Dual-magnetic circuit beads and scattering nephelometry dual channel semiautomatic coagulometers are used for the coagulational evaluation of the 5 blood contact medical devices which consist of metals and polymers. The partial thromboplastin time(PTT) and prothrombin time(PT) tests are made based on the GB/T 16886.4-2003 standard. The results indicate that the coefficient of variation in the two groups is in the identical order of magnitude. In the PTT tests, they give the similar evaluational results. With the smaller numerical values of the PT tests, the different coagulometers give the high consilience results. So, both of dual-magnetic circuit beads and scattering nephelometry coagulometers are acceptable in the medical devices' coagulational evaluations. But the interpretation and analysis of the results of the small numerical value tests, PT tests for example, should be noticed.
Blood Coagulation Tests ; instrumentation ; methods ; Magnetics ; instrumentation ; Nephelometry and Turbidimetry ; instrumentation

AIMTo determine phenytoin sodium by a highly accurate nephelometric titration.

METHODSThe titration operating conditions were optimized and the solubility product constant of phenytoin silver precipitation was determined.

RESULTSThe result of the titration is comparable to those of control experiments.

CONCLUSIONThe proposed method has been found to be accurate, precise, specific, reproducible, and linear.

Nephelometry and Turbidimetry ; methods ; Phenytoin ; analysis ; Reproducibility of Results ; Solutions ; Titrimetry ; methods

The followings are the results for external quality assessment (EQA) in immunoserology for 2004: 1. Evaluation of EQA was done in 2 trials in May and November, about 99% of laboratories participating average 8.4 items. EQA for anti-HBc test was newly started in 2004. 2. Commercial control, MASR Immunology Control from Medical Analysis Systems (Camarillo, CA, USA) was used to assure the quality of quantitative results of C-reactive protein (CRP), rheumatoid factor (RF) and anti-streptolysin O (ASO) tests in 2004. All the specimens for Immunoserology in EQA were delivered refrigerated for the first time, being received within 48 hours after sending. 3. EQA for detection of HBsAg mutants was tried for the first time, using the recombinant HBsAg mutant (Gly/Arg 145) kindly provided by Abbott Laboratories, USA. 4. The laboratories using immunochromatography assay (ICA) were increased, however, many laboratories using ICA reported falsely negative for the positive specimens. The sensitivity of ICA test kits as well as various factors influencing the ICA results should be evaluated. 5. Standardization of methods including calibrators for quantitative results should be required for the harmonization of results.
Allergy and Immunology ; C-Reactive Protein ; Hepatitis B Surface Antigens ; Immunochromatography ; Korea* ; Nephelometry and Turbidimetry ; Rheumatoid Factor

Serum Immunoglobulin (Ig)A, IgG, IgM, levels were measured in 99 coal workers' pneumoconiosis (CWP) patients and 12 healthy coal workers and 9 non-miners to compare with each group by the radiological categories, its complications and working period in coal mine. Serum were measured by nephelometry. The findings were as follows: 1) Serum IgA levels were significantly different between three groups of CWP patient, healthy coal worker and non-miner (mean+/-standard deviation: 226.4+/-87.7, 221.3+/-45.1, 170.1+/-65.7 respectively). 2) There were no significant differences of Ig levels among radiological categories of CWP. 3) There were no significant differences of Ig levels among simple pneumoconiosis and its complicated disorders. 4) The three Ig levels were slightly increased in the group of mining years less than 20 years (IgA: r=0.1869, p<0.10 IgG: r=0.2902, p<0.05 IgM: r=0.2889, p<0.05).
Coal* ; Humans ; Immunoglobulin A ; Immunoglobulin G ; Immunoglobulin M ; Immunoglobulins* ; Mining ; Nephelometry and Turbidimetry ; Pneumoconiosis*

