DOA OPI One Step Opiates Testwith CE certificate urine Uncut sheet

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.

Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products.

With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of abuse, our research and development team continues to grow.

Based in Hangzhou, the company has long-term cooperation with various R&D institutions in greater China, the United States and Europe, offering the strongest technical support for the development of the company.

We are also a certified ISO and CE organization. By employing strict quality control system, our management team assures exceptional customer service and high quality products.