Search Results

The CAPI 3 NEONAT Hb kit is intended as a qualitative screen for the detection of normal hemoglobins (F and A) and abnormal hemoglobins (S, C, E, D and Bart's) in blood from human new-born collected on filter paper. This analysis is performed by capillary electrophoresis with the CAPILLARYS 3 DBS instrument. The CAPILLARYS 3 DBS instrument is a capillary electrophoresis based automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins (A, F, S, C, D, E and Bart's). The assay is performed on the hemolysate of whole blood samples previously collected on filter paper. The test result must be interpreted in conjunction with other biological and clinical findings. In case of abnormal hemoglobin presence, it should be confirmed by additional tests as per local recommendations. The device is intended for professional use only. For In Vitro Diagnostic Use only.

The CAPI 3 NEONAT Hb kit is intended for the detection of normal hemoglobins (F and A) and abnormal hemoglobins (S, C, E, D and Bart's) in blood from human new-born collected on filter paper. The resulting electrophoregrams are automatically evaluated for pattern abnormalities with identification of normal and pathological patterns. The CAPILLARYS 3 DBS instrument uses the principle of capillary electrophoresis in free solution which is the most common form of capillary electrophoresis. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow. The CAPILLARYS 3 DBS instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm. which is the absorbance wavelength specific to hemoglobins. Before each run. the capillaries are washed with a wash solution and prepared for the next analysis with buffer. The CAPILLARYS 3 DBS performs all sequences automatically to obtain a complete hemoglobin profile for the qualitative analysis of hemoglobins. The assay is performed on the hemolysate of whole blood samples previously collected on Guthrie filter paper and punched to obtain a paper circle. By using alkaline pH buffer. normal and abnormal (or variant) hemoglobins are detected in the following order. from cathode to anode: C, A2, E, S, D, F, degraded F, A, degraded A and Bart's. Variants generated by the mutation of the y chain may appear in different zones of the electrophoretic pattern. The carbonic anhydrase is not visualized on the hemoglobin electrophoretic patterns with capillary electrophoresis.

The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant. The Premier Resolution System is intended for Professional Laboratory Use only. The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech. The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

The Premier Resolution System consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC).

The V8 Nexus Hemoglobin UltraScreen method is designed for the separation of normal hemoglobins (A, A2, and F) in human blood samples, and for the detection of major hemoglobins variants (S and C) by using a capillary zone electrophoresis (CZE) buffer with the V8 instrument. The V8 Nexus Hemoglobin UltraScreen test is indicated for use in patients 2 years of age and older. This test is designed for in-vitro diagnostic use only in conjunction with other laboratory and clinical findings.

The V8 instrument is an automated analyzer which performs a complete hemoglobin profile for quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S and C. The assay is performed on the hemolysate of venous whole blood collected in tubes containing K2EDTA as the anticoagulant. The V8 Nexus Hemoglobin UltraScreen method uses capillary zone electrophoresis (CZE) buffer with the V8 instrument for the separation of normal hemoglobins (A, A2, and F) and detection of major hemoglobin variants (S and C). The V8 AFSA2 Hemo Control is a control material derived from whole blood used as a quantitative and/or qualitative control for the Hemoglobin UltraScreen on the V8 Capillary Electrophoresis (CE) system.

The CAPI 3 HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A. A2 and F) in human venous blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 3 TERA instrument. The CAPILLARYS 3 TERA instrument is an automated analyzer which performs a complete for the quantitative analysis of the normal hemoglobin fractions A. A2 and F and for themoglobin variants S. C. E and D. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K2EDTA or K3EDTA as anticoagulant. The CAPI 3 HEMOGLOBIN(E) is intended to be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use

