Active Member
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[China]
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Contact name:Edward YU
Hangzhou Aichek Medical Technology Co.,Ltd |
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| 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.
