Drug Abuse Test Kit MOP(MORPHINE) Rapid Diagnostic Test,4mm dipcard detecting MORPHINE in urine,

Intended Use

The MOR Rapid Test cassette (Urine) is a rapid visual immunoassay for the qualitative presumptive detection of morphine and other opiates in human urine specimens at the cut-off concentrations listed below:

Test Principle

The MOR Rapid Test cassette (Urine) has been designed to detect morphine and other opiates through visual interpretation of color development in the strip. The membrane was immobilized with morphine conjugates on the test region, and the sample pad was pre-coated with colored anti-morphine antibodies colloidal gold conjugates. After specimens were added, the gold-conjugates move along the membrane chromatographically by capillary action and antibodies get to the test region. If there is no drug molecule in the urine the antibody gold conjugate would attach to the drug conjugate to form a visible line. Therefore, the formation of a visible precipitant in the test region occurs when the urine is negative for the drug. If morphines are present in the urine, the drug antigen competes with the immobilized drug conjugate on the test region for limited antibody sites. In case of sufficient concentration of the drug, it fills the limited antibody binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate to the drug conjugate zone on the test region. Therefore, absence of the colored band on the test region indicates a positive result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane

wicking has occurred.

DIRECTIONS FOR USE

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.

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.

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

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

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

(Please refer to the illustration above)

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. 141positive urine specimens and 159 negative urine specimens were confirmed by GC/MS. These specimens were randomized and tested using the MOP One Step Morphine Test Strip (Urine). Specimens were rated as either positive or negative at 5minutes. The test results are shown in Table 1.

Table 1: Specimen Correlation

Positive agreement with GC/MS: 141/(141+0)> 99%

Negative agreement with GC/MS: 150/(150+9) = 94 %

Total agreement with GC/MS: (141+150)/(141+0+9+150) = 97%