Antibodies. for the Diagnostics Industry

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1 Antibodies for the Diagnostics Industry

2 Antibodies for Diagnostics from Roche Custom Biotech Diagnostics manufacturers require antibodies and antibody mixes of proven quality specifically produced for use in diagnostic kits. Roche Custom Biotech offers a dedicated product line of highquality antibodies for use in clinical chemistry and immunological applications, such as thyroid diagnostics, tumor markers, and fertility testing. All Roche antibodies: are specifically developed for diagnostic kits have guaranteed specifications, stability, and availability show robust lot-to-lot consistency are available in industrial-scale amounts are available as customized products for filling, packaging and labeling GMP production backmix reactor for final stage crystallization Antibody Nomenclature Clone MAB<H-S-AMY>M-Tu88E8 IgG(DE) Prime Term Animal Species Preparation Products are for further processing only. Trademarks COBAS and ELECSYS are trademarks of Roche. Other brands or product names are trademarks of their respective holders. The immunogen is described by its full name or as an abbreviation (in brackets) Animal Species B = bovine, RB = rabbit, M = mouse, S = sheep, H = human Preparation RS = raw serum IgG(DE) = immunoglobulin fraction, purified, for example, by dextran chromatography IgG(IS) = immunoglobulin fraction, purified by immuno sorption F(ab)' 2 = fragment, derived from pepsin digestion of IgG Fab = fragment, derived from papain digestion of IgG

3 Antibodies for Clinical Chemistry CRP Testing C-reactive protein (CRP) is a member of the globulin family of human plasma proteins. Increased levels of CRP are involved in a variety of inflammatory diseases. Elevated CRP serum levels indicate tissue injury, transplant rejection, carcino-genesis, and acute myocardial infarction. In turbidimetric/nephelometric assays, PAB<CRP>S IgG is coupled onto latex surfaces. These aggregates can be detected at 340/700 nm. Specifications Antibody PAB<CRP>S IgG Appearance Purity (HPLC, Mono Q) Bioburden Calibration curve characterization da (turbidimetric.: A340/700) Stability Working concentration Frozen solution Human C-reactive protein 90% IgG 1000 cfu/ml 1 mg/dl mg/dl mg/dl months at 15 to 25 C; avoid repeated freeze/thaw cycles 15 mg/ml Test Components PAB<CRP>S IgG Tris buffer N-Methylisothiazolone (MIT) Pancreatic -Amylase Testing In human serum and urine, the two major iso enzymes of human- -amylase, salivary (s) and pancreatic (p) amylase, are present. For selective measurement of acute pancreatitis, blocking of salivation, -amylase is necessary. The combi nation of MAB<H-S-AMY>Tu88E8 and MAB<H-S-AMY>Tu66C7 inhibits the human salivary -amylase 97%, while maintaining the activity of the pancreatic -amylase. Specifications Antibody MAB<H-S-AMY>Tu88E8 MAB<H-S-AMY>Tu66C Appearance Spleen donor Antibody class Purity (HPLC, Mono Q) Cross-reactivity Synergistic effects at +37 C Stability Lyophilizate Human salivary amylase Mouse balb/c IgG 2a, kappa 90% IgG h-pancreas amylase: 1 U/gW h-salivary amylase + MAB: 3% amylase activity h-pancreas amylase + MAB: 98% amylase activity 36 months at 15 to 25 C; avoid repeated freeze/thaw cycles Test Components MAB<H-S-AMY>Tu88E MAB<H-S-AMY>Tu66C Glucosidase ,6-Ethylidene-G7PNP (EPS) Polidocanol N-Methylisothiazolone (MIT) Hepes buffer

