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DOA OXY One Step Oxycodone Test with CE Certificate Urine uncut sheet

Hangzhou Aichek Medical Technology Co.,Ltd
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DOA OXY One Step Oxycodone Test with CE Certificate Urine uncut sheet

Brand Name : Aichek

Model Number : OXY-A01

Certification : CE

Place of Origin : China

MOQ : 5000 Test

Price : negotiable

Payment Terms : T/T

Supply Ability : negotiable

Packaging Details : 40box/carton

Storage : 2℃-30℃

Sample Type : Urine

User : Professional

Accuracy : 99.9%

Certificate : CE ISO 13485

OEM : OEM customized packing avaliable

Formats : 25T/box 1T/box

After-sales Service : Available

Key words : OXY rapid Test with CE certificate urineuncut sheet

Combo Device : Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette

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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.


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