PURPOSE: Tumor marker concentrations in a given specimen measured by different analyzers vary according to assay methods, epitopes for antibodies used, and reagent specificities. Although great effort in quality assessment has been instituted, discrepancies among results from different analyzers are still present. We evaluated the assay performance of the UniCel(TM) DxI 800 automated analyzer in measuring the alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 125, CA 15-3 and CA 19-9 tumor markers. MATERIALS AND METHODS: The linearity and precision performance of the five tumor marker assays were evaluated, and concentrations of the respective markers as measured by DxI were compared to those measured by other conventional analyzers (ADVIA Centaur(TM) and Vitros(TM) ECi) using 200 specimens collected from 100 healthy persons and 100 patients with respective cancers. RESULTS: The linear fits for all five tumor markers were statistically acceptable (F=4648 for AFP, F=15846 for CEA, F=6445 for CA 125, F=2285 for CA 15-3, F=7459 for CA 19-9; p<0.0001 for all). The imprecision of each tumor marker assay was less than 5% coefficient of variation, except for low and high concentrations of AFP. The results from UniCel(TM) DxI 800 were highly correlated with those from other analyzers. CONCLUSION: Our results demonstrate that UniCel(TM) DxI 800 has good linearity and precision performance for the tumor markers assayed in this study. However, there were discrepancies between assaying methods. Efforts to standardize tumor marker assays should be undertaken, and the redetermination of cut-off levels is necessary when developing methods of analyzing tumor markers.
CA-125 Antigen/blood ; CA-19-9 Antigen/blood ; Carcinoembryonic Antigen/blood ; Humans ; Immunoassay/*instrumentation/*methods ; Tumor Markers, Biological/*blood ; alpha-Fetoproteins/metabolism

BACKGROUND: Hepatitis B virus DNA quantification is essential for managing chronic hepatitis B (CHB). We compared the performance of artus HBV QS-RGQ (QIAGEN GmbH, Germany) and CAP/CTM v2.0 HBV assays (Roche Molecular Diagnostics, USA) in CHB patients. METHODS: A comparative evaluation between two assays was performed with 508 clinical serum samples. Precision, linearity, and the limit of detection (LOD) of QS-RGQ assay was evaluated by using the WHO standard 97/750 and clinical samples. RESULTS: Detection rates and viral loads as determined QS-RGQ assay were significantly lower than those from the CAP/CTM v2.0 assay (52.8% vs 60.6%; 3.55±1.77 IU/mL vs 4.18±1.89 IU/mL, P<0.0001). The kappa coefficient between qualitative results was 0.79 (95% confidence interval, 0.74 to 0.85). Bland-Altman plot found a mean difference of (QS-RGQ − CAP/CTM v2.0)=−0.63 log₁₀ IU/mL (95% limit of agreement, −1.48 to 0.22). Repeatability and total imprecision (% CV) of the QS-RGQ assay were 1.0% and 1.1% at 2,000 IU/mL, and 0.7% and 1.4% at 20,000 IU/mL, respectively. Linearity of this assay ranged from 31.6 to 1.0±10⁷ IU/mL, and the LOD was 2.95 IU/mL. CONCLUSIONS: The artus HBV QS-RGQ assay showed good performance but significantly decreased detection rate and viral load compared with CAP/CTM v2.0 assays. This assay recommends using plasma; however, we used stored serum because of the retrospective study design. Usually HBV DNA quantification is performed in plasma or serum, but sample type and clinical relevance of quantitative values should be considered when determining the clinical application of this reagent.
DNA ; DNA, Viral* ; Hepatitis B virus ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Limit of Detection ; Pathology, Molecular ; Plasma ; Retrospective Studies ; Viral Load

Area Under Curve ; Biomarkers, Tumor ; Carcinoembryonic Antigen ; Carcinoma, Non-Small-Cell Lung ; Carcinoma, Squamous Cell ; Diagnosis ; Keratin-19 ; Lung Neoplasms ; Lung ; Medical Records ; Multivariate Analysis ; Retrospective Studies ; ROC Curve ; Sensitivity and Specificity

Clinical neuropsychological test were developed originally for the diagnosis of neurological and neuro-surgical diseased. Recently, these tests are being introduced to psychiatric patients. Authors had the experience to use these tests in pychiatric outpatient clinic. Results were as follows. There was a significantly increase in language and attentional function in residual schizophrenia compared to normal control. In chronic neurosis, as visuospatial function was reduced, language and attentional functions were enhanced. With these results, authors suggest that application of neuropsychological tests in psychiatric patients may be very helpful in classifying the subgroups of disease, in selecting the modality of treatment. and in expecting prognosis.
Ambulatory Care Facilities ; Diagnosis ; Humans ; Neuropsychological Tests* ; Neuropsychology ; Outpatients* ; Prognosis ; Schizophrenia

