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1.
Antonio Buo Soto Katell Peoch Tommaso Fasano Jorge Diaz-Garzon Bernardino Gonzlez de la Presa Valerie Chicha-Cattoir Simone Canovi Maria Sanz de Pedro Nayra Rico Tiphaine Robert Efrem Bonelli Pilar Fernndez Calle Aurea Mira Guillaume Lefevre Luigi Vecchia Jose Luis Bedini 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2022,32(2)
IntroductionThe Fourth Universal Definition of Myocardial Infarction Global Taskforce recommends the use of high sensitive troponin (hs-Tn) assays in the diagnosis of acute myocardial infarction. We evaluated the analytical performance of the Atellica IM High-sensitivity Troponin I Assay (hs-TnI) (Siemens Healthcare Diagnostics Inc., Tarrytown, USA) and compared its performance to other hs-TnI assays (Siemens Advia Centaur, Dimension Vista, Dimension EXL, and Abbott Architect (Wiesbaden, Germany)) at one or more sites across Europe.Materials and methodsPrecision, detection limit, linearity, method comparison, and interference studies were performed according to Clinical and Laboratory Standards Institute protocols. Values in 40 healthy individuals were compared to the manufacturer’s cut-offs. Sample turnaround time (TAT) was examined.ResultsImprecision repeatability CVs were 1.1–4.7% and within-lab imprecision were 1.8–7.6% (10.0–25,000 ng/L). The limit of blank (LoB), detection (LoD), and quantitation (LoQ) aligned with the manufacturer’s values of 0.5 ng/L, 1.6 ng/L, and 2.5 ng/L, respectively. Passing-Bablok regression demonstrated good correlations between Atellica IM analyser with other systems; some minor deviations were observed. All results in healthy volunteers fell below the 99th percentile URL, and greater than 50% of each sex demonstrated values above the LoD. No interference was observed for biotin (≤ 1500 µg/L), but a slight bias at 5.0 g/L haemoglobin and 50 ng/L Tn was observed. TAT from was fast (mean time = 10.9 minutes) and reproducible (6%CV).ConclusionsReal-world analytical and TAT performance of the hs-TnI assay on the Atellica IM analyser make this assay fit for routine use in clinical laboratories. 相似文献
2.
Goce Dimeski Breeann Silvester Jacobus Ungerer Leslie Johnson Jennifer H. Martin 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2013,23(3):296-302
Background:
Overcrowding and prolonged length of stay in emergency departments (ED) are increasing problems in hospitals. Rapid availability of all laboratory results has an impact on clinical decision-making, admissions or discharge decisions and resource utilisation. Increasing number of our urinary drugs of abuse (DOA) screens had a turnaround time (TAT) of up to 33 days after the discharge of the patient.Materials and methods:
Following an audit and a consultation period with clinicians using the service, a policy change was implemented to reduce the use of gas chromatography mass spectroscopy (GCMS): all requests would have a standard immunoassay (IA) test panel undertaken unless specifically they requested GCMS (including medico-legal) analysis.Results:
Almost all of the clinicians interviewed had no understanding of the DOA screening or the difference in the information generated between a confirmatory GCMS urine toxicology screen and IA DOA panel. It appeared none of the patients surveyed in the audit would have had a different clinical decision made if a GCMS had not been undertaken. Post change audit showed only 4.3% of drug requests for IA also received a confirmatory GCMS testing. The estimated saving post change implementation was $127,000 (AU $) in test costs alone over a two year period. The TAT of GCMS results was reduced to 3–4 days.Conclusion:
A laboratory-led behavioural change in test requesting is possible and sustainable provided the reason is clinically sound and accompanied by consultation and availability of advice by phone when requested on test requesting or interpretation. 相似文献3.
