<p>Sickle cell disease is a genetically inherited structural variation of hemoglobin most commonly encountered among people of African, Arabian and Indian origin. In this study, we aimed to evaluate the diagnostic accuracy of two point of care testing kits for Hemoglobin Sin laboratory settings. We conducted a prospective study among participants older than two years of age, excluding those who received blood transfusion in the last 3 months, recruited at a tertiary care hospital located in Maharashtra, India. The candidate test for the study were lateral flow immunoassay sickle SCAN™, and paper-based microchip electrophoresis device Gazelle™ (candidate tests) for screening hemoglobin S, while high performance liquid chromatography (HPLC) was the reference standard test. A consecutive sample of 470 patients were tested for both the candidate tests as well as HPLC. All positive tests on HPLC were also tested with sickling test before reporting as positive for hemoglobin S. We used HPLC followed by sickling test for diagnosis of hemoglobin SS and AS for the study. All positive as well as 10% of the negative results were randomly cross verified by an independent expert. The study participants consisted of 139 (29.5%) males and 331 females participants. The results were categorised as Hb SS (44) for homozygous sickle cell disease, Hb AS (64) for heterozygous sickle cell trait and non-S Hb (362) for any other hemoglobin phenotype detected (normal or any variant other than Hb S). Both the candidate tests were 100% sensitive for detecting Hb SS. The sensitivity for detecting Hb AS by Sickle Scan™ and Gazelle™ was 96.8% (89.1–99.6) and 98.4% (91.4–99.6) respectively. Both the candidate tests had high diagnostic accuracy for detecting Hb SS and Hb AS phenotypes. The intended used for the candidate tests is screening of Hb S among target population at point of care.</p>

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

  • Neha Singh,
  • Richa Juneja,
  • Shashi Kant,
  • Tulika Seth,
  • Ravneet Kaur,
  • Sanjay K. Rai,
  • Rasika Gadkari

摘要

Sickle cell disease is a genetically inherited structural variation of hemoglobin most commonly encountered among people of African, Arabian and Indian origin. In this study, we aimed to evaluate the diagnostic accuracy of two point of care testing kits for Hemoglobin Sin laboratory settings. We conducted a prospective study among participants older than two years of age, excluding those who received blood transfusion in the last 3 months, recruited at a tertiary care hospital located in Maharashtra, India. The candidate test for the study were lateral flow immunoassay sickle SCAN™, and paper-based microchip electrophoresis device Gazelle™ (candidate tests) for screening hemoglobin S, while high performance liquid chromatography (HPLC) was the reference standard test. A consecutive sample of 470 patients were tested for both the candidate tests as well as HPLC. All positive tests on HPLC were also tested with sickling test before reporting as positive for hemoglobin S. We used HPLC followed by sickling test for diagnosis of hemoglobin SS and AS for the study. All positive as well as 10% of the negative results were randomly cross verified by an independent expert. The study participants consisted of 139 (29.5%) males and 331 females participants. The results were categorised as Hb SS (44) for homozygous sickle cell disease, Hb AS (64) for heterozygous sickle cell trait and non-S Hb (362) for any other hemoglobin phenotype detected (normal or any variant other than Hb S). Both the candidate tests were 100% sensitive for detecting Hb SS. The sensitivity for detecting Hb AS by Sickle Scan™ and Gazelle™ was 96.8% (89.1–99.6) and 98.4% (91.4–99.6) respectively. Both the candidate tests had high diagnostic accuracy for detecting Hb SS and Hb AS phenotypes. The intended used for the candidate tests is screening of Hb S among target population at point of care.