In-field Evaluation of SD Bioline HBsAg Whole Blood Rapid Test in Pregnant Women in Cambodia: the ANRS 12345 TA PROHM Study

The objective is to assess the in -field performance of HBsAg whole blood rapid diagnosis test (RDT) as com-pared to plasmatic HBsAg RDT to diagnose HBV infection among pregnant women in Cambodia. Blood was collected on EDTA tubes from pregnant woman screened for the TA PROHM -ANRS 12345 study. Whole blood HBsAg RDT results were crossed compared with the plasmatic HBsAg RDT results, which was defined for this study as the gold standard. From December 2018 to May 2019, 4997 pregnant women were screened. The median age was 27.2 years old, 14% were screened in Phnom Penh and 86% in Siem Reap. Whole blood HBsAg RDT perform excellently with a sensitivity of 100% (95% CI, 98.7 - 100) and specificity of 100% (95% CI, 99.9 - 100). Whole blood HBs Ag RDT is as accurate as plasmatic one and could be used in remote areas. (c) 2021 Elsevier Inc. All rights reserved.