scholarly journals Effects of Fecal Sampling on Preanalytical and Analytical Phases in Quantitative Fecal Immunochemical Tests for Hemoglobin

2017 ◽  
Vol 32 (3) ◽  
pp. 261-266 ◽  
Author(s):  
Stefano Rapi ◽  
Margherita Berardi ◽  
Filippo Cellai ◽  
Samuele Ciattini ◽  
Laura Chelazzi ◽  
...  
Keyword(s):  
Analytical Method ◽  
Laboratory Medicine ◽  
Sample Collection ◽  
Commercial Sample ◽  
Iso 15189 ◽  
Quantitative Measurements ◽  
Volume Of Interest ◽  
Immunochemical Test ◽  
Preanalytical Variability ◽  
Fecal Sampling

Background Information on preanalytical variability is mandatory to bring laboratories up to ISO 15189 requirements. Fecal sampling is greatly affected by lack of harmonization in laboratory medicine. The aims of this study were to obtain information on the devices used for fecal sampling and to explore the effect of different amounts of feces on the results from the fecal immunochemical test for hemoglobin (FIT-Hb). Methods Four commercial sample collection devices for quantitative FIT-Hb measurements were investigated. The volume of interest (VOI) of the probes was measured from diameter and geometry. Quantitative measurements of the mass of feces were carried out by gravimetry. The effects of an increased amount of feces on the analytical environment were investigated measuring the Hb values with a single analytical method. Results VOI was 8.22, 7.1 and 9.44 mm3 for probes that collected a target of 10 mg of feces, and 3.08 mm3 for one probe that targeted 2 mg of feces. The ratio between recovered and target amounts of devices ranged from 56% to 121%. Different changes in the measured Hb values were observed, in adding increasing amounts of feces in commercial buffers. Conclusions The amounts of collected materials are related to the design of probes. Three out 4 manufacturers declare the same target amount using different sampling volumes and obtaining different amounts of collected materials. The introduction of a standard probes to reduce preanalytical variability could be an useful step for fecal test harmonization and to fulfill the ISO 15189 requirements.

Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

2015 ◽  
Vol 53 (8) ◽  
Author(s):  
Marc H.M. Thelen ◽  
Florent J.L.A. Vanstapel ◽  
Christos Kroupis ◽  
Ines Vukasovic ◽  
Guilaime Boursier ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Position Paper ◽  
European Federation ◽  
Medical Field ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Flexible Scope ◽  
Scientific Disciplines

AbstractThe recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.

Aerosol Analysis Using Handheld Raman Spectrometer: On-site Quantification of Trace Crystalline Silica in Workplace Atmospheres

2021 ◽  
Author(s):  
Shijun Wei ◽  
Belinda Johnson ◽  
Michael Breitenstein ◽  
Lina Zheng ◽  
John Snawder ◽  
...  
Keyword(s):  
Crystalline Silica ◽  
Breathing Zone ◽  
Sample Collection ◽  
Short Term ◽  
Limit Of Quantification ◽  
Measurement Capability ◽  
Matrix Interferences ◽  
Raman Spectrometer ◽  
Quantitative Measurements ◽  
Shift Analysis

Abstract A method for aerosol chemical analysis using handheld Raman spectrometer has been developed and its application to measurement of crystalline silica concentration in workplace atmosphere is described. The approach involves collecting aerosol as a spot sample using a wearable optical aerosol monitor, followed by direct-on-filter quantitative analysis of the spot sample for crystalline silica using handheld Raman spectrometer. The filter cassette of a commercially available optical aerosol monitor (designed to collect aerosol for post-shift analysis) was modified to collect 1.5-mm-diameter spot sample, which provided adequate detection limits for short-term measurements over a few tens of minutes or hours. The method was calibrated using aerosolized α-quartz standard reference material in the laboratory. Two Raman spectrometers were evaluated, one a handheld unit (weighing less than 410 g) and the other a larger probe-based field-portable unit (weighing about 5 kg). The lowest limit of quantification for α-quartz of 16.6 μg m−3 was obtained using the handheld Raman unit at a sample collection time of 1 h at 0.4 l min−1. Short-term measurement capability and sensitivity of the Raman method were demonstrated using a transient simulated workplace aerosol. Workplace air and personal breathing zone concentrations of crystalline silica of workers at a hydraulic fracturing worksite were measured using the Raman method. The measurements showed good agreement with the co-located samples analyzed using the standard X-ray powder diffraction (XRD) method, agreeing within 0.15–23.2% of each other. This magnitude of difference was comparable to the inter- and intra-laboratory analytical precision of established XRD and infrared methods. The pilot study shows that for silica-containing materials studied in this work it is possible to obtain quantitative measurements with good analytical figures of merit using handheld or portable Raman spectrometers. Further studies will be needed to assess matrix interferences and measurement uncertainty for several other types of particle matrices to assess the broader applicability of the method.

