IVDT_In Vitro Diagnostics Technology

IVD Technology, Spring 2013

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Synthetic blocking buffer Commercially available BSA-blocker OD (650 nm) 0.16 0.12 0.08 0.04 0 NSB Figure 2. Blocking strength of the synthetic blocking buffer compared with a commercially available standard blocking buffer containing BSA. One hundred μl of the different blocking buffers were added to the microwells of a high binding plate. After emptying the plate, 100 μl of HRP-conjugate was added in each microwell. The conjugate was removed and nonspecifc binding (NSB) of the conjugate was detected using TMB PLUS2. commonly found in bufers used after the blocking step. One commonly used blocking agent is bovine serum albumin (BSA). BSA is popular because it is inexpensive, efcient, and biochemically inactive. However, BSA is heavily regulated worldwide because of the risk of contamination by the prion responsible for the bovine spongiform encephalopathy (BSE). Alternatively, casein (milk protein) has been used; however, it tends to be inconsistent from batch to batch and unstable in solution. An eco-sensible alternative to using BSA and casein is a synthetic blocker. Synthetic blockers have less variability between batches and are efective blocking agents (Figure 2). Additionally, synthetic blockers are inert and do not carry any risk of biological hazards, making worldwide transportation and distribution of these components easier. 3. Replace Substrates Based on Organic Solvents In ELISA detection steps, substrates used to amplify the signal can be very toxic both because of the chemical nature of the substrate and the way it is stored. Tese substrates—commonly 3, 3', 5, 5'tetramethylbenzidine (TMB) for HRP and nitrophenyl phosphate (pNPP) for AP—traditionally have been stored in organic solvents to ensure long-term stability. Te organic solvents typically used include the aprotic solvents N,N-dimethylformamide (DMF), dimethyl sulfoxide (DMSO), and methanol. Methanol is highly toxic to humans.2 DMSO is the least toxic of these solvents, but its breakdown by bacteria releases a sulfur-based compound with a strong, disagreeable odor. More importantly, all three solvents are combustible, making transportation and distribution a challenge. To avoid the use of these solvents, substrates can be prepared from multiple individual components that get mixed at the time of use. Although Medical Device Design Manufacturing IP Innovations Engineering Exceptional Results For over 15 years, Minnetronix has combined design and manufacturing, and our own innovative IP solutions, to help customers transform ideas into commercial success. Our teams expand the boundaries of device performance to create sophisticated medical devices that reliably meet regulatory and market needs. FDA Registered ISO 13485 Certified Visit us at www.minnetronix.com/ivdt Medical Device Innovation concept commercialization+ © 2013 Minnetronix. All rights reserved. Visit us at MD&M East, Booth #2701 ivd tech n o lo gy.com magenta cyan yellow black I VD T EC H N O LO G Y | S PR I NG 2 0 1 3 1 9 ES237151_IV1305_019.pgs 04.25.2013 00:54 UBM

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