The following article comes from CELULA (author: celula). 

 

Good news! 

 

On June 18, Celula China Med-Technology Co., Ltd. (hereinafter referred to as “Celula”), an enterprise in Tianfu Life Science Park, announced that Celula’s 8 sperm flow cytometry reagents for male infertility had recently been approved for marketing, so that Celula would continuously provide the most complete flow solution in the field of infertility.

One of approval certificates

 

Sperm testing 

 

Approximately 15 percent of couples at the right age for child-bearing are infertile all over the world.

● The infertility rate among people of childbearing age has risen to 12.5% to 15% in China.

● By investigation, there is 50% due to female, 30% due to male, and 10% both. 

● About 81% of the patients have received the treatment, 71% received more than two treatments, and 66% failed in the treatment; 98.9% of the patients with failed treatment have not undergone comprehensive and scientific testing, so that their causes cannot be identified.

 

Routine sperm analysis cannot fully assess male fertility and sperm quality, of which only 70% is consistent with actual fertility. 

● Clinically, the routine semen analysis results of about 1/3 male infertile patients are normal or close to normal. Except for azoospermia or oligospermia, asthenospermia and teratozoospermia, the routine semen analysis cannot completely distinguish the patients with fertility or infertility.

 

For a long time, it is quite difficult in clinical diagnosis of male infertility. 

● The main reason is that traditional semen analysis only measures the number, motility rate and movement grade of sperms. These indicators can only reflect the most basic semen quality, other than the complete sperm function.

 

At present , the flow cytometry is the fastest, most accurate and reliable method of sperm function testing.

● The whole operation process is simple, fast, stable and reliable.

● The requirements for operators are low.

● The whole process is automatic and does not require human intervention.

● The test results are objective and accurate.

Celula flow cytometer 

 

What are the features of the eight testing kits approved for marketing this time? Let's look at them in the following: ↓ 

 

 

Sperm DNA Staining Kit 

Product name: Sperm DNA Staining Kit 

Packing specification: 50 tests/kit, 10 tests/kit 

Product No.: FC0412AR 

Filing No.: CRXB20190087 

Intended use: This kit is mainly used for the detection of male adult's sperm nucleus staining.

Sample requirements: fresh semen samples or liquid nitrogen frozen samples.

 

 

Acrosome Reaction Staining Kit 

Product name: Acrosome Reaction Staining Kit

Packing specification: 20 tests/kit 

Product No.: FC1711AR 

Filing No.: CRXB20200140 

Intended use: It is mainly used to detect the condition of sperm acrosome reaction induced in vitro in adult males.

Sample requirements: The induced sperm acrosome reaction should be tested immediately after the fresh semen sample is liquefied.

 

 

Acrosome Staining Kit 

Product name: Acrosome Staining Kit 

Packing specification: 20 tests/kit 

Product No.: FC0611AR 

Filing No.: CRXB20200144 

Intended use: This kit is mainly used to detect the acrosome staining of adult males and observe the integrity of the acrosome.

Sample requirements: The acrosome integrity test should be performed immediately after the fresh semen specimen is liquefied. 

 

 

Sperm White Blood Cell Staining Kit 

Product name: Sperm White Blood Cell Staining Kit 

Packing specification: 20 tests/kit 

Product No.: FC1511AR

Filing No.: CRXB20200141

Intended use: it is mainly used for determination of white blood cells in the semen of adult male.

Sample requirements: the white blood cell in the sperm should be tested immediately after the fresh semen specimen is liquefied.

 

 

Sperm Plasma Membrane Staining Kit 

   

Product name: Sperm Plasma Membrane Staining Kit

Packing specification: 20 tests/kit 

Product No.: FC0811AR

Filing No.: CRXB20200146

Intended use: This kit is used to evaluate the survival rate of sperm by detecting the integrity of the sperm plasma membrane.

Sample requirements: The integrity of the sperm plasma membrane should be tested immediately after the fresh semen specimen is liquefied.

 

 

Sperm Mitochondrial Membrane Staining Kit

    

Product name: Sperm Mitochondrial Membrane Staining Kit

Packing specification: 20 tests/kit

Product No.: FC1711A

Filing No.: CRXB20200143

Intended use: It is mainly used to detect the mitochondrial membrane potential of adult males' sperms and evaluate their motility.

Sample requirements: The mitochondrial membrane test should be performed immediately after the fresh semen specimen is liquefied.

 

 

Sperm Reactive Oxygen Staining Kit 

Product name: Sperm Reactive Oxygen Staining Kit

Packing specification: 20 tests/kit 

Product No.: FC1611AR

Filing No.: CRXB20200145

Intended use: This kit is mainly used for testing active oxygen in adult male's sperms.

Sample requirements: the active oxygen in the sperm should be tested immediately after the fresh semen specimen is liquefied. 

 

 

Apoptotic Sperm Staining Kit 

    

Product name: Apoptotic Sperm Staining Kit

Packing specification: 20 tests/kit 

Product No.: FC1711A

Filing No.: CRXB20200142

Intended use: It is mainly used to test sperm apoptosis in adult males.

Sample requirements: The apoptotic sperm should be tested immediately after the fresh semen specimen is liquefied.

 

 

About Celula China Med-Technology Co., Ltd. 

Address: B1-902, Tianfu Life Science Park, 88 Keyuan South Road, Chengdu Hi-Tech Industrial Development Zone, Chengdu, Sichuan 

 

Based in San Diego, California, USA, Celula China Med-Technology Co., Ltd. owns advanced genetic testing technology. Zhang Haichuan, the founder, chairman/general manager of the Company obtained the doctorate degree in precision instruments and mechanics from Tsinghua University in 1997. He has worked for over ten years in high-tech research & development and business management in the United States of America, led the establishment of various core technologies, e.g. non-invasive prenatal and flow cytometers, owned over 50 patents and published over 20 papers.

 

In 2013, Celula (China) established its headquarters in Chengdu, branches in Beijing and Shanghai, and offices in many provinces across the country. At present, it has established a complete scientific research, technical transformation, production and service base of over 5,000 square meters. At present, it has a R&D management team of over 100 people and has established close cooperation with many well-known domestic and foreign companies and experts.

 

Source | Celula WeChat Official Account

    It has been authorized .