATERIALS

Materials Provided

Test panel
Package insert

Materials Required But Not Provided

Specimen collection container
Timer
DIRECTIONS FOR USE

Allow the test device, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.
1. 1. Bring the pouch to room temperature before opening it. Remove the test panel from the sealed pouch and use it as soon as possible.
2. 2. Remove the cap from the end of the test panel. With arrows pointing toward the urine specimen, immerse the strip(s) of the test card vertically in the urine specimen for at least 10-15 seconds. Immerse the strip(s) to at least the level of the wavy lines, but not above the arrow(s) on the test panel.
3. 3. Replace the cap and place the test card on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
4. INTERPRETATION OF RESULTS
  
  (Please refer to the illustration)
  
  NEGATIVE:* Two lines appear. One red line should be in the control region (C), and another apparent red or pink line should be in the test region (T). This negative result indicates that the drug concentration is below the detectable level of the relevant strip.
  
  *NOTE: The shade of red in the test line region (T) may vary, but it should be considered negative whenever there is even a faint pink line.
  
  POSITIVE: One red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the drug concentration exceeds 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 your local distributor.
  
  LIMITATIONS
  1. For professional in vitrodiagnostic use only.
  2. 1. The Multi-Drug Test Panel (Urine) 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) is the preferred confirmatory method.^1,2
  3. 2. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
  4. 3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.
  5. 4. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in urine.
  6. 5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.
  7. 6. Test does not distinguish between drugs of abuse and certain medications.
  8. 7. 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.
  9. 8. 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.