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ABSTRACT BACKGROUND: Computer-aided diagnosis in low-dose (≤ 3 mSv) computed tomography (CT) is a potential screening tool for lung nodules, with quality interpretation and less inter-observer variability among readers. Therefore, we aimed to determine the screening potential of CT using a radiation dose that does not exceed 2 mSv. OBJECTIVE: We aimed to compare the diagnostic parameters of low-dose (< 2 mSv) CT interpretation results using a computer-aided diagnosis system for lung cancer screening with those of a conventional reading system used by radiologists. DESIGN AND SETTING: We conducted a comparative study of chest CT images for lung cancer screening at three private institutions. METHODS: A database of low-dose (< 2 mSv) chest CT images of patients at risk of lung cancer was viewed with the conventional reading system (301 patients and 226 nodules) or computer-aided diagnosis system without any subsequent radiologist review (944 patients and 1,048 nodules). RESULTS: The numbers of detected and solid nodules per patient (both P < 0.0001) were higher using the computer-aided diagnosis system than those using the conventional reading system. The nodule size was reported as the maximum size in any plane in the computer-aided diagnosis system. Higher numbers of patients (102 [11%] versus 20 [7%], P = 0.0345) and nodules (154 [15%] versus 17 [8%], P = 0.0035) were diagnosed with cancer using the computer-aided diagnosis system. CONCLUSIONS: The computer-aided diagnosis system facilitates the diagnosis of cancerous nodules, especially solid nodules, in low-dose (< 2 mSv) CT among patients at risk for lung cancer.
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【Objective】 To verificate the performance of enzyme-linked immunosorbent assay (ELISA) in blood screening laboratory. 【Methods】 The repeatability, precision, sensitivity, specificity, compliance, detection limit and anti-interference of ELISA items in the laboratory detection system were verified. 【Results】 The repeatability was 100%.The intra batch imprecision of each system was less than 10%, and the inter batch imprecision was less than 15%. The sensitivity, specificity and compliance were 100%, with the minimum detection limits of the two reagents at 0.75 NCU/mL and 0.25 NCU/mL respectively, The anti-interference met the requirements of the reagent manual. 【Conclusion】 The analysis of the performance verification data of ELISA test items will help continuously improve the performance of detection system and ensure the safety of clinical blood use.
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Objective:To explore the feasibility of using the sigma metrics calculated with the data of internal quality control for the comparison of the analytical performance between different biochemical analyzers.Methods:The internal quality control results of twenty-five biochemical assays in the biochemical analyzers of the department of clinical laboratory in Cancer Hospital from February 1, 2021 to July 31, 2021 were collected. The formula sigma =( TEa- Bias)/ CV was used to calculate the sigma metrics of two different levels of the biochemical assays including albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, cholesterol, creatine kinase, chlorine, creatinine, γ- glutamyltranspeptidase, blood glucose, high density lipoprotein cholesterol, immunoglobulin A, immunoglobulin G, immunoglobulin M, potassium, lactate dehydrogenase, low density lipoprotein cholesterol, sodium, inorganic phosphorus, total bilirubin, triglyceride, total protein, urea, uric acid. The imprecision was obtained by the coefficient of variation of internal quality control. The bias was calculated by the deviation between the mean of internal quality control of the comparison instrument and the target instrument. The allowable total error ( TEa) was based on People's Republic of China Health Industry Standard (WS/T403-2012) or EQA standard of National Center for Clinical Laboratories (NCCL). Compared the sigma values of the comparison instrument relative to the target instrument with the average percentage bias obtained by the traditional comparison method. Quality goal index was used to analyze the causes of poor performance and judge the results of comparison. Results:Compared with the target instrument Beckman AU5800-3, the comparison instrument Beckman AU5800-1 had 10 assays with σ>6, accounting for 40%, 23 assays with σ>3, accounting for 92%, and only albumin and blood glucose showed σ<3. Through statostical analysis, the comparisons of all assays were passed. The comparison instrument Beckman AU5800-2 had 8 assays with σ>6, accounting for 32%, 20 assays with σ>3, accounting for 80%. Only alkaline phosphatase, calcium, lactate dehydrogenase, total protein and urea showed σ<3. Through statostical analysis, the comparisons of GGT and IgM failed. For the traditional comparison method, the percentage bias between the comparison instruments and the target instrument were all within the range of the evaluation standard. But there was no significant correlation between the σ value and the average bias of the traditional comparison method, and the biases were correlated.Conclusions:Using the sigma metrics calculated with the data of internal quality control for the comparison of different detection systems is a convenient and operable method. It can monitor the comparability between different detection systems in the laboratory at any time and be the supplement of the traditional comparison method.
