ABSTRACT
Objetivo: Optimizar el control interno de calidad de RT-PCR en tiempo real para detección cualitativa de SARS-CoV-2, utilizando los valores Cq de controles negativos y positivos. Material y método: Estudio prospectivo-longitudinal. La muestra estuvo constituida por 143 valores Cq para los controles negativos de alicuotado y extracción, así como para el control positivo. Se analizó la distribución normal de los valores Cq mediante la prueba de Anderson-Darling (AD) y se aplicaron pruebas de aleatoriedad. Se calculó límites de control a partir de 51 valores Cq, para luego, mediante gráficas de control, monitorizar 92 valores Cq obtenidos desde noviembre del 2020 hasta marzo del 2021. Se evaluó aceptación de lote e índices Cpk como indicadores de optimización. Los cálculos se hicieron con el programa Minitab. Resultados: Se aceptaron los lotes de valores Cq y se obtuvieron índices Cpk superiores a 1.33 para los tres tipos de control. Discusión: No existen estudios publicados que apliquen control estadístico de calidad a la detección cualitativa de SARS-CoV-2. Conclusiones: Es posible utilizar los valores Cq de los controles para optimizar el control interno de calidad de RT-PCR en tiempo real para detección cualitativa de SARS-CoV-2, como si se tratara de una técnica de tipo cuantitativo.
Objective: To optimize the internal quality control of real-time RT-PCR for the qualitative detection of SARS-CoV-2, using the Cq values of negative and positive controls. Material and method : Prospective-longitudinal study. The sample consisted of 143 Cq values for the negative aliquot and extraction controls, as well as for the positive control. The normal distribution of Cq values was analyzed using the Anderson-Darling (AD) test and randomness tests were applied. Control limits were calculated from 51 Cq values, and then, using control charts, to monitor 92 Cq values obtained from November 2020 to March 2021. Lot acceptance and Cpk indices were evaluated as optimization indicators. The calculations were made with the Minitab program. Results: The batches of Cq values were accepted and Cpk indices higher than 1.33 were obtained for the three types of control. Discussion : There are no published studies that apply statistical quality control to the qualitative detection of SARS-CoV-2. Conclusions : It is possible to use the Cq values of the controls to optimize the internal quality control of real-time RT-PCR for qualitative detection of SARS-CoV-2, as if it were a quantitative technique.
ABSTRACT
【Objective】 To help quality control laboratory of blood station select suitable internal quality control rules using Westgard sigma rules. 【Methods】 The accumulated coefficient of variation of internal quality control was used as the measurement imprecision in quality control laboratory of blood station, and the bias of the results of EQA in 2020 was regarded as Bias. The allowable total error (TEa) of WS/T406-2012 was used as the evaluation index to calculate the σvalue of laboratory blood testing items to select reasonable and feasible quality control rules using the Westgard sigma rule. 【Results】 The average σvalues of total protein in the three national EQAS were 14.2, 8.7 and 9.6, respectively. The average σvalues of fibrinogen in two national EQAS were 3.6 and 4.1. The average σvalues of Plt counts and MCHC were <4 and >3, and those of other items were more than 6 in two national EQAS. 【Conclusion】 The rule of 13s, 13s/22s/R4s/41s/ and 13s/22s/R4s/41s/ should be used in total protein, fibrinogen and whole blood cell count testing, respectively, by Westgard sigma rule, which can effectively help the blood quality control laboratory select appropriate quality control rules.