Monitoring and Root Cause Analysis of Clinical Biochemistry Turn Around Time at an Academic Hospital
Kiran P. Chauhan Amit P. Trivedi Dharmik Patel Bhakti Gami N. Haridas 《Indian journal of clinical biochemistry : IJCB》2014,29(4):505-509
Quality can be defined as the ability of a product or service to satisfy the needs and expectations of the customer. Laboratories are more focusing on technical and analytical quality for reliability and accuracy of test results. Patients and clinicians however are interested in rapid, reliable and efficient service from laboratory. Turn around time (TAT), the timeliness with which laboratory personnel deliver test results, is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This study is aims to provide clue for laboratory TAT monitoring and root cause analysis. In a 2 year period a total of 75,499 specimens of outdoor patient department were monitor, of this a total of 4,142 specimens exceeded TAT. With consistent efforts to monitor, root cause analysis and corrective measures, we are able to decreased the specimens exceeding TAT from 7–8 to 3.7 %. Though it is difficult task to monitor TAT with the help of laboratory information system, real time documentation and authentic data retrievable, along with identification of causes for delays and its remedial measures, improve laboratory TAT and thus patient satisfaction. 相似文献
4.
Suprava Patel Rachita Nanda Sibasish Sahoo Eli Mohapatra 《Indian journal of clinical biochemistry : IJCB》2018,33(3):341-347
Proficiency of laboratory services is the mainstay in clinical medicine in providing error free diagnostic results. The efficiency of the laboratory needs to be evaluated as per standard international criterion. The quality indicators of the different phases of total testing process are considered the fundamental measurable tool for evaluation of laboratory performance. In order to optimize the laboratory’s proficiency and accreditate it as per international standard in our newly established lab, the study was conducted to evaluate the frequency of errors incurred by laboratory and nonlaboratory professionals during the whole testing process. Retrospective analysis was done for data received from April 2016 to Dec 2016 in our lab. Total number of samples received was 61,674, out of which 43200 samples could be analyzed for quality indicators. Total numbers of tests processed in these samples were 172,800. In the study samples, 26.5% errors were due to pre-analytical factors whereas 9.4% of errors were contributed by analytical phase and 18% by post-analytical phase. Inappropriateness of test requisition was observed to be the major attributing determinant for pre-analytical errors. Instrumentation efficiency in form of frequent breakdown (~7%), greatly affected the proficiency of analytical phase in our lab. 12% of post-analytical errors were ascribed by excessive turn-around-time. However, timeliness of critical value call out and reporting for STAT samples revealed high proficiency up to 97%. High error rates were observed in pre–pre- and pre-analytical phases that also accorded for high error frequency in post analytical phase. This emphasizes urgent need to formulate guidelines for processing all steps of total testing process and initiate strategic measures for reducing risk of errors and increasing patient safety. 相似文献
5.
Rachna Agarwal Sujata Chaturvedi Neelam Chhillar Renu Goyal Ishita Pant Chandra B. Tripathi 《Indian journal of clinical biochemistry : IJCB》2012,27(1):61-68
Quality in laboratory has huge impact on diagnosis and patient management as 80–90% of all diagnosis is made on the basis
of laboratory tests. Monitoring of quality indicators covering the critical areas of pre-analytical, analytical and post-analytical
phases like sample misidentification, sample rejection, random and systemic errors, critical value reporting and TATs have
a significant impact on performance of laboratory. This study was conducted in diagnostic laboratories receiving approximately
42,562 samples for clinical chemistry, hematology and serology. The list of quality indicators was developed for the steps
of total testing process for which errors are frequent and improvements are possible. The trend was observed for all the QI
before and after sensitisation of the staff over the period of 12 months. Incomplete test requisition form received in the
lab was the most poor quality indicator observed (7.89%), followed by sample rejection rate (4.91%). Most significant improvement
was found in pre- and post-analytical phase after sensitisation of staff but did not have much impact on analytical phase.
Use of quality indicators to assess and monitor the quality system of the clinical laboratory services is extremely valuable
tool in keeping the total testing process under control in a systematic and transparent way. 相似文献
6.
