scholarly journals Optimizing Available Tools for Achieving Result Standardization: Value Added by Joint Committee on Traceability in Laboratory Medicine (JCTLM)

2021 ◽  
Author(s):  
Mauro Panteghini ◽  
Federica Braga ◽  
Johanna E Camara ◽  
Vincent Delatour ◽  
Katleen Van Uytfanghe ◽  
...  
Keyword(s):  
Task Force ◽  
Certified Reference Materials ◽  
Clinical Sample ◽  
Metrological Traceability ◽  
Value Added ◽  
Higher Order ◽  
Measuring System ◽  
Clinical Samples ◽  
Field Methods ◽  
Reference Measurement

Abstract Background The JCTLM created a Task Force on Reference Measurement System Implementation (TF-RMSI) to provide guidance on metrological traceability implementation for the in vitro diagnostics (IVD) community. Content TF-RMSI investigated the reference measurement systems (RMS) for 13 common measurands by applying the following procedural steps: (a) extracting data from the JCTLM database of available certified reference materials (CRMs) and reference measurement procedures (RMPs); (b) describing the RMS to which each recruited CRM or RMP belongs; (c) identifying the intended use of the CRMs, and, if used as a common calibrator for IVD measuring systems and/or trueness assessment of field methods was included, checking the CRM’s certificate for information about commutability with clinical samples; and (d) checking if the CRM or RMP measurement uncertainty (MU) has the potential to be small enough to avoid significantly affecting the analytical performance specifications (APS) for MU of clinical sample results when the MU from the IVD calibrator and from the end-user measuring system were combined. Summary We produced a synopsis of JCTLM-listed higher-order CRMs and RMPs for the selected measurands, including their main characteristics for implementing traceability and fulfilling (or not) the APS for suitable MU. Results showed that traceability to higher-order references can be established by IVD manufacturers within the defined APS for most of the 13 selected measurands. However, some measurands do not yet have suitable CRMs for use as common calibrators. For these measurands, splitting clinical samples with a laboratory performing the RMP may provide a practical alternative for establishing a calibration hierarchy.

scholarly journals Implementation of metrological traceability in laboratory medicine: where we are and what is missing

2020 ◽  
Vol 58 (8) ◽  
pp. 1200-1204 ◽  
Author(s):  
Mauro Panteghini ◽  
Federica Braga
Keyword(s):  
Mass Spectrometry ◽  
Measurement System ◽  
Task Force ◽  
Metrological Traceability ◽  
Laboratory Medicine ◽  
Isotopic Dilution ◽  
Clinical Samples ◽  
Reference Measurement ◽  
Reference Measurement System

AbstractBackgroundThe Joint Committee on Traceability in Laboratory Medicine (JCTLM) has recently created the Task Force on Reference Measurement System Implementation (TF-RMSI) for providing guidance on traceability implementation to in vitro diagnostics (IVD) manufacturers. Using serum creatinine (sCr) as an example, a preliminary exercise was carried out by checking what type of information is available in the JCTLM database and comparing this against derived analytical performance specifications (APS) for measurement uncertainty (MU) of sCr.ContentAPS for standard MU of sCr measurements were established as a fraction (≤0.75, minimum quality; ≤0.50, desirable quality; and ≤0.25, optimum quality) of the intra-individual biological variation of the measurand (4.4%). By allowing no more than one third of the total MU budget for patient samples to be derived from higher-order references, two out of the four JCTLM reference materials (RMs) at least allow minimum APS to be achieved for the MU of patient samples. Commutability was explicitly assessed for one of the JCTLM-listed matrixed RMs, which was produced in compliance with ISO 15194:2009 standard, whereas the remaining three RMs were assessed against the ISO 15194:2002 version of the standard, which only required the extent of commutability testing to be reported. Regarding the three listed reference methods, the MU associated with isotopic dilution-mass spectrometry coupled to gas chromatography (ID/GC/MS) and isotopic dilution-mass spectrometry coupled to liquid chromatography (ID/LC/MS) would allow APS to be fulfilled, while the isotope dilution surface-enhanced Raman scattering (ID/SERS) method displays higher MU.SummaryThe most recently listed RM for sCr in the JCTLM database meets the ISO 15194:2009 requirements with MU that would allow APS to be fulfilled and has had commutability demonstrated for use as a common calibrator in implementing traceability of sCr measurements. Splitting clinical samples with a laboratory performing ID/GC/MS or ID/LC/MS provides an alternative but would also require all components of uncertainty of these materials to be assessed.OutlookUsing appropriately derived APS to judge whether reference measurement system components are fit for purpose represents a novel approach. The TF-RMSI is planning to review a greater number of measurands to provide more robust information about the state of the art of available reference measurement systems and their impact on the ability of clinical measurements to meet APS.

