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Newborn Screening for Sickle Cell Disease Using Point-of-Care Testing in Low-Income Setting
Ofelia A Alvarez1,2, Tally Hustace3,2, Mimose Voltaire2
1Division of Pediatric Hematology, Department of Pediatrics, and oalvarez2@med.miami.edu.
Insights
Newborn screening for sickle cell disease (SCD) in Haiti using Sickle SCAN is reliable. This point-of-care test improves early diagnosis and healthcare access for affected infants.
Area of Science:
- Medical Diagnostics
- Public Health
- Pediatrics
Background:
- Newborn screening (NBS) is crucial for early diagnosis of sickle cell disease (SCD), significantly reducing mortality.
- Haiti faces challenges in SCD diagnosis and management, necessitating accessible screening tools.
Purpose of the Study:
- To evaluate the reliability of the point-of-care (POC) Sickle SCAN test for newborn screening of SCD in Haiti.
- To assess the impact of POC Sickle SCAN on healthcare access for infants diagnosed with SCD.
Main Methods:
- Dried blood spots from 360 infants were analyzed using isoelectric focusing (IEF) and POC Sickle SCAN.
- High-performance liquid chromatography (HPLC) served as the gold standard for quality assurance and comparison.
- Specificity and sensitivity of POC Sickle SCAN were calculated against HPLC results.
Main Results:
- The incidence of SCD among screened newborns was 0.83%.
- POC Sickle SCAN demonstrated high specificity (0.97) and sensitivity (0.90) for SCD detection.
- Implementation of POC Sickle SCAN improved confirmatory testing rates and expedited crucial early interventions, including penicillin prophylaxis and vaccinations.
Conclusions:
- POC Sickle SCAN is a reliable and effective tool for newborn screening of SCD in Haiti.
- The test facilitates earlier diagnosis and treatment, leading to improved health outcomes for infants with SCD.
- Point-of-care testing significantly shortens the time to healthcare access for newborns identified with SCD.
Background:
Newborn screening provides early diagnosis for children with sickle cell disease (SCD), reducing disease-related mortality. We hypothesized that rapid point-of-care (POC) Sickle SCAN would be reliable in Haiti and would assist newborn screening.
Methods:
Dried blood specimens were obtained from infant heel sticks and analyzed by isoelectric focusing (IEF) at a public hospital in Cap-Haïtien during a 1-year period. A total of 360 Guthrie cards were also analyzed for quality assurance by high-performance liquid chromatography at the Florida Newborn Screening Laboratory. In addition, two-thirds of the infants were also screened by the POC to assess differences with the IEF. The hemoglobinopathy incidence and the specificity and sensitivity of the POC scan were assessed.
Results:
Overall, 1.48% of the children screened positive for SCD. The specificity and the sensitivity of POC Sickle SCAN were 0.97 (confidence interval 0.95-0.99) and 0.90 (confidence interval 0.55-1.00), respectively, relative to high-performance liquid chromatography gold standard. The confirmatory testing rate was 75% before POC and improved to 87% after POC was added for dual screening. Confirmatory testing revealed that 0.83% of children screened had SCD. Children who screened positive for SCD by POC started penicillin earlier, had their first pediatric follow-up a median of 38 days earlier, and received antipneumococcal vaccination on time when compared with those who screened positive for SCD by IEF alone.
Conclusions:
The observational study revealed a high incidence of SCD among Haitian newborns. Sickle SCAN had excellent specificity and sensitivity to detect SCD during newborn screening and shortened health care access for children positive for SCD.
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