50 ng/ml EDDP Drug Abuse Test Kit Methadone Metabolite whole blood/serum/plasma Testing
The EDDP Rapid Test Cassette (whole blood/serum/plasma) is a lateral flow chromatographic immunoassay for the detection of EDDP in whole blood or serum or plasma at a cut-off concentration of 50ng/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.
Methadone 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.1Exacerbating this problem. there is a subsection of the population classified as “extensive metabolizers” of methadone. In these individuals, a whole blood/serum/plasma specimen may not contain enough parent methadone to yield a positive drug screen even if the individual is in compliance with their methadone maintenance. EDDP represents a better whole blood/serum/plasma marker for methadone maintenance than unmetabolized methadone.
How to use?
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
For serum or plasma specimen:
1. Bring the pouch to room temperature (15-30℃) before opening it. Remove the cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 1 full drop of serum or plasma (approximately 40μl), then add 2 drops of buffer (approximately 80μl) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.
3. Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not interpret the result after 10 minutes.
For whole blood specimen:
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 1 drop of whole blood (approximately 40μl) to the specimen well, then add 2 drops of buffer (approximately 80μl), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 40μl of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer(approximately 80μl) and start the timer. See illustration below.
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
(Please refer to the illustration above)
NEGATIVE:* Two lines appear. One colored line should be in the control line region (C), and another apparent colored line should be in the test line region (T). This negative result indicates that the EDDP concentration is below the detectable cut-off level.
*NOTE: The shade of color in the test line region (T) may vary, but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). This positive result indicates that the EDDP concentration exceeds the detectable cut-off 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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.