Methadone (MTD) Drug Abuse Test Kit, Methadone urine drug test, 300ng/ml cut-off

Product Name

MTD Rapid Diagnostic Test/ Methadone Rapid Diagnostic Test

Specimen: Urine

Intended Use

The MTD Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Methadone in human urine specimens at the cut-off concentrations listed below:

Test Principle

The MTD Rapid Test Device (Urine) detects Methadone through visual interpretation of color development on the device. Drug conjugates are immobilized on the test region of the membrane. During testing, the specimen reacts with antibodies conjugated to colored particles and precoated on the sample pad. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are insufficient drug molecules in the specimen, the antibody-colored particle conjugate will bind to the drug conjugates, forming a colored band at the test region of the membrane. Therefore, a colored band appears in the test region when the urine is negative for the drug. If drug molecules are present in the urine above the cut-off concentration of the test, they compete with the immobilized drug conjugate on the test region for limited antibody binding sites. This will prevent attachment of the antibody-colored particle conjugate to the test region. Therefore, the absence of a colored band at the test region indicates a positive result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

DIRECTIONS FOR USE

1. Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

2. Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.

3. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

4. As the test begins to work, color will migrate across the membrane.

5. Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes

INTERPRETATION OF RESULTS

NEGATIVE:* A colored line appears in the Control region (C) and colored lines 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 card. If the result is still invalid, contact your manufacturer.

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.

performance characteristics

The specimen correlation study was performed on 300 urine specimens. 123 positive urine specimens and 177 negative urine specimens were confirmed by GC/MS. These specimens were randomized and tested using the MTD One Step Methadone Test Strip (Urine). Specimens were rated as either positive or negative at 5 minutes. The test results are shown in Table 1.

Table 1: Specimen Correlation

Positive agreement with GC/MS: 122/(122+1) = 99%

Negative agreement with GC/MS: 167/(167+10) = 94%

Total agreement with GC/MS: (122+167)/(122+1+10+167) = 96%