International assessment results on non-NIOSH approved respirators by the national personal protective technology laboratory (NPPTL): a data note.

OBJECTIVES: Due to the COVID-19 pandemic and the shortage of the National Institute for Occupational Safety & Health (NIOSH)-approved N95 respirators, the Food and Drug Administration granted an Emergency Use Authorization to allow the use of non-NIOSH approved respirators provided that these respirators must undergo tests by a protocol of TEB-APR-STP-0059, similar methods of NIOSH standard testing procedure. This initiative safeguards the quality of respirators and the effectiveness of occupational protection. The dataset of all the testing results could benefit further analysis of COVID-19 infection rates in relation to different types of N95 respirators used and identify potential correlations of various test parameters in the testing system for validation. The analysis enhances understanding of the quality, effectiveness, and performance of N95 respirators in the prevention of respiratory infectious transmission and develops improved occupational safety measures. DATA DESCRIPTION: The dataset was transformed, transcribed, and compiled from the official testing data of non-NIOSH-approved N95 respirators reported in the NIOSH website under the Centers for the Disease Control and Prevention in the United States. The dataset included details of 7,413 testing results of N95 respirators (manufacturer, model, and maximum and minimum filtration efficiency) and test parameters (flow rate, initial filter resistance, and initial percent leakage). Supplementary items were added to increase the availability of data analysis and enhance the interpretability of the assessments of the quality of N95 respirators.

Creation of an international laboratory network towards global microplastics monitoring harmonisation.

Infrastructure is often a limiting factor in microplastics research impacting the production of scientific outputs and monitoring data. International projects are therefore required to promote collaboration and development of national and regional scientific hubs. The Commonwealth Litter Programme and the Ocean Country Partnership Programme were developed to support Global South countries to take actions on plastics entering the oceans. An international laboratory network was developed to provide the infrastructure and in country capacity to conduct the collection and processing of microplastics in environmental samples. The laboratory network was also extended to include a network developed by the University of East Anglia, UK. All the laboratories were provided with similar equipment for the collection, processing and analysis of microplastics in environmental samples. Harmonised protocols and training were also provided in country during laboratory setup to ensure comparability of quality-controlled outputs between laboratories. Such large networks are needed to produce comparable baseline and monitoring assessments.

Technical and health governance aspects of the external quality assessment system for classical and new psychoactive substances analysis testing in blood.

New psychoactive substances (NPS) are uncontrolled analogues of existing drugs or newly synthesized chemicals that exhibit psychopharmacological effects. Due to their diverse nature, composition, and increasing prevalence, they present significant challenges to the healthcare system and drug control policies. In response, healthcare system laboratories have developed analytical methods to detect NPS in biological samples. As a Regional Reference Centre, the Sicilian CRQ Laboratory (Regional Laboratory for Quality Control) developed and conducted an External Quality Assessment (EQA) study to assess, in collaboration with the Istituto Superiore di Sanità (ISS), the ability of different Italian laboratories to identify NPS and traditional drugs of abuse (DOA) in biological matrices. Two blood samples were spiked with substances from various drug classes, including synthetic cannabinoids, cathinones, synthetic opiates, and benzodiazepines, at concentrations ranging from 2 to 10 ng/mL. The blood samples were freeze-dried to ensure the stability of DOA and NPS. Twenty-two laboratories from the Italian healthcare system participated in this assessment. The information provided by the laboratories during the registration in an in-house platform included a general description of the laboratory, analytical technique, and the chosen panels of analytes. The same platform was employed to collect and statistically analyze the data and record laboratory feedback and comments. The evaluation of the results revealed that the participating laboratories employed three different techniques for analyzing the samples: GC-MS, LC-MS, and immunoenzymatic methods. Approximately 90 % of the laboratories utilized LC-MS techniques. Around 40 % of false negative results were obtained, with the worst results in the identification of 5-chloro AB PINACA. The results showed that laboratories that used LC-MS methods obtained better specificity and sensitivity compared to the laboratories using other techniques. The results obtained from this first assessment underscore the importance of external quality control schemes in identifying the most effective analytical techniques for detecting trace molecules in biological matrices. Since the judicial authorities have not yet established cut-off values for NPS, this EQA will enable participating laboratories to share their analytical methods and expertise, aiming to establish common criteria for NPS identification.

