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Accu-Tell® Sperm Concentration Rapid Test Cassette

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Accu-Tell® Sperm Concentration Rapid Test Cassette is used to in-vitro qualitative testing of human sperm protein SP10 in human sperm samples. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
Sperm Concentration CassetteSemenABT-FT-B30940T/20T


KEY POINTS

Detection for: Human sperm protein SP10 in human sperm samples;

Reading time: 5-10 minutes;

Limit of detection:15 × 106 / ml of sperm concentration.

 

INTRODUCTION

Accu-Tell® Sperm Concentration Rapid Test Cassette 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.

 

INTENDED USE

Accu-Tell® Sperm Concentration Rapid Test Cassette is used to in-vitro qualitative testing of human sperm protein SP10 in human sperm samples. The test is intended for use as an aid in the determination of a man's fertility status.

For in vitro, over the counter home use.

 

TEST PROCEDURE

Sperm Rapid Test 4.JPGSperm Rapid Test 4.JPG

1. Preparation of Sample

(1)Let semen stand for at least twenty (20) minutes in the Semen Collection Cup before testing, but no more than 3 hours. Semen is too thick to be tested immediately after ejaculation, so you must wait at least 20 minutes for semen to become thin (liquefied).

NOTE: Liquefied semen sample should be thoroughly mixed in the original container, but can not be shaken vigorously.

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.

(2)Use a sperm transfer to absorb 0.1 ml of fully liquefied semen sample and add to a tube containing sample dilution tube.  Note: Avoid gel or viscous substances in semen.

(3)Close the cap of sample dilution tube, shake until the semen sample dilution and semen sample are thoroughly mixed, rotate the tube at least 5-10 times, if the sample is still very dense or very viscous, rotate 10 times again. Finally allow the tube containing semen to stand for 2 minutes.

2. Perform the test

(1)Remove the test device from foil pouch. Use device as soon as possible within 1 hour after removal from pouch.

(2)Put it flat. Open the cap of dilution tube then add two drops of diluted sample directly to the sample pad 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)Start timing. Reaction result should be observed within 5-10 minutes. Result read after 10 minutes is invalid


PERFORMANCE CHARACTERISTICS

Limit of detection:

When use quality control samples of company to for testing, detection limit of sperm concentration shall be 15 × 106 / ml

Specificity:

When test specificity control samples including 1000ng / mL prostate specific antigen (PSA), 1000ng / mL prostatic acid phosphatase (PAP), results should be negative

 

LIMITATIONS

1. This test kit is only used to evaluate sperm concentration through detection of sperm marker protein SP10. 

2. This test kit can not be used to identify fatherhood or as indicator for contraception. 

3. This test does not protect against sexually transmitted diseases.

4. This test assesses sperm concentration only. It can not determine the exact number of sperm. It does not detect all fertility issues.

5. 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 agarin for test after an interval of 1 to 2. Usually 2 to 3 times of re-test is recommended.

6.At the test level, the following substances would not affect the test result: 1 × 107 / mL escherichia coli, 1 × 107 / mL neisseria gonorrhoeae, 1 × 107 / mL chlamydia trachomatis, 20μg / mL testosterone , 20μg / mL of estradiol, 10% of whole blood, 200×106 / ml leukocytes, 10% of saliva, 10% of urine.

7. This test kit is only used to evaluate sperm concentration through detection of sperm marker protein SP10. The lowest concentration at which hook effect appears is 423 million/mL.

8. 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.

9. The following situations may cause inaccurate results.

(1)Not collecting the entire ejaculate, especially the first drops of the ejaculate.

(2)The semen sample was collected less than 48 hours or more than seven (7) days after your last ejaculation. This may lead to inaccurate results.

(3)Failure of the ejaculate to liquefy

(4)The semen in the Sample Collection Cup was not mixed well enough before it was added to the Sperm Solution Tube.

(5)The semen-solution mixture in the Sperm solution tube was not mixed well enough before it was added to the test device.

(6) Too little or too much semen-solution mixture was added to the sample well.

 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.