Graziella Bonetti Mariarosa Carta Martina Montagnana Claudia Lo Cascio Anna Rita Bonfigli Andrea Mosca Roberto Testa 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2016,26(1):68-76
Introduction
Glycolysis affects glucose determination in vitro. The placement of sample tubes in ice-water slurry with plasma separation within 30 minutes is recommended, or alternatively the use of a glycolysis inhibitor. The aim of our two-steps study was to evaluate which Terumo tube is best for glucose determination in routine clinical setting.Materials and methods
In the first study, blood from 100 volunteers was collected into lithium heparin (LH), NaF/Na heparin (FH) and NaF/citrate buffer/Na2EDTA (FC-Mixture) tubes. LH sample was treated as recommended and considered as reference, while FH and FC-Mixture samples were aliquoted, maintained at room temperature (RT) for 1, 2 and 4 hours; centrifuged and plasma analysed in triplicate. In the second study, samples from 375 volunteers were collected in LH, FH and FC-Mixture tubes and held at RT before centrifugation from 10 to 340 minutes, depending on each laboratory practice. Samples were analysed in one analytical run.Results
In the first study, FH glucose concentrations were 5.15 ± 0.66 mmol/L, 5.05 ± 0.65 mmol/L and 5.00 ± 0.65 mmol/L (P < 0.001) in tubes stored at RT for 1, 2 and 4 hours, respectively. Mean biases in all time points exceeded the analytical goal for desirable bias based on biological variation criteria. FC-Mixture glucose concentrations were 5.48 ± 0.65 mmol/L, 5.46 ± 0.6 mmol/L and 5.46 ± 0.64 mmol/L in tubes stored at RT for 1, 2 and 4 hours, respectively. Mean biases for FC-Mixture glucose in all time points reached optimal analytical goals. In the second study, the biases for LH and FH glucose compared to reference FC-Mixture glucose exceeded the preset analytical goals, regardless of the blood collection to centrifugation time interval.Conclusions
FC-mixture tubes glucose concentrations were preserved up to 4h storage at RT. We confirmed that NaF alone does not allow immediate glycolysis inhibition in real life pre-centrifugation storage conditions (up to 340 minutes). FC-Mixture should be used exclusively for glucose determination in laboratories unable to implement the recommended blood samples’ treatment.Key words: glucose, pre-analytical phase, sodium fluoride, citrate acidification, stability 相似文献7.
Marija Kocijancic Jelena Cargonja Alma Delic-Knezevic 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2014,24(3):368-375
Introduction:
Preanalytical variables account for most of laboratory errors. There is a wide range of factors that affect the reliability of laboratory report. Most convenient sample type for routine laboratory analysis is serum. BD Vacutainer® Rapid Serum Tube (RST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) blood collection tube provides rapid clotting time allowing fast serum separation. Our aim was to evaluate the comparability of routine chemistry parameters in BD Vacutainer® RST blood collection tube in reference with the BD Vacutainer® Serum Separating Tubes II Advance Tube (SST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA).Materials and methods:
Blood specimens were collected from 90 participants for evaluation on its results, clotting time and stability study of six routine biochemistry parameters: glucose (Glu), aspartate aminotransferase (AST), alanine aminotransferase (ALT), calcium (Ca), lactate dehidrogenase (LD) and potassium (K) measured with Olympus AU2700 analyzer (Beckman Coulter, Tokyo, Japan). The significance of the differences between samples was assessed by paired t-test or Wilcoxon Matched-Pairs Rank test after checking for normality.Results:
Clotting process was significantly shorter in the RSTs compared to SSTs (2.49 min vs. 19.47 min, respectively; P < 0.001). There was a statistically significant difference between the RST and SST II tubes for glucose, calcium and LD (P < 0.001). Differences for glucose and LD were also clinically significant. Analyte stability studies showed that all analytes were stable for 24 h at 4 °C.Conclusions:
Most results (except LD and glucose) from RST are comparable with those from SST. In addition, RST tube provides shorter clotting time. 相似文献8.
