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OPI, MET, KET One Step Opiate Test Device


Short Description:

The OPI One Step Opiate Test Device (Urine) is a lateral flow chromatographic immunoassay for the detection of Drug Test in human urine at the cut-off concentration of 2,000 ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert. This assay provides only a qualitative, preliminary analytical 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 test result, particularly when preliminary positive results are used.



Product Detail

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KIT COMPONENTS(Device)

Individually packed Test Devices
Each device contains a strip with colored conjugates
and reactive reagents pre-spreaded at the
corresponding regions.
Disposable pipettes
For adding specimens use.
Package insert
For operation instruction.

PROCEDURE

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 µL) 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.

INTERPRETATION OF RESULTS

POSITIVE RESULT:

Only one colored band appears in the control region (C). No

apparent colored band appears in the test region (T).

1

NEGATIVE RESULT:

Two colored bands appear on the membrane. One band appears

in the control region (C) and another band appears in the test

region (T).

2

INVALID :

Control band fails to appear. Results from any test which has not

produced a control band at the specified reading time must be

disgarded. Please review the procedure and repeat with a new

test. If the problem persists, discontinue using the kit

immediately and contact your local distributor

3

NOTE

1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are
the most likely reasons for control band failure.


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