One-Step AMP Rapid Test

INTENDED USE

Amp Gold Rapid Screen Test is a qualitative competitive binding immunoassay for determination of Amphetamine in urine.

SUMMARY AND EXPLANATION OF THE TEST

Amp Gold Rapid Screen Test is a fast and easy to read immunoassay with no need for instrument. The method employs a unique combination of monoclonal and polyclonal antibodies to specifically identify Amphetamine (Amp) in urine with a high degree of sensitivity. Amphetamine and the structurally related “designer” drugs are sympathominetic amine whose biological effects include potent central nervous system stimulation, anorectic, hypothermic, and cardiovascular properties. They are usually taken orally, intravenously, or by smoking. Amphetamines are readily absorbed from the gastrointestinal tract and are then, either deactivated by the liver or excreted unchanged in the urine with a half-life of about 12 hours. It can be detected in the urine for 1- 2 days after use. Amphetamine is metabolized to deaminated (hippuric and benzoic acids) and hydroxylated metabolites. Methamphetamine is partially metabolized to amphetamine and its major active metabolite. Amphetamines increase the heart rate and blood pressure and suppress the appetite. Some studies indicate that heavy abuse may result in permanent damage to certain essential nerve structures in the brain. Amphetamine is controlled substances. GC/MS or immunoassay method has been developed for the determination of 1000ng/ml for Amphetamine as set by the National Institute on Drug Abuse (NIDA).

PRINCIPLE

Amp Gold Rapid Screen Test is a chromatographic absorbent device in which drug or drug metabolites in a sample compete with drug antigen immobilized on a porous membrane support for limited antibody sites. Labeled antibody-dye conjugate mixes with sample specimen and binds to the free drug presented in sample forming an antibody-antigen complex. This complex prevents the formation of pink color bands in the test zone immobilized antigen conjugate when the drug is presented in the sample urine above the detection levels (1000ng/ml for Amphetamine). Unbound dye conjugate binds to the reagent in the 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, one for the control in the “C” zone and one for Amphetamine in the “T” zone.

REAGENTS AND MATERIALS PROVIDED

1. Test Device                         

A pouched cassette contains a single test for Amphetamine

2. Dropper                              

A transfer pipette seal in foil pouch together with test device

3. Operating Instruction

MATERIALS REQUIRED BUT NOT PROVIDED

1.        Clock or Timer

2.        A container for specimen collection

WARNING AND PRECAUTIONS

1.        For in vitro diagnostic use only.

2.        Do not use kit beyond the expiration date.

3.        Urine specimens may be infectious; properly handle and dispose of all used reaction devices in biohazard container.

STORAGE

The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (18months).

SAMPLE COLLECTION AND PREPARATION

Collect a fresh urine sample in a clean, dry container, either plastic or glass, without any preservatives. Urine specimens may be refrigerated (2-8°C) and stored up to 48 hours before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged or allowed to settle. Use only clear aliquots for testing.

ASSAY PROCEDURE

1.        Bring the urine sample and test components to room temperature if refrigerated.

2.        When ready to test, open the pouch at the notch and remove the test device. Place the test device on a clean, flat surface.

3.        Fill the urine dropper with specimen. Holding the dropper vertically, dispense 2-3 drops (about 50-80ml) of urine without air bubble into the sample well.

4.        Read the result in 5-10 minutes.