What is Gazelle™ Hb Variant Test?
Identifies Hemoglobin Disorders Rapidly, Easily, and Inexpensively
Over seven percent of the world’s population is at risk of inheriting hemoglobin disorders, including sickle cell disease (SCD) and beta thalassemia.
Gazelle Hb Variant is a miniaturized version of the gold standard test known as cellulose acetate electrophoresis. Administration of the test requires minimal training. Results are displayed in 8 minutes, including hemoglobin percentages by type, and can be stored within the device or printed.
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An in-depth dive into the Gazelle™ Hb Variant Test
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Beta thalassemia and sickle cell disease (SCD) has a burden on the healthcare system of many MENA countries.
The prevalence of sickle cell trait varies from: 1.02%-45.8%1
One of the major risk factors is consanguinity.
Despite the premarital screening and genetic counselling program in place in most MENA countries, the incident of high-risk couples cannot be effectively diminished.
1- Sickle cell disease in gulf cooperation council countries: a systematic review., Abu-Shaheen A et Al., 2022 Expert Rev Hematol
Gazelle delivers rapid laboratory-quality results to facilitate early detection
Gazelle reliably identifies and quantifies Hb A (normal), Hb S (sickle), Hb F (fetal) and Hb A2/C/E. The device offers interpretative statements for beta thalassemia disease (intermedia and major) and trait (beta-thalassemia minor) as sickle cell disease and trait.
Gazelle showed high accuracy (sensitivity and specificity) in detecting Beta thalassemia Trait and Disease and Sickle Cell Trait and Disease when compared with HPLC.
Accuracy of Gazelle’s Hb Variant test when compared with HPLC¹
* Disease: HbSS, HbSC, β-Thalassemia major/intermedia
** Trait: HbAS, HbAC, HbA/ β-Thalassemia
*** Normal: HbAA
¹ Data on file: GZL-S10-RPT-0027 r7 Gazelle Hb Variant Performance
Characteristics Summary
Early diagnosis of sickle cell disease is essential so that children can be started on affordable, life-saving treatments. At birth, babies have only a small concentration of the abnormal hemoglobin (S) that causes sickle cell disease.
The Gazelle Hb Variant point-of-care test can detect very low levels of hemoglobin S, enabling babies born as early as 37 weeks to be tested for sickle cell disease.
Hb S LoD: 4%
Gazelle’s fetal hemoglobin accuracy can be useful for clinicians who are monitoring hydroxyurea therapy for sickle cell disease patients. Gazelle results are with 95% confidence, on average, within 3.3% of HPLC Hb F quantification results. The average error for the 48 samples included in this report was 2.6%, with a standard deviation of 2.2%.
The Hb F quantification data ranges from 3% to 43%, with a Pearson correlation coefficient of 95%*
*Source: GZL-S10-RPT-0027 r9 Gazelle Hb Variant Performance Characteristics Summary (Data from Korle Bu Teaching Hospital, Accra, Ghana; Study to be published later in 2023)
