Evaluation of a fully automated high-throughput serology assay for detection of Hepatitis D virus antibodies.

BACKGROUND: HDV antibody testing is recommended for universal screening and as the first line in an HDV double reflex testing strategy for effectively identifying patients with active infection for therapeutic treatments. OBJECTIVE: The aim of this study is to evaluate the performance of a newly developed ARCHITECT HDV Total Ig (ARCHITECT HDV Ig) prototype assay. STUDY DESIGN: Performance characteristics were determined for the ARCHITECT HDV Ig and a reference test, LIAISON XL Anti-HDV using a well-characterized specimen panel, comprising HDV RNA positive (n = 62) and negative (n = 70) samples, and healthy US blood donors. RESULTS: Healthy US blood donors (n=200) showed 99.5% (199/200, 95%CI=97.65-99.98) specificity with ARCHITECT HDV Ig and 98.5 % (197/200, 95 %CI = 96.10-99.64) with LIAISON Anti-HDV. Among known HDV RNA positive samples, ARCHITECT HDV Ig detected 59/62 demonstrating 95.2 % sensitivity while LIAISON Anti-HDV sensitivity was 90.3 % (56/62). Among 101 HBV positive samples, 70 were reactive in the ARCHITECT test, 59 of which tested positive for HDV RNA for a positive predictive value (PPV) for the presence of HDV RNA was 84.3 %. For LIAISON Anti-HDV, 79 specimens were reactive and 56 contained HDV RNA: PPV for HDV RNA was 70.9 %. Among 70 HDV RNA negative samples, 39 were HBV positive. ARCHITECT HDV Ig negative predictive value (NPV) was 71.8 % and LIAISON Anti-HDV NPV was 41 % for the HBV positive group, respectively. CONCLUSION: When compared to the LIASON Anti-HDV test, the ARCHITECT HDV Ig assay demonstrated enhanced sensitivity and specificity and better NPV and PPV values for HDV RNA status. The ARCHITECT HDV Ig assay represents a promising tool for universal screening of all HBsAg-positive persons.

Iron deficiency in whole blood donors in a resource-poor setting: A cross-sectional study in Uganda.

BACKGROUND AND OBJECTIVE: Blood donation is known to result in iron deficiency (ID), with a higher prevalence in females. There is little published data on the frequency of ID among blood donors in resource-poor settings. We determined the prevalence of ID in blood donors in Uganda. METHODS: We conducted a descriptive cross-sectional study at the Uganda Blood Transfusion Service, Kampala from December 2021 to February 2022. A sample of 500 whole blood donors was enrolled. The evaluation included demographic characteristics, donation history, nutritional history, complete blood count, and serum ferritin. The primary outcome was the proportion of donors with serum ferritin <15 µg/L. RESULTS: The median (IQR) serum ferritin was 25 (12-47) µg/L and 89 (52-133) µg/L among female and male donors respectively. The prevalence of iron deficiency (serum ferritin <15 µg/L) among donating individuals was 11.5% (8.7-14.9), while among low haemoglobin deferrals, 61.5% (50.9-71.1). The prevalence was high among females [33.0% (27.9-38.6)] compared with males [2.5% (1.0-5.8)], but even higher among females younger than 24 years [35.4% (29.2-42.1)]. Factors associated with ID (adjusted odds ratio, 95% Cl, and significance) were; female donors (15.81, 5.17, 48.28, p < 0.001) and a high RDW (6.89, 2.99, 15.90, p < 0.001). We found a moderate correlation between serum ferritin and RDW (r = -0.419 and -0.487 for males and females respectively). CONCLUSION: Iron deficiency is common among blood donors in Uganda, affecting mostly young female donors. Considerations to adopt evidence-based strategies to prevent and manage ID among blood donors-such as serum ferritin monitoring and iron supplementation are highly recommended.