OBJECTIVE: To analyze the clinical features and laboratory characteristics of patients with cold agglutinin disease (CAD)/cold agglutinin syndrome (CAS) who were positive for acidified-serum lysis test (Ham test), and to compare them with Ham test negative CAD/CAS patients and paroxysmal nocturnal hemoglobinuria (PNH) patients, in order to provide references for the differential diagnosis of these diseases. METHODS: 53 patients diagnosed with CAD/CAS and 67 patients diagnosed with classic PNH in our hospital from January 2015 to December 2020 were retrospectively analyzed. The patients were grouped according to clinical diagnosis and results of cold agglutinin test (CAT), direct antiglobulin test (DAT), Ham test and PNH clone detection. The clinical and laboratory characteristics of each group were compared. RESULTS: The patients were grouped as follows: Ham^- CAD/CAS group, CAD/CAS patients negative for Ham test (n=36); Ham⁺ CAD/CAS group, CAD/CAS patients positive for Ham test (n=17); classic PNH group (n=67). Compared with the classic PNH group, the Ham⁺ CAD/CAS group had a higher median age (P =0.024), weaker positivity of Ham test, higher positive rates of CAT and DAT, and lower positive rate of PNH clone detection (all P <0.001). The proportions of patients with splenomegaly and cyanosis in Ham⁺ CAD/CAS group were significantly higher than those in classic PNH group (P =0.002 and P <0.001). Ham⁺ CAD/CAS group displayed lower red blood cell count (RBC) and lactate dehydrogenase (LDH) level (P =0.007 and P <0.001), and higher mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and indirect bilirubin (IBIL) level (P =0.003, P =0.004 and P =0.006) than those in classic PNH group. The levels of serum complement C3 and C4 in Ham⁺ CAD/CAS group were lower than those in classic PNH group (P =0.001 and P <0.001). The positive rate of urinary occult blood in Ham⁺ CAD/CAS group was lower than that in classic PNH group (P =0.010). The clinical and laboratory characteristics of Ham⁺ CAD/CAS group were similar to those of Ham^- CAD/CAS group, except for median age, hemoglobin (Hb), MCHC, mean corpuscular volume (MCV), reticulocyte ratio (Ret), Ham test results, DAT positive types, and proportion of splenomegaly. CONCLUSION Some clinical features and laboratory indicators of CAD/CAS patients with positive results of Ham test are different from those of classic PNH patients, but relatively similar to those of CAD/CAS patients with negative results of Ham test. These results may provide a reference for differential diagnosis of related diseases.
Humans ; Anemia, Hemolytic, Autoimmune/blood* ; Retrospective Studies ; Hemoglobinuria, Paroxysmal/diagnosis* ; Female ; Male ; Coombs Test ; Diagnosis, Differential ; Middle Aged ; Adult

OBJECTIVE: To investigate the clinical features and laboratory characteristics of primary autoimmune hemolytic anemia (AIHA) patients with negative results of direct antiglobulin test (DAT) by tube test but positive results by microcolumn gel assay, in order to provide references for the diagnosis of these patients. METHODS: 59 patients diagnosed with primary AIHA in our hospital from January 2015 to December 2020 were retrospectively analyzed. According to the results of tube test and microcolumn gel assay, the cases were divided into 3 groups, and the clinical and laboratory characteristics of each group were compared. RESULTS: The cases were grouped as follows: Group I, cases with negative results by both methods of DAT (n=5); Group II, cases with negative results by tube test but positive results by microcolumn gel assay (n=26); Group III, cases with positive results by both methods of DAT (n=28). There was no significant difference in age and sex between Group II and other groups, whereas the positive rate of anti-IgG + anti-C3d of Group II was lower than that in Group III (P=0.015). The main clinical manifestations of Group II were chest tightness, shortness of breath, fatigue, as well as yellow skin and sclera or dark urine, but the incidence rate of these symptoms was not significantly different from other groups. Anemia related indexes in Group II such as red blood cell (RBC) count and hemoglobin (Hb) were lower than the reference intervals, but there was no significant difference compared with other groups. Hemolysis related indexes in Group II such as reticulocyte (Ret) ratio, indirect bilirubin (IBIL), lactate dehydrogenase (LDH) and free-hemoglobin (F-Hb) were higher than the reference intervals, and the latter two items were signficantly higher than those in Group I (P=0.031 and P=0.036). Serum complement C3 and C4 in Group II were higher than those in Group III (P=0.010 and P=0.037). CONCLUSION Anemia severity of primary AIHA patients who were negative of DAT by tube test but positive by microcolumn gel assay was similar to those with negative or positive results by both DAT methods, but the mechanism and degree of complement system involved in hemolysis might be different. Results above may be helpful for laboratory diagnosis of this kind of patients.
Anemia, Hemolytic, Autoimmune/diagnosis* ; Bilirubin ; Complement C3 ; Coombs Test/methods* ; Erythrocytes ; Hemolysis ; Humans ; Lactate Dehydrogenases ; Negative Results ; Retrospective Studies

