The 11th Five-Year Plan of the National Science and Technology Major Project - "Research on HIV Diagnosis and Prevention Technology and Product Development" and "Research on Diagnosis and Clinical Monitoring of Viral Hepatitis B and C" were formally implemented.
Excellence 220/230 Automatic Biochemistry Analyzer was launched. KHB Vacuum Blood Collection Tubes produced by Shanghai Kewa Laboratory Products Co., Ltd. obtained the medical device registration certificate.
Excellence 300 series automatic biochemical analyzer was launched.
Excellence 400 and 300 series passed CE certification.
Shanghai Kehua Dongling Diagnostic Supplies Co., Ltd. completed the CE registration of Albumin Kit and Total Protein Kit.
By the end of 2008, 49 products of Kewa Bio*** had completed CE registration. The development of HBV/HCV/HIV Nucleic Acid Detection Kit (PCR Fluorescence Method), a project of Shanghai Municipality, was completed.
Excellence 400 Automatic Biochemistry Analyzer was successfully put into production.
Five biochemical reagents completed the traceability certification by relevant international organizations and obtained 11 traceability certificates.
42 kinds of biochemical reagents, as well as L-3180 semi-automatic biochemical analyzer and ST-36WT plate washer completed the CE registration in EU. ST-36W plate washer passed the CE certification by TUV, the authoritative certification body of EU.
Automatic Real-Time Fluorescence PCR Instrument and Automatic DNA Nucleic Acid Extraction System were successfully put into production. ST-360 Enzyme Labeling Instrument passed the CE certification of TUV, an authoritative certification organization in EU.
Proline Pipette, ST-36W Plate Washer, L-3280 Semi-Automatic Biochemistry Instrument, DP-1000 Nucleic Acid Extractor were successfully put into production.
Successfully developed the "Hepatitis B Virus Core Antibody IgM Enzyme Immunoassay Kit", which was the first one to obtain the document number in China, filling the gap in the country. Successfully developed AIDS rapid diagnostic kit (colloidal gold method). The kit passed the evaluation of the World Health Organization (WHO) with excellent results, and was included in the procurement lists of the World Health Organization (WHO), the United Nations Children's Fund (UNICEF) and the Clinton Foundation of the United States.
Successfully developed real-time fluorescence PCR test kits for hepatitis B, hepatitis C, HIV, coronavirus (SARS), etc., among which, the SARS test kit won the first place in China in the evaluation by the Ministry of Science and Technology. Successfully developed human immunodeficiency virus HIV (1+2) antibody enzyme immunoassay kit.
We were the first in China to launch liquid double-dose clinical chemistry diagnostic kits, which promoted the upgrading of clinical chemistry diagnostic reagents in China. We solved the stability problem of long-term preservation of enzyme plates and working solution of enzyme conjugate after encapsulation, and were the first to develop the Hepatitis B 2.5 kit by enzyme immunoassay in China, which marked the beginning of the era of large-scale commercial production of enzyme immunoassay kits in China.