Interpretative comments - need for harmonization? Results of the Croatian survey by the Working Group for Post-analytics

IntroductionInterpretation of laboratory test results is a complex post-analytical activity that requires not only understanding of the clinical significance of laboratory results but also the analytical phase of laboratory work. The aims of this study were to determine: 1) the general opinion of Croatian medical biochemistry laboratories (MBLs) about the importance of interpretative comments on laboratory test reports, and 2) to find out whether harmonization of interpretative comments is needed.Materials and methodsThis retrospective study was designed as a survey by the Working Group for Post-analytics as part of national External Quality Assessment (EQA) program. All 195 MBLs participating in the national EQA scheme, were invited to participate in the survey. Results are reported as percentages of the total number of survey participants.ResultsOut of 195 MBLs, 162 participated in the survey (83%). Among them 59% MBLs implemented test result comments in routine according to national recommendations. The majority of laboratories (92%) state that interpretative comments added value to the laboratory reports, and a substantial part (72%) does not have feedback from physicians on their significance. Although physicians and patients ask for expert opinion, participants stated that the lack of interest of physicians (64%) as well as the inability to access patient’s medical record (62%) affects the quality of expert opinion.ConclusionAlthough most participants state that they use interpretative comments and provide expert opinions regarding test results, results of the present study indicate that harmonization for interpretative comments is needed.     

External quality assessment of RIA for thyroid related hormones

An external quality assessment was conducted for RIA of thyroid related hormones. Thirtyfive laboratories (35 for T₄, 34 for T₃ and 23 for TSH) from different parts of country participated in the programme. Twentyfour samples (16 pools: 5 simple and 11 manipulated pools) in 8 batches, 3 per batch per month were sent for analysis of T₄, T₃ and TSH. Some of the samples were repeated 3 times at different occasions to assess the imprecision of the laboratory. The overall mean percent CV obtained for T₄, T₃ and TSH were 22.7, 36.32 and 52.38 respectively. The recovery for added T₄ was 86.73% while that for T₃ was 117.4%. A large variation was obtained for recovery of TSH. For T₄ estimations, 13 laboratories had a desirable performance i. e. bias less than ±10.0% and variability of bias (VB) and imprecision (IP) less than 15.0%. None of the laboratories had a desirable performance for T₃ or TSH. The number of laboratories with acceptable performance i. e. bias between ±10.0–15.0%, VB and IP between 20.0–25.0% for T₄, T₃ and TSH were 4, 3 and 0 respectively. The number of laboratories which required attention (bias between ±15.0–20.0%; VB and IP between 20.0–25.0%) were 5,7 and 1 respectively. The unacceptable results with larger bias, VB and IP for T₄, T₃ and TSH were 6, 18 and 17 respectively. Our results are in general agreement that the performance of T₄ assay is better than T₃ and both in turn are much better than TSH. Quantitation of circulating thyroid hormones (TH) viz. tri-iodothyronine (T₃), thyroxine (T₄) and thyroid stimulating hormone (TSH), which form the largest percentage of hormones estimated in a clinical laboratory is mainly done by radio-immunoassay (RIA) procedures. The reliability and reproducibility of these assays are generally monitored by using internal quality control (IQC) samples in every assay batch. Thus, the IQC provides information whether the assay results are satisfactory and can be released. However, external quality assessment (EQA) is a procedure whereby an external agency undertakes evaluation of the quality of an analytical service by providing samples for analysis to individual laboratories performing the assay. The data gathered is analysed collectively. EQA therefore provides a means by which performance of a laboratory is assessed in relation to other laboratories and matching the assay unbiased by removing systematic error, if present. This is important since RIA procedure involves several steps (collection and storage of samples, quality of the reagents, procedure followed for performance of an assay, counting equipment used and the mode of the data analysis) and therefore prone to systematic errors. We therefore undertook the EQA programme for assessment of thyroid related hormones as a joint collaborative project of Bhabha Atomic Research Centre, India and International Atomic Energy Agency.     

Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data

IntroductionThe interest in quality management tools/methodologies is gradually increasing to ensure quality and accurate results in line with international standards in clinical laboratories. Six Sigma stands apart from other methodologies with its total quality management system approach. However, the lack of standardization in tolerance limits restricts the advantages for the process. Our study aimed both to evaluate the applicability of analytical quality goals with Roche Cobas c 702 analyser and to determine achievable goals specific to the analyser used.Materials and methodsThe study examined under two main headings as Sigma_laboratory and Sigma_analyser. Sigma_laboratory was calculated using internal and external quality control data by using Roche Cobas c 702 analyser for 21 routine biochemistry parameters and, Sigma_analyser calculation was based on the manufacturer data presented in the package inserts of the reagents used in our laboratory during the study. Sigma values were calculated with the six sigma formula.ResultsConsidering the total number of targets achieved, Sigma_analyser performed best by meeting all CLIA goals, while Sigma_laboratory showed the lowest performance relative to biological variation (BV) desirable goals.ConclusionsThe balance between the applicability and analytical assurance of “goal-setting models” should be well established. Even if the package insert data provided by the manufacturer were used in our study, it was observed that almost a quarter of the evaluated analytes failed to achieve even “acceptable” level performance according to BV-based goals. Therefore, “state-of-the-art” goals for the Six Sigma methodology are considered to be more reasonable, achievable, and compatible with today’s technologies.     

Estimation of CKMB from riqas control serum at 37 degree celsius

The quality control sera commonly available in market does not provide the value of CKMB. The CKMB kit of Randox laboratories contains two lyophilized control sera. But the stability of the control serum after reconstitution with 2ml of distilled water is 5 days at 2–8 degree Celsius, 8hrs at 25 degree Celsius and 4 weeks at-20 degree Celsius when frozen once. Hence stability after reconstitution is not sufficient to fulfill the daily need of a laboratory. In quest of a good internal quality assessment (IQA) sample trial run has been performed at 37 degree Celsius using external quality assessment (EQA) samples obtained from Randox international quality assessment sample (RIQAS). The trial run was found to be successful.     

How to conduct External Quality Assessment Schemes for the pre-analytical phase?

In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.     

Inter-laboratory ring trial to evaluate real-time reverse transcription polymerase chain reaction methods used for detection of infectious pancreatic necrosis virus in Chile

BackgroundInfectious Pancreatic Necrosis Virus (IPNV) is the etiological agent of a highly contagious disease that affects salmonids. In Chile, the second worldwide salmon producer, IPNV causes great economic loss and is one of the most frequently detected pathogens. Due to its high level of persistence and the lack of information about the efficiency of its diagnostic techniques, the National Reference Laboratory (NRL) for IPNV in Chile performed the first inter-laboratory ring trial, to evaluate the sensitivity, specificity and repeatability of the qRT-PCR detection methods used in the country.ResultsResults showed 100% in sensitivity and specificity in most of the laboratories. Only three of the twelve participant laboratories presented problems in sensitivity and one in specificity. Problems in specificity (false positives) were most likely caused by cross contamination of the samples, while errors in sensitivity (false negatives) were due to detection problems of the least concentrated viral sample. Regarding repeatability, many of the laboratories presented great dispersion of the results (Ct values) for replicate samples over the three days of the trial. Moreover, large differences in the Ct values for each sample were detected among all the laboratories.ConclusionsOverall, the ring trial showed high values of sensitivity and specificity, with some problems of repeatability and inter-laboratory variability. This last issue needs to be addressed in order to allow harmonized diagnostic of IPNV within the country. We recommend the use of the NRL methods as validated and reliable qRT-PCR protocols for the detection of IPNV.     

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China

Introduction

To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones.

Materials and methods

479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires.

Results

The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories.

Conclusions

Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.Key words: quality indicators, quality control, clinical laboratory services     

Moving average procedures as an additional tool for real-time analytical quality control: challenges and opportunities of implementation in small-volume medical laboratories

