Assessing Non-Laboratory Healthcare Professionals' Attitude towards the Importance of Patient Preparation for Laboratory Tests.

(1) Background: Various guidelines address patient preparation and its importance for venous blood sampling, such as the GP41 guideline issued by the Clinical Laboratory Standards Institute (CLSI) and the blood collection guidelines published by the World Health Organisation. Recommendations provided by national societies or international organisations in the field of radiology, such as The Contrast Media Safety Committee of the European Society of Urogenital Radiology, or in the field of laboratory medicine, such as the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI), also guide this practice. There is a notable lack of understanding regarding the viewpoints held by non-laboratory healthcare professionals concerning the significance of patient preparation for laboratory testing and the impact of typical factors associated with patient preparation. This study endeavours to bridge this gap by assessing the attitude of non-laboratory healthcare professionals in Lithuania regarding these pivotal aspects. (2) Methods: A self-designed anonymous questionnaire was disseminated among 141 public healthcare institutions in Lithuania. The internal consistency of the questionnaire was evaluated by computing Cronbach's alpha. Descriptive statistics were utilised for the variables, while comparisons of attitude among groups were conducted using Mann-Whitney U (for two groups) or Kruskal-Wallis (for more than two groups) for categorical and discrete indicators. The Kruskal-Wallis post-hoc test was employed for pairwise comparisons. A significance level of p-Value < 0.05 was applied to establish statistical significance. (3) Results: A total of 158 respondents constituted two distinct groups of healthcare professionals: nurses and physicians. Most of the participants either agreed or strongly agreed that patient preparation could introduce bias into laboratory test results. Professionals with less than 20 years of work experience or those who attended training in patient preparation for sampling within a 5-year timeframe exhibited stronger agreement regarding different preanalytical factors in patient preparation and their impact on laboratory test results compared to their counterparts. (4) Conclusions: Non-laboratory healthcare professionals who participated in this survey consider proper patient preparation for laboratory testing to be a significant step towards obtaining accurate test results. They also recognize the commonly acknowledged preanalytical factors as important for ensuring reliable test results. However, attitudes towards the importance of several preanalytical factors vary depending on whether non-laboratory healthcare professionals have more or less than 20 years of work experience, as well as whether they have attended any training on this topic within the last five years or have never attended such training.

Nationwide Trends in Non-COVID-19 Infectious Disease Laboratory Tests in the Era of the COVID-19 Pandemic in Korea.

The coronavirus disease 2019 pandemic has brought significant changes to infectious disease management globally. This study explored changes in clinical microbiological testing trends and their implications for infectious disease incidence and medical utilization during the pandemic. We collected nationwide claims for monthly clinical microbiology tests from January 2018 to March 2022 using the National Health Insurance Service database. Seasonal autoregressive integrated moving average models were employed to make predictions for each disease based on the baseline period (January 2018 to January 2020). The results showed a significant decrease in general bacterial and fungal cultures, respiratory infectious disease-related, and inflammatory markers, while the representatives of tests for vector-borne diseases, healthcare-associated infections, and chronic viral infections remained stable. The study highlights the potential of clinical microbiological testing trends as an additional surveillance tool and offers implications for future infectious disease management and surveillance strategies in pandemic settings.

Changing Diagnostic Testing Practices for Foodborne Pathogens, Foodborne Diseases Active Surveillance Network, 2012-2019.

Background: Pathogen detection has changed with increased use of culture-independent diagnostic tests (CIDTs). CIDTs do not yield isolates, which are necessary to detect outbreaks using whole-genome sequencing. The Foodborne Diseases Active Surveillance Network (FoodNet) monitors clinical laboratory testing practices to improve interpretation of surveillance data and assess availability of isolates. We describe changes in practices over 8 years. Methods: During 2012-2019, 10 FoodNet sites collected standardized data about practices in clinical laboratories (range, 664-723 laboratories) for select enteric pathogens. We assessed changes in practices. Results: During 2012-2019, the percentage of laboratories that used only culture methods decreased, with the largest declines for Vibrio (99%-57%) and Yersinia (99%-60%). During 2019, the percentage of laboratories using only CIDTs was highest for Shiga toxin-producing Escherichia coli (43%), Campylobacter (34%), and Vibrio (34%). From 2015 to 2019, the percentage of laboratories that performed reflex culture after a positive CIDT decreased, with the largest declines for Shigella (75%-42%) and Salmonella (70%-38%). The percentage of laboratories that routinely submitted isolates to a public health laboratory decreased for all bacterial pathogens examined from 2015 to 2019. Conclusions: By increasing use of CIDTs and decreasing reflex culture, clinical laboratories have transferred the burden of isolate recovery to public health laboratories. Until technologies allow for molecular subtyping directly from a patient specimen, state public health laboratories should consider updating enteric disease reporting requirements to include submission of isolates or specimens. Public health laboratories need resources for isolate recovery.

Prevalence of COVID-19 and the Continued Citizen-Based Control in Japan.