BACKGROUND: The domestic quantity of blood components consumed has been decreasing since 2002, but the rate of a single unit RBC transfusion (SUT) has been on the increase. In the past, a SUT was regarded as an uncesssary procedure, but currently is considered as an effective method to maintain a minimal hemoglobin concentration for physiological needs. We investigated the actual conditions of a SUT. METHODS: We analyzed 800 cases of SUTs performed at a tertiary care university hospital between March 2006 March and February 2007. The subjects of the study were divided into a surgical group (n=561) and medical group (n=239) for the purpose of RBC unit usage and were analyzed by groups and ordering departments, with an analysis of the pre and post-transfusion hemoglobin concentration and hematocrit values. The distribution according to the pre and post-transfusion hemoglobin ranges were calculated. RESULTS: The mean hemoglobin concentration increment of the surgical group was significantly lower than that of the medical group (P<0.0001) and the mean pre and post-transfusion hemoglobin concentrations of the medical group were lower than that of the surgical group (P<0.0001). Approximately 26% cases of the SUTs performed in the surgical group were appropriate, based on a post-transfusion hemoglobin concentration below 10 g/dL. In the medical group, about 75% of the SUTs were appropriate based on a pre-transfusion hemoglobin concentration below 9 g/dL. CONCLUSION: Most transfusions are decided based on various clinical situations and opinions of the clinicians. Therefore, continuous evaluation of the appropriateness of transfusion is necessary. In our study, the appropriateness of a SUT was estimated indirectly based on the pre and post-transfusion hemoglobin concentration. Consequently, policies and strategies for performing asingle unit RBC transfusion are required.
Hematocrit ; Tertiary Healthcare

BACKGROUND: We evaluated the diagnostic performance of a newly developed Elecsys Anti-HCV II assay in Korean patients. METHODS: A total of 500 serum samples (400 antibody to hepatitis C virus [anti-HCV]-negative and 100 anti-HCV-positive samples) were collected after testing with Elecsys Anti-HCV assay (Roche Diagnostics, Germany). All the samples were tested for anti-HCV by using Vitros Anti-HCV (Ortho-Clinical Diagnostics, UK) and Elecsys Anti-HCV II (Elecsys II) (Roche Diagnostics, Germany) assays. Specimens that were found to be positive or negative in all the 3 assays were considered positive or negative for anti-HCV, respectively, and medical records of the patients, including results of previous HCV tests, were reviewed to determine the final results for anti-HCV when there were discrepancies among the results of the anti-HCV assays. RESULTS: Discrepancies between the results of the 3 anti-HCV assays were found for 4 of the 500 samples (0.8%). Sensitivity/specificity values for Elecsys II were 98.0%/100.0%, and the corresponding values for Elecsys and Vitros assays were 100.0%/100.0% and 100.0%/99.5%. Concordance rates between the results of any 2 of the 3 assays were equal or greater than 99.2%, with a kappa coefficient of 0.98 or greater (P < 0.0001). CONCLUSIONS: Sensitivities and specificities of the anti-HCV assays evaluated in this study were high enough for being used in clinical laboratories, and the results of the 3 assays showed good agreement. However, samples for which weak-positive results were obtained would need to be retested, considering the discrepancies between the anti-HCV assays.
Hepacivirus ; Hepatitis C Antibodies ; Humans ; Medical Records

PURPOSE: Early identification of causative agents in lower respiratory infection of pediatric patients can reduce morbidity and prevent an overuse of antimicrobials. Two kinds of multiplex polymerase chain reaction (PCR) and a commercial shell vial viral culture were performed to identify causative agents in pediatric patients. MATERIALS AND METHODS: Nasopharyngeal aspirates of 220 children diagnosed with viral pneumonia were obtained. Two kinds of multiplex PCR (Seeplextrade mark RV detection kit, and Labopasstrade mark RV detection kit), and a shell vial culture by R-Mix were performed. RESULTS: Positive samples from 220 total samples by two multiplex PCRs were 52.7% and 46.4%, respectively. We also cultured 103 samples that showed positive results of the adenovirus, influenza virus, parainfluenza virus, and respiratory syncytial virus (RSV) by two multiplex PCR. The RSV was most frequently detected in 53.0% (Seeplex) and 51.7% (Labopass) of patients. The detection rate of adenovirus (AdV) was 10.3% and 12.1%, influenza virus (IFV) A and B was 12.5% and 3.4%, and parainfluenza virus (PIFV) 1, 2, and 3 were 2.9% and 2.6%. Shell vial cultures showed concordant results with each multiplex PCR by 96.1% and 77.7%, respectively. Sequencing results were 90% consistent with multiplex PCR. CONCLUSION: Multiplex PCR showed more positivity than the shell vial culture and it can be an effective primary test. Other complementary efforts such as viral cultures and sequencing analysis could be considered, according to clinical and laboratory conditions.
Adenoviridae/genetics/*isolation & purification ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Orthomyxoviridae/genetics/*isolation & purification ; Pneumonia, Viral/*virology ; Polymerase Chain Reaction/*methods ; Respiratory Syncytial Viruses/genetics/*isolation & purification ; Respirovirus/genetics/*isolation & purification

