Intended use and summary
| TEST | COMMON NAMES | CUT-OFF |
| Amphetamine (AMP) | Speed, Meth, Uppers, Ice, Obex | 1000 ng/mL |
| Cocaine (COC) | Cocaine, Crack, Rocks | 300 ng/mL |
| Dagga (THC) | Dagga, Hash, Marijuana | 50 ng/mL |
| Methamphetamine (MET) | Tik, Ecstacy | 1000 ng/mL |
| Morphine (MOP) | Morphine, Heroin, Opiates | 300 ng/mL |
The assay provides only a preliminary analytical test result. A more specific alternative clinical method must be used in order to obtain a confirmed analytical result.
Precautions, storage and stability:
For in vitro diagnostic use only. The test panel should remain in the sealed pouch until used. The kit should be stored at or below room temperature ( 5 - 30⁰C ). The test panel is stable until the expiry date printed on the sealed pouch. Do not use after the expiry date.
Specimen collection and preparation:
The urine specimen must be collected in a clean and dry container. Urine collected anytime of day may be used.
Directions for use:
Remove the test panel from the sealed pouch. Remove the cap from the test panel. With the white strips pointing toward the urine specimen, immerse the test panel vertically into the urine specimen for at least 10 seconds. Do not immerse the test panel past the mark line indicated on the test panel. See panel illustration below. Place the cap back onto the test panel. Place the test panel on a non-absorbent, flat surface and wait for the red line(s) to appear. The results should be read at 5 minutes. Do not interpret the results after 10 minutes.
Interpretation of results:
Positive : One red line should be in the control region (C) of the specific drug test. No line appears in the test region (T) of the specific drug test. The absence of a test line indicates a positive result for that drug.
Negative: Two red or pink lines below each drug name will appear. One line should be in the control region (C) , and another line should be in the test region (T) of each specific drug test.
NOTE: The shade in the test region (T) may vary, but it should be considered negative whenever there is a faint pink line.
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.
Limitations:
1. The multi-drug one step screen test panel (urine) provides only a preliminary analytical result. A more specific chemical methods must be used to obtain a confirmed result.
2. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimen may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.
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.
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.
Disclaimer: The manufacturer, distributor, pharmacy and healthcare professional does not accept any liability whatsoever for any consequent actions resulting from interpretations of the test result.
Distributed by:
Pinnacle Pharmaceutical Ltd, 15 Estmil Road, Diep River, 7800.
Tel: 021 715 5221 Fax: 021 715 8205 Website: www.pinpharm.co.za
Date of publication of the package insert: June 2013