Since an outbreak of COVID-19 was detected among the crew and passengers of the Diamond Princess cruise ship in early 2020, the total number of cases of SARS-CoV-2 has surpassed 440,000 in Japan. However, that number remains small compared with other countries, such as the United States, a few European countries, and China. Despite the Japanese government not imposing a lockdown or implementing large-scale testing at the municipal level, the country has managed to contain the smaller outbreaks. To avoid infection, it is important to wear a face mask, wash one's hands, and observe social distancing. In addition, we focus on the clinical laboratory testing performed using the latest technology to detect SARS-CoV-2 RNA in a hospital in Yokohama, Japan. Large-scale testing of viral RNA would be useful for detecting asymptomatic virus carriers as is done in other countries, and could be carried out as a future measure for controlling COVID-19.

The Future of Blood Testing Is the Immunome.

It is increasingly clear that an extraordinarily diverse range of clinically important conditions-including infections, vaccinations, autoimmune diseases, transplants, transfusion reactions, aging, and cancers-leave telltale signatures in the millions of V(D)J-rearranged antibody and T cell receptor [TR per the Human Genome Organization (HUGO) nomenclature but more commonly known as TCR] genes collectively expressed by a person's B cells (antibodies) and T cells. We refer to these as the immunome. Because of its diversity and complexity, the immunome provides singular opportunities for advancing personalized medicine by serving as the substrate for a highly multiplexed, near-universal blood test. Here we discuss some of these opportunities, the current state of immunome-based diagnostics, and highlight some of the challenges involved. We conclude with a call to clinicians, researchers, and others to join efforts with the Adaptive Immune Receptor Repertoire Community (AIRR-C) to realize the diagnostic potential of the immunome.

Using clinical guidelines to assess the potential value of laboratory medicine in clinical decision-making.

INTRODUCTION: It is often quoted that 70% of clinical decisions are based on laboratory results, but the evidence to substantiate this claim is lacking. Since clinical guidelines aim to document best-practice decision making for specific disease conditions, inclusion of any laboratory test means that the best available evidence is recommending clinicians use it. Cardiovascular disease (CVD) is the world's most common cause of mortality, so this study reviewed all CVD guidelines published by five national/international authorities to determine what proportion of them recommended laboratory testing. MATERIALS AND METHODS: Five leading CVD guidelines were examined, namely the European Society of Cardiology (ESC), the UK National Institute for Health and Clinical Excellence (NICE), the American College of Cardiology (ACC), the Australian Heart Foundation (AHF) and the Cardiac Society of Australia and New Zealand (CSANZ). RESULTS: A total of 101 guidelines were reviewed. Of the 33 individual ESC guidelines relating to CVD, 24/33 made a direct reference to the use of clinical laboratory tests in either diagnosis or follow-up treatment. The same applied to 15/20 of NICE guidelines, 24/32 from the ACC and 15/16 from the AHF/CSANZ. Renal function and blood count testing were the most recommended (39 and 26 times), with lipid, troponin and natriuretic peptide measurement advocated 25, 19 and 19 times respectively. CONCLUSIONS: This study has shown that laboratory testing is advocated by between 73% and 94% of individual CVD guideline recommendations from five national/international authorities. This provides an index to assess the potential value of laboratory medicine to healthcare.

Influence of anticardiolipin and anti-ß2 glycoprotein I antibody cutoff values on antiphospholipid syndrome classification.

BACKGROUND: Anticardiolipin (aCL) and anti-ß2 glycoprotein I (aß2GPI) immunoglobulin (Ig) G/IgM antibodies are 2 of the 3 laboratory criteria for classification of antiphospholipid syndrome (APS). The threshold for clinically relevant levels of antiphospholipid antibodies (aPL) for the diagnosis of APS remains a matter of debate. The aim of this study was to evaluate the variation in cutoffs as determined in different clinical laboratories based on the results of a questionnaire as well as to determine the optimal method for cutoff establishment based on a clinical approach. METHODS: The study included samples from 114 patients with thrombotic APS, 138 patients with non-APS thrombosis, 138 patients with autoimmune disease, and 183 healthy controls. aCL and aß2GPI IgG/IgM antibodies were measured at 1 laboratory using 4 commercial assays. Assay-specific cutoff values for aPL were obtained by determining 95th and 99th percentiles of 120 compared to 200 normal controls by different statistical methods. RESULTS: Normal reference value data showed a nonparametric distribution. Higher cutoff values were found when calculated as 99th rather than 95th percentiles. These values also showed a stronger association with thrombosis. The use of 99th percentile cutoffs reduced the chance of false positivity but at the same time reduced sensitivity. The decrease in sensitivity was higher than the gain in specificity when 99th percentiles were calculated by methods wherein no outliers were eliminated. CONCLUSIONS: We present cutoff values for aPL determined by different statistical methods. The 99th percentile cutoff value seemed more specific. However, our findings indicate the need for standardized statistical criteria to calculate 99th percentile cutoff reference values.

