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1.
Chinese Journal of Laboratory Medicine ; (12): 853-859, 2023.
Article in Chinese | WPRIM | ID: wpr-995801

ABSTRACT

Objective:To investigate the analytical performance verification protocols and performance specifications of CD34+cell enumeration by flow cytometry for clinical laboratories.Methods:According to international guidelines and National Health Standard of China, we designed the performance verification protocols of CD34 +cell enumeration (including percent count and absolute count) by flow cytometry. Four quality assessment materials, three leukapheresis products and three samples of peripheral blood were selected to verify the precision, linearity, carryover, trueness and accuracy of FACSCanto Ⅱ measurement system, and the assessment criterion was set according to the detection technologies of clinical laboratories. Results:The CVs of intra-run precision of percent count and absolute count were 2.5% to 8.9% and 3.0% to 9.0%; the CVs of inter-run precision were 2.8% to 10.5% and 3.8% to 9.9%, respectively. The slopes of linearity regression equation of low range (3.6/μl to 123.6/μl) and high range (113.2/μl to 1196.3/μl) were 0.993 2 and 0.965 2, and R2 were 0.999 6 and 0.993 9, and the biases were -8.67% to 0.22%. The carryover of percent and absolute count were 0.07% and 0.00%. When percent count≤0.2% or absolute count≤20/μl, the absolute biases of trueness were in the range of ±0.006% or ±0.5/μl, and the absolute biases of accuracy were in the range of ±0.02% or ±0.9/μl; when percent count>0.2% or absolute count>20/μl, the relative biases of trueness were in the range of ±5.65%, and the relative biases of accuracy were in the range of ±8.19%. The verification results met the assessment criterion set in this study. Conclusions:The performance verification protocols and assessment criterion formulated in this study not only conform to the recommendations of domestic and foreign guidelines, but also conform to state of the detection technologies of native clinical laboratories, which can be taken as a reference of performance verification for clinical laboratories.

2.
Chinese Journal of Blood Transfusion ; (12): 830-834, 2023.
Article in Chinese | WPRIM | ID: wpr-1004752

ABSTRACT

【Objective】 To explore the performance verification of the Shengxiang automatic NAT system for HBV DNA, HCV RNA and HIV RNA-1 using PCR-fluorescence in the laboratories of blood stations, in order to meet the requirements of T/CSBT and ensure the quality of nucleic acid detection. 【Methods】 Samples used in the external quality assessment (EQA) of National Center for Clinical Laboratories of the year 2022 were taken to verify the concordance. The standard materials of HBV DNA, HCV RNA and HIV RNA-1 were used to verify the analytical sensitivity, endogenous interfering substances, repeatability, anti-cross contamination ability and stability. 【Results】 The concordance rate of 20 EQA samples was 100%. The analytical sensitivity of HBV DNA, HCV RNA and HIV RNA-1 were all reactive and met T/CSBT. The yielding of HBV DNA, HCV RNA and HIV RNA-1 was affected little with lipemia at 3g/L and hemolysis at 4g/L. The coefficients of variation(CV) of intra-assay and inter-assay which met T/CSBT were all less than 5%, and the intra-assay variation coefficient was less than the inter-assay variation coefficient. The test results of 40 negative samples tested for cross contamination resistance were 100% negative, and 40 positive samples of HBV with 10 000 IU/mL were 100% positive. The stability verification results showed that the detection rate of weak positive samples was 100%. The coefficient of variation of the test results of the reagent after 1 and 5 freeze-thaw cycles were less than 5%,and the difference between the detection Ct value of reagent underwent once freeze-thaw and five-time freeze-thaw was not statistically significant. 【Conclusion】 The analytical sensitivity,endogenous interfering substances, repeatability,anti-cross contamination ability,stability and the compliance rate of domestic Shengxiang Gene automatic NAT system and supporting reagents by PCR-fluorescence method all meet T/CSBT, so it can be used for nucleic acid detection in blood screening in blood station laboratory.