OBJECTIVE: To study the serological detection characteristics and antibody specific distribution of hemolytic disease of the newborn (HDN) caused by irregular antibodies through retrospective case analysis. METHODS: A total of 3 047 suspected cases of HDN were submitted by the Neonatal Department of our hospital from January 2014 to December 2019. Non ABO-HDN cases confirmed in our laboratory were taken as the research objects, while some cases of ABO-HDN were randomly selected as control. Disease-causing antibody specificity, serological detection characteristics, total bilirubin change trend and gender ratio of non ABO-HDN patients were explored. RESULTS: Sixty-seven cases of non ABO-HDN were confirmed from the suspected cases of HDN, Among which 45 males and 22 females were detected with the positive rate 1.48% and 0.72%, respectively. The mothers of 65 cases had two or more pregnancies. The detected irregular antibodies were mainly involved with Rh system, MNS system, Kidd system and Lewis system, among which Rh system accounted for 88.07% of the total antibody detection rate. Compared with that of ABO-HDN patients, the total bilirubin of non ABO-HDN patients developed more rapidly with a higher peak and a longer duration (P<0.001). In terms of serological detection, the positive rate of non ABO-HDN direct antibody test was 97.01%, which was higher than 47.00% of ABO-HDN (P<0.001), and the agglutination strength was often ≥ 2+, but there were still weak positive or negative cases of direct antibody test. CONCLUSION Non ABO-HDN caused by irregular antibodies mostly occurs in fetuses whose mothers experience multiple pregnancies, and the number of males is more than females. The irregular antibodies detected are mainly attributed to Rh system. The peak value of bilirubin in non ABO-HDN patients is higher and lasts longer than that in ABO-HDN patients. Direct antiglobulin test may be used to roughly distinguish ABO-HDN from non ABO-HDN.
ABO Blood-Group System ; Blood Group Incompatibility ; Coombs Test ; Erythroblastosis, Fetal ; Female ; Humans ; Infant, Newborn ; Male ; Pregnancy ; Retrospective Studies

OBJECTIVE: To explore the relationship between the serological detection of neonatal hemolytic disease (HDN) and related factors, and to observe the detection rate and specificity of the antibodies against the blood group in the newborn hemolytic disease. METHODS: Maternal-neonatal blood type was detected firstly, and then the direct antiglobulin test(DAT), the free antibody test and the antibody release test were used to detect the occurrence of HDN; For those suspected hemolytic disease except ABO or direct DAT result over 2+, the indirect antiglobulin test with irregular antibody were used for screening cells and the plasma of the patient and mother, and then to detezmine whether there is a corresponding antigen in the red blood cells of the patient to confirm whether hemolytic disease of the other blood type system exists or not. The analysis was carried out by SPSS 22 software. The statistical analysis of classified data was tested by χ test. P<0.05 was considered as statistically significance. RESULTS: A total of 501 cases of hyperbilirubinemia were collected. Among them 250 cases of HDN were diagnosed as HDN, and the detection rate was 49.90%.The detection rate of the male was 45.14%, and that of the female was 56.34%(χ =6.143, P<0.05). The average day-age of patients was 3.97±2.81 days. The analysis of relatianship between the detected rate of HDN and the day-age of HDN chilren showed that the day-age of HDN chilren affected the detected rate of HDN(χ =63.489, P<0.05). The analysis of positive rate of 3 test in HDN childen of every group found that the day-age had an infuence on the detected rate of direct antiglobulin test(χ=18.976，P<0.01) and also had an influence on the detected rate of the free antibody test(χ=9.650，P<0.05). The positive rate of the release test in HDN patients was highest（100%）. 244 cases suffered from ABO hemolysis, including 1 case of ABO hemolysis combined with Rh system (anti -E) hemolysis, 4 cases of Rh system (anti -D), 2 cases of MN system (1 case was caused by anti -M, 1 case was caused by low frequency anti -Mur). ABO HDN caused by anti-A or anti-B were not statisticaly significant. CONCLUSION Hemolytic disease of the newborn is a common cause of neonatal hyperbilirubinemia. The positive rate of HDN has a certain relations with the sexual distinction and the day-age. But there is no significant difference between anti-A and anti-B type. At the same time, screening and identification of irregular antibodies should be carried out to avoid diagnostic errors caused by undetected antibody when necessary.
ABO Blood-Group System ; Coombs Test ; Female ; Hematologic Diseases ; diagnosis ; Hemolysis ; Humans ; Infant, Newborn ; Male ; Neonatal Screening