BACKGROUND AND OBJECTIVES: Immunoglobulin G (IgG) subclass deficiency has been reported in patients with bronchial asthma and is associated with recurrent respiratory tract infections. Aspirin-sensitive asthma (ASA) which affects 10% of adult asthmatics, asthma runs a chronic course with frequent asthma exacerbations, often related to respiratory infections. We performed this study to identify the prevalence of IgG subclass deficiency and evaluate the association between recurrent asthma exacerbations and IgG subclass deficiency in ASA. SUBJECTS AND METHODS: We measured serum levels of IgG and IgG subclass in 26 aspirin- sensitive asthmatic patients (15 steroid used and 11 steroid not used) and 55 healthy controls using nephelometry. Reference values of each IgG subclass was defined as cumulative percentile between 2.5% to 97.5% of controls. RESULTS: Total IgG, IgG1, IgG2 and IgG3 of aspirin-sensitvie asthmatics, were significantly lower than for those of controls (p<0.05, respectively). However, there were no significant differences in total IgG and IgG subclass concentrations, between steroid-not-used asthma group and controls (p>0.05, respectively). CONCLUSION: Lowered levels of IgG, IgG1, IgG2 and IgG3 were noted in ASA sensitive asthma patients, which might be associated with use of steroid. Further studies will be needed to evaluate their clinical significance.
Adult ; Asthma* ; Humans ; Immunoglobulin G* ; Nephelometry and Turbidimetry ; Prevalence ; Reference Values ; Respiratory Tract Infections

OBJECTIVE: Rheumatoid factor (RF) is used as one of the criteria for the diagnosis of rheumatoid arthritis (RA). Nephelometers are widely used in laboratories to quantitatively measure RF. In nephelometric ways of measurement, there are endpoint nephelometry and rate nephelometry. BN II System (BN II) (Dade Behring Marburg GmbH, USA) is a well known endpoint nephelometer while IMMAGE System (IMMAGE) (Beckman Coulter, USA) is a well known rate nephelometer. We compared these two automatic nephelometric analyzers to evaluate which method shows the best results. METHODS: We measured RF (n=195) using the two machines. We evaluated the correlation between BN II and IMMAGE. We compared the results of BN II with those of IMMAGE in terms of interference and clinical usefulness. RESULTS: The correlation coefficient (r) of RF was 0.9310 (p<0.0001). We could not find any significant interference for BN II with high concentration of triglyceride or bilirubin, but IMMAGE showed significant interferences with high concentrations of triglyceride and bilirubin. The sensitivity and specificity of BN II for the diagnosis of RA were 90.3% and 82.4%. Those of IMMAGE were 86.1% and 74.5%. CONCLUSION: BN II was enough to satisfy the analytical features and it showed better results than IMMAGE. We expect BN II, the endpoint nephelometer, to be the best equipment in measuring RF for diagnosis of RA.
Arthritis, Rheumatoid ; Bilirubin ; Diagnosis ; Nephelometry and Turbidimetry ; Rheumatoid Factor* ; Sensitivity and Specificity ; Triglycerides

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

OBJECTIVETo determine bacterial endotoxin in the replacement solution of on-line hemodiafiltration (on-line HDF) using kinetic turbidimetric limulus test.

METHODS AND RESULTSValidation test was performed with the replacement solution of on-line HDF in which quantified standard endotoxin was added. The recovery rates of endotoxin from the replacement solution and its dilutions at 1/5, 1/10, and 1/20 were 58.17%, 106.7%, 99.00% and 98.79%, respectively, suggesting that the optimal dilution was at 1/10. Standard endotoxin was added into the replacement solution of on-line HDF of 3 batches (040408, 040511,040527), and the recovery rates in their dilution at 1/10 were 76.32%, 99.00% and 96.24%, respectively. The standard endotoxin in the working curve was 1.00, 0.125, and 0.0156 Eu/ml (endotoxin unit/ml), and the dilution at 1/10 of the replacement solution is effective to eliminate the interference in limulus test.