ABSTRACT
OBJECTIVE: To understand the development of therapeutic drug monitoring (TDM) in domestic hospitals and provide guidance for disciplinary development. METHODS: A range of professions involved in 7 aspects (33 questions) of TDM were surveyed by questionnaire on WeChat in late 2018. Information gathered included: basic information, development of TDM laboratories and clinical departments, monitoring drug types and quantity, quality control, interpretation of reports and individual drug regimen, and approval and management. These data were exported in Excel, and the valid data were included. RESULTS: Five hundred and four responses were received, of which 463 were valid and included, of which 177 hospitals developed TDM. The results of the above 7 aspects which were from those 177 hospitals in 2018 were summarized as follows. The educational backgrounds were mainly the master degree (43%) and the bachelor degree (33%). Most hospitals (75%) established chromatographic methods. The monitoring items were mainly blood drug concentration test(63%) and drug genetic testing (36%). In all clinical departments, TDM was most applied in Neurology. Eleven categories of drugs applying TDM in 2018 were investigated, of which psychotic drugs with the most varieties included eighteen drugs, and immunosuppressive agents had the most samples monitoring (57%). Over one half of hospital (64%) carried out the quality control. Only one half of hospitals (89/177) developed clinical interpretation, of which 75% showed that clinical pharmacists participated in the interpretation; 82% developed individualized plans based on the results. Most hospitals (65%) carried out the TDM review and the systems of examination and approval, and TDM in 47% of the hospitals was included in the hospital pharmacy management and drug therapy committee management system. CONCLUSION: This survey has obtained information of the seven aspects, and has mastered the TDM profile of 11 categories of drugs in 2018. However, there is still insufficient development in the quality control, clinical interpretation, individualized regimen development and TDM management. In addition to conducting drug monitoring, TDM work in the future will focus on improving and developing the above deficiencies and promoting clinical rational drug use.
ABSTRACT
Objective To investigate the internal quality control(IQC) of hemoglobin A2 (HbA2) and hemoglobin F (HbF) from 2014 to 2017 in China.Methods The results of IQC were collected from the laboratories which participated in external quality assessment (EQA) of National Center for Clinical Laboratories (NCCL) from 2014 to 2017,then the coefficient of variation (CV) was compared with 1/3TEa (6.67 ％),1/4TEa (5 ％).The proportion of laboratories meeting criteria were calculated to analyze IQC of HbA2 and HbF in China.The data were grouped based on the instruments used in laboratories,the acceptable rates of CVs of HbA2 and HbF in each group under two criteria in 2017 were calculated,respectively.Results In HbA2,more than 84％ of participant laboratories met 1/3TEa criteria and 70.83％ ～84.47％ of laboratories met 1/ 4TEa criteria.In HbF except for 2015,the more than 80％ laboratories whose month and cumulative CVs met 1/3TEa and 1/4TEa criteria accounted for 68.42 ％ ～ 85.07 ％,respectively.Under 1/3TEa and 1/4TEa criteria,sebia capillarys 2 instru ment and fully automatic hemoglobin analyzer bole Variant Ⅱ instrument group the acceptable rates of CVs above 85％,showed good precision for HbA2 and HbF detection.Conclusion At present,the precision level of HbA2 and HbF need to be further improved in laboratories of China,especially HbF.Laboratory should continue to strengthen the internal quality control,establish strict internal quality system to improve detection capacity.
ABSTRACT
Objective To investigate the current status of the coefficients variations (CVs) of internal quality control (IQC) data for serum procalcitonin in China.Methods Data had been collected by Web based submission system,the laboratories which enrolled in 2017 serum procalcitonin external quality assessment (EQA) program had attended.The data had includ ed:the CVs of two levels of IQC materials (level 1 and 2) in March of 2017 and long-term cumulative in control data.Mi crosoft Office Excel 2007 was used to analyze and process the data,the acceptable rates of CVs were calculated based on the 1/3TEa and 1/4TEa standards.The instruments which was used in laboratory internal quality control system of EQA,were grouped and counted,the acceptable rates of each group was calculated according to two evaluation standards.According to the laboratory detecting system was matched or not,to calculate the proportion of laboratories,and to adapt to the two standards.Results The acceptable rates of the same standards were close and the acceptable rates of level 2 were relatively higher.After grouping according to the instruments,the acceptable rates of each group were uneven.According to the labo ratory detecting system was matched or not,the acceptable rates of the matching system were much more higher.Conclusion To strengthen internal quality control system,and to improve the detection quality level much further.Laboratory should pay more attention to the mission of internal quality control,in order to ensure the reliability of test results.
