Pregnancy testing with hCG – future prospects

•Accurate reliable hCG measurements are critically important for pregnancy management.•IFCC nomenclature for hCG and variants enables clear description of what is measured.•Calibrating assays against hCG IS 07/634 enables reporting of results in molar units.•WHO hCG Reference Reagents allow comparison of method specificities in molar terms.•Method agreement for hCG will be improved using antibodies of agreed specificities.

Pregnancy tests for human chorionic gonadotrophin (hCG) are used widely in hospital and home settings. Assays measuring hCG also have uses in prenatal screening and oncology. The output from three recent international workshops provides a framework for reliable measurement of hCG. Requirements for future hCG assays include use of clear descriptive nomenclature, informed selection of antibodies of well-defined epitope specificities, and design of robust methods. Tests will be precisely characterized and calibrated in SI units using six International Reference Reagents (IRR) for hCG and variants, and the Fifth International Standard for hCG 07/364, making it possible to report clinical results in molar units. These measures will help to increase patient safety by reducing the risk of erroneous or misleading hCG results.