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The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human (K2EDTA) plasma on Tosoh AIA System Analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.

The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK BNP test cups. BNP present in the test sample is bound with monoclonal antibody immobilized on magnetic beads and enzyme-labeled monoclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the BNP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using the curve.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in venous whole blood specimens using ion-exchange high-performance liquid chromatography (HPLC). This test is an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes, and for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is an automated High-Performance Liguid Chromatography (HPLC) system that separates and reports stable hemoglobin A1c (sA1c) percentage in venous whole blood. The operational portion of the G8 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, smart media card, operation panel, and a printer. The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 uses ion-exchange HPLC for rapid, accurate, and precise separation of the stable form of HbA1c (sA1c) from other hemoglobin fractions. The G8 uses a non-porous cation exchange column and separates the hemoglobin components in the blood. Separation is achieved by utilizing differences in ionic interactions between the cation and exchange group on the column resin surface and the hemoglobin components in a step gradient elution. The hemoglobin fractions (designated as A1a. A1b. F. LA1c+, SA1c, A0, and, if present, H-V0, H-V2, H-V2 and H-V3) are subsequently removed from the column by performing a step-wise elution gradient using the varied salt concentrations in the Variant Elution Buffers HSi 1, 2 and 3. The peaks, H-V0, H-V1, H-V2 and H-V3 are typically presumptive HbAD, HbAS, HbAC and HbAE respectively. The software compares the retention times of hemoglobin fractions in a sample to the expected "windows of retention" and labels each fraction that correctly elutes within a defined expected window of retention. The software designates a hemoglobin fraction as POX (where X is the order of the peak as it elutes from the column) if it does not match a defined window of retention. All automated processes in the G8 are controlled by internal microprocessors, using software downloaded via a smart media card. The result report is printed and can be stored on the instrument. The data can be transmitted to a host computer through a bi-directional interface. The result report includes the sample ID, date, percentage and retention time of each fraction of hemoglobin, sA1c percentage and total A1 percentage, along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the fraction depending upon its charge.

The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.

- 2 x 1 mL ST AIA-PACK hsE2 Calibrator (1) 0 pg/mL Human serum containing no detectable concentration of estradiol with sodium azide as a preservative. - 2 x 1 mL ST AIA-PACK hsE2 Calibrator (2) 25 pg/mL (approx.) - ST AIA-PACK hsE2 Calibrator (3) 50 pg/mL (approx.) - ST AIA-PACK hsE2 Calibrator (4) 100 pg/mL (approx.) - ST AIA-PACK hsE2 Calibrator (5) 500 pg/mL (approx.) - ST AIA-PACK hsE2 Calibrator (6) 1,100 pg/mL (approx.) Human serum containing the assigned concentration of estradiol (described on each vial) with sodium azide as a preservative. ST AIA-PACK hsE2 Calibrator Set P/N # 025325 The ST AIA-PACK hsE2 Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials. The ST AIA-PACK hsE2 Calibrator Set is designed for use with ST AIA-PACK hsE2 and ST AIA-PACK hsE2 Sample Diluting Solution.

The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.

- 2 x 1 mL ST AIA-PACK PROG III Calibrator (1) 0 nq/mL Bovine protein matrix containing no detectable concentration of progesterone with sodium azide as a preservative (Liquid). - 2 x 1 mL ST AIA-PACK PROG III Calibrator (2) 0.5 ng/mL (approx.) - ST AIA-PACK PROG III Calibrator (3) 1.5 ng/mL (approx.) - ST AIA-PACK PROG III Calibrator (4) 5.0 ng/mL (approx.) - ST AIA-PACK PROG III Calibrator (5) 15 ng/mL (approx.) - ST AIA-PACK PROG III Calibrator (6) 45 ng/mL (approx.) Bovine protein matrix containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative. The ST AIA-PACK PROG III Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials. The ST AIA-PACK PROG III Calibrator Set is designed for use with ST AIA-PACK PROG III and ST AIA-PACK PROG III Sample Diluting Solution.

ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na-heparinized plasma or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency. The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for in vitro diagnostic use only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay.

