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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 forthe qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), an inactive metaboliteof 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) isthe preferred confirmatory method. Clinical consideration and professional judgment should be applied to anydrug 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 thisproblem, there is a subsection of the population classified as “extensive metabolizers” of methadone. Inthese individuals, a urine specimen may not contain enough parent methadone to yield a positive drug screeneven if the individual is in compliance with their methadone maintenance. EDDP represents a better urinemarker for methadone maintenance than unmetabolized methadone.
The EDDP Rapid Test Cassette (Urine) is a rapid urine screening test that can be performed without the useof 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 onthe antibody.
During testing, a urine specimen migrates upward by capillary action. EDDP, if present in the urine specimenbelow 300 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. Theantibody-coated particles will then be captured by immobilized EDDP conjugate and a visible colored line willshow up in the test line region. The colored line will not form in the test line region if the EDDP level exceeds300 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-negativeurine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in thetest line region. To serve as a procedural control, a colored line will always appear at the control line regionindicating 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-proteinconjugate. 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 aninfectious 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 pouchand use it within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full dropsof urine (approx. 120 uL) to the specimen well (S) of the test cassette, and then start the timer. Avoidtrapping 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.
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 anotherapparent colored line should be in the test line region (T). A negative result indicates that the EDDPconcentration 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 wheneverthere 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 arethe most likely reasons for control line failure. Review the procedure and repeat the test using a new test. Ifthe 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) isconsidered an internal procedural control. It confirms sufficient specimen volume, adequate membranewicking and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and negativecontrols be tested as good laboratory testing practice to confirm the test procedure and to verify proper testperformance.
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
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer,Exporter,Trading Company
Total Annual:
80000000-100000000
Employee Number:
500~10000
Ecer Certification：
Verified Supplier
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 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.
...