Effect of sample storage temperature and buffer formulation on faecal immunochemical test haemoglobin measurements

2017 ◽  
Vol 24 (4) ◽  
pp. 176-181 ◽  
Author(s):  
Erin L Symonds ◽  
Stephen R Cole ◽  
Dawn Bastin ◽  
Robert JL Fraser ◽  
Graeme P Young
Keyword(s):  
Room Temperature ◽  
Storage Temperature ◽  
Test Accuracy ◽  
Sample Collection ◽  
Storage Duration ◽  
Initial Concentration ◽  
Faecal Immunochemical Test ◽  
Immunochemical Test ◽  
New Formulation ◽  
And Storage

Objectives Faecal immunochemical test accuracy may be adversely affected when samples are exposed to high temperatures. This study evaluated the effect of two sample collection buffer formulations (OC-Sensor, Eiken) and storage temperatures on faecal haemoglobin readings. Methods Faecal immunochemical test samples returned in a screening programme and with ≥10 µg Hb/g faeces in either the original or new formulation haemoglobin stabilizing buffer were stored in the freezer, refrigerator, or at room temperature (22℃–24℃), and reanalysed after 1–14 days. Samples in the new buffer were also reanalysed after storage at 35℃ and 50℃. Results were expressed as percentage of the initial concentration, and the number of days that levels were maintained to at least 80% was calculated. Results Haemoglobin concentrations were maintained above 80% of their initial concentration with both freezer and refrigerator storage, regardless of buffer formulation or storage duration. Stability at room temperature was significantly better in the new buffer, with haemoglobin remaining above 80% for 20 days compared with six days in the original buffer. Storage at 35℃ or 50℃ in the new buffer maintained haemoglobin above 80% for eight and two days, respectively. Conclusion The new formulation buffer has enhanced haemoglobin stabilizing properties when samples are exposed to temperatures greater than 22℃.

scholarly journals Quality Improvement of Sample Collection Increases the Diagnostic Accuracy of Quantitative Fecal Immunochemical Test in Colorectal Cancer Screening: A Pilot Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Ru-chen Zhou ◽  
Pei-zhu Wang ◽  
Yue-yue Li ◽  
Yan Zhang ◽  
Ming-jun Ma ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Diagnostic Accuracy ◽  
Fecal Immunochemical Test ◽  
Secondary Outcome ◽  
Diagnostic Efficiency ◽  
Sample Collection ◽  
Crc Screening ◽  
Significant Difference ◽  
Immunochemical Test ◽  
Operant Training

Objective: The diagnostic efficiency of the quantitative fecal immunochemical test (qFIT) has large variations in colorectal cancer (CRC) screening. We aimed to explore whether the practical sample collection operant training could improve the diagnostic accuracy of the qFIT in CRC screening.Methods: Moderate-/high-risk individuals aged 50–75 years old were invited to participate in a prospective observational study between July 2020 and March 2021. Participants took a qFIT sample without fecal sample collection operant training in advance and then completed another qFIT sample after the operant training. The primary outcome was the sensitivity and specificity of the qFITs for CRC and advanced colorectal neoplasia (ACRN). The secondary outcome was the difference in the area under the curves (AUCs) and the concentrations of the fecal hemoglobin (Hb) between the qFIT without and after the operant training.Results: Out of 913 patients, 81 (8.9%) patients had ACRN, including 25 (2.7%) patients with CRC. For CRC, the sensitivities of the qFIT without and after the operant training at 10 μg/g were 80.4 and 100.0%, respectively, and the specificities were 90.1 and 88.4%, respectively. For ACRN, the sensitivities were 49.4 and 69.1% and the specificities were 91.7 and 91.3%, respectively. The AUC of the qFIT after the operant training was significantly higher than that without the operant training for CRC (p = 0.027) and ACRN (p = 0.001). After the operant training, the concentration of the fecal Hb was significantly higher than that without the operant training (p = 0.009) for ACRN, but there was no significant difference for CRC (p = 0.367).Conclusion: Practical sample collection operant training improves the diagnostic accuracy of the qFIT, which increases the detection of the low concentrations of fecal Hb. Improving the quality of the sample collection could contribute to the diagnostic efficiency of the qFIT in CRC screening.

