MOR Gold Rapid Screen Test Strip

【For the qualitative detection of MOR in urine】

 

G2MOR-113

 

INTENDED USE

The y.b.t MOR Gold Rapid Screen Test Strip is a rapid qualitative competitive binding immunoassay for determination of Morphine and their metabolites in urine.

 

SUMMARY AND EXPLANATION OF THE TEST

The y.b.t MOR Gold Rapid Screen Test Strip is a fast and easy to read membrane chromatographic immunoassay with no need for instrument. The method employs a unique combination of monoclonal and polyclonal antibodies to specifically identify Morphine in urine with a high degree of sensitivity.

Morphine, one of opiates’ derivatives, is central nervous system stimulants that produce alertness, wakefulness, increased energy, reduced hunger, and an overall feeling of well-being. Morphine has been the preferred drug for the management of pain in cases of advanced cancer and other severe conditions. Morphine and other Opiates’ metabolites may be detected in urine as a result of heroin morphine, codeine, or poppy seed intake. Administration of large doses of Morphine can cause tolerance and physiological dependence in users, and can lead to substance abuse. D-Morphine is controlled substances. GC/MS or immunoassay method has been developed for the determination of 300ng/ml for Morphine.

 

PRINCIPLE

During a test labeled antibody-dye conjugate mixes with urine specimen and binds to the free drug if it is presented in the sample, to form an antibody-antigen complex. This complex prevents the formation of pink color bands in the test zone of the dip-stick if drug to be detected in specimen is above the detection levels (300ng/ml for Morphine). In case of absent of drug and its metabolites, unbound dye conjugate will bind to the antigens immobilized in the test zone to form a pink reaction line. To serve as a quality control for the assay, another pink line will always appears in the test zone regardless positive or negative result.

 

REAGENTS AND MATERIALS PROVIDED

1. Test Device A pouched strip contains a single test for Amphetamine

2. Urine cup

3. Operating Instruction

 

MATERIALS REQUIRED BUT NOT PROVIDED

• Clock or Timer

 

WARNING AND PRECAUTIONS

• For in vitro diagnostic use only.
• Do not use kit beyond the expiration date.
• 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 (18 months).

 

SAMPLE COLLECTION AND PREPARATION

Collect a fresh urine sample in the urine cup, 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

• Bring the urine sample and test components to room temperature if refrigerated.
• When ready to test, remove the test device by tearing.
• 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.

 

INTERPRETATION OF RESULTS

 

 

• Negative: Two pink color bands appear. This indicates MOR in the specimen is below the detection sensitivity (300ng/ml).
• Positive: Only one pink band for control appears. This indicates the MOR in the specimen is above the detection sensitivity.
• 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 and T lines.

 

LIMITATION OF THE PROCEDURE

• This product is designed for use with human urine only
• Although the test is very accurate, there is a possibility false results will occur due to the presence of interfering substances in the urine.
• The test is a qualitative screening assay and is not for determining quantitative concentration levels or the level of intoxication.
• 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

• Sensitivity:

 

The y.b.t MOR Gold Rapid Screen Test Strip is designed for the detection of Morphine and the major metabolite in human urine at the cut-off detection level of 300ng/ml. To verify test sensitivity, a standard panel of MOR was prepared by spiking fresh normal human pooled urine specimens with MOR standard at concentrations of 0, 150, 300 and 600ng/mL. This procedure tested 13 devices per standard level. All samples at concentrations below 300ng/ml tested negative. All samples at concentrations equal to or above 300ng/ml tested positive. The sensitivity of the y.b.t MOR Gold Rapid Screen Test Strip was thus determined to be 300ng/ml. Results per MOR standard concentration are tabulated on the Table below:

 

y.b.t MOR Gold Rapid Screen Test	MOR Concentration (ng/ml)
	0	150	300	600
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 MOR Gold Rapid Screen Test Strip. The Negative and Positive results are 100% accuracy.

 

• Specificity:

Cross-Reactivity Testing:

The y.b.t MOR Gold Rapid Screen Test Strip 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	Amphetamine

 

Interference Testing:

The following Morphine-related substances yield a positive result for Morphine:

 

Morphine	300ng/ml	Oxycodone	1,000ng/ml
Morphine-3-β-D-Glucuronide	300ng/ml	Levorphanol	600ng/ml
Codeine	300ng/ml	Naloxone	1,000ng/ml
Heroin	300ng/ml	Thebaine	1,500ng/ml
Norcodeine	2,000ng/ml	Imipramine	50,000ng/ml
Nalorphine	300ng/ml	Atropine	100,000ng/ml
Hydrocodone	500ng/ml	Meperidine	100,000ng/ml
Hydromorphone	300ng/ml	Ranitidine	100,000ng/ml

 

REFERENCE:

• Huang, W., Andollo, W., Hearn W.L.J. Anal. Toxicol., 16: 307-310 (1992).
• Cone, E.J., Dickerson, S., Paul, B.D., Mitchell, J.M., J. Anal. Toxicol., 17: 156-164 (1993).
• Glare P.A., Walsh, T.D., and Pippenger, C.E., Ther. Drug Monit., 13: 226-232 (1991).
• Walsh, T.D., Cheater, F.M., Pharm. J., 10: 525-527 (1983).
• Mitchell, J.M., Paul, B.D., Welch, P., Cone, E.J. J. Anal. Toxicol., 15: 49-53 (1991).

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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-MOR

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.

 

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