Fatma Emel Ko?ak Mustafa Y?ntem ?zlem Yücel Mustafa ?ilo ?zlem Gen? Ayfer Meral 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2013,23(2):206-210
Introduction:
Today, the pneumatic tube transport system (PTS) is used frequently because of its advantages related to timing and speed. However, the impact of various types of PTS on blood components is unknown. The aim of this study was to examine the influence of PTS on the quality of routine blood cell counts, erythrocyte sedimentation, and certain blood coagulation tests.Materials and methods:
Paired blood samples were obtained from each of 45 human volunteers and evaluated by blood cell count, erythrocyte sedimentation, and several coagulation tests, including prothrombin time (PT) and activated partial thromboplastin time (aPTT). Blood samples were divided into 2 groups: Samples from group 1 were transported to the laboratory via the PTS, and samples from group 2 were transported to the laboratory manually. Both groups were evaluated immediately by the tests listed above.Results:
The blood sample test results from groups 1 and 2 were evaluated and compared. No statistically significant differences were observed (P = 0.069–0.977).Conclusion:
The PTS yielded no observable effects on blood cell counts, erythrocyte sedimentation, or PT and aPTT test results. We concluded that the PTS can be used to transport blood samples and yield reliable results for blood cell counts, erythrocyte sedimentation, and several coagulation tests. 相似文献9.
Xi Zhang Goce Dimeski Chamindie Punyadeera 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2014,24(2):258-265
Introduction:
We have previously shown that the concentrations of D-dimer are significantly elevated in saliva compared with plasma. Saliva offers several advantages compared with blood analysis. We hypothesised that human saliva contains plasminogen activator inhibitor-1 (PAI-1) and that the concentrations are not affected by the time of saliva collection. The aim was to adopt and validate an immunoassay to quantify PAI-1 concentrations in saliva and to determine whether saliva collection time has an influence in the measurement.Materials and methods:
Two saliva samples (morning and afternoon) from the same day were collected from healthy subjects (N = 40) who have had no underlying heart conditions. A customized AlphaLISA® immunoassay (PerkinElmer®, MA, USA) was adopted and used to quantify PAI-1 concentrations. We validated the analytical performance of the customized immunoassay by calculating recovery of known amount of analyte spiked in saliva.Results:
The recovery (95.03%), intra- (8.59%) and inter-assay (7.52%) variations were within the acceptable ranges. The median salivary PAI-1 concentrations were 394 pg/mL (interquartile ranges (IQR) 243.4–833.1 pg/mL) in the morning and 376 (129.1–615.4) pg/mL in the afternoon and the plasma concentration was 59,000 (24,000–110,000) pg/mL. Salivary PAI-1 did not correlate with plasma (P = 0.812).Conclusions:
The adopted immunoassay produced acceptable assay sensitivity and specificity. The data demonstrated that saliva contains PAI-1 and that its concentration is not affected by the time of saliva collection. There is no correlation between salivary and plasma PAI-1 concentrations. Further studies are required to demonstrate the utility of salivary PAI-1 in CVD risk factor studies. 相似文献10.
Singh B Goswami B Gupta VK Chawla R Mallika V 《Indian journal of clinical biochemistry : IJCB》2011,26(2):131-135
Ensuring quality of laboratory services is the need of the hour in the field of health care. Keeping in mind the revolution
ushered by six sigma concept in corporate world, health care sector may reap the benefits of the same. Six sigma provides
a general methodology to describe performance on sigma scale. We aimed to gauge our laboratory performance by sigma metrics.
Internal quality control (QC) data was analyzed retrospectively over a period of 6 months from July 2009 to December 2009.