ABSTRACT
The matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is one of the first choice techniques for clinical microbiological identification owing to its fast,accuracy,low cost and easy to be operated.The accuracy of identification of MALDI-TOF MS relies on good instrument status,appropriate pre-trement,standardized operation and the rules of interpretation.Any errors in this process will directly influence the accuracy of identification.Therefore,strict internal quality control for the microbiological identification by MALDI-TOF MS is very important.Based on six years of research and clinical application experience,our laboratory establishes a relatively complete internal quality control system for the microbiological identification by MALDI-TOF MS,including all aspects of hardware,software and manual operation,the parameter settings,maintenance and calibration of the instrument,the preparation of strains and reagents,spectra acquisition and the interpretation and analysis of results,Which can make abnormal results be quickly traced and timely handled.
ABSTRACT
BACKGROUND: Maintaining the quality of cryopreserved cord blood is crucial. In this pilot study, we describe the results of the internal quality control program for a cord blood bank thus far. METHODS: Donated cord blood units unsuitable for transplantation were selected for internal quality control once a month. One unit of cord blood, aliquoted into 21 capillaries, was cryopreserved and thawed annually to analyze the total nucleated cell count, CD34⁺ cell count, cell viability test, and colony-forming units assay. RESULTS: No significant differences in the variables (total nucleated cell count, cell viability, CD34⁺ cell count) were observed between samples cryopreserved for one and two years. Upon comparing the variables before cryopreservation and post thawing with the capillaries of one year of storage, cell viability and CD34⁺ cell counts decreased significantly. The use of cord blood samples in capillaries, which can be easily stored for a long period, was similar to the methods used for testing segments attached to the cord blood unit. CONCLUSIONS: The results of this study may be useful for determining the period during which the quality of cryopreserved cord blood units used for transplantation is maintained.
Subject(s)
Humans , Antigens, CD34/metabolism , Blood Banks , Cell Count , Cell Survival , Cryopreservation/standards , Fetal Blood/cytology , Pilot Projects , Quality Control , Republic of Korea , Time FactorsABSTRACT
Objective To find out the detection level of the blood routine test in clinical laboratories of basic medical institutions in Hefei ,and to analyze the results of inter‐laboratory comparison among township health centers and community health service cen‐ters in Hefei and explore the main factors .Methods Forty‐three township health centers and community health service centers were randomly selected to conduct field investigations and take blood routine test inter‐laboratory comparison .Results Both 41 .9% of the passing rate and the average score 72 .37 points in Inter‐laboratory comparisons were significantly lower than the An‐hui province clinical inspection center(94 .1% and 95 .97 points) ,the differences were statistically significant(P<0 .05);Comparing to the results of the Anhui province clinical inspection center ,there was statistically significant difference on parameter(WBC ,RBC , Hb ,HCT ,PLT) average pass rate of blood routine test(P<0 .05);the personnel primary education was low ,18 .80% of the staff in clinical laboratories were not professionals ;most of blood analyzers were domestic and 53 .49% of all instruments had been used for more than 5 years;the overall laboratory quality management level was low .Conclusion The blood routine test detection level in clinical laboratories of basic medical institutions in Hefei was far below than that of secondary and tertiary medical institutions .The daily laboratory internal quality control should be strengthened and the quality management system should be improved gradually .
ABSTRACT
Objective To investigate the preparation of internal quality control products of NT‐proBNP by electrochemilumines‐cence detection .Methods The serum with high and normal levels of NT‐proBNP were collected and divided into low‐value group and high ‐value group .The expected target value ,inter‐batch duplicability ,imprecision and the stability within batch were detected . After effective verification ,we evaluated the bias between self developed internal quality control products and Roche factory quality control materials by comparative test .Results The repeatability ,stability and imprecision of self developed NT‐proBNP were all appropriate to internal quality control products and meeting meet the clinical testing standards .The control range was significantly less than that permitted by Roche ,so it can meet the internal quality control requirements .Conclusion The self developed NT‐proBNP internal quality control products can replace the imports quality control products .
