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is an alkaloid present in leaves of coca plant. It has been used medicinally as an anesthetic agent, but its addictive properties have minimized its modern daily use. As a potent central nervous system stimulant, has been defined as a controlled substance by the National Institute on Drug Abuse. is excreted in urine primarily as benzoylecgnonine in a short period of time. Benzoylecgnonine has a biological half-life of 5 to 8 hours, which is much greater than that of , and can generally be detected within 24-60 hours after use.

The One Step Test for is a lateral flow, one-step, competitive immunoassay. This one step test is fast and easy to use, and results are read visually without the need for instrumentation. The test system employs unique monoclonal antibodies to selectively identify and its metabolites in urine samples with a high degree of sensitivity. The cut off concentration for and its metabolites have been developed at 300 ng/ml, the concentration set by the National Institute on Drug Abuse for the qualitative detection of in human urine. This product is not intended to monitor drug levels, but only to screen urine for the presence of and its metabolites.

Note: This test provides only a preliminary analytical test result, which should be confirmed by a more specific method. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Principle of the Test

The One Step Test for is based on the principle of a competitive inhibition immunoassay, in which a chemically labeled drug (drug conjugate) competes with the drug, which may be present in urine, for limited antibody binding sites. The test device consists of a membrane strip, which is pre-coated with -BSA conjugate on the test band region, and a colored anti- monoclonal antibody-colloid gold conjugate pad, which is placed at the end of the membrane.

In the absence of drug in the urine, the colored antibody-colloid gold conjugate moves with the sample by capillary action along the membrane until it reaches the immobilized drug conjugate in the test band region. At this point, the antibody-colloid gold conjugate reacts with the pre-coated drug conjugate and forms a visible red colored line as the antibodies form complexes with the drug conjugate. Therefore, the formation of a visible color line on the test band region shows the urine sample tested for is negative.

When the drug is present in the urine, the drug/metabolite antigen will compete with the drug conjugate coated in the test band region for the limited antibody sites. When a sufficient concentration of drug is present, it will fill the limited antibody binding sites, and thus will prevent attachment of the colored antibody-colloid gold conjugate to drug conjugates pre-coated in the test band region. Therefore, absence of the color band on the test region indicates a positive result.

A control band with a different antigen/antibody reaction is also added to membrane strip to indicate that the test is performed properly. This control line should always be seen. A

negative urine sample produces two distinct color bands, and a positive sample produces only one color band in the control zone.

Specimen Collection

A fresh urine specimen should be used, no special pre-treatment is necessary. The specimen may be refrigerated (2-8°C) and stored up to 2 days, or frozen (-20°C or below) prior to assaying. If samples are refrigerated they should be brought to room temperature before testing.

Test Procedure

. Review “Specimen collection” instructions. Test device, patient’s samples, and controls should be brought to room temperature (20-30℃) prior to testing. Do not open pouches until ready to perform the assay.

• Remove the test device from its protective pouch (bring the device to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the device with patient or control number.
• Hold the dropper vertically and transfer 3 full drops of urine (approx. 0.15ml) to the specimen well (S) of the test device,(if the test is strip,Immerse the strip into the urine with the arrow end pointing toward the urine. Do not cover the urine over the max (maximum) line. You may leave the strip in the urine or you may take the strip out after a minimum of 15 seconds in the urine and lay the strip flatly on a non-absorptive clean surface.)
•  and then start the timer. Use a separate pipette and device for each sample or control.
• Read result between 3 to 8 minutes after the addition of samples. Do not read result after 8 minutes.

size:12.0pt;mso-fareast-font-family: "Times New Roman"'>4.      Read the test result at five minutes.