藥物成份
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Reagent: Access Thyroglobulin ReagentR1a: Dynabeads** paramagnetic particles coated with streptavidin, suspended in a TRIS buffer with protein (bovine), <0.1% sodium azide, and 0.1% ProClin*** 300.R1b: Mouse monoclonal anti-thyroglobulin-alkaline phosphatase (bovine)conjugate in a TRIS buffer with protein (bovine, murine), <0.1% sodium azide, and 0.1% ProClin 300.R1c: Mouse monoclonal anti-thyroglobulin antibodies coupled to biotin in a HEPES buffer with protein (bovine and mouse), <0.1% sodium azide, and 0.5% ProClin 300.Access Thyroglobulin CalibratorsS0: HEPES buffer with bovine serum albumin (BSA), <0.1% sodium azide, and 0.5% ProClin*** 300. Contains 0.0 ng/mL thyroglobulin.S1, S2, S3, S4, S5: Human thyroglobulin at levels of approximately 1.0, 10, 100, 250, and 500 ng/mL, respectively, in HEPES buffer with BSA, <0.1% sodium azide, and 0.5% ProClin 300.。處方變更為：空白。
Reagent:Factor X Reagent: lyophilized preparation containing approximately 2 nmol of bovine F.X, tris-(hydroxymethyle)-aminomethan (Tris) Buffer at pH 8 and stabilizers.Factor Ixa Reagent: lyophilized preparation containing approximately 0.6 nmol Bovine F. Ixa, approximately 0.6 nmol of bovine thrombin, approximately 0.06 mmol of calcium chloride, approximately 0.12 umol of phospholipids, Tris buffer at pH 8 and stabilizers.Substrate Reagent: lyophilized preparation containing approximately 3.4μmol of CH3OCO-D-CHG-Gly-Arg-pNA. AcOh, a F.XaSubstrate, Nα-(2-Naphthylsulfonylglycyl) -D, L amidino-phenylala-ninepiperidide(α-NAPAP), 6 a thrombin inhibitor and stabilizers.Stopping Buffer: solution containing Tris, ethylendiamintetraacetic acid, sodium chloride and 0.02% sodium azide.
Reagent:R1a: Paramagnetic particles coated with goat anti-mouse IgG suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA), 8-anilino-1-naphthalenesulfonic acid (ANS), <0.1% sodium azide, and 0.1% ProClin** 300.R1b: Mouse monoclonal antibody to thyroxine diluted in TRIS buffered saline, with surfactant, protein (aves, murine, goat), <0.1% sodium azide, and 0.1% ProClin 300.R1c: Thyroxine-alkaline phosphatase (bovine)conjugate diluted in TRIS buffered saline, with surfactant, protein (aves), <0.1% sodium azide, and 0.1% ProClin 300.Calibrator:S0: Human serum with <0.1% sodium azide, and 0.5% ProClin** 300. Contains 0.0μg/dL(nmol/L) thyroxine.S1, S2, S3, S4, S5: Thyroxine in human serum at levels of approximately 2.0, 4.0, 8.0, 16.0, and 30.0μg/dL(26, 51, 103, 206, and 386 nmol/L), respectively, with <0.1% sodium azide, and 0.5% ProClin 300.Calibration Card: 1
Reagent:\n1EA Reconstitution Buffer: Contains TES (n-tris [hydroxylmethyl] methyl-2-aminoethane sulfonic acid), 30μg/mL mouse monoclonal vancomycin antibody, stabilizer, buffer salts, surfactant and preservative,(17 mL).\n1a EA Reagent: Contains 1.71 g/L Enzyme acceptor, buffer salts, stabilizer and preservative. \n2 ED Reconstitution Buffer: Contains Potassium Phosphate, buffer salts, surfactant and preservative, (17 mL). \n2a ED Reagent: Contains 25 nM Enzyme donor conjugated to vancomycin, 1.64 g/L chlorophenolred-β-D-galactopyranoside, buffer salts, stabilizer, and preservative.\nCalibrators: Vancomycin Low Calibrator 2 x 7.5 mL\n Vancomycin High Calibrator 2 x 5.0 mL\n