Harmonization and Standardization: Where Are We Now?

2020 ◽  
Author(s):  
W Greg Miller ◽  
Neil Greenberg
Keyword(s):  
Reference Materials ◽  
Certified Reference Materials ◽  
Metrological Traceability ◽  
Medical Laboratory ◽  
Clinical Samples ◽  
End User ◽  
Laboratory Service ◽  
Fit For Purpose ◽  
Diagnosis Therapy ◽  
Traceable Calibration

Abstract Background The purpose of a medical laboratory test is to provide information on the pathophysiologic condition of an individual patient as an aid in diagnosis, therapy, or assessment of risk for a disease. For optimal laboratory service, results from different measurement procedures (MPs) for the same measurand should be equivalent (harmonized) within stated specifications, enabling the results to be used reliably for medical decisions. The term “harmonization” refers to any process that enables establishing equivalence of reported values among different end-user MPs. The term “standardization” refers to achieving harmonization by metrological traceability of patients’ results to higher order reference materials and/or reference measurement procedures. Content New procedures for harmonization and standardization were published in 2020 by the International Organization for Standardization (ISO) and by the IFCC. ISO 17511:2020 provides revised requirements for establishing metrologically traceable calibration hierarchies for end-user MPs used in clinical laboratories. ISO 21151:2020 provides new requirements to implement a harmonization protocol to address the situation when there are no fit-for-purpose certified reference materials or reference MPs available for a measurand. The IFCC Working Group on Commutability published recommendations for applying a correction for noncommutability of a certified reference material to enable using that material in a metrologically traceable calibration hierarchy for an end-user MP. Summary We review metrological traceability and how these new approaches will improve the capability to achieve harmonized results for clinical samples.

scholarly journals The utility of measurement uncertainty in medical laboratories

2020 ◽  
Vol 58 (9) ◽  
pp. 1407-1413 ◽  
Author(s):  
Federica Braga ◽  
Mauro Panteghini
Keyword(s):  
Measurement Uncertainty ◽  
Metrological Traceability ◽  
Measuring System ◽  
Medical Laboratory ◽  
Management Tool ◽  
Clinical Samples ◽  
Traceability Chain ◽  
Medical Laboratories

AbstractThe definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference) methods and/or materials, together with a clinically acceptable level of measurement uncertainty (MU), are fundamental requirements to produce accurate and equivalent laboratory results. The MU associated with each step of the traceability chain should be governed to obtain a final combined MU on clinical samples fulfilling the requested performance specifications. MU is useful for a number of reasons: (a) for giving objective information about the quality of individual laboratory performance; (b) for serving as a management tool for the medical laboratory and in vitro diagnostics (IVD) manufacturers, forcing them to investigate and eventually fix the identified problems; (c) for helping those manufacturers that produce superior products and measuring systems to demonstrate the superiority of those products; (d) for identifying analytes that need analytical improvement for their clinical use and ask IVD manufacturers to work for improving the quality of assay performance and (e) for abandoning assays with demonstrated insufficient quality. Accordingly, the MU should not be considered a parameter to be calculated by medical laboratories just to fulfill accreditation standards, but it must become a key quality indicator to describe both the performance of an IVD measuring system and the laboratory itself.