ABSTRACT
Objective To perform the comparative analysis on the test results acquired from three different types of hematology analyzers ,to explore their results comparability or whether their deviations being within the allowable range .Methods The 30 d in‐ternal quality control results collected from the three types of analyzers ,Sysmex XE2100 ,Sysmex XN3000 and Sysmex XT4000i , were analyzed and analyze .The XE2100 hematology analyzer with excellent results in repeatedly participating in the national exter‐nal quality control assessment was taken as the reference instrument ,while the Sysmex XN3000 and Sysmex XT4000i analyzers served as the contrastive instruments .Four blood samples from different patients with high ,medium and low values were randomly selected and detected for 5 d .The results of white blood cell(WBC) ,red blood cell(RBC) ,hematocrit(HCT) ,hemoglobin(HGB) and platelet(PLT) were performed the comparative analysis .Then the accuracy and comparability of the detection results were judged by F test ,regression equation and correlation coefficient .Results The detection result of WBC ,RBC ,HCT ,HGB and PLT had no statistical differences among three instruments (P> 0 .05) .The correlation of various indexes had close correlation (r≥0 .975) .The deviations conformed to the related requirements with comparability .Conclusion When conducting detection by multi‐ple instruments ,the quality control of experimental instrument should be paid attention to ,the different detection instruments should be conducted the calibration and comparison at regular intervals for ensuring the accuracy and consistency of detection re‐sults ,thus better serve clinic .
ABSTRACT
Objective When detecting the blood C peptide by chemiluminescence method,used had confronted the lack of qual-ity control.This paper examines the feasibility of self-made C peptide quality control as indoor quality control products. Methods From the serum of diabetic patients and health examination,C peptide low values(concentration around the 1.20 ng/ml)and high value(concentration around the 12.0 ng/ml)were collected,excluding hemolysis,jaundice and tallow ser-um,preventing bacterial contamination,hepatitis B surface antigen,hepatitis C virus,human immunodeficiency virus indica-tors are negative;then these serum was mixed respectively,embalmed,packaged,-20 DEG preserved.The performance e-valuation of the C peptide mixed serum was carried out using SIEMENS’s C peptide reagent kit.Results Low value,high value of two levels of serum C peptide quality control in batch imprecision respectively were 4.46% and 4.15% respective-ly.Day not precision respectively were 6.00%,5.56%,-20 DEG saved stability for at least 6 months (P>0.05).Com-pared with six months by analysis of variance,F value of the low and high values were 0.665,0.602,P values were 0.471, 0.568 and the difference was not statistically significant (P>0.05),but the difference among bottles was no significant. Conclusion Two levels value of the C peptide in self-made preserved at -20 DEG can meet the requirements of internal quality control products.
ABSTRACT
Objective Developing an internal quality control substance of Ureaplasma urealyticum(UU)‐DNA for real‐time PCR to establish an internal quality control system and preliminary evaluation its clinical value .Methods Internal quality control sub‐stance was prepared by mixing samples which Ct value were 24-25(positive sample) and 32 -33(weak positive sample) ,respec‐tively .At the same time ,selecting samples that test results were negative as negative control .The target value ,standard deviation (s) and coefficient of variation(CV) of internal quality control substance were defined by“instant method”for the first 20 runs and Levey‐Jennings quality control(QC) chart after the first 20 runs .Using the“Westdard” multi‐rule quality control methods to ana‐lyze the detection results .Exporting OPSPecs chart by quality control rules in Unity Real Time (URT ) system and setting up new quality control rules according with OPSPecs chart .Results 131 times of the detection of quality control substance were performed totally .The first 20 runs were defined by“instant method”and later 111 runs were defined by Levey‐Jennings QC chart ,the results were stable of quality control substance and reasonable quality control rules .Conclusion Preparing of internal quality control sub‐stance of UU‐DNA used in real‐time PCR might be easy and stable .So ,the internal quality control substance of UU‐DNA could be worthy for practical application in this PCR laboratory .Design internal quality control rules based OPSPecs chart in molecular de‐tection is very simple and practical .