Reagent:\nELSA: ready for use.\nAnti-AFP monoclonal antibody coated in ELSA fixed to the bottom of the tube.\nANTI-AFP125I: ready for use.\n125I anti-AFP monoclonal antibody, buffer, sheep serum, sodium azide, non-immunized mice immunoglobulins.\n≦ 277.5 kBq (≦7.5 μCi).\nSTANDARD 0: ready for use.\nCalf serum, sodium azide.\nSTANDARDS: ready for use.\nHighly purified AFP (human), calf serum, sodium azide.\n3-30-100-250-500-800 ng/ml.*\nCONTROL: ready for use.\nHighly purified AFP (human)**, calf serum, sodium azide.\nBUFFER: ready for use.\nBuffer, sodium azide, non-immunized mice immunoglobulins.\nPLASTIC BAG
Reagent:\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 12mL:\n Streptavidin-coated microparticles, 0.72 mg/mL; binding capacity:\n 470 ng biotin/mg microparticles; preservative.\nR1 Anti-T3-Ab~Ru(bpy)2+3 (gray cap), 1 bottle, 18mL:\n Monoclonal anti-T3-antibody (sheep) labeled with ruthenium complex\n 10 ng/mL; phosphate buffer 100 mmol/L, pH 7.0; preservative.\nR2 T3~biotin (black cap), 1 bottle, 18 mL:\n Biotinylated T3 2 ng/mL; phosphate buffer 100 mmol/L, \n PH 7.0; preservative.\nCalSet:\nl FT3 Cal1: 2 bottles, each for 1.0 mL of calibrator 1\nl FT3 Cal2: 2 bottles, each for 1.0 mL of calibrator 2\nFT3 in two concentration ranges (approx. 2 pmol/L or 1.3 pg/mL and approx. 40 pmol/L or 26 pg/mL) in a human serum matrix.
Reagent:\nM: Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.\nR1: Anti-digoxin-Ab~Ru(bpy)32+ (gray cap), 1 bottle, 10 mL: Monoclonal anti-digoxin antibody (mouse) labeled with rythenium complex 15μg/L; phosphate buffer 100 mmol/L, pH 7.0; preservative.\nR2: Digoxin-derivative~biotin (black cap), 1 bottle, 10 mL: Biotinylated digoxigenin 1.06 ng/mL; biotin 15μg/L; phosphate buffer 100 mmol/L, pH 7.0; preservative.\nCalSet:\nDIGO Cal1: 2 bottles, each containing 1.5 mL of calibrator 1\nDIGO Cal2: 2 bottles, each containing 1.5 mL of calibrator 2\nDigoxin in two concentration ranges (approx. 0.61 ng/mL or 0.78 nmol/L and approx. 3.61 ng/mL or 4.62 nmol/L) in a buffer/protein (bovine serum) matrix.\n
Reagent:\nR1 Buffer Reagent: 4 x 20 mL, Tris(hydroxymethyl)aminomethane 50 mM, Sodium azide 0.1%\nR2 RF Reagent: 2 x 8 mL, Aggregated (denatured) human IgG 0.2%, Tris(hydroxymethyl)aminomethane 100 mM, Sodium azide 0.1%\nCalibrators A-C: Human serum 3 x 2 mL, Sodium azide 0.1%\nControl:\nLevel 1,2: Human serum (lyophilized) 1 x 2 mL each level, sodium azide 0.1%\nLevel 1,2: Human serum (lyophilized) 2 x 2 mL each level, sodium azide 0.1%\n
Reagent:\nR1a: Paramagnetic particles, coated with goat anti-biotin antibodies, biotinylated anti CA 125 antigen mouse monoclonal antibodies, bovine serum albumin.\nR1b: Mouse monoclonal anti-CA 125 antigen-alkaline phosphatase (bovine) conjugate, bovine serum albumin.\nR1c: Buffered protein solution (bovine, goat, mouse).\nCalibrator:\nS0: Buffered bovine serum albumin (BSA).\nS1，S2，S3，S4，S5: CA 125 antigen at levels of approximately 25, 100, 500, 2000 and 5,000 U/mL, in buffered BSA.\nSample Diluent A: Buffered BSA matrix with surfactant.