The ST AIA-PACK 25-OH Vitamin D is a one-step delayed competitive enzyme immunoassay which, after sample pretreatment, is performed entirely in the ST AIA-PACK 25-OH Vitamin D test cup. Sample pretreatment reagents (containing sodium hydroxide) disassociate 25-OH vitamin D from its binding proteins in the test sample. 25-OH vitamin D present in the pretreated sample is bound to 25-OH vitamin D-specific monoclonal antibody immobilized on magnetic beads. After that, the enzymelabeled 25-OH vitamin D is added to the reaction mixture. The enzyme-labeled 25-OH vitamin D competes with 25-OH vitamin D for binding to the antibody on magnetic beads in the reaction mixture. After the second incubation, the magnetic beads are washed to remove the unbound enzymelabeled 25-OH vitamin D and are then incubated with a fluorogenic substrate, 4- methylumbellifery phosphate (4MUP). The amount of enzyme-labeled 25-OH vitamin D that binds to the beads is inversely proportional to the 25-0H vitamin D concentration in the test sample. A standard curve is constructed, and unknown 25-OH vitamin D concentrations are calculated using this curve. The ST AIA-PACK 25-OH Vitamin D Calibrator Set contains human sera with assigned levels of 25-OH Vitamin D. The calibrator set consists of six calibrators with assigned concentrations of approximately 0, 8, 17, 33, 66 and 135 ng/mL. Each level contains the assigned concentration of the 25-OH vitamin D (described on each vial) with sodium azide as a preservative.

ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay.

The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the ST AIA-PACK C-Peptide II assay.

2 x 2 mL AIA-PACK C-Peptide Control Level 1 Buffered bovine serum albumin containing approximately 2 nq/mL of C-peptide (Lyophilized). See the vial label for the assigned concentration range. AIA-PACK C-Peptide Control Level 2 2 x 2 mL Buffered bovine serum albumin containing approximately 20 ng/mL of C-peptide (Lyophilized). See the vial label for the assigned concentration range. The AIA-PACK C-Peptide Control Set contains buffered bovine serum albumin with assigned levels of C-peptide. The C-peptide controls shall be run at the beginning of each day on which C-peptide assays are scheduled.

The ST AIA-PACK PROG II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG II assay.

2 x 1 mL ST AIA-PACK PROG II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of PROG with sodium azide as a preservative (Liquid). 2 x 1 mL ST AIA-PACK PROG II Calibrator (2) 0.5 ng/mL (approx.) ST AIA-PACK PROG II Calibrator (3) 1.5 ng/mL (approx.) ST AIA-PACK PROG II Calibrator (4) 5.0 ng/mL (approx.) ST AIA-PACK PROG II Calibrator (5) 15 ng/mL (approx.) ST AIA-PACK PROG II Calibrator (6) 45 ng/mL (approx.) Human serum containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative. The ST AIA-PACK PROG II Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials. The ST AIA-PACK PROG II Calibrator Set is designed for use with ST AIA-PACK PROG II and ST AIA-PACK PROG II Sample Diluting Solution.

The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay.

2 x 1 mL ST AIA-PACK C-Peptide II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of C-peptide with sodium azide as a preservative (Liquid). 2 x 1 mL ST AIA-PACK C-Peptide II Calibrator (2) 0.5 ng/mL (approx.) ST AIA-PACK C-Peptide II Calibrator (3) 2 ng/mL (approx.) ST AIA-PACK C-Peptide II Calibrator (4) 6 ng/mL (approx.) ST AIA-PACK C-Peptide II Calibrator (5) 15 ng/mL (approx.) ST AIA-PACK C-Peptide II Calibrator (6) 33 ng/mL (approx.) Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized). The ST AIA-PACK C-Peptide II Calibrator Set is designed specifically for use on the Tosoh AIA Svstem Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials. The ST AIA-PACK C-Peptide II Calibrator Set is designed for use with ST AIA-PACK C-Peptide II, ST AIA-PACK C-Peptide Sample Diluting Solution, AIA-PACK C-Peptide Control Set.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A Ic (HbA 1c) (DCCT/NGSP) and mmol/mo hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable A 1c (sA1c) percentage in whole blood. The operational portion of the G8 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, floppy disk drive unit, operation panel and a printer. The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 uses non-porous ion- exchange high performance liquid chromatography (HPLC) for rapid, accurate and precise separation of the stable form of HbA Ic from other hemoglobin fractions. The G8 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, A 1a, A 1b, F, LA 1c, sA Ic, and A0. The separation is done by eluting the hemoglobins from the column with a stepwise elution of three elution buffers containing different salt concentrations. The result report includes a sample ID, date, percentage and retention time of each fraction, sA1c percentage and total A1 percentage (A1a + A1b + sA1c), along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the material depending upon its charge.