Newborn Screening for Sickle Cell Disease: Technical and Legal Aspects of a German Pilot  Study with 38,220 Participants

<table class="table-group" id="tab5"><tr><td><table class="table"><tr><td class="thead-hr" colspan="10"><hr/></td></tr><tr class="thead"><td align="left"> </td><td align="center">HbF mean <svg height="14.85" id="M43" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M290 -163h-170v866h170v-28q-79 -7 -94 -19.5t-15 -72.5v-627q0 -59 14.5 -71.5t94.5 -19.5v-28z" id="x5B"></path></g>
</svg>%<svg height="14.85" id="M44" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M226 -163h-170v27q79 7 94 20t15 73v627q0 59 -15 72t-94 20v27h170v-866z" id="x5D"></path></g>
</svg></td><td align="center">CV <svg height="14.85" id="M45" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M290 -163h-170v866h170v-28q-79 -7 -94 -19.5t-15 -72.5v-627q0 -59 14.5 -71.5t94.5 -19.5v-28z" id="x5B"></path></g>
</svg>%<svg height="14.85" id="M46" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M226 -163h-170v27q79 7 94 20t15 73v627q0 59 -15 72t-94 20v27h170v-866z" id="x5D"></path></g>
</svg></td><td align="center">HbA mean <svg height="14.85" id="M47" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M290 -163h-170v866h170v-28q-79 -7 -94 -19.5t-15 -72.5v-627q0 -59 14.5 -71.5t94.5 -19.5v-28z" id="x5B"></path></g>
</svg>%<svg height="14.85" id="M48" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M226 -163h-170v27q79 7 94 20t15 73v627q0 59 -15 72t-94 20v27h170v-866z" id="x5D"></path></g>
</svg></td><td align="center">CV <svg height="14.85" id="M49" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M290 -163h-170v866h170v-28q-79 -7 -94 -19.5t-15 -72.5v-627q0 -59 14.5 -71.5t94.5 -19.5v-28z" id="x5B"></path></g>
</svg>%<svg height="14.85" id="M50" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M226 -163h-170v27q79 7 94 20t15 73v627q0 59 -15 72t-94 20v27h170v-866z" id="x5D"></path></g>
</svg></td><td align="center">HbS mean <svg height="14.85" id="M51" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M290 -163h-170v866h170v-28q-79 -7 -94 -19.5t-15 -72.5v-627q0 -59 14.5 -71.5t94.5 -19.5v-28z" id="x5B"></path></g>
</svg>%<svg height="14.85" id="M52" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M226 -163h-170v27q79 7 94 20t15 73v627q0 59 -15 72t-94 20v27h170v-866z" id="x5D"></path></g>
</svg></td><td align="center">CV <svg height="14.85" id="M53" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M290 -163h-170v866h170v-28q-79 -7 -94 -19.5t-15 -72.5v-627q0 -59 14.5 -71.5t94.5 -19.5v-28z" id="x5B"></path></g>
</svg>%<svg height="14.85" id="M54" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M226 -163h-170v27q79 7 94 20t15 73v627q0 59 -15 72t-94 20v27h170v-866z" id="x5D"></path></g>
</svg></td><td align="center">HbC mean <svg height="14.85" id="M55" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M290 -163h-170v866h170v-28q-79 -7 -94 -19.5t-15 -72.5v-627q0 -59 14.5 -71.5t94.5 -19.5v-28z" id="x5B"></path></g>
</svg>%<svg height="14.85" id="M56" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M226 -163h-170v27q79 7 94 20t15 73v627q0 59 -15 72t-94 20v27h170v-866z" id="x5D"></path></g>
</svg></td><td align="center">CV <svg height="14.85" id="M57" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M290 -163h-170v866h170v-28q-79 -7 -94 -19.5t-15 -72.5v-627q0 -59 14.5 -71.5t94.5 -19.5v-28z" id="x5B"></path></g>
</svg>%<svg height="14.85" id="M58" style="vertical-align:-1.95624pt" version="1.1" viewbox="0 0 5.9875002 14.85" width="5.9875002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,12.012)"><path d="M226 -163h-170v27q79 7 94 20t15 73v627q0 59 -15 72t-94 20v27h170v-866z" id="x5D"></path></g>
</svg></td><td align="center"><span style="width: 8.6625004px;"><svg height="7.9499998" id="M59" style="vertical-align:-0.10033pt" version="1.1" viewbox="0 0 8.6625004 7.9499998" width="8.6625004" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,7.675)"><path d="M495 86q-46 -47 -87 -72.5t-63 -25.5q-43 0 -16 107l49 210q7 34 8 50.5t-3 21t-13 4.5q-35 0 -109.5 -72.5t-115.5 -140.5q-21 -75 -38 -159q-50 -10 -76 -21l-6 8l84 340q8 35 -4 35q-17 0 -67 -46l-15 26q44 44 85.5 70.5t64.5 26.5q35 0 10 -103l-24 -98h2
q42 56 97 103.5t96 71.5q46 26 74 26q9 0 16 -2.5t14 -11.5t9.5 -24.5t-1 -44t-13.5 -68.5q-30 -117 -47 -200q-4 -19 -3.5 -25t6.5 -6q21 0 70 48z" id="x1D45B"></path></g>
</svg></span></td></tr><tr><td class="thead-hr" colspan="10"><hr/></td></tr><tr><td align="left">Control FASC</td><td align="center">18.8</td><td align="center">4.8</td><td align="center">35.5</td><td align="center">2.0</td><td align="center">14.5</td><td align="center">4.3</td><td align="center">5.4</td><td align="center">7.7</td><td align="center">5</td></tr><tr class="table-tr"><td colspan="10"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

Interrun precision of CE determined on liquid control samples provided by the manufacturer.

BioMed Research International

tab5

Table 5

Table 5: Newborn Screening for Sickle Cell Disease: Technical and Legal Aspects of a German Pilot  Study with 38,220 Participants 