scholarly journals Two-factor higher-order model of perfectionism in Iranian general and clinical samples

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Reza Moloodi ◽  
Abbas Pourshahbaz ◽  
Parvaneh Mohammadkhani ◽  
Ladan Fata ◽  
Ata Ghaderi
Keyword(s):  
General Population ◽  
Clinical Sample ◽  
Population Sample ◽  
Higher Order ◽  
Clinical Samples ◽  
Order Model ◽  
Obsessive Compulsive ◽  
Depression Anxiety Stress Scale ◽  
Compulsive Disorder ◽  
Males And Females

Abstract Background Studies in Western cultures have shown that perfectionism is conceptualized by two-factor higher-order model including perfectionistic strivings and perfectionistic concerns. However, little is known about the construct of perfectionism in Eastern societies. Thus, we examined the two-factor higher-order model of perfectionism in Iranian general and clinical samples. Methods We recruited a general population sample (n = 384) and patients with major depressive disorder, obsessive compulsive disorder, social anxiety disorder, and eating disorders (n = 152) from Tehran, Iran from September 2016 to December 2017. They completed the Clinical Perfectionism Questionnaire, Perfectionism Inventory, and Depression, Anxiety, Stress Scale-21. Results The two-factor higher-order model of perfectionism showed adequate fit with data for females from the general population and clinical sample. Data for males were only available from the general population, and the model showed adequate fit with the data first after removing the Rumination scale of the perfectionistic concerns. The perfectionistic strivings dimension showed no or negative association with depression, anxiety, and stress symptoms, but perfectionistic concerns dimension showed positive correlation with these indices in all samples for both males and females. Conclusions The results support the two-factor higher-order model of perfectionism in samples of Iranian females from the general population and clinical sample. However, the results were different for males from the general population. In other words, the modified two-factor higher-order model showed acceptable fit with the data for males from the general population only after removing the Rumination scale from perfectionistic concerns. These differences among males and females were discussed.

Are Three Items Sufficient to Measure Sense of Coherence?

2018 ◽  
Vol 34 (4) ◽  
pp. 229-237 ◽  
Author(s):  
Francesca Chiesi ◽  
Andrea Bonacchi ◽  
Caterina Primi ◽  
Alessandro Toccafondi ◽  
Guido Miccinesi
Keyword(s):  
Sense Of Coherence ◽  
Convergent Validity ◽  
Clinical Sample ◽  
Clinical Samples ◽  
Depression Symptoms ◽  
Time Saving ◽  
Positive Role ◽  
Patients With Cancer ◽  
Measure Sense

Abstract. The present study aimed at evaluating if the three-item sense of coherence (SOC) scale developed by Lundberg and Nystrom Peck (1995) can be effectively used for research purpose in both nonclinical and clinical samples. To provide evidence that it represents adequately the measured construct we tested its validity in a nonclinical (N = 658) and clinical sample (N = 764 patients with cancer). Results obtained in the nonclinical sample attested a positive relation of SOC – as measured by the three-item SOC scale – with Antonovsky’s 13-item and 29-item SOC scales (convergent validity), and with dispositional optimism, sense of mastery, anxiety, and depression symptoms (concurrent validity). Results obtained in the clinical sample confirmed the criterion validity of the scale attesting the positive role of SOC – as measured by the three-item SOC scale – on the person’s capacity to respond to illness and treatment. The current study provides evidence that the three-item SOC scale is a valid, low-loading, and time-saving instrument for research purposes on large sample.