scholarly journals Ethics in Laboratory Medicine: An Overview of Considerations for Ethical Issues

2021 ◽  
Author(s):  
Neerja Aggarwal ◽  
Pawan Kumar Kare ◽  
Sudip Kumar Datta
Keyword(s):  
Ethical Issues ◽  
Clinical Chemistry ◽  
Codes Of Conduct ◽  
Laboratory Medicine ◽  
Direct Access ◽  
Medical Laboratory ◽  
Ethical Challenges ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Resource Limited

Several ethical issues exist within the diagnostic medical laboratory. The major ethical challenges such as; consent, confidentiality, codes of conduct, conflict of interest, lab utilisation, proficiency, and direct access testing are some times more prevalent in resource-limited settings. Presently, decisions regarding diagnosis and patient’s treatment are commonly taken on the basis of outcomes and interpretations of laboratory test results. Therefore, ethics plays a significant role in laboratory medicine. Apart from the lab results, laboratory staff is another important aspect of the laboratory. Hence, it is highly recommended that knowledge of ethics helps to protect confidence; operational integrity, capability, impartiality, and safety of the staff. Many countries and their professional societies have developed policies and guidance material with regard to ethical issues in the area of laboratory medicine. The organizations specially; International of federation of clinical chemistry (IFCC), American Association of Clinical Chemistry (AACC) and International Organization for Standardization (ISO) have defined ethical recommendations for clinical laboratories. They are, in general, outlined the responsibilities of laboratory professionals towards their profession, the patient, and the society. However, implication of ethical standards and guidelines are vary between different cultures, geographies, and according to available resources. In this chapter, we have mentioned the ethical consideration of IFCC, AACC and ISO 15189:2012 with regard to laboratory medicine and also addressed the various ethical issues that arises day to day in laboratory medicine in the current scenario.

Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Michael Cornes ◽  
Edmée van Dongen-Lases ◽  
Kjell Grankvist ◽  
Mercedes Ibarz ◽  
Gunn Kristensen ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Venous Blood ◽  
Laboratory Medicine ◽  
European Federation ◽  
Blood Collection ◽  
Sample Collection ◽  
Blood Draw ◽  
Preanalytical Phase ◽  
Analytical Phase

AbstractIt has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%–68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

Transition to ISO 15189 : 2012 for Cytopathology Laboratories Part 1

2016 ◽  
Vol 5 (3) ◽  
pp. 1-21 ◽  
Author(s):  
Eleftherios Vavoulidis ◽  
Stavros Archondakis ◽  
Maria Nasioutziki ◽  
Ourania Oustambasidou ◽  
Angelos Daniilidis ◽  
...  
Keyword(s):  
Quality Management System ◽  
State Of The Art ◽  
Laboratory Medicine ◽  
Quality Level ◽  
Highly Qualified ◽  
High Quality ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Qualified Personnel ◽  
Analytical Equipment

Nowadays, due to the latest advances in Laboratory Medicine, diagnostic medical laboratories with their highly qualified personnel and state-of-the-art analytical equipment, have completely changed the way modern healthcare is offered. In order to maintain or even increase the already high quality level of the provided testing services, diagnostic laboratories including the cytopathology ones, need to design and apply a Quality Management System (QMS) in agreement with the requirements of the ISO 15189 International Standard. The authors present their experience on the implementation of such a QMS in cytopathology laboratories and highlight the most important general and management parameters that should be taken into consideration when moving from ISO 15189:2007 to the latest ISO 15189:2012. In addition, useful recommendations and suggestions that could make the transition to the latest Standard easier are included. Finally, possible issues and potential adverse events associated with the laboratory's implementation of the ISO 15189:2012 are also described.

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