Interlaboratory comparison exercises for organically-bound tritium in the development of reference materials of environmental samples.

The complex behavior of tritium and the probability of increasing tritium concentrations released in the environment were the promotors for the research and development of laboratory methods that enable to accurately determine the various forms of tritium including organically-bound tritium (OBT) for public and regulatory assurance. The measurement of tritium is a key step for dose and risk assessment. The Cernavoda Nuclear Power Plant (NPP) in Romania improved preparation methods and tested environmental matrices for OBT analysis through intercomparison exercises. This paper describes the international Organically-Bound Tritium (OBT) intercomparison exercise, organized by the Cernavoda Nuclear Power Plant (NPP) in 2019-2020, using fruit sample (quince) from Cernavoda town. Evaluation of the results from the participating laboratories was performed using both robust analysis (Algorithm A) method described in the ISO 13528:2015 standard and ANOVA method. The results obtained are encouraging as an increased number of participating laboratories did not change the observed dispersion of the results for activity concentration level around 50 Bq/L of combustion water. The stability of the remaining sample will be checked in time to investigate its use as a reference material for OBT analysis at the environmental levels.

Ten-year results of an international external quality control programme for measurement of anti-tuberculosis drug concentrations.

OBJECTIVES: Participation in an external (interlaboratory) quality control (QC) programme is an essential part of quality assurance as it provides laboratories with valuable insights into their analytical performance. We describe the 10 year results of an international QC programme for the measurement of anti-tuberculosis (TB) drugs. METHODS: Each year, two rounds were organized in which serum (or plasma) samples, spiked with known concentrations of anti-TB drugs, were provided to participating laboratories for analysis. Reported measurements within 80%-120% of weighed-in concentrations were considered accurate. Mixed model linear regression was performed to assess the effect of the measured drug, concentration level, analytical technique and performing laboratory on the absolute inaccuracy. RESULTS: By 2022, 31 laboratories had participated in the QC programme and 13 anti-TB drugs and metabolites were included. In total 1407 measurements were reported. First-line TB drugs (isoniazid, rifampicin, pyrazinamide and ethambutol) represented 58% of all measurements. Overall, 83.2% of 1407 measurements were accurate, and the median absolute inaccuracy was 7.3% (IQR, 3.3%-15.1%). The absolute inaccuracy was related to the measured anti-TB drug and to the performing laboratory, but not to the concentration level or to the analytical technique used. The median absolute inaccuracies of rifampicin and isoniazid were relatively high (10.2% and 10.9%, respectively). CONCLUSIONS: The 10 year results of this external QC programme illustrate the need for continuous external QC for the measurement of anti-TB drugs for research and patient care purposes, because one in six measurements was inaccurate. Participation in the programme alerts laboratories to previously undetected analytical problems.

Quality assurance of SARS-CoV-2 testing laboratories during the pandemic period in India - An experience from a designated provider laboratory.

PURPOSE: Indian Council of Medical Research (ICMR) initiated an Inter-Laboratory Quality Control testing (ILQC) program for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing. Under this program, SARS-CoV-2 testing laboratories across the country submit specimens to the assigned State Quality Control (SQCs) laboratories for ILQC testing. This study aimed to investigate the performance of public and private SARS-CoV-2 testing laboratories in Delhi and highlights the country's effort in ramping up testing facility with close monitoring of the quality of Covid-19 testing results. METHODS: In the present study, two-years of SARS-CoV-2 testing data is included. During July 2020 through February 2022, a total of 1791 anonymised specimens were received from 56 public and private laboratories. These specimens were processed by reverse transcriptase - polymerase chain reaction (RT-PCR) tests as per National Institute of Virology (NIV) protocol and the results were uploaded on the ICMR quality control/quality assurance (QC/QA) portal without directly conveying the results to respective participating laboratories. This portal generated a final report stating concordance and intimate results to individual laboratories. RESULTS: Among the 1791 specimens, 25 were rejected and the remaining 1766 were tested. Among these specimens 1691 (95.75%) revealed concordance, and 75 (4.24%) were discordant. A total of 29 laboratories had 100% concordance, 21 laboratories had over 90% concordance and six laboratories had over 80% concordance. CONCLUSIONS: The study demonstrates that the establishment of an inter-laboratory comparison program for SARS-CoV-2 testing helped in monitoring quality of SARS-CoV-2 testing in the country.