3.
Chinese Journal of Blood Transfusion ; (12): 935-939, 2023.
Article in Chinese | WPRIM | ID: wpr-1004725

ABSTRACT

【Objective】 To validate the performance of a nucleic acid testing(NAT) system for blood screening in the high-altitude Nagqu region of Tibet, in order to assess the capability of NAT in high-altitude areas and further enhance blood safety. 【Methods】 Various methods were employed to evaluate the analytical sensitivity, reproducibility, ability to prevent cross-contamination, and comparison between different NAT systems. 【Results】 The NAT system in the Nagqu region of Tibet achieved a 100% detection rate for high-concentration HBV DNA and HIV-1 RNA samples, and over 90% for medium-concentration samples. PROBIT analysis revealed the lower limits of detection (LOD) for HBV DNA and HIV-1 RNA to be 8.29 IU/mL (95% CI, 5.88~20.55 IU/mL) and 40.52 IU/mL (95% CI, 30.26~85.92 IU/mL), respectively. For HCV RNA genotype 2a, the LOD was 97.14 IU/mL (95% CI, 71.00~182.67 IU/mL), all of which were lower than the declared minimum detectable concentrations in the instructions. Reproducibility analysis demonstrated a 100% level of consistency within the system. Cross-contamination performance verification showed a strong ability to resist cross-contamination. Comparative analysis of repeated testing of low-concentration HBV DNA samples and multi-system testing in plain areas revealed consistency rates of 77.78%(14/18) and 77.27%(17/22), respectively, indicating certain differences between the NAT system in Nagqu region and other systems. 【Conclusion】 The NAT system exhibited excellent performance in blood screening at high altitudes. The results of performance validation in high-altitude blood screening NAT systems were largely consistent with those in plain areas, providing a reliable basis for enhancing blood safety in high-altitude regions.

4.
Chinese Journal of Blood Transfusion ; (12): 1049-1054, 2023.
Article in Chinese | WPRIM | ID: wpr-1004700

ABSTRACT

【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.

5.
Chinese Journal of Blood Transfusion ; (12): 95-98, 2022.
Article in Chinese | WPRIM | ID: wpr-1004055

ABSTRACT

【Objective】 To explore the performance verification of NAT and its procedures for HBV DNA, HCV RNA and HIV RNA-1 using PCR-fluorescence via Cobas s201 automatic NAT system and supporting MPX V2.0 reagents that applied in the laboratories of blood stations, in order to satisfy ISO 15189 accreditation requirements and ensure the accuracy of NAT results. 【Methods】 Samples used in external quality assessment(EQA) of year 2020 were taken to verify the concordance, Performance evaluation panel and sensitivity verification panel of Roche second-generation NAT system were used to verify the sensitivity/ specificity and the lower limit of detection, respectively.And HBV DNA, HCV RNA and HIV RNA-1 quality control products were used to verify the anti-interference ability. 【Results】 The concordance rate of 40 EQA, samples was 100%. The sensitivity and specificity of Cobas s201 automatic NAT system and supporting MPX V2.0 reagents in detecting HBV DNA, HCV RNA and HIV RNA-1 were all 100%. The lower detection limit for HBV DNA, HCV RNA and HIV RNA-1 all met the requirements of reagent instructions. The yielding of HBV DNA, HCV RNA and HIV RNA-1 were affected little with hemolysis at 500 mg/dL but interfered seriously as lipemia reached 3 300 mg/dL. 【Conclusion】 The concordance rate, sensitivity, specificity and lower detection limit of the Cobas s201 fully-automatic NAT system and MPX V2.0 reagents by PCR-fluorescence method all met the requirements of reagent instructions. The verification of anti-interference ability demonstrated the requirements of ISO 15189 and the needs of blood station laboratories could be satisfied, and the detection methods and procedures can ensure the accuracy of NAT results.