ABSTRACT
OBJECTIVE: To summarize and analyze the internal quality control methods and judgment cretiria used by drug quality control laboratories. METHODS: The detailed methods of using five kinds of quality control methods, ie, quality control chart, personnel comparison, equipment comparison, recovery test, and retest the retained sample were described. The experience in judgment cretiria for quality control was summarized. RESULTS AND CONCLUSION: To meet the demands of quality management in drug control laboratories, the above-mentioned five kinds of internal quality control methods need to be adopted flexibly, and cover all the related test fields.
ABSTRACT
Objective To investigate the coefficient of variations(CV) of internal quality control(IQC) of therapeutic drug monitoring in serum (carbamazepine, digoxin, phenytoin, theophylline and valproic acid), and compare with the quality specification derived from allowable total error (TEa). Methods Data was collected by Web-based submission system, the 175 laboratories which enrolled in 2014 therapeutic drug monitoring in serum external quality assessment (EQA) program attended. The data included: the CV of February of 2014 and long-term cumulative data, method and instrument, etc. Microsoft Excel 2013 and SPSS 13.0 was used to analyze the data.The evaluation standard of EQA was considered as TEa(25%and 20% for digoxin). 1/3TEa (8.33% and 6.67% for digoxin) and 1/4TEa (6.25% and 5% for digoxin)were determined to be the evaluation standard of CV of IQC. Results From 175 laborctories 94, 97, 61, 43 and 116 laboratories reported effective results of IQC material of carbamazepine, digoxin, phenytoin, theophylline and valproic acib, respectively. More than 60% laboratories used Bio-Rad measurement system(63.93%-76.29%). Less than 40%laboratories used other measurement systems(23.71%-36.07%). There were significant differences (P<0.05) of the acceptable rates of CV between test items (χ2: 10.689-19.255, P<0.05). There was no significant difference of the acceptable rate of CV between different measurement systems except valproic acid evaluated by 1/3TEa (P<0.05). Conclusion It is an effective method for clinical laboratories to improve test quality by monitoring the current and cumulative CV of IQC and comparing them against proper evaluation criteria to evaluate if the analysis system can meet specific quality requirements or technical specification.
ABSTRACT
Objective To carry out the current status of internal quality control by statistical analysis of the Internal Quality Control (IQC)data of homocysteine in 2014 March.Methods Web-based External Quality Assessment (EQA)system was used to collect IQC data of homocysteine from 292 EQA participant laboratories nationwide.The data include thecoefficient of variation (CV)of IQC data under control in March 2014 and long-term cumulative data.Acceptable rates of CVs of two-lot internal quality controls in homocysteine were calculated according to 5 criteria,that were 1/3TEa,1/4TEa and the speci-fications based on biological variation including the minimal,appropriate and optimal allowable imprecision.The instrument the participant laboratories used were sorted into 6 groups and the passing rate of each group were calculated by the 5 crite-ria.Results 292 laboratories reported the data of level 1 IQC for homocysteine,106 of which reported the data of level 2 IQC.The passing rate was different according to different criteria.The passing rate had few difference by the criteria of 1/3TEa and the minimal allowable imprecision based on biological variation,which were from 63.36% to 76.42%.It was also true for 1/4TEa and the appropriate allowable imprecision based on biological variation,which were from 34.25% to 57.55. The passing rate was only 10.62%~16.98% by the criteria of appropriate allowable imprecision based on biological varia-tion.Statistical results showed that instruments the participant mainly used were HITACHI (77/292),Olympus (61/292), Roche (19/292),Beckman (14/292),Abbott (10/292)and Simens (10/292).The passing rates of all the instrument group had few difference except Simens group.Conclusion Most of the laboratories could meet the criteria of 1/3TEa and the min-imal allowable imprecision based on biological variation.But less than half of the laboratories could meet the criteria of 1/4TEa and the appropriate and optimal allowable imprecision based on biological variation.The precision performance of ho-mocysteine among laboratories needs further improvement.
