INTENDED USE
PocTell® One Step EDDP Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Methadone metabolite in human urine specimens at the cut-off concentrations 100ng/mL.
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Cut-off |
Shelf life |
Kit Size |
|
EDDP |
Cassette |
Urine |
5 mins |
100ng/mL |
24 months |
25T/Kit |
TEST PRINCIPLE
PocTell® One Step EDDP RapidTest Device (Urine) detects Methadone metabolite 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
Bring tests, specimens and/or controls to room temperature (15-30°C) before use.
1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 L) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S).
3.Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.
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