Clinical Insights

Clinical Studies

  • Integration of point-of-care testing for sickle cell disease into primary care in northern Ghana: a prospective feasibility study

    LANCET PRIMARY CARE • August 5, 2026

    This prospective feasibility study evaluated the integration of Gazelle® sickle cell disease testing into routine immunization services at 10 primary health-care clinics in rural northern Ghana. Screening was conducted by existing facility staff, with same-day results, without creating a separate screening program. Among 6,024 children younger than five years, 81 were confirmed to have sickle cell disease. Of those, 97.5% entered specialized care, and 94.9% remained in care after 24 months. The findings demonstrate the feasibility of integrating decentralized screening, confirmatory diagnosis, and long-term care into existing primary-care services.

  • Enhancing access to sickle cell disease diagnosis in Africa using the Gazelle® portable digital microchip electrophoresis platform

    BLOOD CELLS, MOLECULES, AND DISEASES • 2026

    This study evaluated Gazelle in 1,360 participants in Kano, Nigeria, comparing results with HPLC. Testing was performed by locally trained healthcare workers and laboratory personnel, with participants ranging from newborns to adults.

    Gazelle demonstrated 100% sensitivity and specificity for distinguishing sickle cell disease from both normal and sickle cell trait, and 99.7% sensitivity for distinguishing sickle cell trait from normal. The authors concluded that Gazelle’s portability, ease of use, and strong diagnostic performance support its potential integration into screening programs in regions with a high burden of sickle cell disease and limited access to conventional laboratory testing.Description goes here

  • Validation of Gazelle Microchip Electrophoresis for Premarital Hemoglobinopathy Screening in Türkiye

    eJHaem • June 2026

    This study evaluated Gazelle against HPLC for premarital hemoglobinopathy screening in Türkiye, enrolling 616 participants, including 100 known β-thalassemia or sickle cell carriers. Among 516 participants undergoing routine screening, 16 hemoglobinopathy traits were identified, including 14 β-thalassemia traits, one HbS trait, and one HbD trait.

  • Evaluation of Diagnostic Accuracy of Sickle SCAN™, and Gazelle™ for Screening Hemoglobin S in india

    INDIAN JOURNAL OF HEMATOLOGY & BLOOD TRANSFUSION• April 5, 2025

    This prospective study of 470 patients compared the performance of two point-of-care tests for hemoglobin S detection against high-performance liquid chromatography (HPLC). Gazelle™ demonstrated 100% sensitivity for identifying homozygous sickle cell disease and 98.4% sensitivity for sickle cell trait, with strong agreement to HPLC for quantitative hemoglobin S measurements. The authors concluded that Gazelle provides accurate, rapid, and interpretable results suitable for point-of-care screening in high-prevalence settings.

  • Evaluation of low-cost techniques to detect sickle cell disease and β-thalassemia: an open-label, international, multicentre study

    THE LANCET SOUTHEAST ASIA • April 2025

    This international, multicentre study evaluated the diagnostic performance of six low-cost point-of-care tests for detecting sickle cell disease (SCD) and β-thalassemia traits in blood samples from Nepal and Canada, using HPLC as the reference standard. Four tests (HemoTypeSC, Sickle SCAN, Gazelle, and an automated sickling test) accurately identified severe SCD forms, but only Gazelle and the automated sickling test reliably detected both sickle cell trait and β-thalassemia carrier states.

  • Real-World HbF Status in Sickle Cell Disease from an Endemic Zone

    FORTUNE JOURNALS • February 1, 2023

    This real-world observational study evaluated fetal hemoglobin (HbF) levels in 114 patients with sickle cell disease receiving hydroxyurea therapy in an endemic region of India. Point-of-care hemoglobin electrophoresis showed that most patients achieved clinically meaningful increases in HbF, frequently exceeding 20%, despite fixed-dose treatment and limited follow-up. The findings underscore the importance of accessible hemoglobin fraction measurement to support therapeutic monitoring in routine clinical practice.

  • Biosensors Journal logo

    Point-of-Care Diagnostic Test for Beta-Thalassemia

    BIOSENSORS • February 5, 2024

    In this clinical study conducted among 404 subjects in Ghatkopar, Mumbai, India, Gazelle demonstrated 100% sensitivity and specificity for identifying β-Thal major/intermedia vs. healthy subjects as well as subjects with β-Thal major/intermedia vs. β-Thal trait. Additionally, Gazelle demonstrated 100% sensitivity and 98.3% specificity for identifying β-Thal trait vs. healthy subjects.

  • Heliyon • A Cell Press Journal

    Multispectral Imaging for MicroChip Electrophoresis Enables Point-of-Care Newborn Hemoglobin Variant Screening

    HELIYON • December 6, 2022

    In this clinical study conducted among 441 subjects including 250 subjects from 0 to 3 days old, 15 subjects from 4 to 28 days old, and 176 subjects from 28 days to 6 months old in Korle Bu, Ghana, Gazelle-Multispectral demonstrated 100% sensitivity and specificity for identifying newborns with diseases vs. healthy subjects; and subjects with disease vs. subjects with sickle cell trait and Hb C trait; Additionally, Gazelle-Multispectral demonstrated 97.3% sensitivity and 96.6% specificity for identifying subjects with sickle cell trait and Hb C trait vs. healthy subjects.

  • Frontiers in Medicine Journal logo

    Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India

    FRONTIERS IN MEDICINE • December 10, 2021

    In this study, Gazelle, a new point-of-care, microchip-electrophoresis based sickle diagnostic device was compared to conventional laboratory-based hemoglobin electrophoresis and HPLC. The sensitivity and specificity of the Gazelle is comparable to hemoglobin electrophoresis and HPLC and eliminates the need for a laboratory. Gazelle yielded an overall high accuracy (99.0%) compared to reference standard tests (HPLC and hemoglobin electrophoresis).

  • Lab on a Chip logo • Royal Society of Chemistry

    Point-of-care microchip electrophoresis for integrated anemia and hemoglobin variant testing

    LAB ON A CHIP • October 21, 2021

    This article describes the first point-of-care (POC) platform to perform both anemia detection and Hb variant identification, using a single paper-based electrophoresis test.

  • Analyst Journal logo • Royal Society of Chemistry

    Paper-based microchip electrophoresis for point-of-care hemoglobin testing

    ANALYST • April 30, 2020

    HemeChip is a versatile, mass-producible microchip electrophoresis platform technology that may address unmet needs in biology and medicine, when rapid, decentralized hemoglobin or protein analysis is needed.

Clinical Presentations and Webinars

  • Oral Presentation to FSCDR 2025 on reducing wait times for transfusion patients

    Evaluation of a point-of-care device for reducing patient wait times in blood transfusions for hemoglobin disorders, presented by Grace M. Lee, MD, Duke University Medical Center.

  • Oral Presentation to FSCDR 2024 on fetal hemoglobin quantification

    Cathy Segbefia, MD, Department of Child Health, University of Ghana Medical School and Korle Bu Teaching Hospital, Accra, Ghana presented “Point-of-care diagnostic for foetal haemoglobin quantification in children undergoing hydroxyurea therapy for Sickle Cell Disease (SCD) in Ghana” at the 2024 Foundation for Sickle Cell Research conference in Ft. Lauderdale, Florida on June 9th.

  • Prevention and Early Detection of Beta Thalassemia

    Akshat Jain M.D., M.P.H. , Medical Director, International Hematologist, Oncologist & Stem Cell Transplant Specialist from Loma Linda University, shed light on methods and benefits of early beta thalassemia detection on this webinar for World Thalassemia Day, 2024

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