Laboratory Practitioners Research Articles

Canadian College of Medical Geneticists: clinical practice advisory document – responsibility to recontact for reinterpretation of clinical genetic testing

BackgroundAdvances in technology and knowledge have facilitated both an increase in the number of patient variants reported and variants reclassified. While there is currently no duty to recontact for reclassified...

Linearity assessment: deviation from linearity and residual of linear regression approaches.

In this computer simulation study, we examine four different statistical approaches of linearity assessment, including two variants of deviation from linearity (individual (IDL) and averaged (AD)), along with detection capabilities of residuals of linear regression (individual and averaged). From the results of the simulation, the following broad suggestions are provided to laboratory practitioners when performing linearity assessment. A high imprecision can challenge linearity investigations by producing a high false positive rate or low power of detection. Therefore, the imprecision of the measurement procedure should be considered when interpreting linearity assessment results. In the presence of high imprecision, the results of linearity assessment should be interpreted with caution. Different linearity assessment approaches examined in this study performed well under different analytical scenarios. For optimal outcomes, a considered and tailored study design should be implemented. With the exception of specific scenarios, both ADL and IDL methods were suboptimal for the assessment of linearity compared. When imprecision is low (3 %), averaged residual of linear regression with triplicate measurements and a non-linearity acceptance limit of 5 % produces<5 % false positive rates and a high power for detection of non-linearity of>70 % across different types and degrees of non-linearity. Detection of departures from linearity are difficult to identify in practice and enhanced methods of detection need development.

The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript.The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the LEAP checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

The LEAP checklist for Laboratory Evaluation and Analytical Performance Characteristics reporting of clinical measurement procedures

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the LEAP checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

The LEAP checklist for Laboratory Evaluation and Analytical Performance characteristics reporting of clinical measurement procedures

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript.The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the LEAP checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures.

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the LEAP checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures.

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the LEAP checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures.

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the Laboratory Evaluation and Analytical Performance Characteristics (LEAP) checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

What has been The Impact of Laboratory Accreditation in Saudi Arabia? A Cross-Sectional Survey of Laboratory Practitioners

Objectives: While laboratory accreditation has improved laboratory practices in several countries, its effectiveness in laboratories in Saudi Arabia remains unclear. This survey aims to assess the impact of laboratory accreditation on laboratory practices across the country. Materials and Methods: In this cross-sectional study, we surveyed laboratory practitioners (n = 207) across Saudi Arabia from September 21 to October 22 using an online questionnaire created over Monkey Survey. Practitioners were queried regarding their laboratory accreditation, practices, and the observed impact on patient laboratory testing. Data were analyzed using IBM Statistical Package for the Social Sciences (SPSS) software and potential associations were assessed using the Chi-square test. P &lt; 0.05 was considered statistically significant in all cases. Results: Laboratories with a higher number of accreditations were more likely to have documented standard operating procedures (SOPs) (P = 0.039) and more frequent reviews of laboratory policies and procedures (P = 0.002). Practitioners in our study were more likely to have noticed an overall improvement in patient laboratory testing if their institutes adhered to the components of the accreditation process, such as documented SOPs for testing (P = 0.017), availability of safety manuals (P &lt; 0.01), written policies of internal and external quality assurance programs (P = 0.007), regular meetings to maintain accreditations (P ≤ 0.001), and availability of a task force team to maintain the accreditation program (P ≤ 0.001). Conclusion: This survey suggests that accreditation has had an overall positive impact on laboratory practices and patient laboratory testing in Saudi Arabia.

Laboratory Practices, Potentiality, and Material Patienthood in Genomic Cancer Medicine.

