Amp Gold Rapid Screen Test

Cassette

【For the qualitative detection of Amp in urine】

 

G2AMP-213

INTENDED USE

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

 

SUMMARY AND EXPLANATION OF THE TEST

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).

 

PRINCIPLE

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.

 

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.

 

INTERPRETATION OF RESULTS

 

1. Negative: Two pink color bands appear. This indicates Amp in the specimen is below the detection sensitivity (1000ng/ml).
2. Positive: Only one pink band for control appears. This indicates the Amp in the specimen is above the detection sensitivity.
3. Invalid: The presence of a control line is necessary to validate test performance. If no band appears the test should be repeated with a new test device.

Note: There is no meaning attributed to color intensity for C or T lines.

 

LIMITATION OF THE PROCEDURE

1. This product is designed for use with human urine only
2. Although the test is very accurate, there is a possibility false results will occur due to the presence of interfering substances in the urine.
3. The test is a qualitative screening assay and is not for determining quantitative concentration levels or the level of intoxication.
4. Adulterants such as bleach or other strong oxidizing agents, when added to urine specimens may produce erroneous test results regardless of the analysis method used. If an adulteration is suspected, obtain another fresh urine specimen and retest.

 

PERFORMANCE CHARACTERISTICS

1. Sensitivity:

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 Screen Test	AMP Concentration (ng/ml)
	0	500	1000	2000
Qty. Tested	13	13	13	13
Positive	0	0	13	13
Negative	13	13	0	0

 

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.

 

1. Specificity:

Cross-Reactivity Testing:

The y.b.t Amp Gold Rapid Screen Test demonstrates no cross-reactivity with following chemical compounds at 100mg/ml.

 

Acetophenetidin	Lidocaine	Acetylsalicylic acid
Methadone	Amitriptyline	Methamphetamine
D-Norpropoxyphene	Codeine	Caffeine
Cocaine	Diamorphine	Diazepam
Marijuana	Ibuprofen	Narceine
Narcotine

 

Interference Testing:

The following Amphetamine-related substances yield positive results for Amphetamine:

d-Amphetamine	1000ng/mll
Amphetamine	25,000ng/ml
d,l-Amphetamine	1000ng/ml
(+)Phenylpropanolamine	50,000ng/ml
β-Phenylthylamine	90,000ng/ml
Thyramine	100,000ng/ml
(±) 3,4-Methylenediox	600ng/ml
Psuedoephedrine	100,000ng/ml
Ephedrine	250,000ng/ml

 

REFERENCE:

1. Ellerbe, P., Long, T.,Welch, M.J., J. Anal. Toxicol., 17: 165-170 (1993). PCP Test
2. Froelich, P.E., Gross, G.: Separation and Detection of Phencyclidine in Urine by Gas Chromatography. J. Chromatograph 1977; 137; 135-143.
3. Gupta R.C. et al: Determination of Phencyclidine in Urine and Illicit Street Drug Samples.Clin. Toxicol 1975; 8:611-621.
4. Oellerich, M.: Enzyme Immunoassays in Clinical Chemistry: Present Status and Trends. J. Clin. Chem. Biochem., 1980; 18:197-208.
5. Anilineo, Pitts, F.N.: Phencyclidine (PCP): A Review and Perspectives. CRC Crit. Rev. Toxicol 1982; 10:145-177.

 

 

 

 

 

INDEX OF SYMBOLS

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

	0197

 

 

 

 

 

 

NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD.

65 THE 6^TH STREET, TEDA

TIANJIN, 300457, P.R.CHINA

RaZXKJond Lam Saikit

Poolse Winglaan 14, 9501 Sint-Denijs-Westrem, Belgium

Ver.#ZXKJ-JS-CG-7.3-04B-AMP

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 10^th and 11^th 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.

 

Our mission:

 

• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.

 

 

Rebecca Yan