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

COVID-19 ; Humans ; Inflammation/genetics* ; Lung ; Pneumonia ; SARS-CoV-2 ; Serologic Tests

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

two exchange transfusions received 6 days after she was born. Her blood type was B, RhD+, and findings from antibody screening and identification tests showed strong reactivity (3+ to 4+) in all panel cells except in her autologous cells. Based on these results, we concluded that she had an alloantibody to a high-prevalence antigen. Anti-PP₁P(k) alloantibody with p phenotype was identified by additional serological tests in a foreign reference laboratory. To confirm the patient's p phenotype, polymerase chain reaction and sequencing of the A4GALT gene were performed on her blood sample. She was homozygous for c.301delG in the A4GALT gene, which finally confirmed that she had the anti-PP₁P(k) antibody with p phenotype. Fortunately, her anemia caused due to iron deficiency could be treated with iron supplementation without the need for any transfusion. However, it remains extremely difficult to find compatible red blood cells in such settings in Korea. Moreover, there has been very little research on the prevalence of the p phenotype in the Korean population. Therefore, additional research is needed on rare blood group antibodies and high-prevalence antigens, including anti-PP₁P(k) cases.]]>
Anemia ; Antibodies ; Blood Transfusion ; Erythrocytes ; Female ; Humans ; Intellectual Disability ; Iron ; Isoantibodies ; Korea ; Mass Screening ; P Blood-Group System ; Phenotype ; Polymerase Chain Reaction ; Prevalence ; Rehabilitation ; Serologic Tests ; Young Adult

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions. Although viral reactivation is associated with DRESS syndrome, its role in TEN remains unclear. An 80-year-old woman visited our hospital because of fever and skin eruption. DRESS syndrome was diagnosed and was thought to caused by the use of the drug allopurinol. She was treated by discontinuation of the drug and administration of systemic steroids. She recovered from DRESS syndrome and was discharged from the hospital with tapering doses of steroids prescribed. One week after discharge, she visited our hospital again as the skin rash recurred and oral pain as well as oral and ocular mucosal lesions developed. In addition to the skin rash, blisters and Nikolsky's sign that were different from the skin lesions present in the previous DRESS syndrome were observed. Unlike those in DRESS syndrome, the viral serological test results were positive for anti-cytomegalovirus (CMV) IgM and CMV polymerase chain reaction. Therefore, it was thought that TEN was due to reactivation of CMV and she was treated this with ganciclovir and intravenous immunoglobulin. Here, we report a case of TEN caused by viral reactivation after DRESS syndrome developed after use of allopurinol which recovered after steroid treatment.
Aged, 80 and over ; Allopurinol ; Blister ; Cytomegalovirus Infections ; Cytomegalovirus ; Drug Hypersensitivity Syndrome ; Eosinophilia ; Exanthema ; Female ; Fever ; Ganciclovir ; Humans ; Immunoglobulin M ; Immunoglobulins ; Polymerase Chain Reaction ; Serologic Tests ; Skin ; Steroids ; Stevens-Johnson Syndrome

OBJECTIVE: To Establish the shielding threshold value of TP antibody ELISA for unpaid blood donors, so as to shield true positive blood donors from returning to team management. METHODS: The real serological status of 517 samples with anti-TP ELISA reactivity was determined by confirmation test of Treponema pallidum particle agglutination (TPPA). The shielding threshold of TP antibody was preliminarily determined by using 99% specificity of ROC and 95% positive predictive value of percentile method, respectively. 283 TP antibody reactivity specimens routinely tested in our laboratory were selected to determine the applicability of the initial shielding values obtained by the two methods, and finally to determine the shielding threshold values of TP antibody donors. RESULTS: The specific S/CO values of reagent A 99% were 13.33-16.18, that of reagent B 99% was 6.34, that of reagent B 99% was 13.17-19.85, and that of 95% was 6.62. Empirical evidence: 99% specific threshold shielding true positive rates of reagents A and B were 100%, 95% positive expected value shielding true positive rates were 98.4%, 99%. Final determination of 99% specific shielding threshold as a low value of blood donors shielding threshold. The shielding limits of reagent A and B were 13.33 and 13.17. CONCLUSION The shielding threshold of TP antibody ELISA for blood donors established in this study can help to reduce the number of blood donors returning to team management.
Blood Donors ; Enzyme-Linked Immunosorbent Assay ; Humans ; Syphilis ; Syphilis Serodiagnosis ; Treponema pallidum

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

OBJECTIVE: To investigate the methods for verifying and comparing performance of HIV testing methods and procedure analysis in blood station laboratories so as to meet the requirements of ISO15189 accreditation. METHODS: The performance of HIV test was verified by the automatic ELISA analyzer, the intra- and inter-assay precision was analyzed and evaluated by intra- and inter-assay repeat tests, the compliance rate was verified by the test results of the standard serum plate and the external quality assessment from the Ministry of Health in the past 2 years, the limit of detection was verified through continuous dilution of a known amount of reference serum for internal quality control, the status of the instrument was evaluated by testing one HIV-negative specimen, one HIV-negative with other positive markers, one strong HIV-positive specimen and two weak HIV-positive specimens. RESULTS: The intra- and inter-assay precisions were 5.12% and 16.81% respectively, the compliance rate of the serum plate test was 100%, the compliance of the external quality assessment results was 100%, the limits of detection for HIV was 1.42 NCU/ml, and the consistency of the detection systems was 100%. CONCLUSION The analytical performance of the HIV test methods and procedures accords with the requirements of the reagent instructions, the comparison of the test systems meets the verification requirements.
Enzyme-Linked Immunosorbent Assay ; HIV ; Mass Screening ; Quality Control ; Serologic Tests

RHD genotyping is a useful adjunct to serologic testing. Although the use of RHD genotyping in the detection of Asia type DEL in serological D negative Koreans is gradually increasing, it is rarely requested for patients with a known weak D phenotype. This paper reports the first Korean case of a 52-year-old female patient with serologic weak D phenotype and weak D type 33 (c.520G>A at exon 4 of RHD) identified by RHD exon 1 to 10 sequencing. In silico analysis predicted that the RHD c.520G>A (V174M) results in a serologic weak D phenotype.
Asia ; Computer Simulation ; Exons ; Female ; Humans ; Korea ; Middle Aged ; Phenotype ; Serologic Tests