●Specimen collection container should be clean, dry, waterproof and free of media, preservatives and detergents.
●Semen liquefaction is a process in which semen rapidly changes from gelatinous state to semi-gelatinous state, and finally to liquefied state. Fresh samples collected usually liquefy within 60 minutes, and if it does not liquefy for 60 minutes, it is considered abnormal.
●Collect fresh samples and complete the test within 3 hours after semen liquefaction.
Read the entire procedure carefully before performing any tests.
Allow test cassette and urine samples to equilibrate to temperature (20-30℃ or 68-86℉)prior to testing.
1. Ejaculate all semen directly into the specimen collection container, and if the semen is missing, clean the sampling cup with clean water and take samples again within the prescribed time.
2. Shake the semen in the specimen collection container and let it standing for 60 minutes until the semen is liquefied into a flowing liquid.
3. The semen transfer device gently stir the semen sample in the specimen collection container about 10 times until the sample was fully mixed.
4. Transfer 0.1 ml of semen sample with semen transfer device (Avoid air bubble, solids or viscous substances) to the collection tube.
5. Tighten the cap of the collection tube and mix it upside down for 5 to 10 times. If the Sample is still sticky, mix it upside down for 10 times.
6. Bring the test to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
7. Let the mixture stand tor 2 minutes, then unscrew the cap on the collection tube and transfer 2 drops of the mixture to specimen well(S).
8. Wait for the colored line(s) to appear .
Read results at 5~ 10 minutes .
Do not read results before 5 minutes or after 10 minutes.
[INTERPRETATION OF RESULTS]
Positive: Two distinct red lines will appear, one in the test region (T) and another in the control region (C).
Negative: Only one red line appears in the control region (C).
Invalid: The result is invalid if no red line appears in the control region (C), even if a line appears in the test region (T). In any event, repeat the test. If the problem persists, discontinue using the lot immediately and contact your local distributor.
●This cassette mainly detects sperm SP10 protein to achieve the purpose of sperm concentration screening. The test results are only used as a reference index for male infertility. It needs to be combined with other clinical and laboratory data. If the test results do not conform to the clinical evaluation, further examination is needed.
●The Sperm SP10 Protein Rapid Test Cassette is for in vitro diagnostic use only. The test should be used for the detection of SP10 Protein in semen only. The quantitative value of SP10 Protein in semen can not be determined by this qualitative test.
●The number of spermatogenesis varies greatly, so it can not be judged only by one test result. If an abnormal test result occurs, it should be collected again after 1-2 weeks interval. Generally, it should be reviewed 2-3 times.