Reagent:l. Magnetic particles (2.3mL): Magnetic particles coated with HSV recombinant protein, BSA, phosphate buffer, <0.l%sodium azide. 2.Calibrator l (2.5mL): Human serum/plasma containing low HSV IgG levels, BSA, phosphate buffer, preservatives, an inert yellow dye. 3. Calibrator 2 (2.5mL): Human serum/plasma containing High HSV IgG levels, BSA, phosphate buffer, preservatives, an inert blue dye. 4. Buffer C (2.3mL): BSA, phosphate buffer, preservatives 5 .Specimen diluents (28mL): BSA, phosphate buffer, preservatives, an inert yellow dye. 6. Conjugate (23mL):Mouse monoclonal antibodies to human IgG conjugated to an isoluminol derivative, BSA, phosphate buffer, preservatives.\nControl: 1. Negative control (2 x 1.3mL): Human serum/plasma stabilized in PBS buffer, non-reactive for HSV-1 IgG antibodies, BSA, preservatives. 2. Positive control (2 x 1.3mL): Human serum/plasma reavtive for HSV-1 IgG antibodies, stabilized in PBS buffer, BSA, preservatives, an inert yellow dye.
Reagent:l. Magnetic particles 2.3mL: Magnetic particles coated with HSV-2 IgG Recombinant antigen, BSA, phosphate buffer, <0.l%sodium azide. 2.Calibrator l 1.8mL: Human serum/plasma containing low HSV-2 IgG levels, BSA, phosphate buffer, preservatvies, an inert yellow dye. 3. Calibrator 2 1.8mL : Human serum/plasma containing High HSV-2 IgG levels, BSA, phosphate buffer, preservatvies, an inert blue dye. 4. Buffer C 2.3mL: BSA, phosphate buffer, preservatives 5 .Specimen diluents 28mL: BSA, phosphate buffer, preservatives, an inert yellow dye. 6. Conjugate 23mL:Mouse monoclonal antibodies to human IgG conjugated to an isoluminol derivative, BSA, phosphate buffer, preservatives.\nControl: 1. Negative control 2 x 0.7mL: Human serum/plasma stabilized in PBS buffer, non-reactive for HSV-2 IgG antibodies, BSA, preservatives. 2. Positive control 2 x 0.7mL: Human serum/plasma reavtive for HSV-2 IgG antibodies, stabilized in PBS buffer, BSA, preservatives, an inert yellow dye.
Reagents QuantityCRYPTATE CONJUGATE: lyophilized.Anti-NSE monoclonal antibody conjugated witheuropium cryptate, buffer, bovine, albumin,non-immunized mice immunoglobulins. 1 vialXL665 CONJUGATE: lyophilized.Anti-NSE monoclonal antibody conjugated withXL665, buffer, bovine albumin, non-immunizedmice immunoglobulins. 1 vialDILUENT:Human serum. 1 vialB？R？A？H？M？S NSE KRYPTOR CAL: Each vial contains highly purifiedbovin NSE, new born calf serum, and preservatives.B？R？A？H？M？S NSE KRYPTOR QC: Each vial contains highly purifiedbovine NSE, human serum and a preservative.
