300ng Rapid test for the qualitative detection of EDDP in human urine​

Applications:

The EDDP (Methad/one Metabolite) Rapid Test Cassette (Urine) is a rapid immunochromatographic assay for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), an inactive metabolite of meth/adone that acts as a narcotic pain reliever and is used as a treatment for opiate addiction.

This assay provides only a 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.

Description:

Methad/one is an unusual drug in that its primary urinary metabolites (EDDP and EMDP) are cyclic in structure, making them very difficult to detect using immunoassays targeted to the native compound.1 Exacerbating this problem, there is a subsection of the population classified as “extensive metabolizers” of metha/done. In these individuals, a urine specimen may not contain enough parent metha/done to yield a positive drug screen even if the individual is in compliance with their metha/done maintenance. EDDP represents a better urine marker for metha/done maintenance than unmetabolized metha/done.

How to 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 cassette from the sealed pouch and use it within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120μL) to the specimen well (S) of the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10minutes.

【DIRECTIONS FOR PANEL USE】
Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) 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 strip 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 result should be read at 5 minutes. Do not interpret the result after 10 minutes.

【DIRECTIONS FOR DIPSTICK USE】
Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it within one hour.
2. With arrows pointing toward the urine specimen, immerse the test dipstick vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the Test Dipstick when immersing the strip. See the illustration below.
3. Place the test dipstick on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

NEGATIVE:* Two lines appear. One color line should be in the control region (C), and another apparent color line should be in the test region (T). This negative result indicates that the Ethylenediamine-dimethylphosphinic acid (EDDP) concentration is below the detectable cutoff level.

*NOTE: The shade of color in the test region (T) may vary, but it should be considered negative whenever there is even a faint color line.

POSITIVE: One color line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Ethylenediamine-dimethylphosphinic acid (EDDP) concentration is above the detectable cutoff level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test Dipstick. If the problem persists, discontinue using the test Dipstick immediately and contact your local distributor.

Order Information

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.