Transfusion-related acute lung injury (TRALI) is defined as a new episode of acute lung injury that occurs during or within 6 hours of a completed transfusion, which is one of the leading causes of transfusion-related morbidity and mortality. We present a case of TRALI in a 29-year-old parturient with myelodysplastic syndrome scheduled for cesarean section. The parturient developed hypoxemia and dyspnea after preoperative transfusion of platelets following apheresis to eliminate a unit of leucocyte in order to correct thrombocytopenia. She underwent emergent caesarean section for fetal distress. After surgery, the chest radiograph showed diffuse haziness of both lung fields. Direct and indirect antiglobulin tests were negative, and hemolytic transfusion reaction was ruled out. Pro-BNP 347.3 pg/ml also excluded transfusion-associated circulatory overload. The parturient completely recovered after oxygen support for 2 days. It is important to recognize TRALI as soon as possible to minimize perioperative morbidity and mortality.
Acute Lung Injury* ; Adult ; Anoxia ; Blood Component Removal ; Cesarean Section ; Coombs Test ; Dyspnea ; Female ; Fetal Distress ; Humans ; Lung ; Mortality ; Myelodysplastic Syndromes* ; Oxygen ; Pregnancy ; Radiography, Thoracic ; Thrombocytopenia ; Transfusion Reaction

Herein, we report the results of the 2018 survey on the external quality assessment (EQA) scheme for the Transfusion Medicine Program (TMP) in Korea. The proficiency testing specimens were prepared at Ajou University Hospital and were sent to the participants biannually. The average accuracy rates for ten different test items on the regular survey were as follows: ABO typing, 99.5%–99.8% (N=841); RhD typing, 99.8%–100.0% (N=827); crossmatching, 89.4%–99.6% (N=708); ABO subtyping, 94.2% and 94.4% (N=53); Rh CcEe antigen testing, all 100.0% (N=51); weak D test, 80.9% (N=207) for the first trial and not graded for the second trial; antibody screening, 99.7%–100.0% (N=304); direct antiglobulin test (DAT) using a polyspecific reagent, 98.9%–100.0% (N=264); DAT using an immunoglobulin-G monospecific reagent, all 100.0% (N=66); DAT using a C3d monospecific reagent, 97.0%–100.0% (N=67); antibody identification, 98.4%–100.0% (N=127); and ABO antibody titration, 84.6%–100.0% (N=73). There were approximately 10.5% more participants in the 2018 EQA scheme than that in 2017. Excellent survey results were obtained in the 2018 EQA scheme compared with those in 2017, except for the weak D test. The 2018 EQA scheme for the TMP should be helpful for improving the quality of the participating laboratories.
Coombs Test ; Korea ; Laboratory Proficiency Testing ; Mass Screening ; Quality Improvement ; Thymidine Monophosphate ; Transfusion Medicine

Here, we have reported results of the surveys on the external quality assessment scheme (EQA) of the Transfusion Medicine Program (TMP) in Korea that were carried out in 2017. The proficiency testing specimens were prepared at Ajou University Hospital, and sent to the participants biannually. The average accuracy rates (N=the number of participants) for ten different test items on the regular survey were as follows: ABO typing, 99.1%–99.9% (N=714); RhD typing, 99.3%–100.0% (N=695); crossmatching, 88.9%–98.5% (N=618); ABO subtyping, 80.7% and 96.0% (N=51); Rh CcEe antigen testing, 98.8%–100.0% (N=51); weak D test, 99.3% and 100.0 (N=150); antibody screening, 98.6%–100.0% (N=295); direct antiglobulin test (DAT) using a poly-specific reagent, 99.2%–100.0 (N=256); DAT using an immunoglobulin-G monospecific reagent, all 100.0% (N=68); DAT using a C3d-monospecific reagent, 83.6%–100.0% (N=72); antibody identification, 88.7%–99.2% (N=123); and ABO Ab titration, 84.6%–100.0% (N=73). The number of participants for the EQA for TMP in 2017 was much higher than that in 2016. Except for the case of ABO subtyping, excellent survey results for the 2017 EQA for TMP were obtained, compared to those in 2016. Thus, the EQA for TMP in 2017 should be helpful for improving the quality of the participating laboratories.
Coombs Test ; Korea* ; Laboratory Proficiency Testing ; Mass Screening ; Quality Improvement ; Thymidine Monophosphate ; Transfusion Medicine*