Investigation of duck plague virus in hoar areas of Bangladesh

2020 ◽  
Vol 26 (1-2) ◽  
pp. 73-78
Author(s):  
A Hossen ◽  
MH Rahman ◽  
MZ Ali ◽  
MA Yousuf ◽  
MZ Hassan ◽  
...  
Keyword(s):  
Cytopathic Effect ◽  
Clinical Sample ◽  
Chorioallantoic Membrane ◽  
Clinical Samples ◽  
Isolation And Identification ◽  
Duck Plague Virus ◽  
Pcr Method ◽  
Polymerase Chain ◽  
The Individual ◽  
Free Ranging

Duck plague (DP) is the most important infectious disease of geese, ducks and free-ranging water birds. The present study was conducted to determine the prevalence of duck plague virus followed by isolation and identification. For these purposes, a total of 155 cloacal swabs samples were collected randomly from duck of different haor areas of Bangladesh including 45 (41 surveillance and 4 clinical) samples from Netrokona; 42 (40 surveillance and 2 clinical) samples from Kishoregonj; 30 samples from Brahmanbaria and 38 samples from Sunamganj. The samples were processed and pooled (1:5 ratio) for initial screening of target polymerase gene of duck plague virus by polymerase chain reaction (PCR) method. All the samples of a positive pool were then tested individually for identifying the individual positive samples. The result showed that out of 155 samples, 41 (26.45%) were found positive in which 17 were from Netrokona, where 15 (36.58%) were from surveillance samples and 2 (50%) were from clinical sample; 16 were from Kishoregonj, where 14 (35%) were from surveillance samples and 2 (100%) were from clinical sample; 2 (6.6%) were from Brahmanbaria and 5 (13.15%) were from Sunamganj. These positive samples were inoculated into 9-10 days embryonated duck eggs (EDE) through chorioallantoic membrane (CAM) route for the isolation of virus. The EDE died earlier was also chilled, and in a similar way, the CAMs were collected and again performed PCR for id entification of virus. Out of 41 PCR positive samples, 26 samples were isolated and reconfirmed by PCR. Subsequently, DPV was isolated in primary duck embryo fibroblasts cell culture and confirmed by observing cytopathic effect (CPE). Bang. J. Livs. Res. Vol. 26 (1&2), 2019: P. 73-78

SIMULTANEOUS MULTI-ELEMENT (INCLUDING FLUORINE) ANALYSIS OF VARIOUS BIO-MEDICAL SAMPLES

2005 ◽  
Vol 15 (03n04) ◽  
pp. 169-180 ◽  
Author(s):  
K. SERA ◽  
T. TERASAKI ◽  
J. ITOH ◽  
S. FUTATSUGAWA ◽  
Y. SAITOH ◽  
...  
Keyword(s):  
Toxic Elements ◽  
Elemental Concentration ◽  
Urine Analysis ◽  
Arsenic Concentration ◽  
Measuring System ◽  
Clinical Samples ◽  
Fluorine Concentration ◽  
Titanium Concentration ◽  
Quantitative Analyses ◽  
Contaminate Environment

We have measured fluorine concentration in samples taken from humans, such as sweat, saliva, snivel and tear in addition to hair, nail and urine, together with those of other elements by means of a three-detector measuring system. Fluorine has been known as one of the most toxic elements as well as arsenic, lead, mercury and cadmium which contaminate environment over the wide area. This system allowed us to discuss about fluorine concentration related to other elements'. A standard-free method established by us has been applied to quantitative analyses of these samples. By means of these methods, quantitative analysis becomes possible for samples of less than 1mg or 1μl and it is quite suited to tear, snivel and sweat. As one of the conclusion, sweat, snivel and tear give useful information in addition to the samples which have been traditionally analyzed. It is found that titanium concentration in a body is well estimated by analyses of sweat, snivel and saliva, arsenic concentration can be estimated by sweat analysis in addition to urine analysis, and nickel is well evaluated by sweat and tear. In this way, it is required to estimate elemental concentration in a human body by measuring various clinical samples. Especially, correlation between fluorine and arsenic is found in a few bio-medical samples.

