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 />
Quantitative Determination of Hb A2<br />
The levels of Hb A2 were measured in seventy two (72) blood samples with normal and elevated levels of Hb A2 both by electrophoretic separations<br />
obtained with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong> 2 FLEX PIERCING system and a commercially available HPLC<br />
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 0.971 0.398 0.852 0.6 – 4.6<br />
Quantitative Determination of Hb F<br />
The levels of Hb F were measured in sixty (60) blood samples with normal and elevated levels of Hb F both by electrophoretic separations obtained<br />
with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong> 2 FLEX PIERCING system and a commercially available HPLC system<br />
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 0.990 -0.471 1.229 0.0 – 13.1<br />
Quantitative Determination of Hb S<br />
The levels of Hb S were measured in nine (9) 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 HPLC system for 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 -1.594 1.089 26.7 – 91.5<br />
Quantitative Determination of Hb C<br />
The levels of Hb C were measured in four (4) blood samples with Hb C 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 HPLC system for Hb C quantification.<br />
The measured values of Hb C 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 C 0.997 4.965 0.788 25.9 – 35.6<br />
Detection of Hemoglobin Abnormalities<br />
Seventy two (72) different blood samples, including 15 samples with hemoglobin variants such as hemoglobins S and C, were analyzed with the<br />
<strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong> 2 FLEX PIERCING system and a commercially available HPLC system for<br />
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 HPLC system, hospital results and clinical diagnosis. There was no case observed of false positive, i.e., detection of an abnormal<br />
band or abnormal level of a normal band where no such abnormality existed.<br />
Accuracy – External correlations<br />
NOTE: The results presented below have been obtained from 2 external accuracy studies that have been performed in 1 laboratory located in France<br />
and in 1 laboratory located in the USA. The diagnosis was based on a routine HPLC.<br />
In France, the levels of hemoglobin fractions were measured in 307 blood samples, including 34 samples with hemoglobin variants such as<br />
hemoglobins S and C, both by electrophoretic separations obtained with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure with the <strong>CAPILLARYS</strong><br />
2 FLEX PIERCING system and a commercially available HPLC system for hemoglobins analysis.<br />
The measured values of hemoglobin fractions from both procedures were analyzed by a linear regression statistical procedure. The results of linear<br />
regression analysis for Hb A2, Hb F, Hb S and Hb C are tabulated below (y = <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)) :<br />
Hb fraction<br />
Number of samples<br />
Correlation<br />
coefficient<br />
y-Intercept<br />
Slope<br />
Range of Hb % values<br />
<strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E)<br />
Hb A2 307 0.990 0.228 0.917 0.9 – 6.6<br />
Hb F 124 0.993 -0.150 1.036 0.2 – 21.9<br />
Hb S 26 0.997 1.077 0.992 18.5 – 64.1<br />
Hb C 8 0.985 -4.732 1.041 30.4 – 36.7<br />
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