In this paper the system structure The automatic biochemistry analyzer is a necessary instrument for clinical diagnostics. First of is analyzed. The system problems description and the fundamental principles for dispatch are brought forward. Then this text puts emphasis on the modeling for the automatic biochemistry analyzer control system. The objects model and the communications model are put forward. Finally, the implementation method is designed. It indicates that the system based on the model has good performance.
Autoanalysis ; instrumentation ; methods ; Biochemistry ; instrumentation ; methods ; Equipment Design ; Models, Theoretical

BACKGROUND: We evaluated the performance and false positive rate of Mediace RPR test (Sekisui, Japan), a newly introduced nontreponemal test using a chemistry autoanalyzer. METHODS: The sensitivity of Mediace RPR test was analyzed using sera from 50 patients with syphilis in different stages (8 primary, 7 secondary, and 35 latent), 14 sera positive with fluorescent treponemal antibody absorption (FTA-ABS) IgM, and 74 sera positive with conventional rapid plasma regain (RPR) card test (Asan, Korea) and also positive with Treponema pallidum hemagglutination (TPHA) test or FTA-ABS IgG test. The specificity was analyzed on 108 healthy blood donors. We also performed RPR card test on 302 sera that had been tested positive with Mediace RPR test and also performed TPHA or FTA-ABS IgG test to analyze the false positive rate of Mediace RPR test. A cutoff value of 0.5 R.U. (RPR unit) was used for Mediace RPR test. RESULTS: Mediace RPR test on syphilitic sera of different stages (primary, secondary, and latent stages) and FTA-ABS IgM positive sera showed a sensitivity of 100%, 100%, 82.9% and 100%, respectively. Among the 74 sera positive with conventional RPR card test and TPHA or FTA-ABS IgG test, 55 were positive with Mediace test. The specificity of Mediace RPR test on blood donors was 97.2%. Among the 302 sera positive with Mediace RPR test, 137 sera (45.4%) were negative by RPR card and TPHA/FTA-ABS IgG tests. CONCLUSIONS: Although the sensitivities of Mediace RPR were good for primary and secondary syphilis, due to its high negative rate of Mediace RPR over the conventional RPR positive samples, further studies are necessary whether it can replace conventional nontreponemal test for screening purpose. Moreover, in view of the high false positive rate, positive results by Mediace RPR test should be confirmed with treponemal tests.
Autoanalysis/methods ; False Positive Reactions ; Humans ; ROC Curve ; Sensitivity and Specificity ; Syphilis/*diagnosis ; Syphilis Serodiagnosis/*methods

OBJECTIVETo evaluate the application of XT-4000i automatic blood cell analyzer in white cell count and classification of cerebrospinal fluid (CSF).

METHODSThe fluid model of XT-4000i automatic blood cell analyzer was directly used to detect the white cell count and classification in 200 samples of CSF, and compared with the results obtained by manually microscopic counting method. White blood cell classification was performed by manual method under microscope with Wright's staining,and instrumental method with fluorescence staining and flow cytometry.

RESULTSThere is no statistical difference between instrumental and manual method in detecting the absolute counting of WBC, RBC, mononuclear cell and multinucleate cells (P>0.05), and there is a good correlation between the two methods (r=0.987, 0.999, 0.981 and 0.983 for WBC, RBC, mononuclear cell and multinucleate cell counts). Tumor cells in the samples with high fluorescent staining by instrumental method can be identified with Wright's staining by microscope method, which were consistent with the clinical diagnosis.

CONCLUSIONThe fluid model of XT-4000i automatic blood cell analyzer was rapid and accurate in CSF white cell count and classification,and it also can provide preliminary information for tumor cells screening. The fluid model of XT-4000i automatic blood cell analyzer in white cell count and classification of CSF has the value of popularization in clinical application.

Autoanalysis ; instrumentation ; methods ; Cerebrospinal Fluid ; cytology ; Humans ; Leukocyte Count ; instrumentation ; methods ; Leukocytes ; classification

BACKGROUND: Microscopic examination of urine sediment is one of the most commonly performed tests in the clinical laboratory. However, manual microscopic sediment examination is labor-intensive, time-consuming and imprecise. In this study, we evaluated the analytical performance and clinical usefulness of a recently introduced image-based automated urinalysis system, Iris iQ200 (Iris Diagnostics, USA). METHODS: We assessed the iQ200 for linearity, precision and carryover rate using patient's samples and quality control materials. On 337 urine samples, urine sediment analyses performed by the iQ200 were compared with manual microscopy results. RESULTS: The iQ200 showed a good linearity (r2>0.99) for all cellular components analyzed. Within-run and total CVs on urine specimens and quality control samples were less than 10% except for within-run CV for the samples with low concentration of the squamous epithelial cells. The carryover rates were 0.21% for RBCs and 1.92% for WBCs. The agreement rates within one grade between the iQ200 and manual microscopy for RBCs, WBCs, and squamous epithelial cells were 93.8%, 94.2% and 96.9%, respectively. CONCLUSIONS: Since the iQ200 showed a reliable analytical performance and good concordance with manual microscopy, it could be useful in the clinical practice as a screening procedure.
Autoanalysis/methods ; Humans ; Quality Control ; Sensitivity and Specificity ; Urinalysis/*instrumentation ; Urine/*cytology/microbiology

OBJECTIVETo investigate the influence of serum storage on the laboratory results of serum T-PSA, F-PSA and FPSA%.

