加拿大Biolytical Laboratories www.biolytical.com
现有加拿大医药实验室（BioLytical）希望向中国出口其研制的快速HIV检测试剂，该实验室研制方法已通过ISO 9001 和13485认证以及GMP和GLP标准。该快速HIV检测试剂操作简便，1分钟内便知道结果。

bioLytical™ Laboratories develops and manufactures a rapid HIV diagnostic product, the INSTI™ Kit. It is a unique, simple-to-use diagnostic kit used in the diagnosis of HIV infection. At 60 seconds for a reading, INSTI™ Kit is the fastest HIV diagnostic assay in the world today.

The INSTI™ HIV-1/HIV-2* Antibody Test is a rapid in vitro qualitative test for the detection of antibodies to Human Immunodeficiency Virus Type 1 in human whole blood, serum or plasma.

The INSTI™ Kit is manufactured in a state-of-the-art facility with a fully implemented Quality Control System to ensure the integrity and quality of every test. The staff consists of trained professionals in engineering, chemistry and pharmacy, and highly skilled technicians all working together under strict process controls, following Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) standards.

The manufacturing facility contains a dedicated Quality Assurance (Biological) Laboratory and Production Laboratory equipped with automated and duly calibrated process and testing instruments. The Quality Management System is ISO 9001 and ISO 13485 certified.

All raw materials and processed kit components are rigorously inspected and tested to ensure they meet strict quality guidelines. At each step of the manufacturing process there are checks to ensure continued quality control. Finally, before any lot is released to inventory, at least 50 kits are tested with whole blood, serum and plasma.

The color developer used in the INSTI™ is a proprietary formulation allowing us to control quality in our own laboratories. As a result we do not rely on outside suppliers for this critical component of the INSTI™.

The Research and Development team continues to develop and improve the INSTI™ HIV-1/HIV-2* Antibody Test Kit to reflect recent developments in the field of biotechnology. Our regulatory team has upgraded the facility to meet or exceed regulations for the manufacture of medical devices. Our ultimate goal is to provide you with products and service that will exceed your requirements.