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Objective:To explore the performance of the commonly used whole blood C-reactive protein (CRP) detection systems and give related recommendation on the performance requirements of detection systems.Methods:A total of 7 540 venous blood samples from 26 maternal, child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019. The blank check, carryover, repeatability, intermediate precision, linearity, sample stability, influence of hematocrit/triglyceride/bilirubin, comparison with SIEMENS specific protein analyzer and trueness were evaluated. The 5 systems included BC-5390CRP autohematology analyzer, AstepPLUS specific protein analyzer, Ottoman-1000 Automated Specific Protein POCT Workstation, i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument. The 5 systems were labeled as a, b, c, d and e randomly.Results:Within the 5 systems, all values of blank check were less than 1.00 mg/L, the carryovers were lower than 1.00%. The repeatability of different ranges of CRP concentrations including 3.00-10.00, 10.00-30.00 and>30.00 mg/L were less than 10.00%, 6.00% and 5.00%, respectively, and the intermediate precision was less than 10.00%. The linearity correlation coefficients of the 5 systems were all above 0.975, while the slope was within 0.950-1.050. Whole blood samples were stable within 72 hours both at room temperature (18-25 ℃) and refrigerated temperature (2-8 ℃). The CRP results were rarely influenced by high triglyceride or bilirubin, except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab) 2 fragments. When triglyceride was less than 15.46 mmol/L, the deviation of CRP was less than 10.00%. When bilirubin was less than 345.47 μmol/L, the deviation of CRP was less than 10.00%. CRP was more susceptible to Hct on the systems without Hct correction. The deviation of CRP between different Hct dilution concentration and 40% dilution concentration can reach as high as 67.48%. The correlation coefficients ( r) of 5 systems were all more than 0.975 in the range of 0-300.00 mg/L compared with Siemens specific protein analyzer. All systems passed the trueness verification using the samples with specified values of 12.89 and 30.60 mg/L. Conclusion:The performance of 5 systems can basically meet the clinical needs, but it is suggested that the whole blood CRP detection system without automatic Hct correction should be modified manually.
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Aiming at the ECG performance indicators in the YY 0885-2013 "Medical electrical equipment Part 2: Particular requirements for the safety including essential performance of ambulatory electrocardiographic systems", the traditional detection methods are time-consuming and the test results are greatly affected by human factors. In this paper, an automated detection method is proposed. A set of automatic detection software for ECG performance is designed and developed based on a single-channel ECG recorder, and an automated detection system is set up in combination with standard testing equipment. And then, the MSA tool is used to analyze the repeatability and stability of the detection system, and the results show that the detection system is acceptable, and it can improve detection efficiency.
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Humans , Electricity , Electrocardiography , Electrocardiography, Ambulatory , SoftwareABSTRACT
Aiming at the low efficiency and low quality detection level of the manual infusion set, a gas detection system for infusion set based on STM32 single-chip microcomputer was designed. The detection system includes hardware system design and software system design. The hardware system is based on the STM32F103 single-chip microcomputer. It mainly designs the gas pressure sensor acquisition circuit and the multi-way solenoid valve control circuit. The software system uses a C ++ real-time operating system to ensure system monitoring's real-time performance and validity. Test data is transmitted to the upper computer and displayed via USB serial communication. The experiment proves that the infusion set gas detection system can perform gas detection on the infusion set. The system has the characteristics of stability and high accuracy. The relative error of the experimental measurement is within ±5%, and the detection efficiency is better than manual detection.