Preoperative laboratory testing - Comparison of National Institute of Clinical Excellence guidelines with current practice - An observational study.

BACKGROUND AND AIMS: Preoperative laboratory testing is done to detect abnormalities in the body not detected by clinical examination. Often a battery of tests is advocated as a routine for patients scheduled for low or intermediate risk surgery. This prospective observational study was aimed to assess agreement of the current practice of preoperative laboratory investigations with the National Institute of Clinical Excellence (NICE) guidelines, and the impact of investigations on patient care and costs. MATERIAL AND METHODS: The study was conducted at a tertiary referral center on 385 patients aged 18-70 years of either gender, posted for elective general surgical, gynaecological or otolaryngological surgery. Sixteen investigations were examined: hemogram, blood urea, serum creatinine, serum electrolytes, coagulation profile, urinalysis, thyroid function tests, electrocardiogram, echocardiogram, chest x-ray, pulmonary function tests, blood sugar, glycosylated hemoglobin, liver function tests, treadmill test and coronary angiogram. The history and physical examination were reviewed to examine for indication for these laboratory investigations. These were compared with NICE guidelines. Impact of these investigations on anesthetic decision-making was noted. RESULTS: There was almost no agreement of the current practice with the NICE guidelines. The total cost of all tests obtained was Rs 5,48,755. Total additional cost of unindicated tests was Rs 5,10,730 (93%). Average amount spent on additional investigations per patient was Rs 1326.57. CONCLUSION: Most investigations are overprescribed and have minimal agreement with NICE guidelines. None of the tests had any impact on clinical care. Nearly a million rupees is incurred per year in one referral hospital alone, when NICE guidelines are not followed.

[Laboratory evaluation of immunological dysfunctions in primary immunodeficiency diseases]. / Immunológiai eltérések kimutatása laboratóriumi módszerekkel primer immunhiányos betegségekben.

In primary immunodeficiencies, the malfunction of the immune system is caused by genetic alterations. The physician proposes the most probable diagnosis based on symptoms, clinical signs, the family history and the results of the pathogen identification. To confirm this clinical suspicion, it is essential that the immunological malfunction be tested using in vitro diagnostic procedures. This paper summarizes the screening, confirmatory and disease-specific laboratory methods capable of testing the antibody response, the T cells, the phagocytic function, the complement system and other components of the innate immune system. The genetic tests necessary to make the final diagnosis are beyond the scope of this publication. Orv Hetil. 2018; 159(49): 2087-2094.

News from the Biological Stain Commission, No. 17.

In the 17(th) issue of News from the Biological Stain Commission (BSC) under the heading of Regulatory affairs, the Biological Stain Commission's International Affairs Committee presents information from the 20(th) meeting of ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems held on October 15 - 17, 2014 in Toronto, Canada, and from the 29(th) meeting of CEN/TC 140 In vitro diagnostic medical devices held on February 3, 2015 in Berlin, Germany.

Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.

BACKGROUND: On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recommend industries to develop, study and submit CDx and the corresponding drug contemporaneously as much as possible. Following the MHLW's notification, the Pharmaceutical and Medical Device Agency (PMDA) notified on December 26th, 2013, "the technical guidance for co-development of CDx and the drug" that mentioned the regulatory requirements for clinical trial of the drug and CDx as well as analytical validity of CDx required for the trials. These official notifications from the Ministry and the Agency may be useful for pharmaceutical and diagnostics makers to understand how they should co-develop and validate CDx for clinical trials and regulatory submission. However, since the most anticipated technologies such as the next generation sequencer (NGS) are more complex and its medical risks could be high level, the existing regulatory system focusing on only diagnostics reagents and devices that are developed and manufactured by in vitro diagnostics (IVD) makers may be no longer suitable for the characteristics of CDx for the future.As an increase of clinical needs for multiple biomarkers assay by DNA sequencer, on November 19th, 2013, the FDA cleared 510 K for NGS and its universal kit. On October 3rd, 2014, moreover, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) for oversight of laboratory developed tests (LDTs) with medium or high medical risks. These FDA's strategic decisions and new regulatory frameworks may allow the clinical laboratories to develop and perform more easily NGS-based CDx under the certification of Clinical Laboratory Improvement Amendments (CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. To effectively validate LDTs and NGS for medical practice, Japan should learn more the current regulatory changes and initiatives in the US, as well as to reform the regulatory frameworks and create any regulated quality management system for clinical laboratory testing to be reimbursed.

News from the Biological Stain Commission, no. 16.

In the 16(th) issue of News from the Biological Stain Commission (BSC) under the heading of Regulatory affairs, the Biological Stain Commission's International Affairs Committee presents information from the 28(th) meeting of CEN/TC 140 In vitro diagnostic medical devices held on October 23, 2013 in Berlin, Germany. Information is also presented from the 19(th) meeting of ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems held on October 19 - 21, 2013 in Singapore.