Abstract: Objective We investigated the current status of immunohematology laboratory tests for hemolytic disease of the fetus and newborn（HDFN）in China, and provided the basis for the establishment of performance specifications, test standards and expert consensus to improve the ability of laboratory tests for HDFN. Methods We compiled “the questionnaire of laboratory tests for hemolytic disease of the fetus and newborn”and distributed to the domestic medical facilities. The contents of the investigation included prenatal and postpartum immunohematologic tests, methods and laboratory quality control. We collected the survey data for statistical analysis. Results Fifty-seven questionnaires were collected, and the results were as follows: The timing of prernatal immunohematologic tests were performed at different times in pregnancy, mainly at 10 to 20 weeks (38.6%); prenatal immunohematologic tests mainly included ABO and RhD blood group type (95.7%), pregnant woman's husband ABO and RhD blood group type (63.8%), irregular antibody screening (93.6%), antibody identification (83%) and antibody titers [anti-A/B antibody (83%), irregular antibody (53.2%)] and cell-free fetal DNA (cffDNA) (0%); reagents for destroying IgM antibodies were 0.1mol/L 2-mercaptoethanol (82.6%) and 0.01mol/L 2-fimbritol (23.9%); postpartum immunohematologic tests mainly included neonatal ABO and RhD blood group type (100%), direct antiglobulin test (98.1%), serum free antibody test (94.2%), red blood cell (RBC) antibody elution methods (96.2%); RBC antibody elution methods were heat elution (40%) and acid elution method (54%) ; the facilities that carried out laboratory quality control: 42.3% internal quality assessment, 50% external quality assessment, 98.1% standard operating procedures; reference standards for serum antibody (0%). Conclusion There is an urgent need to establish HDFN laboratory standard operating procedures, standardization methods, reference range and quality control monitoring, and develop expert consensus.

Key words: Hemolytic disease of the fetus and newborn, Immunohematology, Laboratory test