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Computers , Equipment Design , Microcomputers , SoftwareABSTRACT
【Objective】 To validate the performance of enzyme-linked immunosorbent assay (ELISA) for the detection of antigens and antibodies for blood-borne diseases, so as to meet the requirements of blood screening laboratories. 【Methods】 The reproducibility, precision, sensitivity, specificity, conformance and detection limit of ELISA reagents under different detection procedures were verified according to relevant standards and reagent instructions. 【Results】 The performance verification results of the test procedures were in line with the relevant standards and laboratory requirements. 【Conclusion】 The performance of ELISA method can meet the relevant standards and requirements, as well as the application requirements of the laboratory. Through the analysis and comparison of the performance verification data, the blood screening laboratory can better understand the performance indicators of the detection system, continuously improve the performance of the detection system, and ensure the safety of clinical blood use.
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@#Automated microbial detection system (AMDs) are design to detect early growth of bacterial and fungal. We herein report a rare case of false positive blood culture by AMDs in Plasmodium falciparum infection. A 41-year-old previously healthy lady, with recent history of travelling to Lagos, Nigeria had presented to the casualty with history of fever and lethargy for three days. There was no malaria prophylaxis taken prior to the travelling history. Peripheral blood smear confirmed the presence of young trophozoite of Plasmodium falciparum with parasitemia of 7%. Concurrent blood culture sent was positive, however all subcultures were negative for any growth. She was treated with intravenous artesunate however succumbed to death on the day of admission due to severe falciparum infection complicated with multiorgan failure and shock. The aim of this report is to highlight, the circumstances that can trigger the false positive AMDs detection and the possible underlying mechanism.
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Objective@#To analyze the comparability of different detection systems and methods for tumor markers (TM) by reviewing the results of TM external quality assessment (EQA) in Shandong province during 2015 and 2017. @*Methods@#The results of TM EQA from the Shandong Provincial Clinical Laboratory Center during 2015 and 2017 were collected, and grouped by the detection system or method. After outliers were removed by the CLInet EQA software, the mean and coefficient of variation (CV) in each group were calculated with median as the target value. The difference of TM results in different detection systems were compared by the Kruskal-Wallis H test. @*Results@#Taking alpha-fetoprotein (AFP) as an example, the average CV of different detection methods of TM EQA during 2015 and 2017 ranged from small to large in order of microparticle enzyme immunoassay, electrochemiluminescence, acridine ester chemiluminescence and chemiluminescence. The trends of CV of the other tumor markers were similar to AFP. The average CV of individual marker in electrochemiluminescence group was lower than that in microparticle enzyme immunoassay group. The intra-group CVs of imported detection systems such as Roche, Beckman etc. were relatively ideal, and the average CVs of most tumor markers were less than 10%. However, the intra-group CVs of domestic detection systems such as Shenzhen Snibe, Zhengzhou Autobio etc. were not ideal, and the average CVs of most tumor markers were more than 10%. The target values of different detection systems varied with different items and batches, and there were great variation in carbohydrate antigen (CA) series. @*Conclusion@#The results of TM detected by the same automatic detection system are comparable. However, the results of TM detected by most different detection systems and methods are not comparable.
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Objective To verify the analytical performance of Hitachi 7600-210automatic biochemical analyzer detection system.Methods The precision, accuracy, linearity and clinical reportable range, limit of quantitative detection and anti-interference capability were validated according to Clinical and Laboratory Standards Institute (CLSI) documents (EP15-A3and EP17-A2) and Clinical Laboratory Improvement Amendment 1988 (CLIA′88) standards.Results The within precisions of high and low two concentrations were both less than1/4CLIA′88TEa (laboratory permissible total error), the day precisions were less than 1/3CLIA′88TEa, the pass rates of three external quality assessments in 2017 were all not less than 80％and range from 0.02mmol/L to 401.80mmol/L.The clinical reportable was ranged from 0.02to 401.80mmol/L with a linear relationship.The LoB, LoD and LoQ of glucose (GLU) detection were 0.01 mmol/L, 0.03 mmol/L and 0.08mmol/L respectively.The anti-interference capability to hemoglobin (Hb), vitamin C (VitC), bilirubin (BIL) and triglyceride (TG) in the detection system to GLU measurement were in accordance with the manufacturer′s statement.Conclusion Performance verification of Hitachi 7600-210automatic biochemical analyzer detection system to GLU detection is consistent with the manufacturer statement also in accordance with CLIA′88standards, which can meet the expectant use of clinical test.
