Sperm Staining Detection Kit (Rapid Staining Method)

SPECIFICATION AND INSTRUCTION

[PRODUCT NAME]

Generic name: Sperm staining Detection Kit (Rapid Staining Method)

[SPECIFICATION]

20 samples per kit

[Intended use]

Sperm shape staining is used for the evaluation of sperm shape to judge malformation rate, to evaluate male fertility.

[Test principle]

The kit can be used for the evaluation of sperm shape and male fertility. Fresh sperm smear directly, cervical part and tail of normal sperm are easily distinguished, equatorial zone can be observed.

[Units of Kit]

Solution A, Solution B, Slide, filter paper et al.

[Storage]

Stored at room temperature for 12 months.

[Equipment]

Optical microscope

[Sample]

Sperm

[Test method]

(1)     One drop of sperm is added on slide, smear uniformly and air drying ;

(2)     Two drops of solution A were added, and added 4 drops of solution B after 1 minute;

(3)     After 3-5 minutes, washed with tap water, microscopic examination, count for 200 sperm and observe sperm shape;

[Reference Results]

Normal rate of shape >30% is normal in normal male.

[Interpretation of the results Indentified]

Copular part of normal sperm is stained lightly, and nuclei is stained deeply, cervical part and tail are easily distinguished, equatorial zone can be observed.

[Limitations of Test Method]

Sperm have to be fresh.

[Product Performance]

Comparison with similar products overseas, Correlation coefficient0.654, P<0.0001

[Precaution]

Staining time should be prolonged if room temperature is too low.

[Medical Device Manufacturing Enterprise License Number] WSYJX 20070120

[The registration Number of Medical Devices] GSYJX (Z) Z2011N1400163.

[Standard Number]  YZB0029-2011.

[Instruction Approval and Modified day] December 7st, 2011

[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