David Male Fertility Sperm Test For Home use(Cassette)
(CATALOG:RH-SP10-C)
Please read instructions carefully before performing the test.
BEFORE YOU BEGIN
1.The unopened test can be stored at room temperature(up to30ºC/ 86ºF) . Do not freeze.
2.Do not open foil pouch until specimen is collected and ready to be tested.
3.Do not use If the foil pouch is torn or not well sealed.
4.Do not use this test past the indicated expiry date on the label.
5.Do not drink too much water or other beverages before test.
CONTENTS OF THE TEST KIT
1.One pouch containing a test cassette and a desiccant.
2.a Sperm Transfer Device(in a sealed pouch)
3.a Sample Dilution Tube (including dilution)
Note: The desiccant is for storage purpose only, and is not used in the test procedures.
WHAT ELSE DO YOU NEED
1.Timer(watch or clock).
2.a Semen collection cup(optional)
SPECIMEN COLLECTION AND PREPARATION
WHEN TO COLLECT SEMEN FOR THE TEST
1.Semen sample collection time should be at least two(2) days after last ejaculation but not longer than seven(7) days.
2.During this period spermiation like masturbation and nocturnal emission should not appear.
HOW TO COLLECT SEMEN
1.Use masturbation methods to obtain semen sample without using any lubricant and lotion; (refer to question 2)
2.Try best to collect all the semen and do not leave out.
3.Try best to use fresh semen samples for test (test within 3 hours after collection is recommended).
HOW TO PRETREAT SEMEN SAMPLE
1.You must wait at least 20 minutes for semen to become thin (liquefied). (refer to question 3)
2.Liquefied semen sample should be thoroughly mixed in the original container,
3.Use a sperm transfer to absorb 0.1 mL and add to a tube containing sample dilution tube. Note: Avoid gel or viscous substances in semen.
4.Close the cap of sample dilution tube, rotate the tube at least 5-10 times. (refer to question 8)
HOW TO DO THE TEST
1.Remove the test Cassette from foil pouch.
2.Put it flat. Open the cap of dilution tube then add two(2) drops of sample well of cassette, or use disposable plastic dropper supplied together with the test to absorb diluted semen specimen then add 2 drops of the sample dilution to the sample pad ( should avoid air bubble).
3.Read the test result between five(5) to ten (10) minutes after adding the specimen. (refer to question 8)
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). (refer to question 5)
2.NEGATIVE RESULT: Only one colored line appears in the Control line(C).No colored line in the Test line(T). (refer to question 6)
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. (refer to question 7)
PRECAUTIONS
1.For in vitro diagnostic use (not for internal use).
2.This test is intended for single use only. DO NOT REUSE.
3.Discard with normal household waste.
4.The test should be stored between 2ºC-30ºC/36ºF-86ºF.
5.Keep out of the reach of children.
6.The test is for home use.
7.Incomplete semen sample can not be used for test.
8.Do not mix different samples and dilution of different lots.
QUESTIONS AND ANSWER
1.How does the DAVID Male Fertility Test work?
The test is a rapid qualitative test detecting the presence of sperm in human semen at 15,000,000 sperm/mL or above. A positive result on this test strip indicates a sperm concentration greater than or equal to 15 million sperm/mL, the current World Health Organization (WHO) reference value of a fertile sperm count, for a normal semen analysis.
2.What are the ways of collecting semen?
Use artificial stimulation (masturbation) or other methods to obtain semen sample without using any lubricant and lotion; or use of non-toxic condoms specifically designed for semen collection.Lubricant on ordinary condom may affect the result.
Semen collected by onanism ejaculation can not be used because the first part of ejaculation which is often of the highest concentration may be lost and vaginal secretions inevitably mixed in will affect the accuracy of test result.
3.Must the collected semen be tested after a period of time?
Let semen stand the Semen Collection Cup before testing.Semen is too thick to be tested immediately after ejaculation, so you must wait at least 20 minutes for semen to become thin (liquefied).
If semen is not fully liquefied after 3 hours, it should be regarded as an exception and collecting samples again two days later is recommended. If situation is the same, you should consult a specialist.
Before testing,liquefied semen sample should be thoroughly mixed in the original container, but can not be shaken vigorously
4.Can I determine the concentration of sperm in my semen by providing a single test?
The number of sperm varies widely so judgement can not be made after only one time of test. Once abnormal test results appear, sample should be collected again for test after an interval of 1 to 2. Usually 2 to 3 times of re-test is recommended.
5.If the result is positive, what shall I do?
Positive test result can not prove infertility but only prove that sperm concentration in the semen sample is not less than 15 million / ml because there are a variety of factors that cause infertility in addition to sperm concentration. If a couple can not conceive after a year or longer time of normal and unprotected intercourse, it is recommended to consult a specialist.
6.If the result is negative,what should I do?
A negative result indicates that your sperm count is less than 15 million per milliliter, which is below that of most fertile men. However, the result of this test alone does not prove infertility, as there are other factors affecting fertility. However, some men with sperm counts below this level are still able to father children naturally. It is also important to understand that your sperm count can vary from day to day.If there is any suspicion of test result, it is recommended to collect sample again after an interval of more than seven days but less than three weeks for test again. If the result is still negative, it is recommended to consult a specialist.
7. How do I know the test was run properly?
The appearance of a coloured line in the control region (C) tells you that you followed the test procedure correctly and the proper amount of urine was absorbed.
8. How long will result last?
The test should be read any time from 5 to 10 minutes. After 10 minutes any change in your result should be disregarded.
9.Which situations can be combined with inaccurate results?
(a)Not collecting the entire ejaculate, especially the first drops of the ejaculate.
(b)The semen sample was collected less than 48 hours or more than seven (7) days after your last ejaculation.
(c)Failure of the ejaculate to liquefy
(d)The semen in the Sample Collection Cup was not mixed well enough before it was added to the Sperm Solution Tube.
(e)The semen-solution mixture in the Sperm solution tube was not mixed well enough before it was added to the test device.
(f) Too little or too much semen-solution mixture was added to the sample well.
10.I have received the positive result and had intercourse during these fertile days. I haven't become pregnant. Why is this?
Many factors can affect your ability to become pregnant. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician.
11.Could the possible interference substances in a man's semen affect the results of this product?
At the test level, the following substances would not affect the test result: 10% whole blood, 200×106 / mL leukocytes, 10% saliva, 10% urine,1000ng / mL PSA, 1000ng / mL PAP.
LIMITATIONS
1.This test kit can not be used to identify fatherhood or as indicator for contraception.
2.This test assesses sperm concentration only. It can not determine the exact number of sperm.
MANUFACTURER
RUNBIO BIOTECH CO., LTD.
Rongsheng Technological Zone, Univ. Rd.
Shantou, Guangdong, P.R.China 515063
EUROPEAN REPRESENTATIVE
MedNet GmbH
Borkstrasse 10, 48163 Münster,Germany
DOCUMENT NUMBER:RH-TD-SP10-6-B02
VERSION NUMBER: SP10-C01-1905A