METHODSUsing automated chemiluminescence, we detected and compared the values of serum T-PSA, F-PSA and F-PSA% in the serum stored in different conditions.

RESULTSWhen the serum was stored at 4 degrees C or at the room temperature (22 - 26 degrees C), FPSA was unstable as compared with T-PSA. Compared with the initial value, after 4 hours at the room temperature, F-PSA was decreased to (0.392 +/- 0.246) microg/L (P < 0.01), while T-PSA and F-PSA% to (1.522 +/- 1.085) microg/L and (25.03 +/- 5.94)%, respectively, with no significant difference; after 8 hours at the room temperature, T-PSA and F-PSA were reduced to (1.513 +/- 1.083) and (0.389 +/- 0.247) microg/L (P < 0.05 and P < 0.01). At 4 degrees C, T-PSA, F-PSA and F-PSA% were decreased to (9.418 +/- 7.965) microg/L, (2.168 +/- 1.558) micro/L and (26.6 +/- 6.63)%, respectively, after 2 days (P < 0.05), and to (9.203 +/- 7.736) microg/L, (2.047 +/- 1.478) microg/L and (25.64 +/- 6.56)% after 1 week (P < 0.01). At -40 degrees C, T-PSA, F-PSA and F-PSA% were (4.532 +/- 4.393) microg/L, (1.178 +/- 1.034) microg/L and (24.45 +/- 8.81)% after 4 weeks. When the serum was stored at -40 degrees C and after 3 freeze-thaws, F-PSA and T-PSA were (5.982 +/- 5.314) and (1.341 +/- 1.029) microg/L, respectively, with no significant difference from the initial values.

CONCLUSIONDifferent conditions of serum storage have different influences on the laboratory results of serum TPSA, F-PSA and F-PSA%, more on F-PSA than on T-PSA, while F-PSA% is relatively stable. At -40 degrees C, T-PSA and F-PSA may remain stable for a month at least. Repeated freeze-thaws of the serum do not affect the laboratory results of F-PSA and T-PSA.

Autoanalysis ; Blood Preservation ; methods ; Humans ; Male ; Prostate-Specific Antigen ; blood ; Serum ; Temperature

BACKGROUND: The performance of Cell-Dyn Sapphire (Abbott Diagnostic, USA) was compared to the Bayer Advia 2120 (Bayer Diagnostics, USA), Sysmex XE-2100 (Sysmex Corporation, Japan), and reference microscopy. METHODS: Three hundred samples for routine CBC and WBC differentials were randomly chosen for a comparison analysis. The Cell-Dyn Sapphire system was evaluated according to the linearity, imprecision, inter-instrument correlations, and white blood cell differential. RESULTS: The CBC parameters (WBC, RBC, hemoglobin and platelet) showed a significant linearity with correlation coefficients greater than 0.99 (P<0.0001). Coefficients of variation (CV) for withinrun and differential count of WBC were less than 5% except for Total CV for monocytes, eosinophils, and basophils and within-run CV for low valued eosinophils. The correlation coefficients with manual count were lower in monocytes, eosinophils, and basophils than in neutrophils and lymphocytes. The correlation with other hematology anlayzers was significant exclusive of basophils. CONCLUSIONS: These results demonstrate that the Cell-Dyn Sapphire has a good linearity, an acceptable reproducibility, a minimal carryover, and a comparable performance with the sysmex XE-2100 and Advia 2120.
Analysis of Variance ; Autoanalysis ; Blood Cell Count/*instrumentation/methods ; Blood Specimen Collection ; Diagnostic Errors ; Humans ; Reproducibility of Results ; Sensitivity and Specificity

OBJECTIVETo evaluate the performance of BNII auto-analyzer system in detecting C3 and C4.

METHODSCLSI protocols (EP15-A, EP6-A, EP9-A2) and other relevant literatures were use to or evaluate the precision, accuracy, linearity of C3 and C4 detection by the auto-analyzer system, and the results were compared with the recognized standards.

RESULTSThe relative bias of C3 and C4 was less than one third of the CLIA'88 standard and the precision met the clinical requirement. The results tested by DADE BNII system were not compatible with those by Roche Modular System. C3 showed good linearity in the tests (R2>0.975, P<0.05) with a linearity range of 0.18-5.1 g/L. The linearity of C4 was not available because of lack of high-level samples.

CONCLUSIONThe performances of DADE BNII System basically meet the recognized standards in clinical detection of C3 and C4, but the method comparison needs further validation.

