AI Article Synopsis
- The study emphasizes the significance of minority RBC donors in meeting the transfusion needs of sickle cell disease patients and aims to validate a DNA-based screening method for sickle cell trait (SCT) instead of relying solely on a hemoglobin solubility assay.
- The researchers conducted a validation process using both the traditional solubility assay and the new DNA test (HEA-HbS), confirming initial results but also encountering some discrepancies that were resolved through gene sequencing and HPLC analysis.
- The conclusion highlights that the HEA-HbS DNA method correlates with HPLC results and presents a more efficient way to screen donors for SCT, facilitating better donor management and reducing the need for repeated testing.
Article Abstract
Background: Minority RBC donors are important to support the transfusion needs of patients with sickle cell disease. Testing of donors for sickle cell trait (SCT) is performed to avoid transfusion of hemoglobin S+ (HbS+) RBCs to specific patient groups and to investigate leukoreduction failures. A screening assay based on hemoglobin solubility is commonly used. The purpose of this study was to validate a DNA approach for HbS screening.
Methods: Hemoglobin solubility screening (Pacific Hemostasis or SICKLEDEX) and PreciseType human erythrocyte antigen (HEA)-HbS (Immucor) targeting c.20A>T in the β-globin gene were performed according to manufacturer's directions. Resolution of differences in results included gene sequencing and high-performance liquid chromatography (HPLC).
Results: Initial validation of HEA-HbS performed by testing 60 known samples, 20 HbS/A, A/A, and S/S, gave expected results. However, in the subsequent parallel testing phase, 4/58 samples HbS+ by solubility assay tested negative by HEA-HbS; the negative results were confirmed by β-globin gene sequencing. Samples from donors self-identifying as White testing HbS+ by solubility assay (n = 60) were retested by HEA-HbS and HPLC. The HEA-HbS assay was concordant with HPLC which is recognized as the gold standard for hemoglobin variation.
Conclusion: A DNA-based approach is an alternative to screen donors for SCT, found in approximately 7% of Black and 1.7% of our random donors. HEA-HbS correlated with HPLC results in all samples tested, supporting the use of HEA-HbS as the test of record. The method allows higher throughput screening and testing at the donor center allows association of the screening result with the donor record to avoid repeat testing.
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| http://dx.doi.org/10.1111/trf.16403 | DOI Listing |
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