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Objective To establish an auditory evoked potential (AEP) detection system in zerbafish.Methods The AEP detection tank was designed and made, and then verified for its quality and reliability via four experiments: anesthesia experiment, swim bladder deflation, noise exposure and goldfish AEP test.Finally, zebrafish (total length form 10 mm to 46 mm) were determined using this system for AEP.Zebrafish randomly were divided into five groups according to total length (TL=12~15 mm, n=6;TL=17~20 mm,n=4;TL=22~26 mm, n=4;TL=32~37 mm, n=9;and TL=42~46 mm,n=12).Goldfish, as control group, were purchased for local petshop (TL=38~54 mm,n=8).Results The results of these four verifying experiments confirmed the biological, rather than artefactual, nature of the responses represented by the recorded waveforms.The AEPs were detected up to a much higher frequency limit (12 kHz) than previously reported.In this study, all fish demonstrated a range of hearing frequency from 100 Hz to 12 kHz without frequency expansion during development.The best hearing was observed at 600 Hz~1 kHz.The mean values of the frequency-averaged thresholds (mean SEM) were 141.7±1.32, 124.8±1.31, 121.8±1.49, 117.8 ±1.09 and 124.4±1.87 dB w, respectively, for the 5 TL groups.The AEP thresholds demonstrated both developmental improvement and age-related loss of hearing sensitivity.Conclusion An auditory evoked potential detection system of zerbafish has been established with stable performance and can be used for AEP detection of zebrafish.
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Objective To explore the differences of using different analytic quality requirements in the comparable validation of blood cell analysis multi-system range test comparable schemes for establishing appropriate analysis quality standards for laboratory.Methods According to WS/T 407-2012 Guideline for Comparability Verification of Quantitative Results in Medical Institution,the range test comparable method was established.According to different sources of analytic quality requirements from the WS/T 406-2012 Analysis Quality Requirements of Clinical Hematological Detection Routine Items,the US Clinical Laboratory Improvement Amendment (88),GB/T 20470-2006 Requirements of External Quality Assessment for Clinical Laboratories and biological variations,corresponding analysis quality requirements standard was designed.Results With the standards designed by using WS/T 406-2012,CLIA′-88 and GB/T 20470-2006 as the analysis quality requirements,only the comparison results of low concentration levels in 3 items of HBC,PLT and HCT were not passed,while other results all were passed;all results passed the consistency verification by suitably revising the analytic quality requirements of low value concentrations.With the biological variations as the analysis quality requirement,the comparison results in WBC three concentration levels,and HBG high and low concentration levels were passed,but other results were not passed.Conclusion The biological variations analytical quality requirements are relative demanding.Using WS/T 406-2012 Analysis Quality Requirements of Clinical Hematological Detection Routine Items and GB/T 20470-2006 Requirements of External Quality Assessment for Clinical Laboratories,fully considering the suitability of low concentration quality requirements and formulating appropriate analysis quality standards of laboratory are the important contents of laboratory comparable validation scheme.
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Objective To evaluate the clinical application value of Xpert detection system of Clostridium difficile (C.difficile).Methods A total of 43 stool specimens from the patients with diarrhea were collected,and C.difficile in stool specimens were detected by the Xpert detection system,the toxigenic culture method,and the toxin detection method which detected the toxin of C.difficile by VⅥDAS automatic analyzer after anaerobic culture,respectively.The analytic performance of Xpert detection system was evaluted based on the toxigenic culture method as the gold standard.Meanwhile,the consistency of the results from different detection methods was compared.The ribotype 027 strain (ATCC BAA-1870) simulating the stool specimen was further used to verify the Xpert detection system.Results Based on the gold standard of the toxigenic culture method,the sensitivity,specificity,positive predictive value and negative predictive value of the Xpert detection system were 90.9％,93.8％,83.3％ and 96.8％,respectively.The Kappa values for the consistency between the Xpert detection system and the toxigenic culture method or the toxin detection method were 0.822 (P ＜ 0.05) and 0.419 (P ＜ 0.05),respectively.Moreover,the ribotype 027 strain simulating the stool specimen was verified by the Xpert detection system successfully.Conclusion The Xpert detection system may rapidly and accurately detect the C.difficile in stool specimens,especially the ribotype 027 strain with high toxicity.
