BACKGROUND: Several factors, including clinical manifestations and laboratory data, have been used to evaluate the disease activity of Sjögren's syndrome (SS). We investigated saliva indicators of disease activity in primary SS patients. METHODS: We enrolled 138 Taiwanese patients with primary SS and 100 Taiwanese normal controls. Interleukin (IL)-6, IL-17A, tumor necrosis factor-alpha (TNF-α), and rheumatoid factor (RF)-IgA levels in saliva samples were measured using ELISA or fluorescent enzyme-linked immunoassay. Serum IgG, IgA, and IgM levels were measured by nephelometry. Erythrocyte sedimentation rate (ESR) was measured with an automatic ESR analyzer. The t-test and Pearson correlation test were used. RESULTS: IL-6 level was higher in primary SS patients than in normal controls (14.23±14.77 vs 9.87±7.32, P=0.012), but there were no significant differences in IL-17A, TNF-α, and RF-IgA levels. In primary SS patients, IL-6 level correlated weakly with ESR and IgG levels (r=0.252, P=0.015, and r=0.248, P=0.017, respectively), and TNF-α level correlated weakly with IgG level (r=0.231, P=0.024). CONCLUSIONS: IL-6 may play a role in SS pathogenesis. Saliva IL-6 might be an indicator of disease activity in primary SS patients.
Blood Sedimentation ; Enzyme-Linked Immunosorbent Assay ; Humans ; Immunoassay ; Immunoglobulin A ; Immunoglobulin G ; Immunoglobulin M ; Interleukin-17 ; Interleukin-6 ; Interleukins ; Nephelometry and Turbidimetry ; Rheumatoid Factor ; Saliva ; Tumor Necrosis Factor-alpha

OBJECTIVETo investigate the significance of serum IgD quantitation in evaluation of clinical efficacy in IgD myeloma.

METHODSSerum IgD and free light chain (sFLC) levels were determined by immune scatter turbidimetry with SPA plus analysis machine in 29 patients with IgD multiple myeloma (MM) achieving VGPR or better response following previous treatments. The concurrent immunofixation electrophoresis (IFE) results were also incorporated and analyzed.

RESULTSIncreased IgD levels were detected in 1 of 12 patients achieving sCR, 2 of 5 patients achieving CR and 4 of 12 patients achieving VGPR, respectively. The median progression-free survival (PFS) was 38.5 months, 34.1 months and 15.5 months for patients achieving sCR, CR and VGPR, respectively, with a significant difference between sCR and VGPR groups (P=0.022), and between CR and VGPR groups (P=0.018). There was no difference in overall survival (OS) among sCR, CR and VGPR groups (P>0.05). The median PFS were 7.8, 33.7 and 43.9 months, respectively for the patients with both abnormal sFLC ratios and IgD levels (6 cases, Group A), with either abnormal sFLC ratios or increased IgD levels (10 cases, Group B) or with normal sFLC ratios and IgD levels (13 cases, Group C). A significant PFS benefit of Group A over Group C was found (P=0.033), and no differences in terms of OS among three groups (P>0.05).

CONCLUSIONIgD levels may remain abnormal in IgD MM patients who have achieved VGPR or better response, and IgD quantitation represented a useful assay complementary to the current lab examinations. IgD quantitation assay was of significance in clinical efficacy evaluation and survival judgement, and should be incorporated into the evaluation parameters used for IgD MM in addition to sFLC and IFE assays.

Disease-Free Survival ; Humans ; Immunoglobulin D ; blood ; Immunoglobulin Light Chains ; blood ; Multiple Myeloma ; blood ; diagnosis ; Nephelometry and Turbidimetry ; Remission Induction ; Treatment Outcome

OBJECTIVETo evaluate the specificity and sensitivity of immunoglobulin heavy/light chain (HLC) and serum free light chain (FLC) level in minimal residual disease monitoring of IgG type multiple myeloma (MM) patients during complete remission (CR).