IntroductionMoving average (MA) is one possible way to use patient results for analytical quality control in medical laboratories. The aims of this study were to: (1) implement previously optimized MA procedures for 10 clinical chemistry analytes into the laboratory information system (LIS); (2) monitor their performance as a real-time quality control tool, and (3) define an algorithm for MA alarm management in a small-volume laboratory to suit the specific laboratory.Materials and methodsMoving average alarms were monitored and analysed over a period of 6 months on all patient results (total of 73,059) obtained for 10 clinical chemistry parameters. The optimal MA procedures were selected previously using an already described technique called the bias detection simulation method, considering the ability of bias detection the size of total allowable error as the key parameter for optimization.ResultsDuring 6 months, 17 MA alarms were registered, which is 0.023% of the total number of generated MA values. In 65% of cases, their cause was of pre-analytical origin, in 12% of analytical origin, and in 23% the cause was not found. The highest alarm rate was determined on sodium (0.10%), and the lowest on calcium and chloride.ConclusionsThis paper showed that even in a small-volume laboratory, previously optimized MA procedures could be successfully implemented in the LIS and used for continuous quality control. Review of patient results, re-analysis of samples from the stable period, analysis of internal quality control samples and assessment of the analyser malfunctions and maintenance log have been proposed for the algorithm for managing MA alarms.     

Recommendations for the application and follow-up of quality controls in medical laboratories

This is a translation of the paper “Recommendations for the application and follow-up of quality controls in medical biology laboratories” published in French in the journal Annales de Biologie Clinique (Recommandations pour la mise en place et le suivi des contrôles de qualité dans les laboratoires de biologie médicale. Ann Biol Clin (Paris). 2019;77:577-97.). The recommendations proposed in this document are the result of work conducted jointly by the Network of Accredited Medical Laboratories (LABAC), the French Society of Medical Biology (SFBC) and the Federation of Associations for External Quality Assessment (FAEEQ). The different steps of the implementation of quality controls, based on a risk analysis, are described. The changes of reagent or internal quality control (IQC) materials batches, the action to be taken in case of non-conform IQC results, the choice of external quality assessment (EQA) scheme and interpretation of their results as well as the new issue of analyses performed on several automatic systems available in the same laboratory are discussed. Finally, the concept of measurement uncertainty, the robustness of the methods as well as the specificities of near-patient testing and rapid tests are described. These recommendations cannot apply for all cases we can find in medical laboratories. The implementation of an objective alternative strategy, supported with documented evidence, might be equally considered.     

External quality assessment for the RIA of thyroid related hormones: Second phase

An external quality assessment was conducted to assess the performance of various laboratories for RIA of thhyroid related hormones in two phases. In the first phase thirty five laboratories participated. At the end of first phase a meeting cum workshop was organised to discuss the results of first phase, difficultires faced by the participants and pinpoint the short oming. A second phase was then initiated with an objective of improvement in the performance, if any, where twelve samples from four pools were distributed to twenty four laboratories who participated for the second phase. The overall return of the results increased significantly from 71.8% (1586/2208) for the first phase to 92.4% (732/792) for the second phase. The inter laboratory %CV for T₃, T₄ and TSH were lower during the second phase (30.6%, 19.0% and 31.6% respectively) as compared to those observed during first phase (36.3%, 22.7% and 52.8% respectively). Similarly, there was an improvement in reproducibility of ALTM as %CV for T₃, T₄ and TSH decreased from 6.0%, 9.8% and 13.4% respectively to 4.5%, 4.6% and 8.5% respectively. The individual performances of the participating laboratories viz. bias, variability of bias and imprecision also showed a trend towards improvement as percent laboratories having desirable or acceptable results for T₃, T₄ and TSH increased from 10.7%, 60.7% and 0.0% respectively to 20.8%, 66.7% and 22.2% respectively. External quality assessment thus appears to be beneficial in assessing the performane of a laboratory in comfparison with other laboratories and indeed helps in improving the performance.     

Implementation of External Quality Assessment Scheme in Clinical Chemistry for District Laboratories in Bhutan

External Quality Assessment Scheme (EQAS) involves evaluation of a number of laboratories by an outside agency on the performance of a number of laboratories based on their analytical performance of tests on samples supplied by the external agency. In developing countries, establishment of national EQAS by preparing homemade quality control material is a useful scheme in terms of resources and time to monitor the laboratory performance. The objective of this study is to implement an EQAS to monitor the analytical performance of the district laboratories in Bhutan. Baseline information was collected through questionnaires. Lyophilized human serum including normal and abnormal levels were prepared and distributed to 19 participating laboratories. Nine routine analytes were included for the study. Their results were evaluated using Variance index scores (VIS) and Coefficient of variations (CV) was compared with Clinical Laboratory Improvement Act (CLIA) Proficiency Testing Criteria (PT) for each analyte. There was significant decrease in CV at the end of the study. The percentages of results in acceptable VIS as ‘A’ were 63, 60, 66, 69, 73 and 74, 75, 76 and 79 % in November 2009–July 2010 respectively. From our results, we concluded that, establishment of EQAS through distribution of home-made quality control material could be the useful scheme to monitor the laboratory performance in clinical chemistry in Bhutan.     

