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WHO Adds Hepatitis E to Essential Dx List

NEW YORK – The World Health Organization on Thursday announced that it has published a fourth edition of its essential diagnostics list (EDL) adding tests for the hepatitis E virus and recommendations related to access to personal-use glucose monitoring devices.

The list, which is updated every two years, is meant to provide evidence-based guidance for countries as they develop national policies on in vitro diagnostic testing and work to improve access to testing and laboratory services. Agencies of the United Nations and non-governmental organizations also use the list in support of efforts to procure and provide IVDs to address global health issues, the WHO said.

"The WHO essential diagnostics list is a critical tool that gives countries evidence-based recommendations to guide local decisions to ensure the most important and reliable diagnostics are available to health workers and patients," WHO Director-General Tedros Adhanom Ghebreyesus said in a statement.

The organization also called on member states to consider establishing diagnostics strategies as part of their national health plans and consider developing their own essential diagnostics lists based on the WHO model list. The WHO published its third edition of the list in 2021, when it added to the list tests for COVID-19 along with other infectious and non-communicable diseases.

The WHO Strategic Advisory Group of Experts on in vitro diagnostics (SAGE IVD), which oversees publication of the EDL, recommended the addition of eight diagnostics to the 2023 edition.

The WHO added a nucleic acid test and two immunoassays to aid the diagnosis of hepatitis E infection. One of the immunoassays is used in community and healthcare facilities without laboratories and the other two assays are intended for use in facilities with clinical labs. It also added to the list glucose meters for use in community and healthcare settings without labs.

The organization also added to the list a point-of-care ABO blood group and Rhesus factor dry-format card test, a Kleihauer-betke acid-elution test to estimate fetomaternal hemorrhage, a high-sensitivity troponin I immunoassay to aid diagnosis of heart attack, a 17-hydroxyprogesterone immunoassay to aid diagnosis or monitoring of congenital adrenal hyperplasia, and a parathyroid hormone immunoassay to aid evaluation and monitoring of calcium homeostasis disorders.

About 4 percent of hepatitis E infections lead to acute liver failure, and the risk of serious complications is far higher in pregnant women, according to the WHO. According to the organizations, 1 percent to 2 percent of infections result in death, while recent study results indicate the case fatality rate jumps to 26 percent among women who become infected while pregnant, 33 percent for fetuses, and 8 percent for neonates. The virus is common in low-income countries.