The Prevalence of Symptoms of Depression in An Australian General Population

1980 ◽  
Vol 14 (1) ◽  
pp. 65-71 ◽  
Author(s):  
D. G. Byrne
Keyword(s):  
Depressive Symptoms ◽  
General Population ◽  
Random Sample ◽  
Clinical Sample ◽  
Depression Scale ◽  
Clinical Samples ◽  
Demographic Differences ◽  
Symptoms Of Depression ◽  
The Subject ◽  
Depressive States

The prevalence of depressive symptoms was estimated in a random sample of an Australian general population by administration of the Zung Self-Rating Depression Scale (S.D.S.). Rates, calculated according to criteria derived from a previously studied clinical sample, were somewhat higher in this population than had been reported in similar studies elsewhere. It was reasoned that this finding related to the relative laxity of criteria employed in the present study. Socio-demographic influences on the reporting of depressive symptoms were evident, the most prominent of these being the sex of the subject. It was suggested that these influences may underlie socio-demographic differences in rates of recognized depressive states occurring within clinical samples.

scholarly journals Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

2019 ◽  
Vol 57 (4) ◽  
pp. 459-464 ◽  
Author(s):  
Marc Thelen ◽  
Florent Vanstapel ◽  
Pika Meško Brguljan ◽  
Bernard Gouget ◽  
Guilaine Boursier ◽  
...  
Keyword(s):  
Metrological Traceability ◽  
Measurement Procedure ◽  
Medical Laboratory ◽  
Clinical Samples ◽  
End User ◽  
Worst Case ◽  
Iso 15189 ◽  
Value Assignment ◽  
Traceability Chain ◽  
Medical Laboratories

Abstract ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer’s selected measurement procedure and the manufacturer’s working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.

scholarly journals ANTIBACTERIAL RESISTANCE PATTERN OF PSEUDOMONAS AERUGINOSA ISOLATED FROM CLINICAL SAMPLES AT A GENERAL HOSPITAL IN PADANG, WEST SUMATRA, INDONESIA

2017 ◽  
Vol 10 (8) ◽  
pp. 158
Author(s):  
Rustini Rustini ◽  
Jamsari Jamsari ◽  
Marlina Marlina ◽  
Nasrul Zubir ◽  
Yori Yuliandra
Keyword(s):  
Pseudomonas Aeruginosa ◽  
Bacterial Resistance ◽  
Clinical Sample ◽  
Opportunistic Pathogen ◽  
Positive Control ◽  
Diffusion Method ◽  
Clinical Samples ◽  
Resistance Pattern ◽  
Tract Infections ◽  
Almost All

Objectives: Pseudomonas aeruginosa is an opportunistic pathogen that has an innate resistance to some antibiotics. This bacterium is one of the mostcommon causes of nosocomial infections that include surgical wound infections, burns, and urinary tract infections. The bacteria have been reportedlyresistant to many antibiotics and have developed multidrug resistance (MDR). The objective of the study was to determine the resistance pattern ofP. aeruginosa isolated from clinical samples of patients against some major antibiotics.Methods: Isolates of P. aeruginosa were obtained from clinical sample of urine, sputum, swabs, pus, feces, and blood and cultured in cetrimide agar. P.aeruginosa ATCC 27853 was used as a positive control. The antibacterial susceptibility testing was conducted against 13 antibiotics: Ceftazidime, cefotaxime,ceftriaxone, cefoperazone, ciprofloxacin, levofloxacin, ofloxacin, gentamicin, amikacin, piperacillin, ticarcillin, meropenem, and imipenem. The examinationwas carried out using agar diffusion method of Kirby-Bauer and following the standards from Clinical and Laboratory Standards Institute (CLSI).Results: The results showed that bacterial resistance was established against all tested antibiotics. The highest number of resistance was shownagainst ceftriaxone (44.21%), whereas the most susceptibility was exhibited against amikacin (only 9.47% of resistance). MDR P. aeruginosa (MDRPA)was detected on almost all clinical samples tested, except the feces. The sample with the highest percentage of MDRPA was the pus.Conclusion: The study concludes that the most effective antibiotic against P. aeruginosa is amikacin (91.51%), whereas the most resistance is exhibited to ceftriaxone (43.16%).

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