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Amp Gold Rapid Screen Test
【For the qualitative detection of Amp in urine】
The y.b.t Amp Gold Rapid Screen Test is a qualitative competitive binding immunoassay for determination of Amphetamine in urine.
The y.b.t 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).
The y.b.t 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.
1. Test Device
A pouched cassette contains a single test for Amphetamine
A transfer pipette seal in foil pouch together with test device
3. Operating Instruction
The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (18months).
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.
Note: There is no meaning attributed to color intensity for C or T lines.
The y.b.t Amp Gold Rapid Screen Test is designed for the detection of Amphetamine and the major metabolite in human urine at the cut-off detection level of 1000ng/ml. To verify test sensitivity, a standard panel of AMP was prepared by spiking fresh normal human pooled urine specimens with AMP standard at concentrations of 0, 500, 1000 and 2000ng/mL. This procedure tested 13 devices per standard level. All samples at concentrations below 1000ng/ml tested negative. All samples at concentrations equal to or above 1000ng/ml tested positive. The sensitivity of the y.b.t Amp Gold Rapid Screen Test was thus determined to be 1000ng/ml. Results per AMP standard concentration are tabulated on the Table below:
y.b.t Amp Gold Rapid
|AMP Concentration (ng/ml)|
In the study, negative and positive human urine were tested by three batches y.b.t Amp Gold Rapid Screen Test. The Negative and Positive results are 100% accuracy.
The y.b.t Amp Gold Rapid Screen Test demonstrates no cross-reactivity with following chemical compounds at 100mg/ml.
The following Amphetamine-related substances yield positive results for Amphetamine:
Do not re-use Manufacture
For In-Vitro Diagnostic use only
Stored at Room Temperature
Attention: See instruction for use
Authorized Representative in the European Company
Use by (Expiration date) Lot number
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD.
65 THE 6TH STREET, TEDA
TIANJIN, 300457, P.R.CHINA
RaZXKJond Lam Saikit
Poolse Winglaan 14, 9501 Sint-Denijs-Westrem, Belgium
Eff. Date: Sep.20, 2007
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Contact Person: Ms. Anna Lee