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<p>Hemoglobinopathies like sickle cell disorder (SCD) and thalassemia are common in India. Newborn screening (NBS) in high-prevalence areas is crucial to initiate early intervention. Traditionally NBS is conducted using dried blood spots (DBS) on special high performance liquid chromatography (HPLC) or capillary zone electrophoresis (CZE) analyzer, however, HPLC analyzers for venous blood samples are widely available. We evaluated diagnostic accuracy of heel prick samples collected in capillary collection kits from BIO-RAD in comparison with cord blood samples for NBS for hemoglobinopathies on Bio-Rad Variant II analyzer. Cord blood and heel prick samples were collected from 100 newborns at a tertiary care center in Central India. Both samples were subjected to HPLC on Bio-Rad variant II analyzer. Sensitivity and specificity of capillary kit sample to detect hemoglobinopathy was compared with cord blood. Quantification of fetal Hb (Hb F), adult Hb (Hb A) and variant Hb was compared across 2 samples using bland altman plot. Capillary kit sample showed sensitivity of 93% and specificity of 99% in detection of hemoglobinopathies. Statistical analysis suggested excellent interclass correlation between both samples through bland Altman plot for quantification of various types of hemoglobin. Heel prick sample collected using Bio-Rad Capillary collection kit has &gt; 90% sensitivity and specificity to detect hemoglobinopathy in newborns. Thus, it can be used to offer NBS in remote areas of developing countries on routine HPLC analyzer bypassing the need of cord blood samples and dedicated costly analyzers to process DBS samples.</p>

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Capillary Collection Kit Can Facilitate Newborn Screening for Hemoglobinopathies: Utilisation of Existing Infrastructure in Resource Constrained Setting

  • 期刊论文

  • 发表日期：

    2025年11月28日

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  • Richa Juneja,
  • M. Vasanthakumari,
  • Akriti Khare,
  • Nishant Banait,
  • Rasika Gadkari

摘要

Hemoglobinopathies like sickle cell disorder (SCD) and thalassemia are common in India. Newborn screening (NBS) in high-prevalence areas is crucial to initiate early intervention. Traditionally NBS is conducted using dried blood spots (DBS) on special high performance liquid chromatography (HPLC) or capillary zone electrophoresis (CZE) analyzer, however, HPLC analyzers for venous blood samples are widely available. We evaluated diagnostic accuracy of heel prick samples collected in capillary collection kits from BIO-RAD in comparison with cord blood samples for NBS for hemoglobinopathies on Bio-Rad Variant II analyzer. Cord blood and heel prick samples were collected from 100 newborns at a tertiary care center in Central India. Both samples were subjected to HPLC on Bio-Rad variant II analyzer. Sensitivity and specificity of capillary kit sample to detect hemoglobinopathy was compared with cord blood. Quantification of fetal Hb (Hb F), adult Hb (Hb A) and variant Hb was compared across 2 samples using bland altman plot. Capillary kit sample showed sensitivity of 93% and specificity of 99% in detection of hemoglobinopathies. Statistical analysis suggested excellent interclass correlation between both samples through bland Altman plot for quantification of various types of hemoglobin. Heel prick sample collected using Bio-Rad Capillary collection kit has > 90% sensitivity and specificity to detect hemoglobinopathy in newborns. Thus, it can be used to offer NBS in remote areas of developing countries on routine HPLC analyzer bypassing the need of cord blood samples and dedicated costly analyzers to process DBS samples.