Reagents QuantityCRYPTATE CONJUGATE: ready-to-use.Anti-PAPP-A monoclonal antibody conjugated with europium cryptate, buffer, bovine albumin, non-immunized mice immunoglobulins, potassium fluoride. 1 vialXL665 CONJUGATE: ready-to-use.Anti-PAPP-A monoclonal antibody conjugated with XL665, buffer, bovine, albumin, non-immunized mice immunoglobulins, potassium fluoride. 1 vialDLUENT: ready-to-use.Calf serum, 1 vialB？R？A？H？M？S PAPP-A KRYPTOR CAL: Each vial contains PAPP-A/proMBP complexes of human origin, human serum.
Reagents - working solutions\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:\n Streptavidin-coated microparticles 0.72 mg/mL; preservative.\nR1 Anti-N-MID Osteocalcin-Ab~biotin (gray cap), 1 bottle, 10 mL:\n Biotinylated monoclonal anti-N-MID Osteocalcin antibody (mouse)\n 1.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative.\nR2 Anti-N-MID Osteocalcin-Ab~Ru(bpy)2+3 (black cap), 1 bottle, 10 mL:\n Monoclonal anti-N-MID Osteocalcin antibody (mouse)\n labeled with ruthenium complex 1.3 mg/L; phosphate buffer \n 100 mmol/L, pH 6.0; preservative.\n\nCalSet - working solutions\n• OSTEOC Cal1: 2 bottles, each for 1.0 mL of calibrator 1\n• OSTEOC Cal2: 2 bottles, each for 1.0 mL of calibrator 2\nOsteocalcin (synthetic peptide, human sequence) in two concentration ranges (approx. 0 ng/mL and approx. 280 ng/mL) in a human serum matrix.\n
Reagents - working solutions\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:\n Streptavidin-coated microparticles 0.72 mg/mL; preservative.\nR1 Anti-IgE-Ab~biotin (gray cap), 1 bottle, 10 mL:\n Biotinylated monoclonal anti-IgE antibody (mouse) 2.5 mg/L;\n phosphate buffer 85 mmol/L, pH 6.5; preservative.\nR2 Anti-IgE-Ab~Ru(bpy)2+3 (black cap), 1 bottle, 10 mL:\n Monoclonal anti-IgE antibody (mouse) labeled with ruthenium\n complex 5.5 mg/L; phosphate buffer 85 mmol/L, pH 6.5; preservative.\n\nCalSet - working solutions\n• IGE Cal1: 2 bottles, each containing 1.0 mL of calibrator 1\n• IGE Cal2: 2 bottles, each containing 1.0 mL of calibrator 2\nIgE (human) in two concentration ranges (approx. 1 IU/mL or 2.4 ng/mL and approx. 100 IU/mL or 240 ng/mL) in an equine serum matrix; preservative.\n
Reagents - working solutions\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 Anti-myoglobin-Ab~biotin (gray cap), 1 bottle, 10 mL: Biotinylated monoclonal anti-myoglobin antibody (mouse) 1.75 mg/L; phosphate buffer 85 mmol/L, pH 6.5; sodium azide < 0.1 %; preservative.\nR2 Anti-myoglobin-Ab~Ru(bpy)2+3 (black cap), 1 bottle, 10 mL: Monoclonal anti-myoglobin antibody (mouse) labeled with ruthenium complex 1.75 mg/L; phosphate buffer 85 mmol/L, pH 6.5; sodium azide < 0.1 %; preservative.\n\nCalSet - working solutions\n• MYO-STAT Cal1: 2 bottles, each containing 1.0 mL of calibrator 1\n• MYO-STAT Cal2: 2 bottles, each containing 1.0 mL of calibrator 2\nMyoglobin (human) in two concentration ranges (approx. 35 ng/mL and approx. 1200 ng/mL) in a liquid buffer/protein (bovine serum albumin) matrix.
