A lateral flow immunoassay test kit for detection of human SP10 protein. This test supports health monitoring and disease detection in reproductive health assessment.
Manufactured by
Nanjing, Jiangsu, China
Jiangsu Medomics Medical Technology Co., Ltd., founded in October 2017, is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R D, production and sales. Medomics focuses on diagnosis of microorganisms, tumors and some rare diseases, mainly engaged in the research and development, production and sales of in vitro diagnostic reagents and automatic instruments. Medomics owns two R D centers in China and the US, independent intellectual property rights of fluorescent staining technology, protein labeling technology, time-resolved immunofluorescence detection technology, image processing and analysis technology and other innovative technology platforms, as well as a total of more than 2,000 square meters of GMP purification production workshop that meets the product standards of FDA, CE and CFDA. Medomics also has a multidisciplinary expert team with abundant experience in the industry, including senior experts in immunology, microbiology, applied physics, polymer materials, medical imaging, optical systems, etc. The members of the technical team are led by doctors from many famous institutions, such as Osaka University, North Carolina University, University of Nebraska Lincoln, Zhejiang University, Sichuan University and other institutions. At the very beginning of COVID-19 on early 2020, Medomics developed IgM/IgG antibody detecting kit with the team of Zhong Nanshang. And Medomics published the first research paper on international journal together with State Key Laboratory of Respiratory Disease (National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health). The detecting kit was validated by CDC, Harvard Medical School and Columbia University Irving Medical Center etc. Until May 2020, the kit has been exported to dozens of countries and areas, making great help against SARS-Cov-2. At present, Medomics s series products of SARS-Cov-2 detection have been developed according to ISO 13485 Quality System and European CE Certification.
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Sekbio Co., Ltd · China
A quantitative fluorescent immunoassay for the measurement of SP10 (ACRV1), a sperm-specific acrosomal membrane glycoprotein, in human semen for male fertility assessment. The assay uses a validated anti-SP10 monoclonal antibody pair optimized for fluorescence lateral flow platforms and delivers quantitative results across a wide dynamic range of 0.6 to 10,000 ng/mL. It demonstrates complete clinical separation between azoospermic and normozoospermic individuals with no overlap, achieving within-run coefficient of variation ≤7.3% and a signal-to-noise ratio of 9 at the lowest calibrator. The product is available as both a finished diagnostic test and as OEM raw material for licensed IVD manufacturers.
Anhui Deepblue Medical Technology Co., Ltd. · China
Rapid test for evaluation of sperm protein 10 in semen samples. Supports assessment of male fertility status and sperm function.
E-proteins SCRL · Belgium
A complete system for rapid and sensitive detection in point-of-care diagnostics utilizing e-Proteins' avidin derivatives. Designed for quick turnaround results in clinical and field settings.
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