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The //COC/ 3 in 1 Test is an easy to use immunoassay intended for use in the qualitative detection of  (THC) metabolites,Cocain and Methamphetamine and its metabolites in human urine all at once at the Substance Abuse Mental Health Services Administration (SAMHSA) recommended level of 50 ng/mland 300 ng/ml and 1000 ng/ml, respectively.  

  /Cocain/Amphetamine 3in 1 Urine Screening Test provides only a preliminary qualitative test result.  Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result.  Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1   Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

For Professional Use Only.

SUMMARY AND EXPLANATION OF THE TEST

The increase in the recreational use of drugs of abuse in the general population and in the workplace has prompted the need for a rapid, simple and tamper proof screening test. 

The /Cocain/ 3 in 1 is a competitive immunoassay utilizing highly specific reactions between antibodies and antigens for the detection of and .

The /Cocain/Amphetamine 3 in 1 Test is an easy-to-use, rapid test.  Results are read visually.  No instrumentation is needed.

PRINCIPLE

The   /Cocain/Amphetamine 3 in 1 Test includes a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane for limited antibody sites. 

Labeled antibody-dye conjugate mixes with sample specimen and binds to the free drug present forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the test zone preventing the formation of a pink-rose color band when the drug    concentration in the specimen is above 50ng/ml 300ng/ml and 1000ng/ml for Cocain and Amphetamine, respectively.  Unbound dye conjugates bind to the reagent in the negative control zone and produces a pink-rose color band, demonstrating that the reagents and device are functioning correctly.

A negative specimen produces two distinct color bands in both the test region and the control region. A positive specimen produces only one color band in the control region.

MATERIALS PROVIDED

Each  /Cocain/Amphetamine 3 in 1 test device is individually sealed in a foil pouch

Each pouch contains:

1. One    /Cocain/Amphetamine 3 in 1 Test device
2. Desiccant

Material required but not provided:

Sample container

Disposable gloves

Timer

WARNINGS AND PRECAUTIONS

For in-vitro diagnostic use.

For professional use only.

Follow general laboratory practices and precautions for handling clinical specimens and reagents.

Do not use if the foil pouch is damaged or opened.

Do not use if the test is expired

STORAGE

The components of this kit are stable until the marked expiration date when stored in the sealed pouch at 2o-30oC(36o-86oF).

SPECIMEN COLLECTION AND HANDLING

Use fresh urine specimens.  Urine specimens do not require any special handling or pretreatment.  It is best to test urine specimens immediately after collection.  However, if necessary, urine specimens may be refrigerated at 2oC – 8oC (36oF – 46oF) for two days or frozen at –20oC (-4oF) or colder for longer periods.  The sample should be free from gross debris. Refrigerated samples should be allowed to warm to room temperature before testing.

ASSAY PROCEDURE

Test device together with patient samples, controls should be brought to room temperature prior to testing.

1. Remove the device from the foil wrapper (bring the container to the room temperature before opening to avoid condensation of moisture in container). Label the device with patient or control identifications.
2. Remove the cap, and then dip only the absorbent tips of the device into the urine sample container for a couple of seconds until the sample is running through the observing window.  Urine sample should not touch the plastic device.
3. After removing the test from your sample container, immediately replace the cap over the absorbent tips, lay the device on a flat surface with the Test and Control windows facing upwards, and then begin timing.
4. Read the result at 5 minutes. DO NOT INTERPRET RESULT AFTER 10 MINUTES.