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NEWS

  1. Expert Review Panel for Diagnostics approval expands access to a G6PD deficiency test that supports P. vivax malaria treatment and elimination initiatives

    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...
    Date2019.10.08 CategoryNEWS Views12
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  2. CE-IVD Certification of STANDARD™ Q HCV Ab

    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...
    Date2019.09.11 CategoryNEWS Views16
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  3. Global Fund ‘ERPD’ Authorization: STANDARD™ Q HIV/Syphilis Combo, Q Syphilis Ab

    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...
    Date2019.08.30 CategoryNEWS Views31
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  4. STANDARD™ G6PD Test’s Official Research Report Is Published!

    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...
    Date2019.01.14 CategoryNEWS Views2318
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  5. STANDARD™ GlucoNavii GDH now available for newborn testing.

    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...
    Date2019.01.09 CategoryNEWS Views2097
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