Reagents - working solutions\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.\nR1 Anti-CA 125-Ab~biotin (gray cap), 1 bottle, 9 mL: Biotinylated monoclonal anti-CA 125 antibody (M 11; mouse) 1 mg/L; phosphate buffer 100 mmol/L, pH 7.4; preservative.\nR2 Anti-CA 125-Ab~Ru(bpy)2+3 (black cap), 1 bottle, 9 mL: Monoclonal anti-CA 125 antibody (OC 125; mouse) Labeled with ruthenium complex 1 mg/L; phosphate buffer 100 mmol/L, pH 7.4; preservative.\n\nCalSet - working solutions\n• CA125 II Cal1: 2 bottles, each containing 1.0 mL of calibrator 1\n• CA125 II Cal2: 2 bottles, each containing 1.0 mL of calibrator 2\nCA 125 II (human) in two concentration ranges (approx. 35 U/mL and approx. 500 U/mL) in a human serum matrix; preservative.
Reagents - working solutions\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:\n Streptavidin-coated microparticles 0.72 mg/mL; preservative.\nR1 Anti-hCG-Ab~biotin (gray cap), 1 bottle, 9 mL: Biotinylated monoclonal anti-hCG antibody (mouse) 2.3 mg/L; phosphate buffer 40 mmol/L, pH 7.5; preservative.\nR2 Anti-hCG-Ab~Ru(bpy) (black cap), 1 bottle, 10 mL: Monoclonal anti-hCG antibody (mouse) labeled with ruthenium complex 6.0 mg/L; phosphate buffer 40 mmol/L, pH 6.5; preservative.\n\nCalSet - working solutions\n• HCG STAT Cal1: 2 bottles, each for 1.0 mL of calibrator 1\n• HCG STAT Cal2: 2 bottles, each for 1.0 mL of calibrator 2\nHuman chorionic gonadotropin (from urine) in two concentration ranges (approx. 10 mIU/mL and approx. 5000 mIU/mL) in a buffered human serum matrix.\n
Reagents - working solutions\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 8 mL: \n Streptavidin-coated microparticles 0.72 mg/mL; preservative.\nR1 Anti-CEA-Ab~biotin (gray cap), 1 bottle, 10 mL:\n Biotinylated monoclonal anti-CEA antibody (mouse/human) 3.0 mg/L;\n phosphate buffer 100 mmol/L, pH 6.0; preservative.\nR2 Anti-CEA-Ab~Ru(bpy)2+3 (black cap), 1 bottle, 8 mL:\n Monoclonal anti-CEA antibody (mouse) labeled with ruthenium\n complex 4.0 mg/L; phosphate buffer 100 mmol/L, pH 6.5; preservative.\n\nCalSet - working solutions\n• CEA Cal1: 2 bottles, each containing 1.0 mL of calibrator 1\n• CEA Cal2: 2 bottles, each containing 1.0 mL of calibrator 2\nCEA (human, from cell culture) in two concentration ranges (approx. 5 ng/mL and approx. 50 ng/mL) in a buffer/protein matrix. 1 ng/mL CEA corresponds to 16.9 mIU/mL.\n
Reagents - working solutions\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.\nR1 Anti-T3-Ab~Ru(bpy) (gray cap), 1 bottle, 16 mL: Polyclonal anti-T3-antibody (sheep) labeled with ruthenium complex 75 ng/mL; ANS 0.8 mg/mL; phosphate buffer 100 mmol/L, pH 7.4; preservative.\nR2 T3~biotin (black cap), 1 bottle, 16 mL: Biotinylated T3 3 ng/mL; ANS 0.8 mg/mL; phosphate buffer 100 mmol/L, pH 7.4; preservative.\n\nCalset - working solutions\n• T3 Cal1: 2 bottles, each for 1.0 mL of calibrator 1\n• T3 Cal2: 2 bottles, each for 1.0 mL of calibrator 2\nT3 in two concentration ranges (approx. 1.25 nmol/L or 0.8 ng/mL and approx. 8.5 nmol/L or 5.5 ng/mL) in a human serum matrix. \n