FDA One Step In Vitro Diagnostic MET Drug Rapid Test Kit

MET Gold Rapid Screen Test Cassette

 

For the qualitative detection of MET in urine

 

Methamphetamine Rapid Screening Test Strip MET Fast Test Kit On Drug Abuse

 

Main Features

 

♦ Reliable: high accurate, early detection of the presence of MET

 

♦ Simple: No Instrument Required

 

♦ Convenient: Room Temperature Storage, Built-In Control line

 

♦ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

 

♦ Certified by Authoritative Certification System and Standards

 

♦ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

 

Summary and Explanation of The Test

 

The Met Gold Rapid Screen Test Cassette employs combination of monoclonal and polyclonal antibodies to identify Methamphetamine in urine.

Methamphetamine and its derivatives are central nervous system stimulants that produce alertness, wakefulness, increased energy, reduced hunger, and an overall feeling of well-being.

 

Administration of large doses of Methamphetamine can cause tolerance and physiological dependence in users, and can lead to substance abuse. D-Methamphetamine is controlled substances. GC/MS or immunoassay Method has been developed for the determination of 1000ng/ml for Methamphetamine as set by the National Institute on Drug Abuse (NIDA).

 

INTENDED USE

 

The MET Gold Rapid Screen Test Cassette is a qualitative competitive binding immunoassay for detection of Methamphetamine.

 

PRINCIPLE

 

Methamphetamine (MET) 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.

 

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 72 hours before testing.

 

SPECIFICATION

 

Product Name	Type	Specimen	Package
Methamphetamine (MET) Gold Rapid Screen Test	cassette	urine	40/kit
	Strip		50/kit

 

PROCEDURE

 

CASSETTE

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.

 

Read the result in 5-10 minutes.

 

STRIP

Dip the strip in the urine sample for a few seconds. Make sure that the urine level is below "Max" line. As soon as solvent front reached the membrane area place the strip on a clean surface.

 

Read the result in 5-10 minutes.

 

 

Reagents and Materials Provided

 

1. Test Device

A sealed pouched contains a single test for Methamphetamine

 

2. Instruction for use

 

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℃, the sealed pouch for the duration of the shelf life (24 months)

 

 

Performance Characteristics

 

1. Minimum detectable quantity

 

The MET Gold Rapid Screen Test Cassette is designed for the detection of Methamphetamine and the major metabolite in human urine at the cut-off detection level of 1000ng/ml.

 

2. Cross-Reactivity Testing:

 

The MET Gold Rapid Screen Test Cassette demonstrates no cross-reactivity with following chemical compounds at 100ug/ml.

 

Acetophenetidin	Lidocaine	Acetylsalicylic acid
Methadone	Amitriptyline	Amphetamine
Narcotine	Codeine	Caffeine
Cocaine	Diamorphine	Diazepam
Marijuana	Ibuprofen	Narceine