6.
Chinese Journal of Blood Transfusion ; (12): 128-131, 2021.
Article in Chinese | WPRIM | ID: wpr-1004614

ABSTRACT

【Objective】 To verify the key performance parameters of Roche Cobas S201 multiplex NAT for blood donors, so as to provide data for the conformation of multiplex NAT performance and establish a scientific and feasible verification scheme. 【Methods】 Comprehensive performance verification on four key parameters of ROCHE COBAS S201 multiplex NAT system, including the 95% detection limit, compliance rate, anti-interference ability and operator comparison were conducted. The data were compared with the specifications provided by the manufacturer to evaluate the performance of laboratory testing system and ensure the quality of blood testing. 【Results】 2 sets of COBAS S201 multiplex NAT system in our laboratory were used to perform 5 times of the 95% detection limit value declared by the manufacturer for individual tests. The experimental results showed that the target NAT can be detected 100% and the lower limit of determination was verified. Single-virus NAT was performed to detect 5 different HBV DNA concentrations (25 ~400 IU/mL), 5 different HCV RNA concentrations (25 ~400 IU/mL), 5 different HIV RNA Concentration (100~1 000 IU/mL), and 5 negative tubes. The experimental results showed that all detected values of 20 tubes were 100% consistent with the true value, and the performance parameter "coincidence rate" was verified. Samples containing lipoemia, hemolysis, with ALT>50 mL/L and syphilis-positive endogenous interfering substances with 3 times of the 95% detection limit value were tested for 3 times, and results showed both response rate (3/3) and yielding rate reached 100%. In the control group (with none or in the normal range of interfering substances), reactivity was detected in samples with extremely low concentration of 3 times of the 95% detection limit, showing no significant difference (P>0.05). Above results fully showed that the existence of interference substances (lipidemia, hemolysis, ALT ≥ 50 and syphilis positive) in the blood of donors had no significant effect on the yielding of HBV/HCV/HIV virus target nucleic acids. Different operators performed the sample loading tests with same instrument, reagent and specimen showed 100% consistency in the results. It could be preliminarily assessed that there was no difference in the operations between the operators in this verification. 【Conclusion】 The verification scheme of the multiplex NAT system for methodology performance index (95% detection limit, coincidence rate, anti-interference ability, and operator comparison) established in this study, showed simple, flexible, scientific and feasible characteristics and could provide reference and data support for domestic blood transfusion services in acid detection.

7.
Chinese Journal of Blood Transfusion ; (12): 1036-1039, 2021.
Article in Chinese | WPRIM | ID: wpr-1004410

ABSTRACT

【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.

8.
Chinese Journal of Blood Transfusion ; (12): 1032-1035, 2021.
Article in Chinese | WPRIM | ID: wpr-1004409

ABSTRACT

【Objective】 To compare the analytical performance of Tigris, Panther, ChiTaS BSS1200 and cobas S201 system to see if they satisfy the requirements of blood screening and to know the concordance of the results presented by these four systems. 【Methods】 According to the relevant documents of ISO15189 and Standard Operating Procedure of Blood Station(2019), the parameters needed to be verified for nucleic acid tests(NAT) included: analytical sensitivity verification, system compare test, anti-jamming capability and anti-cross-contamination ability. 【Results】 The 95% detection limits of Tigris, Panther, ChiTaS BSS1200 and Cobas S201 for HBV-DNA(IU/mL), HIV-RNA(IU/mL) and HCV-RNA(IU/mL) were 2.013 vs 4 vs 2.995 vs 0.99, 13.039 vs 10.21 vs 30.952 vs 32.24, and 2.278 vs 2.077 vs 12.008 vs 3.39, respectively. In the performance comparison verification between NAT systems, the results of the two sets of Tigris systems were in full accordance with serum plate, with a concordance rate of 100%, Kappa value of 1, and none cross-contamination.The concordance rate of No.1 Panther system was 100%, and No.2 98%, with Kappa value of 0.961 and none cross-contamination. Hemolytic samples (5g/L Hb concentration) and lipemic blood samples (13.81 mmol/L TG concentration) had no significant effect on the detection of low-concentration samples. 【Conclusion】 No significant differences in the performance of NAT systems were notable by devices, as the four systems were fully automated with high sensitivity, which can fully satisfy the blood screening requirements. Panther system demonstrates superior analysis sensitivity in HCV-RNA/HIV-RNA and lower in HBV DNA, but also in required criteria, as compared to Tigris system. Neither hemolysis nor lipemic blood had any significant effect on the test results.

9.
Journal of Public Health and Preventive Medicine ; (6): 67-70, 2021.
Article in Chinese | WPRIM | ID: wpr-906621

ABSTRACT

Objective To compare the detection results of three kinds of automated nucleic acid purifiers, and to evaluate the detection performance of the domestic 2019-nCoV RNA purifier. Methods Three automated nucleic acid purifiers, namely A (imported), B (domestic), and C (domestic) automated nucleic acid extraction instruments, were used to purify nucleic acid. The Conchestan 2019-nCoV RNA (Liquid) quality control product S5 (batch number 202007002, reference level 1000cp/ml) was chosen as the experimental object. The quality control product was diluted in a series of 10 to 1000 times to prepare experimental samples of different concentrations. Among them, the A nucleic acid purifier used its own matching reagents, and the B and C purifiers belonged to a same manufacturer with different models and used their own supporting reagents as well as third-party reagents, to evaluate the anti-pollution ability, precision, accuracy, repeatability, detection limit and linear correlation. Results Using the imported brand A as a reference standard for comparison, when using reagents from B, the linear correlation between the two domestic nucleic acid purifiers and the imported equipment were 0.999, 0.915 (N-terminal), and 0.997, 0.825 (ORF1ab-terminal), respectively; when using the third-patty reagents, the linear correlation between the two domestic nucleic acid purifiers and the imported equipment were 0.999, 0.915 (N-terminal) and 0.997, 0.825 (ORF1ab-terminal), respectively. Conclusion The extraction of 2019-NCOV RNA by domestic nucleic acid purifiers can be fully automated with good correlation. The system performance is comparable to international standards. Moreover, the extraction time of the domestic nucleic acid purifiers is shorter than the imported one, which offers obvious advantages when the number of samples is large.