The concurrence of the current postanalytical phase management with the national recommendations: a survey of the Working Group for Postanalytics of the Croatian Society of Medical Biochemistry and Laboratory Medicine

IntroductionThe detection and prevention of errors in the postanalytical phase can be done through the harmonization and standardization of constituent parts of this phase of laboratory work. The aim was to investigate how well the ongoing management of the postanalytical phase corresponds to the document “Post-analytical laboratory work: national recommendations” in Croatian medical biochemistry laboratories (MBLs).Materials and methodsAll 195 MBLs participating in the national external quality assessment scheme, were invited to undertake a part in a survey. Through 23 questions the participants were asked about management of the reference intervals (RI), delta check, reflex/reflective testing, postanalytical quality indicators and other parts of the postanalytical phase recommended in the national recommendations. The results are presented in numbers and percentages.ResultsOut of 195 MBLs, 119 participated in the survey, giving a response rate of 61%. Not all of the respondents provided answers to all the questions. Delta check has not been used in 59% (70/118) of the laboratories. Only 22/113 (20%) laboratories use reflex and/or reflective testing. In 53% of the laboratories, critical results were reported within 30 minutes of the confirmation of the results. In 34% (40/118) of the laboratories, turnaround time and reporting of critical results are two most often monitored postanalytical quality indicators.ConclusionThe results showed the critical results reporting and monitoring of postanalytical quality indicators are in the line with the recommendations. However, the management of RI verification, the use of delta check and reflex/reflective testing still must be harmonized among Croatian MBLs.     

Utilization of biological variation data in the interpretation of laboratory test results – survey about clinicians’ opinion and knowledge

IntroductionTo interpret test results correctly, understanding of the variations that affect test results is essential. The aim of this study is: 1) to evaluate the clinicians’ knowledge and opinion concerning biological variation (BV), and 2) to investigate if clinicians use BV in the interpretation of test results.Materials and methodsThis study uses a questionnaire comprising open-ended and close-ended questions. Questions were selected from the real-life numerical examples of interpretation of test results, the knowledge about main sources of variations in laboratories and the opinion of clinicians on BV. A total of 399 clinicians were interviewed, and the answers were evaluated using a scoring system ranked from A (clinician has the highest level of knowledge and the ability of using BV data) to D (clinician has no knowledge about variations in laboratory). The results were presented as number (N) and percentage (%).ResultsAltogether, 60.4% of clinicians have knowledge of pre-analytical and analytical variations; but only 3.5% of them have knowledge related to BV. The number of clinicians using BV data or reference change value (RCV) to interpret measurements results was zero, while 79.4% of clinicians accepted that the difference between two measurements results located within the reference interval may be significant.ConclusionsClinicians do not use BV data or tools derived from BV such as RCV to interpret test results. It is recommended that BV should be included in the medical school curriculum, and clinicians should be encouraged to use BV data for safe and valid interpretation of test results.     

Reporting of activated partial thromboplastin time (aPTT): Could we achieve better comparability of the results?

