DOA OXY One Step Oxycodone Test with CE certificate urine uncut
sheet
| Product Name | OXY One Step Oxycodone 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 Oxycodone Test is a rapid one step test for the
qualitative detection of Oxycodone and its principal metabolites in
human urine at specified cut-off level.
For in vitro diagnostic use only. For healthcare professional use only.
INTENDED USE
The One Step Oxycodone Test is a lateral flow chromatographic
immunoassay for the detection of Oxycodone in human urine at the
cut-off concentration of 100 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 Oxycodone Test has set the screen cut-off for positive
specimens at 100 ng/mL for Oxycodone as a calibrator. The test
device has been proved to detect above 100 ng/mL of Oxycodone in
urine at 5 minutes.
B. Specificity and cross reactivity
To test the specificity of the test, the test device was used to
test Oxycodone, its 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)
Oxycodone 100
Dihydrocodeine 20,000
Codeine 100,000
Hydromorphone 100,000
Morphine > 100,000
Acetylmorphine > 100,000
Buprenorphine > 100,000
Ethylmorphine > 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 Oxycodone Test at a concentration of100 µg/ml.
SUMMARY
Oxycodone is knwn as Oxycontin, Roxicodone and is an ingredient of
Percodan, Percocet, Roxicet and Tylox. Oxycodone is a
semi-synthetic opiates derived from opium. Like other opiates,
oxycodone is characterized by its analegestic properties, and the
tendency for users to form a physical dependency and develop
tolerance with extended use. Oxycodone is usually administered in
combination with non-opiate analegesics such as acetaminophen and
salicylates for the relief of moderate to severe pain. Oxycodone is
a central nervous system depressant that may cause drowsiness,
dizziness, lethargy, weakness and confusion. Toxicity in an
overdose of oxycodone can lead to stupor, coma, muscle flaccidity,
severe respirator ydepression, hypotension, and cardiac arrest.
Oxycodone is metabolized by N- and O-demethylation. One of the
metabolites, oxymorphone, is a potent narcotic analgesic, while the
other, noroxycodone, is relatively inactive. Between 33 to 61% of a
single dose of oxycodone is excreted in a 24 hour urine collection
and consists of 13-19% free oxycodone, 7-29% glucuronide conjugated
oxycodone, 13-14% glucuronide conjugated oxymorphone and an unknown
amount of noroxycodone. The detection time window of oxycodone is
1-3 days following use.