10.
International Journal of Laboratory Medicine ; (12): 192-195, 2019.
Article in Chinese | WPRIM | ID: wpr-742885

ABSTRACT

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.

11.
Chinese Journal of Clinical Laboratory Science ; (12): 233-236, 2019.
Article in Chinese | WPRIM | ID: wpr-821710

ABSTRACT

Objective@#To establish a method of calibration and performance verification of the GCMS-QP 2010 Ultra gas chromatography-mass spectrometer for urine organic acid detection after annual maintenance, so as to ensure that the performance of the detection system can continuously meet the detection needs. @*Methods@#According to the requirements of the equipment manufacturer and the Calibration Specifications for Benchtop Gas Chromatography-Mass Spectrometer, the gas chromatography-mass spectrometer was calibrated after annual maintenance. According to the CNAS-CL02-A003 Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Chemistry, the analytical performance of the maintained gas chromatography-mass spectrometer was validated. @*Results@#The calibration results of quality range, quality accuracy, resolution, signal-to-noise ratio and repeatability were all met the requirements. The detection results of internal quality control materials were under control, and the results of retained samples kept unchanged. @*Conclusion@#The calibration and performance verification method of the gas chromatography-mass spectrometer for urine organic acid detection after annual maintenance is established successfully, which is of importance for providing accurate and reliable results of urine organic acid.

12.
Chinese Journal of Clinical Laboratory Science ; (12): 152-155, 2019.
Article in Chinese | WPRIM | ID: wpr-821299

ABSTRACT

Objective@#To evaluate the value of methylation detection of plasma Septin9 gene in the diagnosis of colorectal cancer (CRC) and verify its performance. @*Methods@#The plasma samples from 32 CRC patients before colonoscopy and 10 healthy controls during October 2016 and May 2017 were collected, and the methylation levels of Septin9 gene in these samples were detected by the detection kit of plasma Septin9 gene methylation. The coincidence rate, detection limit and precision of the kit in the diagnosis of CRC were evaluated, and its diagnostic value was compared with that of carcinoembryonic antigen (CEA) and facal immunochemical tests (FIT). @*Results@#The positive and negative coincidence rates of the plasma Septin9 gene methylation kit in the detection of CRC were 100%. The reference materials assigned the detection limit were positive, and the coefficient of variation (CV) of precision was less than 5%, which met the basic performance requirements. The sensitivity, specificity, positive predictive value and negative predictive value of the kit in the diagnosis of CRC were 62.50%, 90.00%, 95.20% and 42.90%, respectively. The detection rate of CRC by the kit was 62.50%, significantly higher than those of FIT (28.13%) and CEA (28.13%) (all P<0.05). The area under the ROC curve (AUC ROC ) of the kit in the diagnosis of CRC was 0.762, and the detection rate of stage Ⅰ CRC by the kit was 50.00%. @*Conclusion@#The performance of the plasma Septin9 gene methylation kit meets the anticipated clinical requirements, which may be used as a serological marker for the assistant diagnosis of CRC.