IntroductionActivated partial thromboplastin time (aPTT) is determined and reported as clotting time in seconds aPTT(s), but it is presumed that reporting results as patient-to-normal clotting time ratio, aPTT(r), could minimize within-laboratory variability. The aim of study was to investigate differences in reporting aPTT results that can affect comparability of the results among Croatian laboratories and suggest further steps for its harmonization.Materials and methodsThe questionnaire on aPTT reporting practice was distributed to 83 laboratories through Survey Monkey application in March 2019 as the part of the first regular round of Croatian Centre for Quality Assessment in Laboratory Medicine proficiency testing.ResultsThe survey response rate was 0.49. Majority of laboratories report aPTT results as both, seconds and ratio. Participants reported use of 23 different aPTT(s) reference intervals along with 17 different combinations of reagent/coagulometer and 25 aPTT(s) denominators of different origin for aPTT(r) calculation. Despite the same aPTT(s) results, the use of different denominators caused a dispersion of aPTT(r) results that can lead to exceeding external quality assessment performance criteria of 7%, particularly when results were compared for the same reagent group only. By applying aPTT(s) reference interval mean as denominator for calculation of aPTT(r) reference interval better concordance to harmonized one was obtained (17 vs. 27; χ² = 3.972; P = 0.046).ConclusionIn order to improve comparability of the results, laboratories are advised to use mean of aPTT(s) reference interval as denominator for aPTT(r) calculation. Type of coagulometer need to be considered when evaluating aPTT proficiency test results and its currently acceptable limit of performance evaluated accordingly.     

Institutional practices and policies in acid-base testing: a self reported Croatian survey study on behalf of the Croatian society of medical biochemistry and laboratory medicine Working Group for acid-base balance

Introduction:

The aim of this survey study was to assess the current practices and policies in use related to the various steps in the blood gas testing process, across hospital laboratories in Croatia.

Materials and methods:

First questionnaire was sent by email to all medical biochemistry laboratories (N = 104) within general, specialized and clinical hospitals and university hospital centres to identify laboratories which perform blood gas analysis. Second questionnaire with detailed questions about sample collection, analysis and quality control procedures, was sent only to 47 laboratories identified by the first survey. Questionnaire was designed as combination of questions and statements with Likert scale. Third questionnaire was sent to all participating laboratories (N=47) for additional clarification for either indeterminate or unclear answers.

Results:

Blood gas analysis is performed in 47/104 hospital laboratories in Croatia. In 25/41 (0.61) of the laboratories capillary blood gas sampling is the preferred sample type for adult patient population, whereas arterial blood sample is preferentially used in only 5/44 laboratories (0.11). Blood sampling and sample processing for capillary samples is done almost always by laboratory technicians (36/41 and 37/44, respectively), whereas arterial blood sampling is almost always done by the physician (24/29) and only rarely by a nurse (5/28). Sample acceptance criteria and sample analysis are in accordance with international recommendations for majority of laboratories. 43/44 laboratories participate in the national EQA program. POCT analyzers are installed outside of the laboratory in 20/47 (0.43) institutions. Laboratory staff is responsible for education and training of ward personnel, quality control and instrument maintenance in only 12/22, 11/20 and 9/20 institutions, respectively.

Conclusions:

Practices related to collection and analysis for blood gases in Croatia are not standardised and vary substantially between laboratories. POCT analyzers are not under the direct supervision by laboratory personnel in a large proportion of surveyed institutions. Collective efforts should be made to harmonize and improve policies and procedures related to blood gas testing in Croatian laboratories.     

Evaluation of Imprecision,Bias and Total Error of Clinical Chemistry Analysers

Context Two Biosystems analysers are used in our laboratory, a fully automated A25 and a semi-automated BTS-350. Internal quality control is done for both but external quality control only for A25. As BTS-350 is used for backup, it is important that the results of both analysers are not just comparable but also within predefined limits of systematic, random and total error (TE). Aim To evaluate the imprecision, bias and TE of the two Biosystem analysers. Materials and Methods Biosystems level-1 quality control sera lot number 70A was run in duplicate for 32 days on both the analysers. Between day imprecision (measured by the coefficient of variation), bias and TE were calculated for ten analytes and were checked to see whether they are within the acceptable minimum limits, desirable limits and optimum limits of allowable error based on specifications on Westgard’s website updated in 2014. Results On both the analysers, all the analytes except alkaline phosphatase were within the acceptable minimum limits of TE and most analytes were within the desirable limits of TE. Only TG on A25 was within the optimum limit of TE. Conclusion The two Biosystem analysers performed comparably with errors within acceptable limits for most analytes. BTS-350 was found to be a suitable and ready backup analyser for A25.     

