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- Lee, Naery; Seo, Ji Suk; Kim, Jae Ok; Ban, Sang Ja
- Biologicals 2017 v.47 pp. 59-63
- reference standards, etc ; blood coagulation; freeze drying; geometry; humans; manufacturing; Show all 6 Subjects
- ... Since the 1st Korean national biological reference standard for factor (F)VIII concentrate, established in 2001, has shown declining potency, we conducted this study to replace this standard with a 2nd Korean national biological reference standard for blood coagulation FVIII concentrate. The candidate materials for the 2nd standard were prepared in 8000 vials with 10 IU/ml of target potency, accor ...
- Semenova, Vera A.; Steward-Clark, Evelene; Maniatis, Panagiotis; Epperson, Monica; Sabnis, Amit; Schiffer, Jarad
- Biologicals 2017 v.45 pp. 61-68
- reference standards, etc ; Bacillus anthracis; anthrax; blood serum; detection limit; diagnostic sensitivity; diagnostic specificity; enzyme-linked immunosorbent assay; humans; immunoglobulin G; regression analysis; screening; variance; Show all 13 Subjects
- ... To improve surge testing capability for a response to a release of Bacillus anthracis, the CDC anti-Protective Antigen (PA) IgG Enzyme-Linked Immunosorbent Assay (ELISA) was re-designed into a high throughput screening format.The following assay performance parameters were evaluated: goodness of fit (measured as the mean reference standard r²), accuracy (measured as percent error), precision (meas ...