Laboratory mean, standard deviation and coefficient of variation were calculated for all the parameters. Sigma was calculated
for both the levels of internal QC. Satisfactory sigma values (>6) were elicited for creatinine, triglycerides, SGOT, CPK-Total
and Amylase. Blood urea performed poorly on the sigma scale with sigma <3. The findings of our exercise emphasize the need
for detailed evaluation and adoption of ameliorative measures in order to effectuate six sigma standards for all the analytical
processes. 相似文献
11.
Das B 《Indian journal of clinical biochemistry : IJCB》2011,26(3):235-243
Method validation is pursued as the first step in establishing Lean-Total Quality Management in a new clinical laboratory,
in order to eliminate error in test results. Validation of all the new tests were done (with particular reference to alkaline
phosphatase) by verifying reference intervals, analytical accuracy and precision, inter-assay and intra-assay variations,
analytical sensitivity, limit of detection, linearity and reportable range, i.e. (i) Analytical measurement range (AMR) and
(ii) Clinically reportable range (CRR). Our obtained reference range was within that of the manufacturer’s and showed high
degree of analytical accuracy between two laboratories (r
2 = 0.99). Precision was comparable with the manufacturer’s claim with inter-assay variation CV 1.04% and intra-assay variation
CV 1.54%. Lowest limit of detection was 1.0324 ± 0.007 with CV 0.34%. AMR was also verified with CV 1.26 and 0.69%, for level
1 and level 2 control sera, respectively. The assay was linear with different dilutions. Lean concept was also verified with
high recovery percentage. Validation ensures that accurate and precise results are reported in a clinically relevant turn
around time. 相似文献
12.
Gabriel Lima-Oliveira Gian Luca Salvagno Giuseppe Lippi Elisa Danese Matteo Gelati Martina Montagnana Geraldo Picheth Gian Cesare Guidi 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2014,24(3):343-349
Background:
Presently the necessity of fasting time for coagulation tests is not standardized. Our hypothesis is that this can harm patient safety. This study is aimed at evaluating whether a light meal (i.e. breakfast) can jeopardize laboratory coagulation tests.Materials and methods:
A blood sample was firstly collected from 17 fasting volunteers (12 h). Immediately after blood collection, the volunteers consumed a light meal. Then samples were collected at 1, 2 and 4 h after the meal. Coagulation tests included: activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fbg), antithrombin III (AT), protein C (PC) and protein S (PS). Differences between samples were assessed by Wilcoxon ranked-pairs test. The level of statistical significance was set at P < 0.05. Mean % differences were determined and differences between and baseline and 1, 2 and 4h samples were compared with reference change value (RCV).Results:
A significantly higher % activity of AT was observed at 1 h and 4 h after meal vs. baseline specimen [113 (104–117) and 111 (107–120) vs. 109 (102–118), respectively; P = 0.029 and P = 0.016]. APTT at 2 h was found significantly lower than baseline samples [32.0 (29.9–34.8) vs. 34.1 (32.2–35.2), respectively; P = 0.041]. The results of both Fbg and PS tests were not influenced by a light meal. Furthermore, no coagulation tests had significant variation after comparison with RCV.Conclusion:
A light meal does not influence the laboratory coagulation tests we assessed, but we suggest that the laboratory quality managers standardize the fasting time for all blood tests at 12 hours, to completely metabolize the lipids intake. 相似文献13.