Laboratory practitioners working in oncology are increasingly involved in implementing genomic medicine, operating at the intersection of the laboratory and the clinic. This includes molecular diagnostic work and molecular testing to direct entry into molecular-based clinical trials and treatment decision-making based on molecular profiling. In this article, we draw on qualitative interviews with laboratory practitioners in the United Kingdom to explore the role of laboratory work in genomic cancer medicine, focusing on the handling of patient tissue and making of potentiality to guide patients' present and future care. With an increase in molecular testing to inform standard care and clinical trial participation, we show how practitioners "potentialized" the tissue by carefully negotiating what to test, how to test, and when. This included maximizing and managing small amounts of tissue in anticipation of possible future patient care. Tissue archives also took on new meaning, and potentiality, which practitioners negotiated alongside patient care. Potentiality was key to generating the "big" future of genomic medicine and also involved care work where the tissue emerged as an extension of the patient, as a form of "material patienthood," to secure present and future care for patients through their involvement in genomic medicine.

Inappropriate laboratory testing requests: perspectives of clinical laboratory professionals

Introduction: Laboratory examinations constitute a major factor in achieving the correct clinical diagnosis for patients. However, the ordering of unnecessary or inappropriate laboratory testing remains common, with consequent consumption of laboratory resources whether human or material. The present work evaluated the level of satisfaction of laboratory practitioners toward the appropriateness of laboratory tests ordered by physicians. Methods: This cross-sectional study involved a total of 256 medical laboratory practitioners representing different qualifications and health care sectors, who answered several questions concerning their knowledge and attitudes toward inappropriate laboratory testing ordered by physicians. Results: More than 85% of respondents agreed with the definition provided in the survey, which is substantially consistent with prior studies. More than 90% affirmed the associated drain on time and resources. However, discrepant responses were received concerning physician awareness of test availability, and participants reported laboratory staff arguments with physicians due to orders for unnecessary tests. Data showed that unnecessary orders were mainly requested by physicians of less experience. Conclusions: Ultimately, dissatisfaction was manifest among clinical laboratory professionals, and educational interventions are required to moderate request behaviors.

Knowledge and attitudes of Saudi medical laboratory professionals concerning non-pathological factors influencing test results

Introduction: Successful medical decisions are highly reliant on medical laboratory results; as such, laboratory results are essential to patient health management, and errors in those results may lead to serious complications and death. The aim of the present study was to assess the knowledge of medical laboratory practitioners in Saudi Arabia regarding factors that may influence medical laboratory testing results and the correct actions for troubleshooting. Methods: A total of 256 practitioners participated, representing diverse qualifications and various healthcare sectors. The study utilized a pretested questionnaire comprised of three sections: socio-demographic characteristics, knowledge, and attitudes. Results: The responses demonstrated participants to possess outstanding knowledge of factors that may affect laboratory test results, including biological and pathological factors, diet, and personal habits. Furthermore, participants demonstrated satisfactory attitudes toward such factors. Conclusions: Thus, this study reveals a magnificent image concerning Saudi practitioners’ knowledge and capacity for suitable actions given unexpected test results, and hence their ability to provide correct healthcare services. This constitutes an acceptable overview, particularly as a first pass; nonetheless, more studies on larger cohorts remain required.

Quality improvement in clinical biochemistry laboratory using six sigma metrics and quality goal index

Introduction: One of the most popular quality management system tackle employed for process perfection is six sigma. When the process outcome is measurable, six sigma can be used to assess the quality. Aim: Present study was conducted with the objective to apply six sigma matrices and quality goal index for the assessment of quality assurance in a clinical biochemistry laboratory. Materials and methods: Present study is a retrospective study. Internal and external quality control data were analyzed retrospectively during July 2020 to December 2020. Descriptive statistics like laboratory mean ± standard deviation; bias and coefficient of variation (CV) were calculated for the parameters glucose, urea, creatinine, ALT (SGPT), AST (SGOT), cholesterol, triglyceride and HDL. Sigma value was calculated for both level I &amp; level II of internal quality control (IQC). Results: Satisfactory sigma values (≥3) were elicited for blood glucose, cholesterol, triglyceride, HDL, urea and creatinine, while ALT (SGPT) and AST (SGOT) performed poorly (&lt;3) on the sigma scale. The quality goal index (QGI) ratio was found (&gt; 1.2) for only 2 parameters SGPT and SGOT (with sigma value &lt;3) for both levels 1 and 2, indicating inaccuracy. Conclusion: Results of present study focuses on meticulous appraisal and execution of quality measures to improve sigma standards of all the analytical processes. Even though six sigma provides benefits over former approaches to quality assurance, it also opens newer challenges for laboratory practitioners. Therefore, sigma metric analysis provides a point of reference to design a protocol for IQC for the laboratory; address poor assess performance, and assess the existing laboratory process efficiency.