METHODSImmunoglobulin HLC was assessed in 20 IgG myeloma patients by immune turbidimetry using SPAplus Analyzer. The serum level of HLC and FLC was detected at same time. Combine with those obtained by serum protein electrophoresis (SPE) and immune fixation electrophoresis (IFE), the specificity and sensitivity of HLC in detection of serum immunoglobulin were analyzed. Combined with the clinical efficacy, kappa/lambda ratios of HLC (rHLC) and FLC (rFLC) were compared between the patients and normal controls.

RESULTSAmong 20 patients, there were 10 male and 10 female, the median age was 56 years (35-70). There were 6 patients with abnormal rHLC but normal rFLC; 3 patients with abnormal rFLC but normal HLC; and 11 patients with both normal rHLC and rFLC. During the mean follow-up time of 18 months, 4 of the6 patients with abnormal rHLC accepted intervention therapies, 1 case relapsed in 9 months,the other 2 untreated patients relapsed in 3 months. Among the 3 cases with abnormal rFLC, 2 patients are still in remission after intervention therapies,the other untreated patient relapsed in 1.5 months. Among the 11 untreated patients with both normal rHLC and rFLC, 3 relapsed with the disease free survival time of 3.5 months, 5.0 months and 5.5 months respectively.

CONCLUSIONThe combined detection of HLC and FLC is helpful to assess the curative efficacy and the accuracy of minimal residual disease monitoring, and more effectively evaluate the prognosis of MM patients. Abnormal rHLC and rFLC are correlated with poor prognosis, while early intervention therapies can help to improve disease free survival.

Adult ; Aged ; Female ; Humans ; Immunoglobulin G ; Immunoglobulin Heavy Chains ; Immunoglobulin Light Chains ; Male ; Middle Aged ; Multiple Myeloma ; Neoplasm, Residual ; Nephelometry and Turbidimetry ; Prognosis ; Remission Induction

PURPOSE: To determine if short term effects of intravitreal anti-vascular endothelial growth factor or steroid injection are correlated with fluid turbidity, as detected by spectral domain optical coherence tomography (SD-OCT) in diabetic macular edema (DME) patients. METHODS: A total of 583 medical records were reviewed and 104 cases were enrolled. Sixty eyes received a single intravitreal bevacizumab injection (IVB) on the first attack of DME and 44 eyes received triamcinolone acetonide treatment (IVTA). Intraretinal fluid turbidity in DME patients was estimated with initialintravitreal SD-OCT and analyzed with color histograms from a Photoshop program. Central macular thickness and visual acuity using a logarithm from the minimum angle of resolution chart, were assessed at the initial period and 2 months after injections. RESULTS: Visual acuity and central macular thickness improved after injections in both groups. In the IVB group, visual acuity and central macular thickness changed less as the intraretinal fluid became more turbid. In the IVTA group, visual acuity underwent less change while central macular thickness had a greater reduction (r = -0.675, p = 0.001) as the intraretinal fluid was more turbid. CONCLUSIONS: IVB and IVTA injections were effective in reducing central macular thickness and improving visual acuity in DME patients. Further, fluid turbidity, which was detected by SD-OCT may be one of the indexes that highlight the influence of the steroid-dependent pathogenetic mechanism.
Aged ; Angiogenesis Inhibitors/*therapeutic use ; Bevacizumab/*therapeutic use ; Diabetic Retinopathy/*drug therapy/physiopathology ; Female ; Glucocorticoids/*therapeutic use ; Humans ; Intravitreal Injections ; Macular Edema/*drug therapy/physiopathology ; Male ; Middle Aged ; Nephelometry and Turbidimetry ; Retina/pathology ; *Subretinal Fluid ; Tomography, Optical Coherence ; Treatment Outcome ; Triamcinolone Acetonide/*therapeutic use ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Visual Acuity/physiology

