STANDARD Q HCV Ab Test, STANDARD Q Malaria P.f Ag Test, STANDARD Q Malaria P.f/P.v Ag Test, and STANDARD Q Malaria P.f/Pan Ag Test have been listed on the World Health Organization’s prequalification project. Please find the public reports and performance data through the official website of the World Health Organization. https://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/ If you have any further inquiry, please feel free to contact our sales representatives or via email(sal...

GLOBAL NEWS Expanded Product Lines in 2019 MEDICA! ==================================================================== SD Biosensor participated in the MEDICA from November 18th to 21st. With expanded product lines, SD Biosensor exhibited with a larger booth size this year. Visitors showed a large interest in the new products, and especially to the STANDARD M, which is the Point-of-care MDx platform. STANDARD M can test both quantitative and qualitative parameters, and 7 tests are available now,...

The STANDARD™ G6PD has achieved provisional Expert Review Panel for Diagnostics (ERPD) approval, which enables procurement with Global Fund and Unitaid funds. Point-of-care diagnostics for G6PD deficiency play a critical role in supporting appropriate treatment of Plasmodium vivax malaria and efforts to eliminate the disease. Up to 2.85 billion people may be at risk of infection with Plasmodium vivax malaria. It is the most difficult type of malaria to fully treat because a form of the mal...

SD BIOSENSOR receives CE-IVD mark for STANDARD™ Q HCV Ab Test. It is SD BIOSENSOR’s 1st 'List A' test, in compliance with the in vitro Diagnostic Directive (IVDD) 98/79/EC. STANDARD™ Q HCV Ab Test qualitatively analyzes antibodies specific to hepatitis C virus in serum and plasma using immunochromatography. With a simple test method, the screening test result can be obtained within 5 minutes with outstanding sensitivity and specificity. Diagnostic Sensitivity : 100.0% (4...

The Global Fund concluded that our STANDARD™ Q HIV/Syphilis Combo and Q Syphilis Ab are eligible for procurement with Global Fund and/or UNITAID resources until 25 August 2020. We are working on WHO PQ approval of STANDARD™ Q HIV/Syphilis Combo Test. The expected approval is around Q1 2020 which means the procurement will be continued beyond August 2020. The product was evaluated successfully in Belgium, Germany, Congo, Peru, and more evaluations are ongoing in Ghana and India. [Publi...

SD BIOSENSOR's newsletter is released. 06. SDB NEWSLETTER vol.9 April 2019.pdf This newsletter included topics of distributor meetings, new products, and an upcoming exhibition event. So please have a look at it! Thank you.

Although HIV and syphilis are both sexually transmitted infection, they are very different as syphilis is caused by Treponema pallidum (bacteria), and HIV is a virus caused infection. However, if syphilis is untreated, it could develop to HIV infection which could be life-threating. Therefore, it is important for people to notice the infection when they are infected, and treat with proper ways. SD Biosensor has developed a STANDARD Q HIV/Syphilis Combo which could detect HIV-1, HIV-2, and syphil...

Tafenoquine (TQ; Krintafel) is FDA approved medicine that compensates Primaquine (PQ) in its long term dose (14 days ~ 8 weeks). TQ can cure P. v malaria infection at liver-stage, and prevent relapse. However, because of its potential risks of hemolysis to G6PD deficient people, WHO have recommended that all people should test G6PD or need to know their G6PD activity status before administering to this treatment. G6PD deficiency is associated with X-chromosome, so for male, their G6PD activity is...

The new specification of STANDARD™ GlucoNavii GDH has made it available to test neonate only for professional use. STANDARD™ GlucoNavii GDH has been tested with neonatal samples at Gauhati Medical College & hospital in India from 14th of March to 27th of June, 2018. The total number of newborn samples was 52, and the age of subjects was between 2 hours to 5 days with HCT range of 31%~66%. Each sample was tested twice with 3 different lots of strips which lead to more than 300 tes...

VISIT US AT MEDLAB 2019! SD BIOSENSOR is going to attend MEDLAB in Dubai, UAE, from 4th to 7th in February 2019. During the exhibition, SD BIOSENSOR will exhibit STANDARD™ Q/F/E lines along with BGMS products including various newly developed products. And besides the exhibition, we are also planning to provide product training sessions including trouble shooting and demonstration sessions on 5th to support successful sales in the market. Come visit SD BIOSENSOR’s booth and experience...