13.
International Journal of Laboratory Medicine ; (12): 289-292, 2018.
Article in Chinese | WPRIM | ID: wpr-692662

ABSTRACT

Objective The ADVIA Centaur XP automatic chemiluminescence immunoassay system detec-tion performance of the thyroid hormones and antibodies for validation and evaluation.Methods With refer-ence to the American association of clinical laboratory standardization guide and other related documents,the ADVIA Centaur XP automatic chemiluminescence immunoassay system test 7 items thyroid hormones and an-tibodies(T3,T4,FT3,FT4,TSH,anti-TG,anti-TPO)of precision,accuracy,linear range and carry pollution rate for validation.Results Within the seven thyroid hormones and antibodies batch testing precision of CV and CV between batch precision between 1.51% -6.17% and 1.86% -6.17%.Is the average accuracy of bias of the largest testing project FT3(8.47%),but in the acceptable range,good correlation,correlation coefficient R of 0.994 or higher,Average bias <1/2 CLIA′88 TEa(12.5%).T3,T4,FT3,FT4,TSH,anti-TG and anti-T PO in 1.24-5.59 nmol/L respectively,and 60.07 -195.10 nmol/L,3.40 -22.87 pmol/L,14.59 -40.54 pmol/L,1.63-74.13 μIU/mL,60.10 -381.30 μIU/mL and 180.10 -531.50 μIU/mL range is linear,Carry pollution rate is between 0.04% -0.97%.Conclusion ADVIA Centaur XP automatic chemiluminescence im-munoassay system detecting thyroid hormones and antibodies results consistent with the data provided by the manufacturer,the test results are accurate and reliable,and can be used for the detection of clinical samples.

14.
International Journal of Laboratory Medicine ; (12): 149-152, 2018.
Article in Chinese | WPRIM | ID: wpr-692641

ABSTRACT

Objective To verify the performance of LIAISON chemiluminescence immunoassay analyzer in the prenatal screening for TORCH .Methods Reference to the US Institute of Clinical and Laboratory Stand-ards(NCCLS) series of documents and literature and combining with actual work ,we designed the verification program ,and tested and evaluated the LIAISON chemiluminescent immunoassay systems for the measurement precision ,accuracy ,linearity analysis ,clinical reportable range and biological reference intervals of Tox IgG , Tox IgM ,Rub IgG ,Rub IgM ,CMV IgG ,CMV IgM ,HSV IgG ,HSV IgM .We also compared the results with analysis performance provided by manufacturers (Italy LIAISON ) or recognized quality indicators .Results Intra-assay imprecision CV values were between 3 .58% -7 .03% ,which were less than the predetermined range;inter-assay imprecision CV values were between 3 .13% -10 .73% .Linear range validation regression coefficients a values were between 0 .97 -1 .03 and r2 >0 .95 .The linear relationship met the requirements . Both biological reference interval and reportable range meet the requirements .Conclusion The performance of LIAISON chemiluminescence immunoassay detection system satisfied the clinical requirements ,and the meas-urement results had advantages of high sensitivity ,specificity ,stability ,wide detection range ,good accuracy and repeatability ,which was suitable for clinical application .

15.
Chinese Medical Equipment Journal ; (6): 61-63,88, 2018.
Article in Chinese | WPRIM | ID: wpr-700018

ABSTRACT

Objective To evaluate the automatic biochemical analyzer when used to detect urinary vanilmandelic acid (VMA), and to compare it with manual method. Methods The automatic biochemical analyzer using homogenous enzyme immunoassay technology was compared with the manual method on accuracy, precision, linear range, recovery rate, anti-interference capability and etc when used to detect VMA.The comparison was also carried out on positive rate and etc when the two methods were used to test the urine specimens of the healthy subjects and suspected patients of hypertension, hyperthyroidism and hypothyroidism. Results The two methods both had the results on accuracy, precision, linear range, recovery rate, anti-interference capability meet the requirements described in the instruction of reagent kit, while the analyzer gained advantages over the manual method.The positive rates by the two methods for testing urine specimens were similar,while the analyzer behaved better in diagnosing the patient with critical value.Conclusion The analyzer proves better than the manual method when used to detect VMA,and thus is worthy promoting in clinical trial.

16.
International Journal of Laboratory Medicine ; (12): 654-656, 2017.
Article in Chinese | WPRIM | ID: wpr-511404

ABSTRACT

Objective To conduct the performance verification of the Stago STA-R automatic blood coagulation analysis system once every year to evaluate the analysis system for ensuring its accuracy and reliability .Methods According to the related docu-ments of the Clinical and Laboratory Standards Institute (CLSI) ,5 items of prothrombin time (PT ) ,activated partial clotting en-zyme live time (APTT) ,thrombin time (TT) ,fibrinogen (Fib) and antithrombin Ⅲ (ATⅢ) were selected to conduct the verifica-tion and preliminary evaluation on the accuracy ,imprecision ,carry-over rate ,linearity range and reference interval of the instrument analysis system .Results The relative bias(SE% ) of accuracy in each item was less than 5% .The intra-batch and inter-batch im-precisions (CV) were less than 3% and 5% respectively .The carry-over rates were within 4% .The linearity of Fib and AT Ⅲ was very well ,r2 were 0 .9980 and 0 .9979 respectively .Validated reference interval was consistent with quotative reference range . Conclusion The Stago STA-R automatic blood coagulation analysis system has good analytical performance ,can provide accurate and reliable test results for clinical doctors .