BACKGROUND: Analyzing large numbers of specimens in a short time and generating accurate results while minimizing costs are critical to laboratory tests. The CS-6400 (Dong-A Dirui, China), an automated chemistry analyzer, has been recently developed in China in collaboration with domestic corporations. To assess the performance and usability of the analyzer, we evaluated its analytical performance and clinical usefulness including accuracy and linearity of electrolytes and chemistry tests using HiSens reagent (HBI Co., Korea) with protocols provided by the Clinical and Laboratory Standards Institute, and compared these results with those of the formerly used DXC800 (Beckman Coulter, USA), and Vista500 (Siemens, Germany). METHODS: The accuracy, linearity, recovery factor, and sample carryover of the CS-6400 using HiSens reagent were determined for 29 tests-aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), gamma glutamyl transferase, glucose, total cholesterol, triglyceride (TG), amylase, lipase, creatine kinase (CK), blood urea nitrogen, creatinine, uric acid, total protein, albumin, total bilirubin (TB), direct bilirubin (DB), calcium, inorganic phosphorus, magnesium (MG), HDL cholesterol, rheumatoid factor (RF), LDL cholesterol, C-reactive protein, anti-streptolysin O, sodium, potassium, and chloride and the results were compared with the values obtained from the DXC800 and Vista500 to set reference intervals for each test. Serum samples obtained from 128 healthy adults were used for the reference intervals. and values obtained from DXC800 and Vista500 were used to make comparison on and to set reference intervals for each routine. Serum specimens obtained from a total of 128 healthy adults were used for the reference intervals. RESULTS: The coefficient of variation showed excellent values of < or =5% for all tests except ALP, DB, MG, RF, TB, and TG (> or =5%). The coefficient of determination (R2) was > or =0.993 with linearity between 0.928 and 1.078 within the useful clinical span. In addition, the recovery factor values of the tests were 84% to 108%, and correlation comparisons were 0.975 except for albumin (0.9516), RF (0.7617), and LDL cholesterol (0.9709). We evaluated whether the CS-6400 contributed to the attempt to minimize the test's cost and running time. Developed in China, the CS-6400 has been approved by the Food and Drug Administration and uses indirect ion selective electrodes for electrolytes and colorimetry and turbidimetry for general and specific chemistry items. The tests showed excellent linearity of > or =0.993 using commercial certified linearity material. The recovery factor values of the tests were 93% to 108%, except for LDL cholesterol (84%). Except for the minimum values, percentage sample carryover values for CK and LDH were < or =1% (0.00% and 0.07%, respectively), suggesting that the results of the tests were not affected by sample carryover, and reference interval was present based on sex. CONCLUSIONS: The CS-6400 with HiSens showed excellent analytical performance (precision, linearity, and accuracy). Furthermore, results from the CS-6400 were highly correlated with those obtained from similar tests performed on DXC800 and Vista500. Therefore, the CS-6400 is appropriate for tertiary care hospitals where large volumes of test samples must be processed within a short period with minimal cost.
Adult ; Alanine Transaminase ; Alkaline Phosphatase ; Amylases ; Bilirubin ; Blood Urea Nitrogen ; C-Reactive Protein ; Calcium ; China ; Cholesterol ; Cholesterol, HDL ; Cholesterol, LDL ; Colorimetry ; Cooperative Behavior ; Creatine Kinase ; Creatinine ; Electrolytes ; Glucose ; Humans ; Ion-Selective Electrodes ; L-Lactate Dehydrogenase ; Lipase ; Magnesium ; Nephelometry and Turbidimetry ; Phosphorus ; Potassium ; Rheumatoid Factor ; Running ; Sodium ; Tertiary Healthcare ; Transferases ; United States Food and Drug Administration ; Uric Acid

BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) is known to be one of the ideal biomarkers for acute kidney injury providing early information on damage to the kidney. METHODS: We evaluated the performance for precision and the reportable range of the automated NGAL Test (Bioporto Diagnostics, Denmark) assay and compared the values of these tests with widely used point of care test. The reference interval of NGAL was established in Korean adults. RESULTS: Within run percent coefficient of variation (%CV) and total precision %CV for 2 levels were all within 5%. The reportable range was found to be acceptable for the range of 57.0 - 3182.0 ng/mL (r=0.999). The method comparison was made between Biosite's assay and Bioporto Diagnostics' (Passing and Bablok fit, y=1.94x - 5.29; x, Biosite; y, Bioporto; n=31; y range, 250 to 1,308 ng/mL; r2=0.959). The correlation was linear within the limit of 1,500 ng/mL, but not beyond this limit. The 2.5 and 97.5 percentile of the reference range for the samples were 43.2 ng/mL and 124.8 ng/mL, respectively. CONCLUSIONS: Since NGAL Test can be used in automated chemical analyzer, it can not only reduce the man power and time consumed in but also displayed excellent precision and linearity.
Acute Kidney Injury ; Biomarkers ; Chemistry, Clinical ; Immunoassay ; Lipocalins ; Nephelometry and Turbidimetry ; Neutrophils ; Reference Values

Endotoxins are known to be associated with the occurrence of various chronic diseases. This study was conducted to investigate the role of endotoxins in the pathogenesis of colon polyps through a case-control study. A total of 145 subjects (74 subjects in the polyp group and 71 subjects in the control group) had undergone a colonoscopy. Age, body mass index (BMI) and endotoxin levels were found to be significantly higher in the polyp group than in the control group. The endotoxin level was still significantly higher in the polyp group than in the control group, even after age and BMI had been adjusted (polyp group 0.108 +/- 0.007 EU/mL, control group 0.049 +/- 0.008 EU/mL, P < 0.001). In subgroup analysis, the endotoxin level significantly increased in accordance with the number of colon polyps (one-polyp group, 0.088 +/- 0.059 EU/mL; two-polyp group, 0.097 +/- 0.071 EU/mL; three-or-more-polyp group, 0.149 +/- 0.223 EU/mL). The endotoxin levels also significantly increased in groups with tubular adenoma with high-grade dysplasia (hyperplastic polyp group, 0.109 +/- 0.121 EU/mL; tubular adenoma with low grade dysplasia group, 0.103 +/- 0.059 EU/mL; tubular adenoma with high grade dysplasia group, 2.915 +/- 0.072 EU/mL). In conclusion, the serum level of endotoxins is quantitatively correlated with colon polyps.
Adenoma/pathology ; Adult ; Age Factors ; Aged ; Body Mass Index ; Case-Control Studies ; Colonic Polyps/*pathology ; Colonoscopy ; Endotoxins/*blood ; Female ; Humans ; Male ; Middle Aged ; Nephelometry and Turbidimetry ; Waist Circumference

BACKGROUND: Fibrin-related markers (FRM) such as fibrin monomer (FM) and D-dimer (DD) are considered useful biological markers for the diagnosis of disseminated intravascular coagulation (DIC). However, no studies on the diagnostic performance of different FRMs have been published in Korea. The aim of this study was to evaluate the diagnostic performance of FM for DIC in comparison with DD. METHODS: The reference limit of FM was determined based on plasma sample data obtained from 210 control individuals. To evaluate diagnostic performance, FM data from the plasma samples of 139 patients with DIC-associated diseases were obtained for DIC scoring. FM was measured by immunoturbidimetry using STA-LIATEST FM (Diagnostica Stago, France). Patients were classified according to the DIC score as non-DIC, non-overt DIC, or overt DIC. ROC curve analyses were performed. RESULTS: The reference limit in the control individuals was determined to be 7.80 microg/mL. Patients with DIC-associated diseases were categorized as non-DIC (N=43), non-overt DIC (N=80), and overt DIC (N=16). ROC curve analyses showed that the diagnostic performance of FM was comparable to DD in both non-overt DIC and overt DIC (P=0.596 and 0.553, respectively). In addition, FM had higher sensitivity, specificity, positive predictive value, and negative predictive value than DD for differentiating overt DIC from non-DIC. CONCLUSIONS: This study demonstrated that the diagnostic performance of FM for DIC was comparable to DD. FM might be more sensitive and more specific than DD in the diagnosis of overt DIC, but not non-overt DIC.
Area Under Curve ; Biological Markers/blood ; Disseminated Intravascular Coagulation/blood/*diagnosis ; Fibrin Fibrinogen Degradation Products/*analysis/immunology/standards ; Humans ; Immunoassay/*methods/standards ; Nephelometry and Turbidimetry/*methods/standards ; ROC Curve ; Reagent Kits, Diagnostic ; Reference Values