Impact of heterozygous hemoglobin E on six commercial methods for hemoglobin A1c measurement

Background This study examined the impact of heterozygous HbE on HbA1c measurements by six commonly used commercial methods. The results were compared with those from a modified isotope-dilution mass spectrometry (IDMS) reference laboratory method on a liquid chromatograph coupled with tandem mass spectrometer (LC-MS/MS). Methods Twenty-three leftover samples of patients with heterozygous HbE (HbA1c range: 5.4–11.6%), and nineteen samples with normal hemoglobin (HbA1c range: 5.0–13.7%) were included. The selected commercial methods included the Tina-quant HbA1c Gen. 3 (Roche Diagnostics, Basel, Switzerland), Cobas B 101 (Roche Diagnostics, Basel, Switzerland), D100 (Bio-Rad Laboratories, Hercules, CA, USA), Variant II Turbo HbA1c 2.0 (Bio-Rad Laboratories, Hercules, CA, USA), DCA Vantage (Siemens Healthcare, Erlangen, Germany) and HbA1c Advanced (Beckman Coulter Inc., Brea, CA, USA). Results With the exception of Cobas B 101 and the Variant II Turbo 2.0, the 95% confidence intervals of the Passing–Bablok regression lines between the results from the six commercial methods and the IDMS method overlapped. The latter suggested no statistically significant difference in results and hence no impact on HbA1c result despite the presence of heterozygous HbE. The method of Cobas B 101 gave positive bias at the range of concentrations examined (5.4–11.6%), while that of Variant II Turbo 2.0 gave positive bias at concentrations up to approximately 9.5%. The finding of significant positive bias in the methods of Cobas B 101 and Variant II Turbo 2.0 agrees with the observations of some previous studies, but is contrary to manufacturer’s claim indicating the absence of interference by heterozygous HbE. Our results also clearly showed the impact of heterozygous HbE across a fairly broad measurement range using a laboratory method (the Variant II Turbo 2.0). Laboratory practitioners and clinicians should familiarize themselves with prevailing hemoglobin variants in the population they serve and select the appropriate methods for HbA1c measurement.

Isotope Fractionation of Gaseous-, Supercritical-, and Dual-Phase Carbon Dioxide in Pressurized Cylinders Exposed to Variable Temperatures.