Leptospirosis is a febrile zoonotic disease. Routine diagnosis of leptospirosis is based on the detection of specific antibodies with serological tests. The aim of our study was to determine the usefulness of immunochromatographic assay (ICA), ImmuneMed Leptospira IgM Duo Rapid test kit from Korea, in rapid screening of acute leptospirosis in emergency cases with limited expertise. A total of 197 serum samples (93 positive, 104 negative) were selected randomly. The test has good diagnostic sensitivity 73% and specificity 90%. With positive predictive value of 87% and negative predictive value of 79%, this reassures patients have higher chance of correct diagnosis. This ICA is acceptable for screening of leptospirosis but confirmation with microscopic agglutination test should follow.
Agglutination Tests ; Antibodies* ; Diagnosis ; Emergencies ; Humans* ; Immunochromatography ; Immunoglobulin M* ; Korea ; Leptospira* ; Leptospirosis ; Mass Screening ; Sensitivity and Specificity ; Serologic Tests ; Zoonoses

Malaria is one of the most important public health problems in tropical areas on the globe. Several factors are associated with susceptibility to malaria and disease severity, including innate immunity such as blood group, hemoglobinopathy, and heme oxygenase-1 (HO-1) polymorphisms. This study was carried out to investigate association among ABO blood group, thalassemia types and HO-1 polymorphisms in malaria. The malarial blood samples were collected from patients along the Thai-Myanmar border. Determination of ABO blood group, thalassemia variants, and HO-1 polymorphisms were performed using agglutination test, low pressure liquid chromatography and polymerase chain reaction, respectively. Plasmodium vivax was the major infected malaria species in the study samples. Distribution of ABO blood type in the malaria-infected samples was similar to that in healthy subjects, of which blood type O being most prevalent. Association between blood group A and decreased risk of severe malaria was significant. Six thalassemia types (30%) were detected, i.e., hemoglobin E (HbE), β-thalassemia, α-thalassemia 1, α-thalassemia 2, HbE with α-thalassemia 2, and β-thalassemia with α-thalassemia 2. Malaria infected samples without thalassemia showed significantly higher risk to severe malaria. The prevalence of HO-1 polymorphisms, S/S, S/L and L/L were 25, 62, and 13%, respectively. Further study with larger sample size is required to confirm the impact of these 3 host genetic factors in malaria patients.
Agglutination Tests ; Blood Group Antigens ; Chromatography, Liquid ; Healthy Volunteers ; Heme Oxygenase (Decyclizing) ; Heme Oxygenase-1 ; Heme ; Hemoglobin E ; Hemoglobinopathies ; Hemoglobins ; Humans ; Immunity, Innate ; Malaria ; Plasmodium vivax ; Polymerase Chain Reaction ; Prevalence ; Public Health ; Sample Size ; Thalassemia

The 2016–2017 surveys on the external quality assessment scheme for serologic tests for syphilis in Korea were conducted by the Korean Association of External Quality Assessment Service. Proficiency testing (PT) panels consisting of three pooled serum samples were shipped to 430 and 432 laboratories participating in the program in the 1st and 2nd trials of 2016 and 465 and 503 laboratories in the 1st and 2nd trials of 2017, respectively. The rates of returning results were 94.2% and 50.2% for non-treponemal and treponemal tests, respectively, in the 1st trial of 2016; 94.7% and 49.5% in the 2nd trial of 2016; 94.2% and 49.5% in the 1st trial of 2017; and 92.8% and 48.7% in the 2nd trial of 2017, respectively. The most commonly used methods for non-treponemal tests were rapid plasma reagin (RPR) card test, followed by RPR turbidoimmunoassay and venereal disease research laboratory tests. The most commonly used methods for treponemal tests were Treponema pallidum particle agglutination, followed by immunochromatographic assay, Treponema pallidum latex agglutination, chemiluminescence immunoassay, and fluorescent treponemal antibody-absorption. The accuracy rates of the 2017 PT for non-treponemal and treponemal tests were 92.5%–99.8% and 93.3%–100.0%, respectively, which were significantly lower compared to the 98.4%–100.0% and 97.0%–100.0% in 2016. A possible explanation for the lower accuracy rates in the 2017 PT survey is the matrix effect caused by pooling multiple individual serum samples. These data suggest that pooling of serum samples obtained from a small number of donors may help avoid the matrix effect affecting standard materials used for syphilis serology PT.
Agglutination ; Humans ; Immunoassay ; Immunochromatography ; Korea* ; Latex ; Luminescence ; Plasma ; Serologic Tests* ; Sexually Transmitted Diseases ; Ships ; Syphilis* ; Tissue Donors ; Treponema pallidum