Survey on reporting of epithelial cells in urine sediment as part of external quality assessment programs in Brazilian laboratories

IntroductionEpithelial cells (ECs) are structures regularly observed during urine microscopy analysis. The correct identification of EC subtypes can be useful since renal tubular epithelial cells (RTECs) are clinically relevant. We investigate the urinary ECs report and the judgement of its clinical importance by Brazilian laboratories.Materials and methodsA survey with four questions was made available to participants of the Urinalysis External Quality Assessment Program (EQAP) from Controllab. Laboratories composed 3 groups: (1) differentiating ECs subtypes: “squamous”, “transitional” and “RTECs”; (2) differentiating ECs subtypes: “squamous” or “non-squamous” cells; (3) without ECs subtype identification. Participants did not necessarily answer to all questions and the answers were evaluated both within the same laboratory’s category and within different categories of laboratories.ResultsA total of 1336 (94%) laboratories answered the survey; Group 1, 119/140 (85%) reported that ECs differentiation is important to the physician and 62% want to be evaluated by EQAP, while in Group 3, 455/1110 (41%) reported it is useful to them, however only 25% want be evaluated by EQAP. Group 2 laboratories 37/51 (73%) reported that the information is important, but only 13/52 (25%) are interested in an EQAP with differentiation of the 3 ECs subtypes.ConclusionMost of the laboratories do not differentiate ECs in the three subtypes, despite the clinical importance of RTECs. Education of laboratory staff about the clinical significance of urinary particles should be considered a key priority.     

Application of sigma metrics for the assessment of quality assurance using the MQ-2000 PT HbA1c analyzer

Introduction

Glycosylated hemoglobin (HbA1c) concentrations measured in clinical chemistry laboratories show large differences between their interlaboratory reported values. Laboratory measurements of quality performance should be based on quantitative data. The sigma metrics model provides an objective method for the assessment of current HbA1c assays and is useful in quality management planning. The aim of our study was to evaluate the analytical performance of the MQ-2000 PT HbA1c analyzer test results in the context of our operating conditions on the sigma scale.

Materials and methods

The coefficient of variation was determined from the calculated mean and standard deviation evaluated from internal quality control (QC) (N = 168 days) (Shanghai Huachen Biological Reagent Co. Ltd, China) data, and records of external quality data (KBUDEK, İstanbul, Turkey) measured in the period from May to November 2013 were used to determine the bias. The resulting data and total allowable error rate (TEA = 10%) from the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) were used to calculate the sigma level.

Results

The calculated coefficient of variations (CVs) at the two levels, normal (QC1 = 36.6 ± 2.38 mmol/mol) and pathological (QC2 = 84.7 ± 2.68 mmol/mol), were 6.5% and 3.1%, respectively. The average bias between the external QC and MQ-2000 PT during the study period was 4.3%. The calculated average sigma value was 1.19.

Conclusions

The MQ-2000 PT HbA1c is a new analyser in the market; there is need for improvement and the method should be controlled with greater attention to ensure quality.Key words: diabetes mellitus, hemoglobin A1c protein, human, chromatography, high pressure liquid chromatography     

Controlled electroporation of the plasma membrane in microfluidic devices for single cell analysis

Chemical cytometry on a single cell level is of interest to various biological fields ranging from cancer to stem cell research. The impact chemical cytometry can exert in these fields depends on the dimensionality of the retrievable analytes content. To this point, the number of different analytes identifiable and additionally their subcellular localization is of interest. To address this, we present an electroporation based approach for selective lysis of only the plasma membrane, which permits analysis of the dissolved cytoplasm, while reducing contributions from the nucleus and membrane bound fractions of the cell analytes. The use of 100 μs long pulse and a well defined DC electric field gradient of ∼4.5 kV·cm⁻¹ generated by 3D electrodes initiates release of a cytoplasm marker in ≪1 s, while retaining nuclear fluorescence markers.     

Analytical bias due to calibrator matrix effects

Fresh serum specimens from 50 patients were analysed for all routine analytes using calibration with serum matrix calibrator as well as aqueous matrix calibrators. Despite good correlation, there is statistically significant bias between serum and aqueous matrix calibrations for most of the analytes. In addition, the bias in cases of glucose, cholesterol and triglycerides is more than the medically allowable error. A proportional systematic error was found pointing to a calibration disparity between the two types of calibrators. These findings suggest an analytical bias between serum and aqueous matrix calibrations that could result in a lack of commutability among various laboratories.