ABSTRACT
The right internal quality control rules are really important for improving the quality of patient results report in clinical laboratory.In order to look for faster and simpler tools that will help laboratories select the right internal quality con-trol rules for their own applications,recently Westgard introduced a newer tool “Westgard Sigma Rules”which is quicker and easier to use than previous tools.And it is very easy to figure out the right internal quality control rules by using West-gard Sigma Rules.This article introduced the characteristics and usage of original Westgard Rules and sigma metrics graph, and focusing on the application methods and practices of Westgard Sigma Rules which is the combination of original West-gard Rules and sigma metrics graph.Once the sigma quality of the tests and methods in laboratories are calculated,the West-gard Sigma Rules diagram can make it easy to select the right control rules and the right number of control measurements.
ABSTRACT
Objective To introduce the quality control process and analyze the quality control results of acquired immune defi-ciency syndrome(AIDS)screening center laboratory of Weinan city.Methods Instant technique was adopted to analyze the quality control data from the first 20 times experiments in 2013.Quality control chart of Levey-Jennings was then used to evaluate the sub-sequent data.Results Corresponding data was confirmed in control by the two techniques respectively.The quality of annual test work was effectively guaranteed.Conclusion It is necessary to lay emphasis on factors affecting quality control in primary AIDS screening laboratories,so as to ensure high-quality detection and improve standard of quality control.
ABSTRACT
Objective To discuss the setting problem of control limit for quality control chart during the statistical quality con-trol procedure of clinical laboratory quantitative measurement.Methods The normality test of the monthly quality control data for 3 items of albumin (ALB),alanine aminotransferase (ALT)and creatinine (Cr)was performed by using the SPSS 14.0 statistical software and which was compared with the cumulated data.Results Among 30 groups of data,the normality test was inconformity in 18 groups,among 30 groups of mean t test,the differences in 20 groups showed statistical significance(P <0.05).Therefore,the calculated means and standard deviation(SD)in short term could not be directly set as the control limit of the quality control chart. Conclusion Setting the control limit of internal quality control in clinical laboratory quantitative measurement should be according to the guidance of C24-A3 document in CLSI.The SD estimated value obtained from large amount stable quality control data or the 6-month cumulative values is recommended to be used as SD of the new batch number,which should be regularly assessed.
ABSTRACT
Objective To calculate the measurement uncertainty of clinical chemical analytes according to the internal quality control (IQC)and external quality assessment (EQA)data in clinical laboratory.Methods Collected the IQC data from January to June 2013 and EQA data between 2012~2014 of clinical chemistry in clinical laboratory.Calculated the measure-ment uncertainty and extended uncertainty according to the Nordtest criteria.Results It was effective to evaluate the uncer-tainty using IQC and EQA data.ALP ranked the highest extended uncertainty and Na+ ranked the lowest uncertainty.The range of uncertainty varies greatly,electrolyte 4.27~18.16,enzyme 8.12~24.88,small molecular 4.88~12.44,protein and lipids 4.78~13.1.Conclusion The evaluation of clinical chemistry uncertainty by IQC and EQA data is simple and practi-cal,which is beneficial for assurancing the measurement accuracy.
ABSTRACT
Objective To find an internal quality controlling method for 17-OHP determination by time-resolved fluoroimmuno-assay .Methods 20 quality control data were collected .The data were analyzed by using L-J method ,instant method and improved instant method .Results were used for the construction of quality control charts .Result The first three quality control data had a great impact on the following judgments of internal quality controlling when instant method was used .The subsequent results might be false acceptance .Improved instant method could effectively reduce the situations of false run-away and false acceptance ,which was suitable for the internal quality control of 17-OHP determination by time-resolved fluoroimmunoassay in newborn screening . Conclusion There are many steps of manual operations in 17-OHP determination of time-resolved fluoroimmunoassay .The details of these operations have great impacts on the experimental results .Thus ,the operations of 17-OHP test should be specified and exe-cuted strictly according to requirement .