Antibodies for the Diagnostics Industry
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
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 11 888 714 103 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 0.025 10 mg/dl 0.230 25 mg/dl 0.480 24 months at 15 to 25 C; avoid repeated freeze/thaw cycles 15 mg/ml Test Components PAB<CRP>S IgG 11 888 714 103 Tris buffer 10 153 265 001 N-Methylisothiazolone (MIT) 11 085 905 103 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>Tu66C7 11 543 598 103 11 543 601 103 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>Tu88E8 11 543 598 103 MAB<H-S-AMY>Tu66C7 11 543 601 103 -Glucosidase 11 626 329 103 4,6-Ethylidene-G7PNP (EPS) 10 880 078 103 Polidocanol 10 831 620 103 N-Methylisothiazolone (MIT) 11 085 905 103 Hepes buffer 10 172 944 103
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 04 688 457 103 Hexokinase (HK) 11 370 600 103 G-6-PDH 11 293 206 103 AMP, di-na 10 000 094 103 Diadenosine pentaphosphate, tri-li 10 161 624 103 NADP, mono-k 10 233 536 103 ADP, mono-k 10 233 528 103 Creatine phosphate, di-na 10 003 506 103 Imidazole buffer 10 073 571 103 N-Acetylcysteine 10 068 365 103 Specifications Antibody MAB<CK-MM>Mix 04 688 457 103 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 4570 291.5 with PAB<CK-MM>S-Fab: 1:4 diluted #92975400 18.5 276.9 99.6 5 #10994400 18.5 276.5 99.6 5.1 #90566000 24.9 277.8 99.46 4.7 Initial value 4402 290.4 MAB<CK-MM>Mix 1:80 diluted (R&D lot) 14.7 284.8 99.67 1.9 Initial value 4557 313.5 MAB<CK-MM>Mix 1:80 diluted #10924500 13.9 306.5 99.69 2.2 #10925200 15.7 305.7 99.66 2.5 cobas Bio, +25 C CK-MM CK-BB CK-MM CK-BB CK-MM CK-BB Initial value 2564 369 with PAB<CK-MM>S-Fab 5.16 379 99.8 0 MAB<CK-MM>Mix 1:20 diluted 3.84 440 99.85 0 Products are for further processing only.
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 11 353 713 103 MAB<CEA>M-TU3 IgG 10 777 498 103 Alpha-1-Fetoprotein (AFP) MAB<AFP>M-LJ738 IgG 11 492 101 103 MAB<AFP>M TU11 IgG 11 492 080 103 Ferritin MAB<Ferr>M-3.170 IgG 11 547 089 103 MAB<Ferr>M-4.184 IgG 11 547 119 103 Antibodies for Fertility/Pregnancy Testing Luteinizing Hormone (LH) MAB<LH>M-11412 IgG 11 547 925 103 MAB<LH>M-2.406 IgG 11 547 038 103 Follicle Stimulating Hormone (FSH) MAB<FSH>M-1.303 IgG 11 493 540 103 MAB<FSH>M-W3 IgG 11 493 531 103 Human Choriogonado tropin (HCG) MAB<HCG>M-INN22 IgG 11 812 564 103 MAB<HCG>M-INN2 IgG 03 116 263 103 Prolactin MAB<PRL>M-C4E4 IgG 11 458 701 103 MAB<PRL>M-H12G10 IgG 11 027 689 103 Antibodies for Thyroid Diagnostics Thyroid Stimulating Hormone (TSH) MAB<TSH>M-1.20 IgG 10 767 778 103 MAB<TSH>M-A8 IgG 11 367 978 103 T4/FT4 Thyroid Hormone PAB<T4>S IgG 10 767 794 103 T3/FT3 Thyroid Hormone PAB<T3>S IgG 10 907 332 103 Polyclonal antibodies were obtained from healthy, veterinary-controlled German sheep. Other Antibodies Insulin MAB<INSULIN>M-ST3 IgG 12 208 750 103 MAB<INSULIN>M-BM1 IgG 12 208 725 103 IgE MAB<IGE>M-323 IgG 11 543 393 103 MAB<IGE>M-7H8 IgG 11 988 204 103 CK-MB MAB<CK-MB>M-7.4.5 IgG 11 719 815 103 MAB<CK-MB>M-6.12.47 IgG 11 719 823 103 D-Dimer MAB<DD>M-1.2.57 IgG 12 156 903 103 MAB<DD>M-2.1.16 IgG 12 045 206 103
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