DOA OPI One Step Opiates Testwith CE certificate urine Uncut sheet
| Product Name | OPI One Step Opiates 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 Opiate Test is a rapid one step test for the qualitative detection of Opiate
and its principal metabolites in human urine at specified cut-off
level.
For in vitro diagnostic use only. For professional use only.
INTENDED USE
The One Step Opiate Test is a lateral flow chromatographic
immunoassay for the detection of Opiate in human urine at the
cut-off concentration of 2000 ng/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 Opiate Test has set the screen cut-off for positive
specimens at 2000 ng/mL for Opiate. The test device has been proved
to detect above 2000 ng/mL of Opiate in urine at 5 minutes.
B. Specificity and cross reactivity
To test the specificity of the test, the test device was used to
test opiates, drug metabolites and other components of the same
class 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)
Morphine 2,000
Codeine 2,000
Ethylmorphine 5,000
Hydrocodone 12,500
Hydromorphine 5,000
Levorphanol 75,000
s-Monoacetylmorphine 5,000
Morphine 3-b-D-glucuronide 2,000
Norcodeine 12,500
Normorphone 50,000
Oxycodone 25,000
Oxymorphine 25,000
Thebaine 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 Opiate Test at a concentration of 100 mg/ml.
SUMMARY
Opiate refers to any drug that is derived from the opium poppy,
including the natural products, morphine and codeine, and the
semi-synthetic drugs such as heroin. Opioid is more general,
referring to any drug that acts on the opioid receptor. Opioid
analgesics comprise a large group of substances which control pain
by depressing the central nervous system. Large doses of morphine
can produce higher tolerance levels, physiological dependency in
users, and may lead to substance abuse. Morphine is excreted
unmetabolized, and is also the major metabolic product of codeine
and heroin. Morphine is detectable in the urine for several days
after an opiate dose.