17.
International Journal of Laboratory Medicine ; (12): 56-60, 2017.
Article in Chinese | WPRIM | ID: wpr-510834

ABSTRACT

Objective To verify the performance of VITROS 5600 automatic biochemical analyzer.Methods According to laboratory accreditation criteria and performance verification documents of American CLIA'88,the precision,accuracy,liner range,clinical reportable range and biological reference interval were verified for the test of 17 conventional biochemical indicators performed on VITROS 5600 automatic biochemical analyzer.Results The precision、accuracy、liner range、clinical reportable range and biological reference interval of VITROS 5600 automatic biochemical analyzer were all acceptable.Conclusion VITROS 5600 automatic biochemical analyzer could fully meet the requirements in clinical application.

18.
Chinese Journal of Experimental and Clinical Virology ; (6): 257-261, 2017.
Article in Chinese | WPRIM | ID: wpr-808315

ABSTRACT

Objective@#To evaluate analytical performance and clinical application value of a one-step HBV DNA quantitative detecting system.@*Methods@#Analytical performance of the one-step HBV DNA quantitative detecting reagents included precision, residual contamination, accuracy, functional sensitivity and analytical measurement range were verified by collecting high concentration samples and external quality control samples from Jiangsu provincial clinical test center.@*Results@#The within-run coefficient of variation (CV) of both low and high concentration samples were below 5%, meanwhile the intra-assay CV was below 3/5 TEa and inter-assay CV was below 4/5 TEa. There was no residual contamination and the analytic accuracy met the requirement of external quality assessment (EQA). Functional sensitivity was able to attain 100 IU/ml, while the day to day CV was below 20%. It exhibited a benign linear relation from 7.58×101 to 7.58×108 IU/ml.@*Conclusions@#The analytic performance of a new testing system must be evaluated particularly before detecting samples of patients by quantitative tests. This study proves that the one-step HBV DNA quantitative detecting reagents can meet requirement of hepatitis B screening and clinical therapy monitoring, which is economic and simple for clinical routine tests.

19.
Chinese Medical Equipment Journal ; (6): 86-89, 2017.
Article in Chinese | WPRIM | ID: wpr-668471

ABSTRACT

Objective To verify the performances and evaluate the reliability of ACL-TOP700 automatic coagulation analyzer. Methods The analyzer had its precision, accuracy, carryover, linear range, reference interval and etc analyzed and verified according to the requirements of Clinical and Laboratory Standards Institute (CLSI) for PT, APTT, FIB, TT, DDHS, FDP and etc. Results The within-and between-array precision was both lower than 5%, which met the requirements of medical laboratory ISO 15189 requirements;the accuracy satisfied the requirements of external quality assessment by Beijing Center for Clinical Laboratory; linear analysis found high linearity (r≥0.975 or r2>0.95) in FIB, DDHS; the carryovers of FIB and DDHS were-0.34%and-0.10%respectively;more than 90%test results were restrained in the reference interval according to normal distribution principle. Conclusion ACL-TOP700 automatic coagulation analyzer has high performances and reliable results, and thus is worthy promoting clinically.

20.
Chinese Medical Equipment Journal ; (6): 90-93, 2017.
Article in Chinese | WPRIM | ID: wpr-668470

ABSTRACT

Objective To verify the performance of AutoLumo A2000 chemiluminescence detector in the detection of renin, angiotensin and aldosterone. Methods A set of laboratory verification scheme was proposed with chemiluminescence detector with references to EP15-A2, EP6-A2, EP7-A2 and C28-A2 from Clinical and Laboratory Standards Institute (CLSI), which detected the precision, limit of quantitation, analytical measurement range, interference testing and reference intervals. Results The coefficients of variation (CV) for repeatability precision were between 1.8%and 4.2%, and those for intermediate precision were between 2.4%and 5.4%. The limit of quantitations of renin, angiotensin and aldosterone were 2.7 pg/ml, 10.0 pg/ml, and 9.5 pg/ml, respectively. Analytical measurement ranges were accordance with the manufacturer. The results were interfered by hemolytic, jaundice or cheliform samples. The reference intervals of erect position were verified. Conclusion AutoLumo A2000 chemiluminescence detector behaves well in the precision, limit of quantitation, analytical measurement range and reference intervals. The main performances of the analyzer meet the standards of the quality requirements.

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