DOA EDDP One Step EDDP Rapid Test with CE certificate urine Uncut sheet
| Product Name |
EDDP One Step EDDP Rapid Test
|
| Formats |
Strip(3mm)Device(4mm) Uncut sheet |
| Place of Origen |
China |
| Specimen |
Urine |
| Read Time |
5 minutes |
| Shelf life |
2 years |
| Package |
Uncut sheet |
| Storage |
2℃-30℃ |
One Step EDDP Test is a rapid one step test for the qualitative detection of methadone’s primary metabolite 2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in human urine at specified cut-off level.
For in vitro diagnostic use only. For professional use only.
INTENDED USE
The One Step EDDP Test is a lateral flow chromatographic immunoassay for the detection of EDDP in human urine at the cut-off concentration of 100ng/ml. 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.
PERFORMANCE CHARACTERISTICS
A. Sensitivity
One Step EDDP Test has set the screen cut-off for positive specimens at 100 ng/mL for EDDP. The test device has been proved to detect above 100 ng/mL of EDDP in urine at 5 minutes.
B. Specificity and cross reactivity
To test the specificity of the test, the test device was used to test EDDP and other components that are likely to be present in urine. All the components were added to drug-free normal human urine. These concentrations below also represent the limits of detection for the specified drugs or metabolites
Component Concentration (ng/ml)
EDDP 100
Methadone 100,000
EMDP 100,000
C. Interfering substances
Considering the complexity of clinical urine specimens and the possibility that various urine specimens contain potentially interfering substances, for example Acetoacetic Aci, Acetone, Albumin etc., we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen. The following components show no cross-reactivity when tested with One Step EDDP Test at a concentration of 100 mg/ml.
SUMMARY
EDDP(2-ethylidene -1,5-dimethyl-3,3-diphenylpyrrolidine) is the primary metabolite of methadone. Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. The detection of EDDP is more beneficial than traditional methadone screening since EDDP exists only in urine from individuals that ingested methadone. The tampering of specimens by spiking the urine with methadone can be prevented. Secondly, renal clearance of EDDP is not affected by urinary pH, therefore the EDDP test provides a more accurate result of methadone ingestion than the methadone parent screening.
