DOA COC One Step Cocaine Rapid Test with CE certificate urine Uncut sheet

One Step Cocaine Test is a rapid one step test for the qualitative detection of Cocaine 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 Cocaine Test is a lateral flow chromatographic immunoassay for the detection of Cocaine in human urine at the cut-off concentration of 300 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 Cocaine Test has set the screen cut-off for positive specimens at 300 ng/mL for benzoylecgonine as a calibrator. The test device has been proved to detect above 300 ng/mL of Cocaine in urine at 5 minutes.

B. Specificity and cross reactivity

To test the specificity of the test, the test device was used to test Cocaine, 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)

Benzoylecgonine 300

Cocaine HCl 750

Cocaethylene 12,500

Ecgonine 32,000

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 Cocaine Test at a concentration of 100 mg/ml.

SUMMARY

Cocaine derived from leaves of coca plant, is a potent central nervous system stimulant and a local anesthetic. Among the psychological effects induced by using cocaine are euphoria, confidence and a sense of increased energy, accompanied by increased heart rate, dilation of the pupils,

fever, tremors and sweating. Cocaine is excreted in urine primarily as benzoylecgonine in a short period of time.