Description
Instructions for use for each combination test for the following drugs: Cotinine, Methamphetamine, Morphine/Opiates, and Cocaine. A single-step test for the simultaneous qualitative detection of drugs of abuse in human hair.
During the test, the lysate breaks down keratin, the main component of hair, and releases the drug molecules being tested. The hair lysate migrates by capillary action.
A drug, if present in the hair lysate below its cutoff 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 appear in the test region of the drug-specific dipstick. The presence of drug above the cutoff concentration will saturate all binding sites of the antibody. Therefore, the colored line will not appear in the test region. A drug-positive hair lysate sample will not generate a colored line in the specific test region of the dipstick due to competition with the drug, while a drug-negative hair sample will generate a line in the test region due to the absence of competition with the drug. As a procedural control, a colored line will always appear in the control region, indicating that an adequate volume of sample has been added and that membrane wicking has occurred.

How to use
Allow the test, specimen, swab, and/or controls to reach room temperature.
1. Collect a hair sample from the length of the hair closest to the skin and cut the hair no longer than 3 cm and no less than 100 mg. Cut the collected hair into small pieces.
2. Add the swab to the sample collection tube with catalyst powder and shake well.
3. Add the hair sample to the preparation, tighten the cap on the sample collection tube, and shake the tube vigorously. Leave the tube in the container for 5 minutes.
4. Remove the test cassette from the sealed pouch and use it within one hour. Place the test cassette on a clean, flat surface. Open the cap of the sample collection tube and transfer 3 full drops of sample into the sample well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the sample well (S).
5. Wait for the colored lines to appear. Read the results after 5 minutes. Do not interpret the result after 10 minutes (see the illustration below).

Interpretation of the results
NEGATIVE:* A colored line appears in the control region (C) and a colored line appears in the test regions (T). This negative result means that the concentrations of the target analyte (COT, MET, MOP, and COC) in the hair are below the designated cut-off levels for the target analyte.
*NOTE: The hue of the colored lines in the test region (T) may vary. Even a faint line is present, and the result should be considered negative.
POSITIVE: A colored line appears in the control region (C) and no line appears in the test region (T). A positive result means that the concentration of the target analyte (COT, MET, MOP, and COC) in the hair sample is above the designated cutoff for the target analyte.
INVALID: No line appears in the control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Reread the directions and repeat the test with a new test. If the result is still invalid, contact the manufacturer.

Warnings
- Not for medical or diagnostic use.
- Do not use after the expiration date.
- The test device must remain sealed until ready for use.
- All samples must be considered potentially hazardous and, therefore, must be handled with the precautions expected for potentially infectious products.
- Used test materials must be disposed of in accordance with local regulations.
The kit should be stored at 2-30°C in its sealed pouch. The catalyst powder can be stored at 2-30°C for up to 18 months before testing. However, these are enzyme-based reagents that perform best when stored at 2-8°C. Therefore, although the kit is stable up to 30°C, it is recommended to store it at 2-8°C to enhance the performance of the catalyst powder. The test strip device is stable until the expiration date printed on the pouch label. The test strip device should be stored in its sealed pouch until use. Do not freeze. Do not use after the expiration date.
The Multidrug Rapid Test Cassette (hair) provides only a qualitative and preliminary analytical result. A secondary analytical method is required to obtain a confirmed result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method.
2. It is possible that technical or procedural errors, as well as other interfering substances in the hair sample, may cause erroneous results.
3. Adulterants, such as bleach, in hair samples can produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another hair sample.
4. A positive result indicates the presence of the drug or its metabolites, but does not indicate the level of intoxication, the route of administration, or the concentration in the hair.
5. A negative result does not necessarily indicate drug-free hair. Negative results may occur when the drug is present but below the test cutoff level.
6. The test does not distinguish between drugs of abuse and some medications.

Cod. DOA-H945