The CAPILLARYS 3 instrument uses the principle of capillary electrophoresis in free solution which is the most common form of capillary electrophoresis. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow. The CAPILLARYS 3 instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses for hemoglobin quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer. Direct detection provides accurate relative quantification of individual hemoglobin fraction, and the resulting electrophoregrams are also evaluated visually for pattern abnormalities. In addition, the high resolution of this procedure should allow the identification of hemoglobin variants, in particular, to differentiate hemoglobins S from D, and E from C. The hemoglobin A2 quantification can also be performed when hemoglobin E is present. A2 hemoglobin quantification may be used with other clinical and laboratory findings for ß thalassemia detection. By using alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: δΑ'2 (A2 variant). C. A2, E. S. D. F. and A. The carbonic anhydrase is not visualized on the hemoglobin electrophoretic patterns by capillary electrophoresis, this permits to identify hemoglobin A2 variants in this migration zone. NOTE : the name "CAPILLARYS 3" is used for the SEBIA CAPILLARYS 3 TERA automated instrument. The hemoglobins are reported in % units along with an electrophoresis scan.

The Hemoglobin Variants System is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography (HPLC). The Hemoglobin Variants System is intended for Professional Use Only. For in vitro diagnostic use. The Hemoglobin Variants System is for use only with the Newborn Hemoglobin System (NHS). This device, consisting of the reagents, controls, apparatus, HPLC instrumentation, software is indicated for professional laboratory IVD use to isolate and identify inherently determined abnormal (S, D, C, E) and normal (F, A) hemoqlobin types in neonatal blood samples.

The instrument, Newborn Hemoglobin System (NHS) utilizes same principles of ionexchange high-performance liguid chromatography (HPLC). The NHS instrument is a fully automated, high-throughput hemoglobin analyzer. It utilizes principles of ion-exchange highperformance liquid chromatography (HPLC). The NHS provides an integrated method for the separation and determination of relative percent of specific hemoglobins of dried blood spots. The dried blood spot collected from neonatal heel stick is punched and eluted with deionized water. The punched disc is removed and eluted sample is transferred into microplate well. The eluted sample is analyzed to identify specific inherently abnormal (S, D, C, E) as well as normal (F, A) hemoglobins through the system. The NHS consists of two modules — the Newborn Chromatographic Station (NCS) and the Newborn Auto Sampler (NAS). NCS module delivers buffer solutions (See table 4 for kit components) to the Hemoglobin Variants System CE Mini-Columns and the detector. The NAS module through automatic injection introduces eluted sample from microplate wells. Each sample is processed individually. The mini-column contains a cation exchange gel, and the analyzer makes use of a continuous pre-programmed gradient system. The preprogrammed gradient is designed to have the hemoglobins of interest elute from the minicolumn with retention times that fall within pre-determined windows characteristic of known normal and abnormal hemoglobins. The ionic strength of two phosphate buffers passing through the mini-column is changed over three minutes. The eluted hemoglobins introduced through automatic injection are sequentially detected with a dual-wavelength filter photometer. which monitors hemoglobin absorbance at 415 nm and corrects for any gradient induced absorbance changes at 690 nm. Detection is performed at two wavelengths (415 nm and 690 nm) to ensure a stable baseline. Sample of water immediately following a newborn or quality control sample prevents carryover. A workstation is used to control the Newborn Hemoglobin System using Genetic Disease Management (GDM) software. The GDM software is designed to execute the assay protocol on the NHS instrument using the Hemoglobin Variants System reagent kit components. The software processed HPLC data is outputted in a printed report that contains: 1) sample identification, 2) date and time of analysis, 3) report data (i.e., peak names, retention times, area, relative percent), and 4) chromatogram. Also system assigns a presumptive phenotype "pattern" to each sample result. The pattern is calculated by applying a set of "rules" to the peaks identified in the peak table. The purpose of the pattern rules is to eliminate minor peaks from the pattern, identify system or sample problems, and to focus the operator on the samples that may require further investigation. The pattern rules used by the GDM software were derived from those generated by the Genetic Diseases Laboratory for the state of California, USA, after analysis of 2.5 million newborns by HPLC over a four year period (Eastman, et al., 1996)'. Laboratories using the Newborn Hemoglobin System pattern rules and assignment should perform an internal validation study to confirm the performance of the system for their application. 1.Eastman, J. W.; Wong, R.; Liao, C. L.; Morales, D. R. Automated HPLC Screening of Newborns for Sickle Cell Anemia and Other Hemoglobinopathies. Clin. Chem. 1996, 42 (5), 704—710. The HbReview Software is to support the review of transmitted result and release of an approved result for each neonate sample analyzed on Hemoglobin Variants System with Newborn Hemoglobin System. A screening site using Newborn Hemoglobin Systems (NHS) transmits results from the Genetic Disease Management (GDM) software to the central site. The central site uses HbReview software to review results, identify samples for retesting, add comments and release results to the reporting site. Features are provided to assist Reviewers and Approvers in their tasks of examining results from the Hemoglobin Newborn Screening test. The HbReview software is a Client-Server design. The Review process provides a user interface (client) to a relational database, which is located on a separate computer (the server). The Client software permits an authorized user to make changes to the data maintained on the Server.

