CAPILLARYS HEMOGLOBIN(E)
CAPILLARYS HEMOGLOBIN(E) - Sebia Electrophoresis
CAPILLARYS HEMOGLOBIN(E) - Sebia Electrophoresis
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<strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) - 2010/10<br />
In addition, this same blood sample with Hb S (containing 11.5 g/dL hemoglobin with 39.8 % Hb S) was concentrated twice and serially diluted in saline<br />
and electrophoresed with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure. The tests were determined to be linear within the entire range studied from<br />
23.0 to 1.1 g/dL total hemoglobin and Hb S fraction percentages were not affected by the hemoglobin concentration of the samples.<br />
Accuracy – Internal correlation No. 1<br />
NOTE : The blood samples and their diagnostic assessment, used in the five accuracy studies presented below, were provided by 5 hospital<br />
laboratories in France. The diagnosis was based on a routine HPLC procedure.<br />
Quantitative Determination of Hb A2<br />
The levels of Hb A2 were measured in two hundred and forty three (243) blood samples with normal and elevated levels of Hb A2 both by<br />
electrophoretic separations obtained with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong> 2 FLEX PIERCING system and a<br />
commercially available capillary electrophoresis system for Hb A2 quantification.<br />
The measured values of Hb A2 from both procedures were analyzed by a linear regression statistical procedure. The results of linear regression<br />
analysis are tabulated below (y = <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)) :<br />
Fraction Correlation coefficient y-Intercept Slope<br />
Range of % values<br />
<strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)<br />
Hb A2 0.993 0.024 1.012 0.0 - 6.5<br />
Quantitative Determination of Hb F<br />
The levels of Hb F were measured in one hundred and ten (110) blood samples with normal and elevated levels of Hb F both by electrophoretic<br />
separations obtained with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong> 2 FLEX PIERCING system and a commercially<br />
available capillary electrophoresis system for Hb F quantification.<br />
The measured values of Hb F from both procedures were analyzed by a linear regression statistical procedure. The results of linear regression analysis<br />
are tabulated below (y = <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)) :<br />
Fraction Correlation coefficient y-Intercept Slope<br />
Range of % values<br />
<strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)<br />
Hb F 0.999 0.184 0.997 0.2 - 62.5<br />
Quantitative Determination of Hb S<br />
The levels of Hb S were measured in seventy four (74) blood samples with Hb S both by electrophoretic separations obtained with the <strong>CAPILLARYS</strong><br />
<strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong> 2 FLEX PIERCING system and a commercially available capillary electrophoresis system for<br />
Hb S quantification.<br />
The measured values of Hb S from both procedures were analyzed by a linear regression statistical procedure. The results of linear regression analysis<br />
are tabulated below (y = <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)) :<br />
Fraction Correlation coefficient y-Intercept Slope<br />
Range of % values<br />
<strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)<br />
Hb S 0.999 -0.173 0.998 1.8 - 92.6<br />
Quantitative Determination of Hb C and Hb E<br />
The levels of Hb C and Hb E were measured in, respectively, 14 and 9 blood samples both by electrophoretic separations obtained with the<br />
<strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong> 2 FLEX PIERCING system and a commercially available capillary electrophoresis<br />
system for Hb C and Hb E quantification.<br />
The measured values of Hb C and Hb E from both procedures were analyzed by a linear regression statistical procedure. The results of linear<br />
regression analysis are tabulated below (y = <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)) :<br />
Fraction Correlation coefficient y-Intercept Slope<br />
Range of % values<br />
<strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)<br />
Hb C 0.999 -0.134 0.995 4.6 – 40.9<br />
Hb E 0.999 0.754 0.983 11.4 – 92.9<br />
Detection of Hemoglobin Abnormalities<br />
Two hundred and forty three (243) different blood samples, including 106 samples with hemoglobin variants, such as hemoglobins S, C, D and E, were<br />
analyzed with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong> 2 FLEX PIERCING system and a commercially available capillary<br />
electrophoresis system for hemoglobins analysis.<br />
All abnormal hemoglobins or abnormal levels of normal hemoglobins detected with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure were in agreement<br />
with the comparative capillary electrophoresis system, hospital results and clinical diagnosis. There was no case observed of false positive, i.e.,<br />
detection of an abnormal band or abnormal level of a normal band where no such abnormality existed.<br />
Accuracy – Internal correlation No. 2<br />
NOTE : The blood samples and their diagnostic assessment, used in the five accuracy studies presented below, were provided by 1 hospital laboratory<br />
in France. The diagnosis was based on a routine HPLC procedure.<br />
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