4 Creatine Kinase MB Testing CK-MB measurement is a key parameter for the diagnosis of acute myocardial infarction. The MAB<CK-MM>Mix inhibits the CK-M subunit by more than 99.7%, allowing accurate measurement of the CK-B subunit. Four highly specific mono clonal mouse antibodies enable the same inhibition of CK-MM as a polyclonal antibody. The MAB<CK-MM>Mix inhibits faster than the polyclonal precursor, and can be added to both assay reagents. Due to the absence of proteases, the preparation of stable liquid reagents is possible according to current QC. Test Components MAB<CK-MM>Mix Hexokinase (HK) G-6-PDH AMP, di-na Diadenosine pentaphosphate, tri-li NADP, mono-k ADP, mono-k Creatine phosphate, di-na Imidazole buffer N-Acetylcysteine Specifications Antibody MAB<CK-MM>Mix Appearance Purity (HPLC, Mono Q) Bioburden Inhibitor capacity Stability Frozen solution Human creatine kinase isoenzyme MM (h-ck-mm) Aggregates 10% (TSK 3000) 80% IgG 1000 cfu/ml Roche test CK liquid, +37 C, 25 μg (= 2.1 μl) antibody solution/ml Hitachi reagent inhibits, 4500 U/l CK-MM 99.6%, 300 U/l CK-BB ±5% 24 months at 15 to 25 C; avoid repeated freeze/thaw cycles. Thaw at +25 C. Highly selective and efficient inhibition of CK-MM enzyme activity using MAB<CK-MM>Mix comparable to PAB<CK-MM>S-Fab Activity of CK-sera [U/L] Rest Activity [U/L] Inhibition [%] Hitachi, +37 C CK-MM CK-BB CK-MM CK-BB CK-MM CK-BB Initial value with PAB<CK-MM>S-Fab: 1:4 diluted # # # Initial value MAB<CK-MM>Mix 1:80 diluted (R&D lot) Initial value MAB<CK-MM>Mix 1:80 diluted # # cobas Bio, +25 C CK-MM CK-BB CK-MM CK-BB CK-MM CK-BB Initial value with PAB<CK-MM>S-Fab MAB<CK-MM>Mix 1:20 diluted Products are for further processing only.

5 Antibodies for Immunological Assays The antibodies below sourced from the Roche production department and qualified on the cobas core and Elecsys Modular Platform. They can be supplied in bulk quantities ( 250 mg) on the basis of individually negotiated supply agreements. Product specification sheets, changes to materials, and respective sample material, are available upon request. Reconstitution procedure: Reconstitute the lyophilized antibodies in 0.9% NaCl solution (c =10 mg/ml). Prepare aliquots. Store aliquots for < 1 week at +2 to +8 C, and < 12 weeks at -20 C. Avoid repeated freeze/thaw cycles. Antibodies Against Tumor Markers Carcino Embryonic Antigen (CEA) MAB<CEA>TU2 IgG MAB<CEA>M-TU3 IgG Alpha-1-Fetoprotein (AFP) MAB<AFP>M-LJ738 IgG MAB<AFP>M TU11 IgG Ferritin MAB<Ferr>M IgG MAB<Ferr>M IgG Antibodies for Fertility/Pregnancy Testing Luteinizing Hormone (LH) MAB<LH>M IgG MAB<LH>M IgG Follicle Stimulating Hormone (FSH) MAB<FSH>M IgG MAB<FSH>M-W3 IgG Human Choriogonado tropin (HCG) MAB<HCG>M-INN22 IgG MAB<HCG>M-INN2 IgG Prolactin MAB<PRL>M-C4E4 IgG MAB<PRL>M-H12G10 IgG Antibodies for Thyroid Diagnostics Thyroid Stimulating Hormone (TSH) MAB<TSH>M-1.20 IgG MAB<TSH>M-A8 IgG T4/FT4 Thyroid Hormone PAB<T4>S IgG T3/FT3 Thyroid Hormone PAB<T3>S IgG Polyclonal antibodies were obtained from healthy, veterinary-controlled German sheep. Other Antibodies Insulin MAB<INSULIN>M-ST3 IgG MAB<INSULIN>M-BM1 IgG IgE MAB<IGE>M-323 IgG MAB<IGE>M-7H8 IgG CK-MB MAB<CK-MB>M IgG MAB<CK-MB>M IgG D-Dimer MAB<DD>M IgG MAB<DD>M IgG

6 Published by Roche Diagnostics GmbH Sandhofer Straße Mannheim Germany 2010 Roche Diagnostics. All rights reserved Your Roche Custom Biotech Customer Service Customers in Europe, Middle East, Africa, and Latin America: Roche Diagnostics Deutschland GmbH Sandhofer Straße Mannheim, Germany Phone Fax Customers in the United States: Roche Diagnostics Corporation Roche Applied Science 9115 Hague Road P.O. Box Indianapolis, IN , USA Phone , ext (toll-free) Fax Customers in Canada: Roche Diagnostics 201, Boulevard Armand-Frappier HV 4A2 Laval, Québec, Canada Phone Fax Customers in Japan: Roche Diagnostics K.K. Roche Custom Biotech Applied Science 6-1, Shiba 2-chome Minato-ku, Tokyo , Japan Phone Fax Customers in Asia Pacific: Roche Diagnostics Asia Pacific Pte. Ltd. Regional Sales and Market Development 298 Tiong Bahru Road # 16-01/06 Central Plaza Singapore, Phone Fax custombiotech.roche.com

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