This work examines the stable isotope fractionation of carbon and oxygen in gaseous, supercritical, and liquid carbon dioxide systems at temperatures from −27.1 to +43.5 °C. For pressurized single-, supercritical-, and dual-phase carbon dioxide, both carbon and oxygen isotope fractionations can be measured and are significant when subjected to variations within this temperature range. The δ13C and δ18O values ranged from −41.55 to −41.38 ‰ (VPDB) and −27.74 to −24.9 ‰ (VPDB), respectively, for gas-phase carbon dioxide from 9.3 to 39 °C. A pressure variation of 27.58 barg to 34.48 barg was measured throughout this temperature range. In order to evaluate the effect of supercritical formation and liquefaction on the stable isotope values, cylinders were filled to varying pressures. When stored at cold temperatures, the δ13C value as measured in the headspace of the liquid phase varied from −41.23 to −41.13 ‰ (VPDB) and −41.50 to −41.44 ‰ (VPDB) in the supercritical phase. The δ18O value was between −25.51 and −25.36 ‰ (VPDB) in the liquid phase and between −24.79 and −24.77 ‰ (VPDB) in the supercritical phase. Temperatures in these experiments were selected to mimic outdoor conditions (winter and summer) that stable isotope laboratory practitioners may encounter when storing compressed carbon dioxide cylinders containing stable isotope working reference gases. The carbon and oxygen isotope composition of carbon dioxide gas within these pressurized cylinders return to their precooled isotope values within ∼24 h when warmed to laboratory temperatures (∼24 °C). A headspace analysis performed immediately after the carbon dioxide cylinder was removed from the cold environment yielded δ13C values that were relatively enriched, while δ18O values were relatively depleted. This is likely an effect of 12C and 18O being preferentially partitioned in the liquid phase within the cylinder. As the cylinder warmed, both liquid and gas equilibrated, and carbon and oxygen homogenized isotopically. As the cylinder was heated into the supercritical phase, a slight opposite isotope effect at higher pressure and temperatures was noted. That is, a slight 13C depletion and 18O enrichment were observed in the gas phase. However, these isotope variations were just slightly outside of the analytical error. Additionally, a separate gas-phase carbon dioxide cylinder was kept at a constant laboratory temperature as a control. This carbon dioxide showed no measurable carbon or oxygen isotope variation throughout the duration of the experimental work. The measured isotope fractionation was significantly higher comparing the phase transition from the gaseous to liquid phase versus the gaseous phase to supercritical phase. The proper handling of pressurized carbon dioxide cylinders used as reference gases for an isotope ratio mass spectrometer includes using carbon dioxide at pressures of less than ∼34.88 barg to ensure that the gas is present as a single phase, storing the gas in a temperature-controlled environment, and allowing the gaseous carbon dioxide to equilibrate to ambient conditions for 24–48 h if storage in a controlled ambient environment is not feasible.

On Pathology Laboratory Recruitment and Retention.

The specific aims of the study are to analyze relationships between the personality traits of laboratory professionals and choice of profession and preferred work settings. Data from practicing laboratory professionals were collected via a web-based survey tool to gather information about personality types, choice of profession, and work setting preferences among medical laboratory professionals. Results of the survey showed that INFJ (Introversion, Intuition, Feeling, Judging) is the most common medical laboratory personality type across the various laboratory work settings and that there are no significant differences between the practitioners' personality type and the choice of profession within pathology. The study revealed laboratorians from higher-volume laboratories were 1.2 times more likely to prefer Judging than lower-volume laboratories, and younger medical laboratory practitioners were 2.3 times more likely to gravitate toward Perceiving than their older counterparts. The results of this study shed light on how employers can build on the personality preferences of the laboratory workforce to improve personal job satisfaction and laboratory productivity, quality, and work culture. The research implications are useful for laboratory recruitment and retention.

New Insight for the Prognosis of CCHF: Clinical, Laboratory and Sonography Findings.

Crimean Congo Hemorrhagic Fever (CCHF) is an acute and fatal disease with various clinical and paraclinical characteristics. In this article, we report data on confirmed CCHF cases from Iran and describe the association between studying factors and outcomes of the disease. In the study design, we evaluated demographic characteristics, clinical, laboratory and sonographic findings of 160 CCHF confirmed cases during 2003 and 2012 in Zabol (A city in Sistan and Baluchestan province of Iran). The association between these factors and the fatal outcome were evaluated by regression analysis. The disease had a fatal outcome in 7 (4.4%) patients. Females had more severe symptoms and higher odds for death (odds ratio11.57, p=0.005). Leukocytosis (p<0.001), PT (p<0.001) and PTT (p=0.008) elongation, AST (p=0.010) and ALT (p>0.001) elevation were significantly associated with fatal outcome. CNS related symptoms (odds ratio 5.9, p=0.027) in clinical examination and ascites (odds ratio 38.4, p=0.012) and liquid in the pelvic cavity (odds ratio 24.2, p=0.004) were also identified as risk factors of death in this study. Our data suggest that in addition to clinical and laboratory findings practitioners consider sonography for CCHF prognosis.

Comprehensive preimplantation genetic testing by massively parallel sequencing.