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Objective To evaluate clinical performance on dry chemistry method of Vitros 350 for the determination of serum bilirubin in order to ensure the quality of examination.Methods Evaluation protocols were employed to evaluate the precision,the trueness and the linearity of total bilirubin(TBIL),unconjugated bilirubin (Bu)and conjugated bilirubin (Bc)by dry chemistry method,to verify the reference ranges of TBIL,Bu and Bc simultaneously.Results The precision and trueness of TBIL,Bu and Bc were within the allowable ranges of Clinical and Laboratory Ltandards Institute (CLSI).The linear range of TBIL,Bu and Bc in our laboratory were 6.57-428.83 μmol/L,4.5-320.1 μmol/L and 4.5-364.9 μmol/L respectively.Conclusion Both technical per-formance evaluation and diagnostic performance verification of bilirubin by dry chemical detection system could meet the needs of the clinic.
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Objective To investigate the different biochemical testing system inter laboratory comparability of results,provide reference for promoting inter laboratory test results of the recognition.Methods Five patients with laboratory detection of fresh mixed serum,20 consecutive determination of 10 biochemical items,precision analysis.According to America clinical and Laboratory Standards Institute (CLSI)Document EP9-A2,the Panzhihua Iron and Steel Group General Hospital detec-tion system as the reference system,the remaining four hospital detection system as the detection system,with a fresh mixed serum,determination of five biochemical items (Urea,Cr),(AST,ALT),(TP,ALB),(TG,TC)and (HDL-C,LDL-C),the determination results were compared and analyzed,calculated reference system and the correlation coefficient,linear regres-sion equation between the system and the various medical decision level relative deviation (SE%),and to America Clinical Laboratory Improvement Amendment ability test (CLIA’88)allowed total error of 1/2 as the standard,to the assessment system and the reference system between the comparability and clinical acceptability.Results In Urea,Cr determination for example,CV of five laboratories on Urea and Cr two project was less than CLIA’88 allowed total error of 1/3,the precision could meet the clinical requirements.The detection results significantly correlated (r2 >0.975).The evaluation of clinical ac-ceptability,in Urea low at medical decision level,there were two laboratory determination results that could not be accepted for clinical.In Urea high at medical decision level,there was a laboratory measurement result that could not be accepted for clinical.In the low Cr at medical decision level,there were two laboratory determination results that could not be accepted for clinical.The rest of the system Urea,Cr projects in various medical decision level compared with the system,the SE% was less than CLIA’88 allowed total error of 1/2,for clinical acceptable.Conclusion Laboratory determination results between different biochemical testing system had bias in different degrees,bias part of the project exceeds the allowed error range.
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Objective: Through the introduction of the application background of ATP bioluminescence detection system, the technical principle and the factors of ATP bioluminescence detection system should be taken into account in the procurement, prompted the personnel understand the necessity of ATP bioluminescence detection system using, help procurement staffs purchasing suitable ATP bioluminescence detection system. Methods: introduces the application of ATP bioluminescence detection system background, technical principle and ATP bioluminescence detection system detection accuracy related factors, and gives reasonable purchase suggestions. Results:Improved procurement staffs’ understand to ATP bioluminescence detection system. Conclusion:ATP bioluminescence detection system as a new kind of detection system, with high sensitivity, simple and quick operation, become auxiliary tool of the various departments to conduct self-detection, hospital infection management department to check, understand the principle of technology of ATP bioluminescence detection system and ATP bioluminescence detection system detection accuracy related factors to help procurement staffs purchase the most suitable ATP bioluminescence detection system for clinical.
