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

Adult ; Asian People ; China/epidemiology* ; Exons ; Humans ; Male ; Negative Results ; Polymorphism, Genetic/genetics* ; Polymorphism, Single Nucleotide ; Premature Ejaculation/genetics* ; Serotonin Plasma Membrane Transport Proteins/genetics*

BACKGROUND/AIMS: To investigate the rate of detection of monosodium urate (MSU) crystals in the synovial fluid (SF) of patients with acute gouty arthritis and factors associated with false-negative results. METHODS: A total of 179 patients with acute gouty arthritis who had undergone SF crystal examination were identified from the data warehouse of two university hospitals. Clinical and laboratory data were obtained from the medical records. RESULTS: The overall rate of detection of MSU crystals was 78.8%. In univariate analyses, the only significant differences between the variables of crystal-negative and crystal-positive patients were a lower C-reactive protein level (p = 0.040) and fewer patients undergoing emergent surgery in the crystal-positive group (p = 4.5 x 10(-6)). In logistic regression analyses, MSU crystal-negative results were significantly associated with the interval from arthritis onset to crystal examination (p = 0.042), and this was the most significant risk factor for arthroscopic surgery (p = 2.1 x 10(-4)). Seventeen patients who underwent arthroscopic surgery had a significantly longer hospital stay (p = 0.007) and a significant delay in gout treatment (p = 8.74 x 10(-5)). The distribution of crystal-negative patients differed significantly between the SF samples that were evaluated by both the laboratory medicine and the rheumatology departments (p = 1.2 x 10(-14)), and the kappa value was 0.108. CONCLUSIONS: Although several clinical features were associated with detection failure, SF MSU crystal identification was critically dependent on the observer. Considering the impact on the treatment outcomes, implementation of a quality control program is essential.
Acute Disease ; Aged ; Arthritis, Gouty/diagnosis/*metabolism/*surgery ; Arthroscopy ; Biological Markers/metabolism ; Crystallization ; False Negative Reactions ; Female ; Hospitals, University ; Humans ; Length of Stay ; Logistic Models ; Male ; Microscopy, Polarization ; Middle Aged ; Observer Variation ; Predictive Value of Tests ; Reproducibility of Results ; Republic of Korea ; Retrospective Studies ; Synovial Fluid/*metabolism ; Time Factors ; Time-to-Treatment ; Treatment Outcome ; Uric Acid/*metabolism

BACKGROUND/AIMS: To evaluate a new monoclonal antibody for Helicobacter pylori urease in gastric tissue. METHODS: A total of 107 volunteers were enrolled. All subjects underwent a 13C-urea breath test and esophagogastroduodenoscopy. Gastric aspirates were analyzed for pH and ammonia. Six biopsy specimens in the gastric antrum and body were obtained for a rapid urease test and histology. The new monoclonal antibody-based H. pylori urease test (HPU) was performed to rapidly and qualitatively detect urease in two biopsy specimens. RESULTS: H. pylori infection was diagnosed in 73 subjects. The sensitivity and specificity of the HPU was 89% and 74%, respectively. The subjects were divided into two groups: one with true-positive and true-negative HPU results (n = 90) and the other with false-positive and false-negative HPU results (n = 17). Across all subjects, ammonia levels were 900.5 +/- 646.7 and 604.3 +/- 594.3 mumol/L (p > 0.05), and pH was 3.37 +/- 1.64 and 2.82 +/- 1.51 (p > 0.05). Sensitivity was higher in the presence of atrophic gastritis or intestinal metaplasia. CONCLUSIONS: HPU detected H. pylori in approximately 10 min. Gastric aspirate ammonia and pH levels did not affect the test results. Sensitivity was good in the presence of atrophic gastritis or intestinal metaplasia.
Adult ; Antibodies, Monoclonal/*immunology ; Bacterial Proteins/*analysis/immunology ; Biomarkers/analysis ; Biopsy ; False Negative Reactions ; False Positive Reactions ; Female ; Gastritis, Atrophic/*diagnosis/microbiology ; Helicobacter Infections/*diagnosis/microbiology ; Helicobacter pylori/*enzymology/immunology ; Humans ; *Immunologic Tests ; Male ; Metaplasia ; Middle Aged ; Predictive Value of Tests ; Pyloric Antrum/*microbiology/pathology ; Reproducibility of Results ; Time Factors ; Urease/*analysis/immunology ; Workflow

Adult ; Axilla ; Breast Neoplasms ; pathology ; surgery ; Carcinoma, Ductal, Breast ; pathology ; secondary ; surgery ; Carcinoma, Intraductal, Noninfiltrating ; pathology ; secondary ; surgery ; False Negative Reactions ; Female ; Humans ; Lymph Node Excision ; Lymph Nodes ; pathology ; surgery ; Lymphatic Metastasis ; Mastectomy ; methods ; Reproducibility of Results ; Sentinel Lymph Node Biopsy ; methods ; Technetium Tc 99m Sulfur Colloid

OBJECTIVE: To determine, by means of long-term follow-up evaluation, the outcome and accuracy of stereotactic core-needle biopsy (SCNB) of non-mass calcifications observed at mammography, and to analyze the factors contributing to false-negative findings. MATERIALS AND METHODS: Using a 14-gauge needle, SCNB was performed in cases involving 271 non-mass calcified lesions observed at mammography in 267 patients aged 23 72 (mean, 47) years. We compared the SCNB results with those of long-term follow-up which included surgery, mammography performed for at least six months, and reference to Korean Cancer Registry listings. We investigated the retrieval rate for calcifications observed at specimen mammography and histologic evaluation, and determined the incidence rate of cancer, sensitivity, and the underestimation rate for SCNB. False-negative cases were evaluated in terms of their mammographic findings, the effect of the operators' experience, and the retrieval rate for calcifications. RESULTS: For specimen mammography and histologic evaluation of SCNB, the retrieval rate for calcifications was, respectively, 84% and 77%. At SCNB, 54 of 271 lesions (19.9%) were malignant [carcinoma in situ, 45/54 (83%) ], 16 were borderline, and 201 were benign. SCNB showed that the incidence of cancer was 5.0% (6/120) in the benign mammographic category and 31.8% (48/151) in the malignant category. The findings revealed by immediate surgery and by longterm follow-up showed, respectively, that the sensitivity of SCNB was 90% and 82%. For borderline lesions, the underestimation rate was 10%. For false-negative cases, which were more frequent among the first ten cases we studied (p = 0.01), the most frequent mammographic finding was clustered amorphous calcifications. For true-negative and false-negative cases, the retrieval rate for calcifications was similar at specimen mammography (83% and 67%, respectively; p = 0.14) and histologic evaluation (79% and 75%, respectively; p = 0.47). CONCLUSION: In this study group, most diagnosed cancers were in-situ lesions, and long-term follow-up showed that the sensitivity of SCNB was 82%. Falsenegative findings were frequent during the operators' learning period.
Adult ; Aged ; Biopsy, Needle/*methods/standards/statistics & numerical data ; Breast/*pathology/surgery ; Breast Neoplasms/*diagnosis/epidemiology/surgery ; Calcinosis/*diagnosis/epidemiology/surgery ; Carcinoma in Situ/*diagnosis/epidemiology/surgery ; Diagnosis, Differential ; Disease Progression ; False Negative Reactions ; Female ; Follow-Up Studies ; Human ; Incidence ; Mammography/statistics & numerical data ; Middle Aged ; Reproducibility of Results ; Sensitivity and Specificity ; Time Factors ; Treatment Outcome