Tapasyapreeti Mukhopadhyay Arulselvi Subramanian Shivam Pandey Nirupam Madaan Anjan Trikha Rajesh Malhotra 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2021,31(2)
IntroductionThe COVID-19 pandemic has posed several challenges to clinical laboratories across the globe. Amidst the outbreak, errors occurring in the preanalytical phase of sample collection, transport and processing, can further lead to undesirable clinical consequences. Thus, this study was designed with the following objectives: (i) to determine and compare the blood specimen rejection rate of a clinical laboratory and (ii) to characterise and compare the types of preanalytical errors between the pre-pandemic and the pandemic phases.Materials and methodsThis retrospective study was carried out in a trauma-care hospital, presently converted to COVID-19 care centre. Data was collected from (i) pre-pandemic phase: 1st October 2019 to 23rd March 2020 and (ii) pandemic phase: 24th March to 31st October 2020. Blood specimen rejection rate was calculated as the proportion of blood collection tubes with preanalytical errors out of the total number received, expressed as percentage.ResultsTotal of 107,716 blood specimens were screened of which 43,396 (40.3%) were received during the pandemic. The blood specimen rejection rate during the pandemic was significantly higher than the pre-pandemic phase (3.0% versus 1.1%; P < 0.001). Clotted samples were the commonest source of preanalytical errors in both phases. There was a significant increase in the improperly labelled samples (P < 0.001) and samples with insufficient volume (P < 0.001), whereas, a significant decline in samples with inadequate sample-anticoagulant ratio and haemolysed samples (P < 0.001).ConclusionIn the ongoing pandemic, preanalytical errors and resultant blood specimen rejection rate in the clinical laboratory have significantly increased due to changed logistics. The study highlights the need for corrective steps at various levels to reduce preanalytical errors in order to optimise patient care and resource utilisation. 相似文献
14.
Yang Fei Rong Zeng Wei Wang Falin He Kun Zhong Zhiguo Wang 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2015,25(2):213-221
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 相似文献15.
Ewa St?pień Krzysztof Gruszczyński Przemys?aw Kapusta Artur Kowalik Iwona Wybrańska 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2015,25(2):222-229
Introduction
Centrifugation is an essential step for plasma preparation to remove residual elements in plasma, especially platelets and platelet-derived microparticles (PMPs). Our working hypothesis was that centrifugation as a preanalytical step may influence some coagulation parameters.Materials and methods
Healthy young men were recruited (N = 17). For centrifugation, two protocols were applied: (A) the first centrifugation at 2500 x g for 15 min and (B) at 2500 x g for 20 min at room temperature with a light brake. In protocol (A), the second centrifugation was carried out at 2500 x g for 15 min, whereas in protocol (B), the second centrifugation involved a 10 min spin at 13,000 x g. Thrombin-antithrombin (TAT) and plasmin-antiplasmin (PAP) complexes concentrations were determined by enzyme-linked immunosorbent assays. PMPs were stained with CD41 antibody and annexin V, and analyzed by flow cytometry method. Procoagulant activity was assayed by the Calibrated Automated Thrombogram method as a slope of thrombin formation (CAT velocity).Results
Median TAT and PAP concentrations did not differ between the centrifugation protocols. The high speed centrifugation reduced the median (IQR) PMP count in plasma from 1291 (841-1975) to 573 (391-1010) PMP/µL (P = 0.001), and CAT velocity from 2.01 (1.31-2.88) to 0.97 (0.82-1.73) nM/min (P = 0.049). Spearman’s rank correlation analysis showed correlation between TAT and PMPs in the protocol A plasma which was (rho = 0.52, P < 0.050) and between PMPs and CAT for protocol A (rho = 0.74, P < 0.050) and protocol B (rho = 0.78, P < 0.050).Conclusion
Centrifugation protocols do not influence the markers of plasminogen (PAP) and thrombin (TAT) generation but they do affect the PMP count and procoagulant activity.Key words: cell-derived microparticles, blood coagulation tests, centrifugation, preanalytical phase 相似文献16.
