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 />
Reproducibility between runs<br />
Eight (8) different blood samples were run 10 times using the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure on 3 <strong>CAPILLARYS</strong> 2 FLEX PIERCING<br />
systems and with 3 lots of <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) kits (1 lot per system). The analyzed samples included 3 samples with normal Hb A2 level,<br />
1 sample with elevated Hb A2 level, 1 sample with elevated Hb F level and 3 samples with abnormal hemoglobins (Hb S or Hb C or Hb E). The mean,<br />
SD and CV (n = 10) were calculated for each sample, each hemoglobin component, each lot of kit and each system.<br />
The table shows the ranges of hemoglobins values for the 8 tested blood samples on the 3 <strong>CAPILLARYS</strong> 2 FLEX PIERCING systems with the 3 lots<br />
of kits and a mean CV calculated from the pooled CV's for each hemoglobin component (n = 24 for Hb A and Hb A2, n = 6 for Hb F and Hb S, n = 3<br />
for Hb C and Hb E).<br />
Hb COMPONENT MEAN (%) SD CV (%) MEAN CV (%)<br />
Hb A 49.0 - 97.5 0.03 - 0.22 0.03 - 0.3 0.1%<br />
Hb A2 2.2 - 6.6 0.00 - 0.22 0.0 - 3.4 1.7%<br />
Hb F 7.5 - 24.5 0.05 - 0.11 0.3 - 1.2 0.6%<br />
Hb S 18.4 - 37.0 0.05 - 0.14 0.2 - 0.6 0.3%<br />
Hb C 4.5 - 4.7 0.03 - 0.05 0.7 - 1.1 0.9%<br />
Hb E 26.1 - 26.4 0.08 - 0.13 0.3 - 0.5 0.4%<br />
Reproducibility between lots and between systems<br />
Eight (8) different blood samples (identical as those assayed for the "Reproducibility between runs" study) were run 10 times using the <strong>CAPILLARYS</strong><br />
<strong>HEMOGLOBIN</strong>(E) procedure on 3 <strong>CAPILLARYS</strong> 2 FLEX PIERCING systems and with 3 lots of <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) kits (1 lot per<br />
system). The mean, SD and CV (n = 30) were calculated for each sample, for each hemoglobin component with the 3 lots of kits and the<br />
3 <strong>CAPILLARYS</strong> 2 FLEX PIERCING systems.<br />
The table shows the ranges of hemoglobins values for the 8 samples tested on the 3 <strong>CAPILLARYS</strong> 2 FLEX PIERCING systems and with the 3 lots<br />
and a mean CV calculated from the pooled CV's for all samples (n = 8 for Hb A and Hb A2, n = 2 for Hb F and Hb S, n = 1 for Hb C and Hb E).<br />
Hb COMPONENT MEAN (%) SD CV (%) MEAN CV (%)<br />
Hb A 49.7 - 97.4 0.05 - 0.57 0.1 - 1.1 0.3%<br />
Hb A2 2.3 - 6.5 0.03 - 0.18 1.2 - 4.9 2.5%<br />
Hb F 7.7 - 24.5 0.12 - 0.13 0.5 - 1.5 1.0%<br />
Hb S 18.9 - 36.7 0.26 - 0.46 0.7 - 2.4 1.6%<br />
Hb C 4.6 0.10 2.2 2.2%<br />
Hb E 26.2 0.15 0.6 0.6%<br />
In addition, none of the repeats (reproducibility between runs, systems and lots) showed false positive or false negative values.<br />
Linearity<br />
Different characteristic blood samples were mixed by pairs within different proportions and the dilutions were electrophoresed with the <strong>CAPILLARYS</strong><br />
<strong>HEMOGLOBIN</strong>(E) procedure. The tests were determined to be linear within the entire ranges studied for each of the hemoglobin fraction (Hb A, Hb F,<br />
Hb S and Hb A2).<br />
In addition, three different characteristic blood samples were also serially diluted in saline and electrophoresed with the <strong>CAPILLARYS</strong><br />
<strong>HEMOGLOBIN</strong>(E) procedure. The tests were determined to be linear within the entire ranges studied from 1.1 to 36.0 g/dL total hemoglobin and<br />
hemoglobin fractions percentages were not affected by the hemoglobin concentration of the samples.<br />
Hb A2 linearity<br />
Two different blood samples (one sample containing 13.4 g/dL hemoglobin with 0.0 % Hb A2 and another containing 13.2 g/dL with 9.8 % Hb A2) were<br />
mixed within different proportions and the dilutions were electrophoresed with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure. The tests gave a good<br />
linearity for Hb A and Hb A2 hemoglobin fractions within the entire range studied, with a maximum of about 1.3 g/dL for Hb A2 (between 0.0 and 9.8 %<br />
of Hb A2).<br />
In addition, a normal blood sample (containing 13.3 g/dL hemoglobin with 2.7 % Hb A2) was concentrated twice and serially diluted in saline and<br />
electrophoresed with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure. The tests were determined to be linear within the entire range studied from 26.6<br />
to 1.3 g/dL total hemoglobin and Hb A2 fraction percentages were not affected by the hemoglobin concentration of the samples.<br />
Hb F linearity<br />
One umbilical cord blood sample (containing 18.0 g/dL hemoglobin with 86.0 % Hb F) was mixed with a normal blood sample (containing 13.4 g/dL<br />
hemoglobin with 0.0 % Hb F) within different proportions and the dilutions were electrophoresed with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure.<br />
The tests gave a good linearity for Hb A, Hb A2 and Hb F hemoglobin fractions within the entire range studied.<br />
The <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) tests gave a good linearity for Hb F hemoglobin fraction within the entire range studied, with a maximum of about<br />
15.5 g/dL for Hb F (between 0.0 and 86.0 % of Hb F).<br />
In addition, this same umbilical cord blood sample (containing 18.0 g/dL hemoglobin with 86.0 % Hb F) was concentrated twice and serially diluted in<br />
saline and electrophoresed with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure. The tests were determined to be linear within the entire range studied<br />
from 36.0 to 1.8 g/dL total hemoglobin and Hb F fraction percentages were not affected by the hemoglobin concentration of the samples.<br />
Hb S linearity<br />
One blood sample with Hb S (containing 11.5 g/dL hemoglobin with 39.8 % Hb S) was mixed with a normal blood sample without Hb S (containing<br />
13.4 g/dL hemoglobin) within different proportions and the dilutions were electrophoresed with the <strong>CAPILLARYS</strong> <strong>HEMOGLOBIN</strong>(E) procedure. The<br />
tests gave a good linearity for Hb A, Hb S and Hb A2 hemoglobin fractions within the entire range studied, with a maximum of about 4.6 g/dL for Hb S<br />
(between 0.0 and 39.8 % of Hb S).<br />
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