BACKGROUND: Interpretation of indeterminate results by anti-HIV Western blot assay, which is currently used as a confirmatory test for HIV infection, can be usually difficult. We analyzed outcomes of the patients with indeterminate results by anti-HIV Western blot. METHODS: Medical records of patients, who were indeterminate by the anti-HIV Western blot assay in a university hospital during recent 5 years, were retrospectively reviewed. HIV screening test was performed by chemiluminescent immunoassay autoanalyzer (Abbot Laboratories, USA) with HIV Ag/Ab Combo kits. Confirmatory Western blot assay for the positive samples by HIV screening test was committed to the Korean National Institute of Health. RESULTS: A total of 202,639 specimens were tested for HIV screening during the period, and 644 (0.32%) sera showed positive results. Among these, 46 (7.1%) cases were indeterminate by the Western blot, which were from 20 patients, and 13 of them converted to be anti-HIV positive, and 3 were lost to follow-up. Another four patients were turned out to be negative for HIV infection, including two neonates from HIV-positive mothers receiving antiviral treatment during pregnancy. CONCLUSIONS: Most of the patients who showed Western blot-indeterminate results converted to HIV positive after follow-up. Thus, careful monitoring of patients with indeterminate Western blot results should be essential.
Blotting, Western ; Follow-Up Studies ; HIV ; HIV Infections ; Humans ; Immunoassay ; Infant, Newborn ; Korea ; Lost to Follow-Up ; Mass Screening ; Medical Records ; Mothers ; Retrospective Studies

PURPOSE: The extraction of nucleic acid is initially a limiting step for successful molecular-based diagnostic workup. This study aims to compare the effectiveness of three automated DNA extraction systems for clinical laboratory use. MATERIALS AND METHODS: Venous blood samples from 22 healthy volunteers were analyzed using QIAamp(R) Blood Mini Kit (Qiagen), MagNA Pure LC Nucleic Acid Isolation Kit I (Roche), and Magtration-Magnazorb DNA common kit-200N (PSS). The concentration of extracted DNAs was measured by NanoDrop ND-1000 (PeqLab). Also, extracted DNAs were confirmed by applying in direct agarose gel electrophoresis and were amplified by polymerase chain reaction (PCR) for human beta-globin gene. RESULTS: The corrected concentrations of extracted DNAs were 25.42 +/- 8.82 ng/microLiter (13.49-52.85 ng/microLiter) by QIAamp(R) Blood Mini Kit (Qiagen), and 22.65 +/- 14.49 ng/microLiter (19.18-93.39 ng/microLiter) by MagNA Pure LC Nucleic Acid Isolation Kit I, and 22.35 +/- 6.47 ng/microLiter (12.57-35.08 ng/microLiter) by Magtration-Magnazorb DNA common kit-200N (PSS). No statistically significant difference was noticed among the three commercial kits (p > 0.05). Only the mean value of DNA purity through PSS was slightly lower than others. All the extracted DNAs were successfully identified in direct agarose gel electrophoresis. And all the product of beta-globin gene PCR showed a reproducible pattern of bands. CONCLUSION: The effectiveness of the three automated extraction systems is of an equivalent level and good enough to produce reasonable results. Each laboratory could select the automated system according to its clinical and laboratory conditions.
Automation/methods ; DNA/blood/*isolation & purification ; Humans ; Polymerase Chain Reaction ; *Reagent Kits, Diagnostic ; Reproducibility of Results

STUDY DESIGN: A radiographic study of normal subjects. OBJECTIVES: To analyze sagittal spinal parameters according to the size of pelvic incidence (PI). SUMMARY OF LITERATURE REVIEW: There has been no previous study about the classification of spinopelvic parameters that has used a large cohort of asymptomatic older men with the same ethnic background as those in the current study. MATERIALS AND METHODS: We examined 160 males aged over 50 without disease, trauma, or history of operation on spine or lower extremities. Sagittal standing radiographs of the whole spine on 36-inch film were taken. Group 1 (n=30) had a PI of less than 40degrees. Group 2 (n=71) had PI between 40degrees and 50degrees, and group 3 (n=59) had a PI greater than 50degrees. Thoracic kyphosis, thoracolumbar kyphosis, lumbar lordosis, the vertebral slope of T12, sacral slope, and pelvic incidence were measured. The distances from the plumb line of C7, T12, and the lumbar apex to the posterosuperior corner of the sacrum were also measured. RESULTS: Subjects' average age was 64.1(53~83).Lumbar lordosis, sacral slope and pelvic tilt were all significantly increased in group 3. Thoracic kyphosis and the vertebral slope of T12 were not different between groups. The distances from the plumb line of C7, T12, and the lumbar apex to the posterosuperior corner of the sacrum were significantly translated anteriorly in group 3. CONCLUSIONS: Group 3, who had the largest PI, demonstrated the largest lumbar lordosis and the most forward transition of trunk. However there were no differences in thoracic kyphosis and the vertebral slope of T12 among the three groups.
Aged ; Animals ; Cohort Studies ; Humans ; Incidence ; Kyphosis ; Lordosis ; Lower Extremity ; Male ; Pelvis ; Sacrum ; Spine