Gabriel Lima-Oliveira Giuseppe Lippi Gian Luca Salvagno Martina Montagnana Geraldo Picheth Gian Cesare Guidi 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2012,22(3):342-351
Introduction:
The activities involving phlebotomy, a critical task for obtaining diagnostic blood samples, are poorly studied as regards the major sources of errors and the procedures related to laboratory quality control. The aim of this study was to verify the compliance with CLSI documents of clinical laboratories from South America and to assess whether teaching phlebotomists to follow the exact procedure for blood collection by venipuncture from CLSI/NCCLS H03-A6 - Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture might improve the quality of the process.Materials and methods:
A survey was sent by mail to 3674 laboratories from South America to verify the use of CLSI documents. Thirty skilled phlebotomists were trained with the CLSI H03-A6 document to perform venipuncture procedures for a period of 20 consecutive working days. The overall performances of the phlebotomists were further compared before and after the training program.Results:
2622 from 2781 laboratories that did answer our survey used CLSI documents to standardize their procedures and process. The phlebotomists’ training for 20 days before our evaluation completely eliminated non-conformity procedures for: i) incorrect friction of the forearm, during the cleaning of the venipuncture site to ease vein location; ii) incorrect sequence of vacuum tubes collection; and iii) inadequate mixing of the blood in primary vacuum tubes containing anticoagulants or clot activators. Unfortunately the CLSI H03-A6 document does not caution against both unsuitable tourniquet application time (i.e., for more than one minute) and inappropriate request to clench the fist repeatedly. These inadequate procedures were observed for all phlebotomists.Conclusion:
We showed that strict observance of the CLSI H03-A6 document can remarkably improve quality, although the various steps for collecting diagnostic blood specimens are not a gold standard, since they may still permit errors. Tourniquet application time and forearm clench should be verified by all quality laboratory managers in the services. Moreover, the procedure for collecting blood specimens should be revised to eliminate this source of laboratory variability and safeguard the quality. 相似文献17.
Funda Eren Merve Ergin Tuncay Esra Firat Oguz Salim Neselioglu Ozcan Erel 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2021,31(2)
IntroductionFollowing a pandemic, laboratory medicine is vulnerable to laboratory errors due to the stressful and high workloads. We aimed to examine how laboratory errors may arise from factors, e.g., flexible working order, staff displacement, changes in the number of tests, and samples will reflect on the total test process (TTP) during the pandemic period.Materials and methodsIn 12 months, 6 months before and during the pandemic, laboratory errors were assessed via quality indicators (QIs) related to TTP phases. QIs were grouped as pre-, intra- and postanalytical. The results of QIs were expressed in defect percentages and sigma, evaluated with 3 levels of performance quality: 25th, 50th and 75th percentile values.ResultsWhen the pre- and during pandemic periods were compared, the sigma value of the samples not received was significantly lower in pre-pandemic group than during pandemic group (4.7σ vs. 5.4σ, P = 0.003). The sigma values of samples transported inappropriately and haemolysed samples were significantly higher in pre-pandemic period than during pandemic (5.0σ vs. 4.9σ, 4.3σ vs. 4.1σ; P = 0.046 and P = 0.044, respectively). Sigma value of tests with inappropriate IQC performances was lower during pandemic compared to the pre-pandemic period (3.3σ vs. 3.2σ, P = 0.081). Sigma value of the reports delivered outside the specified time was higher during pandemic than pre-pandemic period (3.0σ vs. 3.1σ, P = 0.030).ConclusionIn all TTP phases, some quality indicators improved while others regressed during the pandemic period. It was observed that preanalytical phase was affected more by the pandemic. 相似文献
18.
M. B. Dave P. K. Chawla A. J. Dherai T. F. Ashavaid 《Indian journal of clinical biochemistry : IJCB》2015,30(3):293-297
Mucopolysaccharidoses, a group of inherited disorders are associated with defects in glycosaminoglycan metabolism. Thus, assessment of urinary glycosaminoglycan is used as a screening test for mucopolysaccharidoses. The detection methods range from qualitative spot tests to quantification using metachromatic dyes. In our laboratory we optimized a spectrophotometric quantitative method using a metachromatic dye, dimethylmethylene blue. Heparan sulfate was used for quantification. The glycosaminoglycan–dye complex showed a marked shift in color with increase in concentration. The color complex was quantified at 520 nm. The method was linear from 10–89 mg/L. An age matched normal range was obtained in 177 healthy individuals, grouped in 8 different age groups from neonates to adults. Urinary glycosaminoglycan concentration varied distinctly amongst the study population wherein the lowest range in healthy neonates was more than 3 times the upper limit of healthy adults. Urine samples from 10 patients with mucopolysaccharidoses were also included in the study for clinical validation. The method qualified both analytical and clinical validation and was found to be simple, robust and ideal to be offered as a screening test for mucopplysaccharidoses in a routine clinical chemistry laboratory. 相似文献
19.