BACKGROUND: Fibrin-related markers (FRM) such as fibrin monomer (FM) and D-dimer (DD) are considered useful biological markers for the diagnosis of disseminated intravascular coagulation (DIC). However, no studies on the diagnostic performance of different FRMs have been published in Korea. The aim of this study was to evaluate the diagnostic performance of FM for DIC in comparison with DD. METHODS: The reference limit of FM was determined based on plasma sample data obtained from 210 control individuals. To evaluate diagnostic performance, FM data from the plasma samples of 139 patients with DIC-associated diseases were obtained for DIC scoring. FM was measured by immunoturbidimetry using STA-LIATEST FM (Diagnostica Stago, France). Patients were classified according to the DIC score as non-DIC, non-overt DIC, or overt DIC. ROC curve analyses were performed. RESULTS: The reference limit in the control individuals was determined to be 7.80 microg/mL. Patients with DIC-associated diseases were categorized as non-DIC (N=43), non-overt DIC (N=80), and overt DIC (N=16). ROC curve analyses showed that the diagnostic performance of FM was comparable to DD in both non-overt DIC and overt DIC (P=0.596 and 0.553, respectively). In addition, FM had higher sensitivity, specificity, positive predictive value, and negative predictive value than DD for differentiating overt DIC from non-DIC. CONCLUSIONS: This study demonstrated that the diagnostic performance of FM for DIC was comparable to DD. FM might be more sensitive and more specific than DD in the diagnosis of overt DIC, but not non-overt DIC.
Area Under Curve ; Biological Markers/blood ; Disseminated Intravascular Coagulation/blood/*diagnosis ; Fibrin Fibrinogen Degradation Products/*analysis/immunology/standards ; Humans ; Immunoassay/*methods/standards ; Nephelometry and Turbidimetry/*methods/standards ; ROC Curve ; Reagent Kits, Diagnostic ; Reference Values

The followings are the results for external quality assessment (EQA) in immunoserology for 2009: Evaluation of EQA was done in 2 trials in April and November, about 99% of laboratories participating average 7.4 items. The results were collected via internet and about 98% of laboratories have sent their results via internet. Control materials used in EQA were pooled sera including commercial controls, MASR Immunology Control from Medical Analysis Systems (Camarillo, CA, USA), which were delivered refrigerated for stability of control materials, being received within 48 hours after sending. Latex agglutination tests for rheumatoid factor (RF) showed frequently false positive or false negative results especially in commercial controls, possibly due to matrix effect. False negative and positive results were frequently found in the laboratories using immunochromatography assay (ICA) for anti-HCV and anti-HIV. More careful quality control should be required for ICA tests. New tests measuring non-treponemal and trponemal antibody such as turbidoimmunoassay (TIA) and chemiluminescence immunoassay (CLIA) were introduced. Standardization of instruments and reagents including calibrators for quantitative results should be required for the harmonization of results.
Hepatitis B Surface Antigens ; Immunoassay ; Immunochromatography ; Indicators and Reagents ; Internet ; Korea ; Latex Fixation Tests ; Luminescence ; Nephelometry and Turbidimetry ; Quality Control ; Rheumatoid Factor