CE Marked One Step Male Fertility Sperm Test Kit for Home Use

• Customization: Available
• Type: IVD Instrument
• Shelf Life: 2 Years
• Model NO.: SP10
• Format: Cassette
• Certification: ISO 13485/CE
• Transport Package: Carton
• Specification: 3mm
• Trademark: David or neutral
• Origin: China

Product Description

INTENDED USE
David Male Fertility Sperm Test is a rapid test for use at home to detect the concentration of sperm in semen. This simple test will quickly let you know whether your sperm count is considered within normal limits.
David Male Fertility Sperm Test is a quick screening test that will give you either a positive or negative result.
An explanation of how to read and interpret the test results is given in the "Interpret Results" Section. Regardless of the test result, it is important that you fully understand what your test means before deciding whether or not to consult your physician. Use only in accordance with the instructions provided.


PRINCIPLE OF METHOD
This assay is a one-step lateral flow two-site sandwich chromatographic immunoassay. The membrane is pre-coated with mouse anti-human sperm antigen monoclonal antibody on the test band region(T line) and goat anti-mouse IgG polycolonal antibody on the control band region(C line).
When sample is added, the gold-antibody conjugate is rehydrated and sperm antigens interact with the gold conjugated antibodies. The antigen-antibody-gold complex then migrates towards the test window until the Test region (T) where it will be captured by immobilized antibodies, forming a visible pink line (Test band), indicating a positive result.

HOW TO READ THE RESULT
Pay attention to the position of the Control Line(C) and Test Line (T).
1.POSITIVE RESULT: Two colored lines appear both one at the test line(T) and another at the control line(C).
2.NEGATIVE RESULT: Only one colored line appears in the Control line(C).No colored line in the Test line(T).
3.INVALID RESULT: Absence of a colored line in the control region is an invalid result. You should repeat the test with a new test device.  
 

Test   Item	Specimen	Sensitivity	Qualification	Format
One Step Male Fertility Sperm Test For Home   use	Male Semen	15×10^6/ml	ISO/CE	Strip
One Step   Male Fertility Sperm Test For Home use	Male Semen	15×10^6/ml	ISO/CE	Cassette