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Objective To evaluate the comparability of the detection results of different blood cells analysis systems in same hos-pital.Methods Referring to the Guideline for Comparability Verification of Quantitative Test Results in Medical Institutions,the comparability validation protocol was established.The EDTA-K2 anticoagulation fresh whole blood samples with proper concentra-tion were detected for 5 parameters of HGB,RBC,HCT,PLT and WBC by 4 systems (Sysmex XT-1800i,Sysmex XT-2000,Sys-mex XT-4000i and Mindray BC-5800).The range was calculated and the detection results consistency analysis was performed.Re-sults The acceptable standard of critical differentials was intended to be HGB3.5%,RBC3%,HCT3%,PLT12.5% and WBC 7.5%.The replication detection was at least 2 times and up to 5 times.The ranges of 3 concentrations after replication detection and sample comparison were 2.87%-6.29%,1.57%-2.99%,1.95%-4.77%,12.81%-25.74% and 6.72%-11.13% respective-ly.The ranges of RBC detection results in 4 systems were smaller than the critical differentials,the validation was passed.The ran-ges of HGB,HCT,PLT and WBC detection results in 4 systems all had the condition of more than the critical differentials,the vali-dation did not passed.After removing the test system with obvious bias,the validation of the detection results by other test systems was passed.Conclusion The RBC detection results by 4 systems have the comparability;the HGB,HCT and PLT detection results by Sysmex XT-1800i,Sysmex XT-2000i and Sysmex XT-4000i have the comparability;the WBC detection results by Sysmex XT-1800i,Sysmex XT-2000i and Mindray BC-5800 have the comparability.
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Objective To analysis of the thyroid hormone test results of Abbott Architect ci16200 automatic biochemical-im-mune analyzer (Abbott system) and Roche Cobas e601 automated immunoassay analyzer (Roche system) .Methods The thyroid hormone(including T4 ,FT4 ,T3 ,FT3 ,TSH ) levels of 93 cases of serum samples were respectively detected by Abbott system (CMIA) and Roche system (ECLIA) ,and the results were analyzed .Results The thyroid hormone test results of the two systems had a good correlation ,and the coefficients of T4 ,FT4 ,T3 ,FT3 ,and TSH were 0 .960 ,0 .962 ,0 .976 ,0 .900 ,and 0 .999(P<0 .01) . However ,there were significant difference of the detection results of the two systems(P<0 .05) .Conclusion The thyroid hormone test results of Abbott system and Roche system are not comparable .
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Objective To evaluate the of feasibility of Roche e601 for detecting hepatitis B virus surface antigen(HBsAg).Meth-ods To evaluate the feasibility of Roche e601 for detecting hepatitis B virus surface antigen(HBsAg).Results The coefficient of variation(CV)of inter-run and between-run from low and high value specimens was lower than the requirements of manufacturers;the negative and positive coincidence rates in detecting 60 external quality assessment controls were 100%(40/40)and 100%(20 /20),respectively;the detection threshold values of the system was 0.01 IU/mL;the results detected by this detecting system in 40 samples,in which the concentration of HBsAg was 0.8
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Objective To develop a candidate reference method for the determination of serum creatinine and to evaluate the ac-curacy of conventional detection systems though method comparison to achieve traceability .Methods The candidate reference method was established according to the sarcosine oxidase and the accuracy and reliability of the method was verified through par-ticipation in international reference laboratories EQA activities (IFCC-RELA) .20 fresh single human serum samples with different concentration and calibrator were simultaneously measured by using conventional detection system and candidate reference method . Results The calibration curve for serum creatinine was linear in the concentration range from 50-2 000 μmol/L with a correlation coefficient of 0 .999 9 under the optimum experimental conditions (the linear equation was Y=0 .000 884 2X-0 .000 325 3) and the imprecision was less than 1 .0% .The proposed method has been applied to the determination of RELA samples with satisfactory re-sults .The measured results with conventional detection systems were consistent with candidate reference method ,and the slope of the regression equation was 1 .005 6 .Conclusion The candidate reference method of serum creatinine is successfully established and which can be used for traceability and standardization .It may provide an effective way for conventional detection system traceable to the reference method or reference material .