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                                            MAR Diagnostic Kit for Anti-Sperm Antibody


SPECIFICATION AND INSTRUCTION

[Product Name]

Diagnostic Kit for Anti-sperm Antibody (MAR / Mixed Antiglobulin Reaction Test)

[Specification]

20 samples per kit

[Intended use ]

Assistant diagnosis for immunity infertility

[Test Principle]

The kit is based on classical Coombs Test. Sheep red blood cells are sensitized by human IgG. Antiserum is developed in sheep using the human IgG as the immunogen, is to detect IgG-AsAb  by the method of MAR test, and exerts actions of the invitro diagnosis of immunological infertility.

[Units of Kit]

1.  Solution A             sensitized sRBC                            0.5ml

2.  SolutionB              sheep serum anti-IgG of human       0.5ml

3.  Solution C(20x)    washing solution for semen             2.5mlx2

4.  Slide                                                     10 pieces

5.  Coverslip                                               20 pieces

6.  One-off pipette                                       20 pieces

7.  Rubber nipple                                          2 pieces

8.  Instruction                                               1 sheet

[Storage]

Stored at 2~8℃ for 10 months

[Equipment]

Common optical microscope

[Sample]

Fresh and liquefied semen

[Test Method]

(1) 20 ul of fresh semen is put on slide and mixed with 20 ul of Solution A adequately for 15 seconds.

(2) Add 20 ul of Solution B and mix adequately, put a coverlip on the slide. After 3 minutes, observe the results under the Optics Microscope (40x10) or Phase Contrast Microscope

(3) Recount after 10 minutes.

(4) Quality Control: It proof that the reagent is reliable if the liquid A and B is grumose (++~+++).

[Reference Results]

(1) R≤10%, negative

(2) R>0%, positive

(3) R≥40%, Strong positive, Strong Positive. Inferetility caused by AsAb should be considered especially.

[Interpretation of the Results Identified]

If without AsAb on the surface of the spermatozoa, the spermatozoa will swim freely among the adhered sRBC.

If AsAb exist on the surface of the spermatozoa, the sensitized will adhere to the spermatozoa. Under the condition of strong positive, the agglutinates become very massive and the spermatozoa will only twist in the agglutinates marked with sRBC.

At least 100 active spermatozoa should be counted, and calculate the percentage of the active spermatozoa with sRBC compared with the total active spermatozoa.

The Positive Ratio = (The quantity of active spermatozoa with sRBC / The quantity of total active spermatozoa) 100%

[Limitations of Test Method]

Samples of fresh liquefied semen required and the ratio of motile sperm with Sperm antibodies observed.

[Index of the Product Property]

Strong specificity and good reproducibility.

[Precaution]

(1) Please read this Instruction carefully before using.

(2) Fresh semen only.

(3) Agitate the Solution A adequately before using.

(4) All the solution should be balanced to room Temp., and the crystal in Solution C should be dissolved completely before using.

(5) Pipette could be used to smear for twice in order to agitate adequately. The proper area is about 1~2 cm2.

(6) If semen liquefy poorly,it can be deteced after physical blowing and inhaling or wash with C (Application Solution).

[License Number]

GYZZS20040075

[Instruction Approval and Modified day]

September 21st , 2004      

[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.ankebio.com

E-mail: info@ankebio.com


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