Fatma Emel Kocak Bahadir Ozturk Ozben Ozden Isiklar Ozlem Genc Ali Unlu Irfan Altuntas 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2015,25(3):430-438
Introduction
Total 25-hydroxyvitamin D [25(OH)D] is the most reliable indicator of vitamin D status. In this study, we compared two automated immunoassay methods, the Abbott Architect 25-OH Vitamin D assay and the Roche Cobas Vitamin D total assay, with the liquid chromatography-tandem mass spectrometry (LC-MS/MS).Materials and methods
One hundred venous blood samples were randomly selected from routine vitamin D tests. Two of the serum aliquots were analyzed at the Abbott Architect i2000 and the Roche Cobas 6000’s module e601 in our laboratory within the same day. The other serum aliquots were analyzed at the LC-MS/MS in different laboratory. Passing-Bablok regression analysis and Bland-Altman plot were used to compare methods. Inter-rater agreement was analyzed using kappa (κ) analysis.Results
The Roche assay showed acceptable agreement with the LC-MS/MS based on Passing-Bablok analysis (intercept: -5.23 nmol/L, 95% CI: -8.73 to 0.19; slope: 0.97, 95% CI: 0.77 to 1.15). The Abbott assay showed proportional (slope: 0.77, 95% CI: 0.67 to 0.85) and constant differences (intercept: 17.08 nmol/L; 95% CI: 12.98 to 21.39). A mean bias of 15.1% was observed for the Abbott and a mean bias of -14.1% was observed for the Roche based on the Bland-Altman plots. We found strong to nearly perfect agreement in vitamin D status between the immunoassays and LC-MS/MS. (κ: 0.83 for Abbott, κ: 0.93 for Roche) using kappa analysis.Conclusion
Both immunoassays demonstrated acceptable performance, but the Roche Cobas assay demonstrated better performance than the Abbott Architect in the studied samples.Key words: 25-Hydroxyvitamin D, chromatography, immunoassay, methods, tandem mass spectrometry 相似文献20.
Sanju Jalla Sunil Sazawal Salkat Deb robert E. Black Satya Narayan Das Archana Sarkar Maharaj K. Bhan 《Indian journal of clinical biochemistry : IJCB》2004,19(2):95-99
Lymphocyte subset estimations by flow cytometry in population-based studies require transportation of samples from the field
site to the laboratory. As samples arrive late in the day they have to wait overnight before being processed. The effect of
two possible approaches, sample storage for 24 h before staining and immediate staining with analysis after 24 h and 48 h
were evaluated. Two sets of experiments were performed with EDTA (ethylenediamine tetra-acetate) anticoagulated peripheral
blood. In the first experiment, after collection, each sample was divided into two portions. One portion was stained at the
time of blood collection and the other 24 h later after keeping it at room temperature (38–45°C). In the second experiment,
blood samples were stained within 1–2 h. Each sample was analyzed immediately upon completion of staining process and subsequently
after 24 h and 48 h of storage at 4°C. Results suggest that blood collected in EDTA can be processed using whole blood lysis
method, after storage at room temperature (38–45°C) for 24 h with some but not significant alteration in T-cell subsets. Storage
at 4°C after staining for 24 h results in a lesser and insignificant loss of cells or alteration of T-cell subsets and may
be the method of choice. 相似文献