HANGZHOU, CHINA - March 30, 2026 - Hangzhou Singclean Medical Products Co., Ltd. (Singclean Medical), a leading manufacturer of biomedical materials and in vitro diagnostic devices, today announced the domestic launch of its Human Immunodeficiency Virus (HIV1/2) Urine Antibody Detection Kit (Colloidal Gold Method) . The product has received approval from China's National Medical Products Administration (NMPA Registration No.: 20263400640) and is among the first domestically approved HIV self-test kits using urine samples.
This launch marks a significant milestone for Singclean Medical in the field of in vitro diagnostics, offering a more private, convenient, and non-invasive testing option for HIV screening.
Closing the HIV-2 Detection Gap with 99.8% Accuracy
The kit uses the colloidal gold method to detect HIV-1 and HIV-2 antibodies in urine samples. Unlike traditional finger-stick blood tests, urine sampling is painless and non-invasive, significantly lowering the barrier to testing.
Incorporating dual-patented technology, the test simultaneously covers both HIV-1 and HIV-2 antibodies, effectively filling a gap in rapid HIV-2 detection in the domestic market. Clinical data shows a positive agreement rate of 99.8%, ensuring reliable screening results.
Results in 15 Minutes – Private and Convenient
Designed for self-testing, the kit requires only a small urine sample and delivers clear results in 15 minutes without the need for additional equipment or professional assistance. This ensures complete user privacy and helps eliminate the hesitation often associated with clinic-based testing.
Strengthening a Diverse Portfolio – Global Reach
Founded in 2003, Hangzhou Singclean Medical Products Co., Ltd. is a national high-tech enterprise integrating R&D, production, and sales. The company's portfolio includes absorbable biomaterials, dermal fillers, hemostatic products, and in vitro diagnostic devices. Singclean Medical now serves over 120 countries and regions, with local registrations in more than 50 countries.
The launch of the HIV1/2 Urine Antibody Detection Kit further strengthens the company's IVD product line. Moving forward, Singclean Medical will continue to leverage its Class 10,000 (including Class 100) cleanroom R&D center to drive innovation and expand its global presence.
About Hangzhou Singclean Medical Products Co., Ltd.
Founded in 2003, Singclean Medical is dedicated to developing, manufacturing, and marketing high-quality medical devices. With a patient-centered approach, the company holds core expertise in absorbable biomaterials, aesthetic fillers, hemostatic products, and in vitro diagnostics. For more information, please visit www.singclean.org.
Media Contact:
Marketing Department
Hangzhou Singclean Medical Products Co., Ltd.
Email: marketing@singclean.com
Website: www.singclean.org