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The G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC). The G7 Automated HPLC Analyzer: Beta-thalassemia Mode reagents and software are intended only for use on the Tosoh G7 Automated HPLC Analyzer.

The G7 Automated HPLC Analyzer - Beta-thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. A chromatographic tracing of the hemoglobin products found in the sample is also produced which allows for the comparison of an individual chromatogram with standard patterns of known composition. The operational portion of the G7 Beta-thalassemia Mode is composed of a sampling unit, liquid pump, degasser, detector, microprocessors, sample loader, floppy disk drive unit, operational panel and a printer all of which have already been cleared by the FDA (K011434). The reagents and software program specific to the Beta-thalassemia Mode consist of calibrators, elution buffers, column and software only. The G7 Automated HPLC System - Beta-thalassemia Mode uses a cation exchange column and separates the hemoglobin in the blood into fractions. The separation is accomplished by eluting the hemoglobins from the column with a gradient of three elution buffers containing increasing salt concentrations. The resulting report is printed out on the on-board printer and can be stored on a floppy disk in the on-board floppy disk drive. The data can also be transmitted to a host computer through the RS232 port. The result report includes a sample ID, date, time, area percentages and retention time in minutes of each individual peak detected. Peaks that meet the retention time "windows" pre-set in the software are labeled as F, A0, A2, D+, S+, C+. All others are designated in order of appearance as PXX and are listed in order of appearance. All automated processes in the G7 Beta-thalassemia Mode are controlled by internal microprocessors using software downloaded via the on-board floppy disk drive.

The VARIANT™ II ß-thalassemia Program is intended for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC). The VARIANT™ II ß-thalassemia Program is intended for use only with the Bio-Rad VARIANT™ II Hemoglobin Testing System For in vitro diagnostic use only.

The VARIANT™ II is a fully automated HPLC system which can be used to separate and determine area percentages for hemoglobins A, and F and to provide qualitative determinations of abnormal hemoglobins. The VARIANTM II B-thalassemia Short Program utilizes principles of ion exchange high performance liquid chromatography(HPLC). The samples are automatically mixed and diluted on the VARIANT™ II Sampling Station(VSS) and injected into the analytical cartridge. This is a change from the unmodified program(VARIANT) where samples had to be mixed and diluted manually before being placed on the instrument. The VARIANT™ II chromatographic station(VCS) dual pumps deliver a programmed buffer gradient of increasing ionic strength to the cartridge, where the HbA, F are separated based on their ionic interactions with the cartridge material. The separated HbA. F then pass through the flow cell of the filter photometer, where changes in the absorbance at 415 nm are measured. An additional filter at 690 nm corrects the background absorbance. The VARIANT™ II Clinical Data Management(CDM) software performs reduction of raw data collected from each analysis. One level calibration is used for the adjustment of the calculated HbAyF values. A patient sample report and a chromatogram are generated by CDM for each sample. Minor differences in the separation efficiency of individual analytical cartridges are corrected by the use of the Hemoglobin A /F Calibrator.