The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 FLEX-PIERCING instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use. The CAPILLARYS 2 FLEX-PIERCING instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K₂EDTA or K3EDTA as anticoagulant. For In Vitro Diagnostic Use.

The CAPILLARYS 2 FLEX-PIERCING instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K₂EDTA or K3EDTA as anticoagulant.

The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use. The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing KoEDTA or KsEDTA as anticoagulant. For In Vitro Diagnostic Use.

The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing KoEDTA or KsEDTA as anticoagulant.

The CAPILLARYS NEONAT Hb kit is designed for the separation of the normal hemoglobins (F and A) in blood samples from human new-borns, and for the major hemoglobin vanants (S, C, E, D and Bart's), by electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 System. The CAPILLARYS NEONAT Hb kit is designed for laboratory use. The CAPILLARYS 2 is an automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins. The assay is performed on the hemolysate of whole blood samples previously collected on filter paper. For In Vitro Diagnostic Use. The Hb AF Control is designed: - for the migration control before starting a new analysis sequence and for the qualitative quality control, for human hemoglobins A and F with the SEBIA CAPILLARYS NEONAT Hb electrophoresis procedure used with the CAPILLARYS 2 system, and, - for the quantitative quality control for detection of the human hemoglobins A, F and A2 with the SEBIA electrophoresis procedures : HYDRAGEL HEMOGLOBIN(E) used with the HYDRASYS system, CAPILLARYS HEMOGLOBIN(E) used with the CAPILLARYS system and MINICAP HEMOGLOBIN(E) used with the MINICAP system. The Hb AF Control is designed for laboratory use. It should be used (with its bar code label for the CAPILLARYS and MINICAP procedures) like a normal human blood. The values obtained must fall within the range provided with each batch of Hb AF Control. For In Vitro Diagnostic Use.

The CAPILLARYS 2 is an automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins. The assay is performed on the hemolysate of whole blood samples previously collected on filter paper.

The MINICAP HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System. The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative anailysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis. For In Vitro Diagnostic Use

The MINICAP HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System. The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative anailysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis.

The Bio-Rad VARIANT™nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C, and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT™nbs Sickle Cell Program is intended for Professional Use Only. For In Vitro Diagnostic Use. The Bio-Rad VARIANT™nbs Sickle Cell Program is for use only with the Bio-Rad VARIANT™nbs Newborn Screening System. The presence of hemoglobin S (HbS) in a patient blood sample is indicative of sickle cell disease or sickle cell trait. Diagnosis of sickle cell disease prior to the age of four months allows for the administration of a prophylactic treatment with penicillin. Prophylactic treatment with penicillin has shown to decrease morbidity and mortality.

The VARIANTnbs Newborn Screening System uses the principles of high-performance liquid chromatography (HPLC). The VARIANTnbs Sickle Cell Program is based on the chromatographic separation of hemoglobins F, A, S, D, C, and E on a cation exchange cartridge. The new feature in this submission is the upgrade of the Genetic Data Management (GDM) software. The current software (GDM 2.01) requires Microsoft Windows NT. This product is nearing the end of its lifecycle. GDM 3.0 software is needed to transfer the GDM software to the Microsoft Windows XP Operating System.