MedEx Multi-Drug 5 Drugs Rapid Test Panel (Urine)

Instruction Sheet for testing of any combination of the following drugs: MOP/COC/THC/AMP/MET.
Materials provided: Test panels, Package insert.
Materials required but not provided: Timer, Specimen collection containers.

Principle (For DOA tests excluding Alcohol): During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine 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 region of the specific drug dipstick. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test region.
A drug-positive urine specimen will not generate a colored line in the specific test region of the dipstick because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of drug competition.
To serve as a procedural control, a colored line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Reagents (For DOA tests excluding Alcohol): Each test line contains anti-drug mouse monoclonal antibody and corresponding drug-protein conjugates. The control line contains goat anti-rabbit IgG polyclonal antibodies and rabbit IgG.
Performance Characteristics: Accuracy: (See Table 1.)

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Precision: A study was conducted at three hospitals using three different lots of product to demonstrate the within-run, between-run and between-operator precision. An identical card of coded specimens, containing drugs at concentrations of negative, 50%, and 25% cut-off level, was labeled, blinded and tested at each site. The results gained ≥75% accuracy in ±25% cut-off level specimen and 100% accuracy in negative and ±50% cut-off level specimen.
Analytical Sensitivity: A drug-free urine pool was spiked with drugs at the listed concentrations. The results are summarized as follows: (See Table 2.)

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Analytical Specificity: The following table lists the concentrations of compounds (ng/mL) that are detected as positive in urine by the Multi-Drug Rapid Test at 5 minutes. (See Table 3.)

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Effect of Urinary Specific Gravity: Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.005-1.045) were spiked with drugs at 50% below and 50% above cut-off levels, respectively. The Multi-Drug Rapid Test was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity do not affect the test results.
Effect of Urinary pH: The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine was tested with the Multi-Drug Rapid Test. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.
Cross-Reactivity: A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or drug-positive urine containing previously mentioned related calibrator substances. The following compounds show no cross-reactivity when tested with the Multi-Drug Rapid Test at aconcentration of 100 μg/mL. (See Table 4.)

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The Multi-Drug Rapid Test Panel is a rapid chromatographic immunoassay for the qualitativedetection of multiple drugs and drug metabolites in human urine at the following cut-off concentrations: (See Table 5.)

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Configurations of the Multi-Drug Rapid Test Panel come with any combination of the previously listed drug analytes without S.V.T. This assay provides only a preliminary test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse testresult, particularly when preliminary positive results are indicated.

Specimen Collection and Preparation: Urine Assay: The urine specimen should be collected in a clean and dry container. Urine collected at anytime of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
Specimen Storage: Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.
Directions for Use: Allow the test, urine specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test panel from the sealed pouch and use it within one hour.
2. Remove the cap.
3. With the arrow pointing toward the urine specimen, immerse the test panel vertically in the urine specimen for at least 10 to 15 seconds. Immerse the dipstick to at least the level of the wavy lines, but not above the arrow on the test panel.
4. Replace the cap and place the test panel on a non-absorbent flat surface.
5. Start the timer and wait for the colored line(s) to appear.
6. The drug strip result should be read at 5 minutes. Do not interpret the result after 10 minutes.
Interpretation of Results: NEGATIVE: *A colored line appears in the control region (C) and another colored line appears in the test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the test region (T) may vary. The result should be considered negative whenever there is even a faint line.
POSITIVE: A colored line appears in the control region (C) and no line appears in the test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.
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. Read the directions again and repeat the test with a new test. If the result is still invalid, contact the manufacturer. (See figure.)

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Quality Control: A procedural control is included in the test. A line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking, and correct procedural technique.
Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.
Limitations: The Multi-Drug Rapid Test Panel provides only a qualitative, preliminary result. A secondary analytical method must be used to obtain a confirmed result. Gas Chromatograph/Mass Spectrometry (GCIMS) is the preferred confirmatory method.
There is a possibility that technical or procedural errors, as well as interfering substances inthe urine specimen, may cause erroneous results.
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.
A positive result does not indicate level or intoxication, administration route, or concentrationin urine.
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.
This test does not distinguish between drugs of abuse and certain medications.
A positive test result may be obtained from certain foods or food supplements.

For healthcare professionals including professionals at point of care sites.
Immunoassay for in vitro diagnostic use only.
All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
The used test should be discarded according to local regulations.

Store as packaged in the sealed pouch at 2-30°C.
The test must remain in the sealed pouch until use.
Do not freeze.

Personal Care