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MOR Gold Rapid Screen Test Strip
【For the qualitative detection of MOR in urine】
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.
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.
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.
1. Test Device A pouched strip contains a single test for Amphetamine
2. Urine cup
3. Operating Instruction
The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (18 months).
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.
Note: There is no meaning attributed to color intensity for C and T lines.
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
|MOR Concentration (ng/ml)|
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.
The y.b.t MOR Gold Rapid Screen Test Strip demonstrates no cross-reactivity with following chemical compounds at 100mg/ml.
The following Morphine-related substances yield a positive result for Morphine:
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