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                                          Diagnostic Kit for Leptin (ELISA)  

SPECIFICATION AND INSTRUCTION

[Product Name]

Diagnostic Kit for Leptin (ELISA)

[Specification]

96 samples per box

[Intended Usage]

Auxiliary diagnosis of obesity and diabetes type

[Testing Principle]

This product consists of microwell plate which is coating of purified anti-leptin, enzyme-labeled anti-Leptin, quantificational leptin and some other reagents. According on the principle of double antibody sandwich method (ELISA),this product can detect the leptin in human serum, blood plasma and other samples.

[Units of Kit]

(1)   quantificational leptin: 0ng/ml,1ng/ml,10ng/ml,25ng/ml,50ng/ml

(2)   microwell plate with the coating antibody

(3)   enzyme-labeled anti-Leptin

(4)   washing buffer

(5)   chromogenic solution A and B

(6)   stop solution.

[Storage]

Dark at 2~8ºC, keep dry for 6 months.

[Equipment]

Microtiter plate reader

[Sample Requirement]

Serum, blood plasma

[Test Method]

(1)   Pipette 100ul of  the serum sample and 100ul of quantificational leptin of each density to each well of the microtiter plate, and double-pored , incubate  at 37℃ for 1 hour.

(2)   Remove the above solution, wash three times with washing buffer and clap it to dry. Add 100ul of the enzyme labelled antibody solution to each well,  incubate  at 37℃ for 1 hour.

(3)   Remove the above solution, wash five times with washing buffer and clap it to dry. Add one drop of each chromogenic solution A and B to each well, keep away from light for 10 minutes.

(4)   Add one drop of stop solution to each well , misce bene.Take it into the microtiter plate reader equipped with a 450nm filter to determine the optical density value of each well.

[Reference Results]

Male: 1.56-2.52ng/ml; Female: 4.75-5.99ng/ml.

[Interpretation of the Results Identified]

Draw a standard response curve on coordinate paper with optical density value of the quantificational leptin as the ordinate  and the density of the quantificational leptin as the abscissa. To find out the density of the leptin in the samples.

[Limitations of Test Method]

Range of the curve: 0-50ng/ml. With the sanmples above the range, dilute them to appropriate density before re-testing.

[Index of the Product Property]

CV<15%

[Precaution]

(1)   Balance at room temperature before use;

(2)   Forbid to use the different batch number of the kits.

[Medical Device Manufacturing Enterprise License Number] WSYJX 20070120

[The registration Number of Medical Devices] GSYJX(Z)Z2009N2400014

[Standard Number]  YZB/W0006-2009

[Instruction Approval and Modified day] March 23rd , 2009

[Manufactured by]

Anhui Anke Biotechnology (Group) Co., Ltd.

[Address]

Ankebio Buildings, 669, Changjiang Road, West ,Hefei, 230088, P.R. China.

Tel: +86-551-65319890, 65318811

Fax:+86-551-65319895

Website: www.ctdgc.com

E-mail: info@ctdgc.com