Ethylenediamine-dimethylphosphinic acid (EDDP) Rapid Test,
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)
A rapid test for the qualitative detection of EDDP in human urine. For medical and other professional in vitro diagnostic use only.
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Cup |
| Specimen | Urine, WB/S/P |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 97.90% |
| Specificity | 99.40% |
| Accuracy | 98.80% |
| Cut-Off | 300 ng/mL*, 100 ng/mL, 50 ng/mL |
INTENDED USE
The EDDP (Methadone 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 methadone 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 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.
SUMMARY
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.1 Exacerbating this problem, there is a subsection of the population classified as
“extensive metabolizers” of methadone. In these individuals, a urine 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 urine marker for methadone maintenance than unmetabolized methadone.
The EDDP Rapid Test Cassette (Urine) is a rapid urine screening
test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to
selectively detect elevated levels of EDDP in urine. The EDDP Rapid Test Cassette (Urine) yields a positive result when
EDDP in urine exceeds 300 ng/mL.
PRINCIPLE
The EDDP Rapid Test Cassette (Urine) is an immunoassay based on the
principle of competitive binding. Drugs which may be present in the urine specimen compete against
the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary
action. EDDP, if present in the urine specimen below 300 ng/mL, will not saturate the binding sites of
antibody-coated particles in the test device. The antibody-coated particles will then be captured by immobilized EDDP
conjugate and a visible colored line will show up in the test line region. The colored line will not form in
the test line region if the EDDP level exceeds 300 ng/mL because it will saturate all the binding sites of
anti-EDDP antibodies.
A drug-positive urine specimen will not generate a colored line in
the test line region, while a drug-negative urine specimen or a specimen containing a drug concentration less
than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line
will always appear at the control line region indicating that proper volume of specimen has been added and
membrane wicking has occurred.
REAGENTS
The test cassette contains mouse monoclonal anti-EDDP
antibody-coupled particles and EDDP-protein conjugate. A goat antibody is employed in the control line system.
PRECAUTIONS
- For medical and other professional in vitro diagnostic use only. Do
not use after the expiration date.
- The test should remain in the sealed pouch until use.
- All specimens should be considered potentially hazardous and
handled in the same manner as an infectious agent.
- The used test should be discarded according to local regulations.
DIRECTIONS FOR 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 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. 120 uL) 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 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). A
negative result indicates that the EDDP concentration is below the detectable level (300 ng/mL).
*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). A positive result indicates that the EDDP concentration
exceeds the detectable level (300 ng/mL).
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 using a new test. If the problem persists, discontinue using the lot immediately and
contact your local distributor.
QUALITY CONTROL
A procedural control is included in the test. A colored line
appearing in the control line 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 testing practice to confirm
the test procedure and to verify proper test performance.
Order Information
| Cat. No. | Product | Specimen | Pack |
| DED-102 | Ethylenediamine-dimethylphosphinic acid (EDDP) Rapid Test Cassette | Urine | 40 T |
| DED-114 | Ethylenediamine-dimethylphosphinic acid (EDDP) Rapid Test Panel | Urine | 40 T |
| DED-101 | Ethylenediamine-dimethylphosphinic acid (EDDP) Rapid Test Dipstick | Urine | 50 T |
| DED-402 | Ethylenediamine-dimethylphosphinic acid (EDDP) Rapid Test Cassette | WB/S/P | 40 T |
