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Quantitative Fetal Hemoglobin Measurement: GazelleTM Point-of-Care Electrophoresis versus Standard HPLC Methodology

11 more authors
  1. 1KEMRI-Wellcome Trust Research Programme

Abstract

Quantitative measurement of fetal hemoglobin (HbF) using high-performance liquid chromatography (HPLC) is standard but expensive and widely unavailable in low-income settings. The newer Gazelle method, which employs single-use alkaline electrophoresis cartridges, provides a portable and relatively inexpensive potential alternative. In the current study, we tested 3055 venous blood samples collected from 1780 children with sickle cell anemia who were enrolled into the H-PRIME trial by both Gazelle and the Bio-Rad D-10 HPLC instrument, before and during hydroxyurea treatment. Data reinterpretation was required to quantify accurately high HbF values derived using the D-10. Mean (standard deviation) baseline HbF values by HPLC and Gazelle (N=2042) were 11.4% (SD 5.9%) versus 16.3% (SD 7.5%), respectively, while mean on-treatment HbF values (N=1013) were 18.9% (SD 9.0%) versus 25.4% (SD 11.5%), respectively. While overall agreement was good (Lins concordance 0.76, 95% CI 0.75-0.78), HbF values derived using Gazelle were modestly higher than HPLC values (Bland-Altman agreement mean +5.4%, 95%CI -2.4% to +13.2%), with the difference between measures increasing at higher HbF percentages. With strong concordance and more easily interpretable HbF values, Gazelle represents an attractive and inexpensive alternative to HPLC for HbF quantification in the low-income settings where most patients with sickle cell anemia live.

Key PointsO_LIPoint-of-care Gazelle electrophoresis compares favorably to standard HPLC hemoglobin separation to quantify fetal hemoglobin. C_LIO_LIGazelle HbF quantitation is accurate, inexpensive, and suitable for use in low-income settings including sub-Saharan Africa. C_LI

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BibTeX
@misc{williams2026quantitative,
  title = {{Quantitative Fetal Hemoglobin Measurement: GazelleTM Point-of-Care Electrophoresis versus Standard HPLC Methodology}},
  author = {T. N. Williams and R. Connon and R. Muhindo and D. Amorut and P. Ongodia and C. Okalebo and J. Abeso and F. Alaroker and S. Asio and A. Odiit and C. Kiyaga and S. Uyoga and G. Mochamah and G. Nyutu and C. Mogaka and A. Muyinda and G. Abongo and K. Maitland and D. Gibb and A. S. Walker and E. C. George and R. Ware and P. Olupot Olupot},
  howpublished = {medRxiv},
  year = {2026},
  month = sep,
  doi = {10.64898/2026.09.30.26364074},
  url = {https://www.medrxiv.org/content/10.64898/2026.09.30.26364074v1},
  note = {CC BY},
}
RIS
TY  - UNPB
TI  - Quantitative Fetal Hemoglobin Measurement: GazelleTM Point-of-Care Electrophoresis versus Standard HPLC Methodology
AU  - T. N. Williams
AU  - R. Connon
AU  - R. Muhindo
AU  - D. Amorut
AU  - P. Ongodia
AU  - C. Okalebo
AU  - J. Abeso
AU  - F. Alaroker
AU  - S. Asio
AU  - A. Odiit
AU  - C. Kiyaga
AU  - S. Uyoga
AU  - G. Mochamah
AU  - G. Nyutu
AU  - C. Mogaka
AU  - A. Muyinda
AU  - G. Abongo
AU  - K. Maitland
AU  - D. Gibb
AU  - A. S. Walker
AU  - E. C. George
AU  - R. Ware
AU  - P. Olupot Olupot
PY  - 2026
DA  - 2026/09/30
PB  - medRxiv
DO  - 10.64898/2026.09.30.26364074
UR  - https://www.medrxiv.org/content/10.64898/2026.09.30.26364074v1
AB  - Quantitative measurement of fetal hemoglobin (HbF) using high-performance liquid chromatography (HPLC) is standard but expensive and widely unavailable in low-income settings. The newer Gazelle method, which employs single-use alkaline electrophoresis cartridges, provides a portable and relatively inexpensive potential alternative. In the current study, we tested 3055 venous blood samples collected from 1780 children with sickle cell anemia who were enrolled into the H-PRIME trial by both Gazelle and the Bio-Rad D-10 HPLC instrument, before and during hydroxyurea treatment. Data reinterpretation was required to quantify accurately high HbF values derived using the D-10. Mean (standard deviation) baseline HbF values by HPLC and Gazelle (N=2042) were 11.4% (SD 5.9%) versus 16.3% (SD 7.5%), respectively, while mean on-treatment HbF values (N=1013) were 18.9% (SD 9.0%) versus 25.4% (SD 11.5%), respectively. While overall agreement was good (Lins concordance 0.76, 95% CI 0.75-0.78), HbF values derived using Gazelle were modestly higher than HPLC values (Bland-Altman agreement mean +5.4%, 95%CI -2.4% to +13.2%), with the difference between measures increasing at higher HbF percentages. With strong concordance and more easily interpretable HbF values, Gazelle represents an attractive and inexpensive alternative to HPLC for HbF quantification in the low-income settings where most patients with sickle cell anemia live.  Key PointsO_LIPoint-of-care Gazelle electrophoresis compares favorably to standard HPLC hemoglobin separation to quantify fetal hemoglobin. C_LIO_LIGazelle HbF quantitation is accurate, inexpensive, and suitable for use in low-income settings including sub-Saharan Africa. C_LI
ER  -