CONCLUSIONKinetic turbidimetric limulus test provide a means to detect endotoxin in the replacement solution of on-line HDF.

Endotoxins ; analysis ; Hemodiafiltration ; methods ; Hemodialysis Solutions ; analysis ; Humans ; Kinetics ; Limulus Test ; Nephelometry and Turbidimetry ; methods

BACKGROUND: The serologic tests for syphilis infection have been performed manually, but the procedures are time-consuming and interpretations may be subjective. Recently, automated assays were developed for rapid and efficient testing for syphilis infection. In this study, we evaluated the performances of IMMUNOTICLES Auto3 RPR and Auto3TP (A&T Corporation, Japan) using latex agglutination turbidimetry method. METHODS: Using 236 serum samples referred for syphilis at Ewha Womans University, Mokdong Hospital, between March 2004 and April 2007, we evaluated precision, linearity, detection limit and compared with the results of manual serologic tests, RPR (RPR card test, ASAN Pharmaceutical, Korea) and TPHA (ASAN-TPHA, ASAN Pharmaceutical). RESULTS: The within-run and between day precisions of Auto3RPR and Auto3TP were from 2.1% to 4.8%. The linearity was good up to 5.0 RU for Auto3RPR and to 250 TU for Auto3TP. Agreement of Auto3RPR with RPR was 65.7% (155/236) and 32.6% of patients (77/236) were RPR positive and Auto3RPR negative. RPR titers were less than 1:8 in 99% of these discrepant samples (76/77) and 65% (50/77) were latent infection and the others were false positive (32%, 27/77). Agreement of Auto3TP with TPHA was 97.1%. CONCLUSIONS: IMMUNOTICLES Auto3RPR and Auto3TP may be useful for rapid and efficient testing for syphilis. However, discrepant results were present in patients with low titer RPR positivity and method of reporting shoud be considered in individual clinical situation. In addition, linear range was not wide and further study is needed for reporting of quantitative results.
Agglutination ; Automation ; Chungcheongnam-do ; Female ; Humans ; Latex ; Limit of Detection ; Nephelometry and Turbidimetry ; Serologic Tests ; Syphilis*

PURPOSE: Measurement of antistreptolysin O (ASO) is often necessary to confirm a clinical diagnosis of recent streptococcal infection, especially in patients suspected of rheumatic fever and acute glomerulonephritis. Standard normal ranges for ASO should be established locally for each age group. We analyzed ASO to determine the upper limit of normal (ULN) ASO in children in the Gyeonggi-Incheon area. METHODS: ASO in normal individual concentrations were measured quantitatively by nephelometry on sera from 753 children (Male:381, Female:372). ULN were determined by separating the upper 20% from the lower 80% of the group (80 percentile). RESULTS: The mean ASO concentration calculated in a total cases was 149.9+/-7.2 IU/mL. The ASO concentration in neonates was 83.4+/-10.7 IU/mL, and lowest in the 1 year of age group, 26.7+/-6.6 IU/ mL, and increased to 318.0+/-33.2 IU/mL gradually in the 9 years of age group. Thereafter, ASO concentration decreased. The ULN for neonates was 122 IU/mL, for 0-3 years, 40 IU/mL; for 4-6 years, 113 IU/ mL; for 7-9 years, 489 IU/mL; for 10-19 years, 433 IU/mL; for 20-29 years, 122 IU/mL. CONCLUSION: The age-specific ULN for children in the Gyeonggi-Incheon area were determined. The distribution of ASO concentration according to age groups was different from previous reports. These results should be of clinical value to physicians to interprete the ASO results of their patients.
Antistreptolysin* ; Child* ; Diagnosis ; Glomerulonephritis ; Humans ; Infant, Newborn ; Nephelometry and Turbidimetry ; Pediatrics ; Reference Values ; Rheumatic Fever ; Streptococcal Infections