Can whole genome sequencing (WGS) offer a relatively cost-effective approach for embryonic genome-wide haplotyping and preimplantation genetic testing (PGT) for monogenic disorders (PGT-M), aneuploidy (PGT-A) and structural rearrangements (PGT-SR)? Reliable genome-wide haplotyping, PGT-M, PGT-A and PGT-SR could be performed by WGS with 10× depth of parental and 4× depth of embryonic sequencing data. Reduced representation genome sequencing with a genome-wide next-generation sequencing haplarithmisis-based solution has been verified as a generic approach for automated haplotyping and comprehensive PGT. Several low-depth massively parallel sequencing (MPS)-based methods for haplotyping and comprehensive PGT have been developed. However, an additional family member, such as a sibling, or a proband, is required for PGT-M haplotyping using low-depth MPS methods. In this study, 10 families that had undergone traditional IVF-PGT and 53 embryos, including 13 embryos from two PGT-SR families and 40 embryos from eight PGT-M families, were included to evaluate a WGS-based method. There were 24 blastomeres and 29 blastocysts in total. All embryos were used for PGT-A. Karyomapping validated the WGS results. Clinical outcomes of the 10 families were evaluated. A blastomere or a few trophectoderm cells from the blastocyst were biopsied, and multiple displacement amplification (MDA) was performed. MDA DNA and bulk DNA of family members were used for library construction. Libraries were sequenced, and data analysis, including haplotype inheritance deduction for PGT-M and PGT-SR and read-count analysis for PGT-A, was performed using an in-house pipeline. Haplotyping with a proband and parent-only haplotyping without additional family members were performed to assess the WGS methodology. Concordance analysis between the WGS results and traditional PGT methods was performed. For the 40 PGT-M and 53 PGT-A embryos, 100% concordance between the WGS and single-nucleotide polymorphism (SNP)-array results was observed, regardless of whether additional family members or a proband was included for PGT-M haplotyping. For the 13 embryos from the two PGT-SR families, the embryonic balanced translocation was detected and 100% concordance between WGS and MicroSeq with PCR-seq was demonstrated. The number of samples in this study was limited. In some cases, the reference embryo for PGT-M or PGT-SR parent-only haplotyping was not available owing to failed direct genotyping. WGS-based PGT-A, PGT-M and PGT-SR offered a comprehensive PGT approach for haplotyping without the requirement for additional family members. It provided an improved complementary method to PGT methodologies, such as low-depth MPS- and SNP array-based methods. This research was supported by the research grant from the National Key R&D Program of China (2018YFC0910201 and 2018YFC1004900), the Guangdong province science and technology project of China (2019B020226001), the Shenzhen Birth Defect Screening Project Lab (JZF No. [2016] 750) and the Shenzhen Municipal Government of China (JCYJ20170412152854656). This work was also supported by the National Natural Science Foundation of China (81771638, 81901495 and 81971344), the National Key R&D Program of China (2018YFC1004901 and 2016YFC0905103), the Shanghai Sailing Program (18YF1424800), the Shanghai Municipal Commission of Science and Technology Program (15411964000) and the Shanghai 'Rising Stars of Medical Talent' Youth Development Program Clinical Laboratory Practitioners Program (201972). The authors declare no competing interests. N/A.

Impact of Digital Marketing Strategy for Successful Laboratory and Clinical Practitioners - A Questionnaire Based Study

Impact of Digital Marketing Strategy for Successful Laboratory and Clinical Practitioners - A Questionnaire Based Study

소방과학교실에 관한 과학교사들의 인식에 관한 연구

In this study, fire defense science classes centered on science were trained for scientific laboratory practitioners and science teachers at elementary, junior high and high schools, and the recognition and investigation were conducted on the educational effects of the fire defense science classes, the possibility of practical use in actual education sites, the necessity for fire defense safety and science cooperation, and the necessity for introduction into the current curriculum. As part of various programs for youth fire defense safety, the basic data for the nationwide expansion of fire defense science classes were obtained. According to the survey, 95% of the respondents said that fire science classes could be used in schools, while 98% said that education would be effective. In addition, 99% of the respondents said the subject of the fire defense science class was appropriate for safety and scientific cooperation, while 94% said the current curriculum needed to be introduced.