Autoanalysis ; methods ; Blood Chemical Analysis ; instrumentation ; methods ; Complement C3 ; analysis ; Complement C4 ; analysis ; Humans ; Nephelometry and Turbidimetry ; instrumentation ; methods ; Proteins ; analysis ; Sensitivity and Specificity

OBJECTIVETo investigate the comparison method on internal control of hematology analyzer by using fresh blood.

METHODSThe hematology analyzer with well function was selected as the reference analyzer, fresh blood samples from healthy subjects were measured by reference analyzer and the values were used to calibrate compared hematology analyzers. The acceptable limits of relative deviation of WBC,RBC, HGB,HCT, PLT were established by comparative experiments during three months. The results of fresh blood samples from patients with low/medium/high levels measured by compared analyzer were compared with those from reference analyzer, the relative deviation of WBC, RBC, HGB, HCT, PLT was calculated respectively. The internal quality control charts in laboratory information system were established, with date as x-axis, relative deviation as y-axis. The acceptable relative deviation limits were set to be +/-2 s, and to be used for laboratory quality control.

RESULTThe relative deviation of WBC, RBC, HGB, HCT, PLT with high, medium, low levels were(0.75+/-2.964)%, (1.19+/-2.488)%,(1.43+/-2.439)%; (-0.39+/-1.327)%, (-0.26+/-1.297)%, (-0.35+/-1.095)%û(-0.43+/-1.393)%, (-0.17+/-1.139)%, (0.24+/-1.166)%û(-.43+/-1.362)%, (-0.36+/-1.381)%, (-0.57+/-1.299)%û(-0.93+/-4.330)%,(0.04+/-4.118)%, (-0.41+/-4.149)%, respectively in 2006. As the second instrument, the compared analyzer was involved in College of American Pathologists Proficiency Testing with satisfactory results, the bias of WBC,RBC, HGB, HCT, PLT were within (-0.5 approximately 5.1)%, (-1.0 approximately 1.6)%, (-1.7 approximately 1.4)%, (-1.5 approximately 1.3)%, (-4.5 approximately 7.4)%, respectively.

CONCLUSIONThe quality control on compared hematology analyzer can be effectively, conveniently and economically performed using this method.

Autoanalysis ; methods ; Blood ; Erythrocyte Count ; instrumentation ; Hematology ; instrumentation ; methods ; standards ; Hemoglobins ; analysis ; Humans ; Leukocyte Count ; instrumentation ; Platelet Count ; instrumentation ; Quality Control ; Reference Standards ; Weights and Measures

BACKGROUND: The aim of the study was to establish a new syphilis test algorithm using Architect Syphilis TP (Abbott Japan, Japan: AST), a fully automated treponemal antibody test, as a screening test in a university hospital laboratory. We evaluated performance characteristics of AST in various patient groups. METHODS: A total of 1,357 serum samples obtained from patients at a university hospital from June to August, 2008 were categorized into checkup, preoperative, other diseases, diagnosis (clinically suspected of syphilis), and follow up groups. We compared the results of AST with those of RPR (N=1,276) or Treponema pallidum hemagglutination assay (TPHA, N=81). Samples with discrepant results between RPR or TPHA and AST were retested by fluorescent treponemal antibody absorption test (FTA-ABS) and all patients' clinical records were thoroughly reviewed. RESULTS: The positive rate of AST was significantly higher than that of RPR in preoperative and other diseases groups and was the same as that of RPR in diagnosis group. There were no significant differences in check up and follow up groups. The results of AST showed 97.4% (1,243/1,276) and 97.5% (79/81) concordance rates with those of RPR and TPHA, respectively. Among 26 RPR-AST discrepant and FTA-ABS confirmed cases, there were 20 RPR false-negatives, 4 RPR false-positives, 1 AST false-negative, and 1 AST false-positive. CONCLUSIONS: Based on the results and literature review, we established a new syphilis test algorithm using AST as a screening test, which would be helpful for detection of more syphilis patients including latent infections.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Algorithms ; Autoanalysis ; Child ; Child, Preschool ; False Positive Reactions ; Female ; Fluorescent Treponemal Antibody-Absorption Test/methods ; Hemagglutination Tests/methods ; Humans ; Male ; Middle Aged ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Syphilis/*diagnosis ; Syphilis Serodiagnosis/*methods

In this paper, a new, fully-automatic method for the quantification of brain atrophy based on CT volume data is put forward by taking advantage of the characteristics of cerebral CT images in combination with the prior medical knowledge. This algorithm has been verified through the calculation of 2388 cases of normal and brain atrophy subjects.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Algorithms ; Autoanalysis ; methods ; Brain ; diagnostic imaging ; Child ; Child, Preschool ; Humans ; Infant ; Middle Aged ; Pick Disease of the Brain ; diagnostic imaging ; Tomography, X-Ray Computed ; methods ; Young Adult