Development of a Group B Streptococcus Antenatal Diagnostic Medical Device for the Needs of Cross-Straits Medical Market

• Main Authors: Yen-Po Wang, 王彥博
• Other Authors: Wei-Jung Chen, Ph.D.
• Format: Others
• Language: zh-TW
• Published: 2015
• Online Access: http://ndltd.ncl.edu.tw/handle/7g429r

碩士 === 國立宜蘭大學 === 生物資源學院碩士在職專班 === 103 === Group B Streptococcus (GBS, Streptococcus agalactiae) is a common normal flora in human. GBS infection can cause serious sepsis, meningitis, neonatal pneumonia, and sometimes death, especially in newborn infants by causing upper genital tract infection. Testing for GBS is recommended at antenatal appointment during 35 to 37 week in pregnancy. In this study, we provided a simplified procedure for GBS detection from specimen collection, enrichment, culture, isolation to identification. These results suggested that GBS can be detected 1 to 2 days earlier than traditional method (using Lim Broth to enrich and identify). It also reduced the cost of the materials and manpower for GBS detection. The market research and product trial of CMPTMGBS TranSwab, CMPTMGBS Carrot Agar and CMPTMGBS β/γ detection agar have been done in medical centers and local hospitals in Taiwan and China, respectively, and compared with current method. Then we made product positioning: let the medical laboratory staffs in hospitals in Taiwan and China have more convenient and accurate test reagents; lowering disease risk for pregnant women and newborns; provide salespeople with suitable products for their needs, and ultimately achieve the tripartite win-win goal for hospitals, patients and suppliers.