Within-laboratory reproducibility of Ames test results: Are repeat tests necessary?

The Ames test is required by regulatory agencies worldwide for assessing the mutagenic and carcinogenic potential of chemical compounds. This test uses several strains of bacteria to evaluate mutation induction: positive results in the assay are predictive of rodent carcinogenicity. As an initial step to understanding how well the assay may detect mutagens present as constituents of complex mixtures such as botanical extracts, a cross-sector working group examined the within-laboratory reproducibility of the Ames test using the extensive, publicly available National Toxicology Program (NTP) Ames test database comprising more than 3000 distinct test articles, most of which are individual chemicals. This study focused primarily on NTP tests conducted using the standard Organization for Economic Co-operation and Development Test Guideline 471 preincubation test protocol with 10% rat liver S9 for metabolic activation, although 30% rat S9 and 10 and 30% hamster liver S9 were also evaluated. The reproducibility of initial negative responses in all strains with and without 10% S9, was quite high, ranging from 95% to 99% with few exceptions. The within-laboratory reproducibility of initial positive responses for strains TA98 and TA100 with and without 10% rat liver S9 was ≥90%. Similar results were seen with hamster S9. As expected, the reproducibility of initial equivocal responses was lower, <50%. These results will provide context for determining the optimal design of recommended test protocols for use in screening both individual chemicals and complex mixtures, including botanicals.

Analysis of carbon nanotube levels in organic matter: an inter-laboratory comparison to determine best practice.

Carbon nanotubes (CNTs) are increasingly being used in industrial applications, but their toxicological data in animals and humans are still sparse. To assess the toxicological dose-response of CNTs and to evaluate their pulmonary biopersistence, their quantification in tissues, especially lungs, is crucial. There are currently no reference methods or reference materials for low levels of CNTs in organic matter. Among existing analytical methods, few have been fully and properly validated. To remedy this, we undertook an inter-laboratory comparison on samples of freeze-dried pig lung, ground and doped with CNTs. Eight laboratories were enrolled to analyze 3 types of CNTs at 2 concentration levels each in this organic matrix. Associated with the different analysis techniques used (specific to each laboratory), sample preparation may or may not have involved prior digestion of the matrix, depending on the analysis technique and the material being analyzed. Overall, even challenging, laboratories' ability to quantify CNT levels in organic matter is demonstrated. However, CNT quantification is often overestimated. Trueness analysis identified effective methods, but systematic errors persisted for some. Choosing the assigned value proved complex. Indirect analysis methods, despite added steps, outperform direct methods. The study emphasizes the need for reference materials, enhanced precision, and organized comparisons.

International circumpolar surveillance: update on the interlaboratory quality control program for Streptococcus pneumoniae, 2009 to 2020.

The International Circumpolar Surveillance (ICS) program is a population-based surveillance network for invasive bacterial diseases throughout Arctic countries and territories. The ICS quality control program for Streptococcus pneumoniae serotyping and antimicrobial susceptibility testing has been ongoing since 1999. Current participating laboratories include the Provincial Laboratory for Public Health in Edmonton, Alberta; Laboratoire de santé publique du Québec in Sainte-Anne-de-Bellevue, Québec; the Centers for Disease Control's Arctic Investigations Program in Anchorage, Alaska; the Neisseria and Streptococcus Reference Laboratory at Statens Serum Institut in Copenhagen, Denmark; the Department of Clinical Microbiology, Landspitali in Reykjavik, Iceland; and Public Health Agency of Canada's National Microbiology Laboratory in Winnipeg, Manitoba. From 2009 to 2020, 140 isolates of S. pneumoniae were distributed among the six laboratories as part of the quality control program. Overall serotype concordance was 96.9%, with 99.3% concordance to pool level. All participating laboratories had individual concordance rates >92% for serotype and >97% for pool. Overall concordance by modal minimum inhibitory concentration (MIC) for testing done by broth microdilution or Etest was 99.1%, and >98% for all antimicrobials tested. Categorical concordance was >98% by both CLSI and EUCAST criteria. For two laboratories performing disc diffusion, rates of concordance by modal MIC were >97% for most antimicrobials, except chloramphenicol (>93%) and trimethoprim/sulfamethoxazole (>88%). Data collected from 12 years of the ICS quality control program for S. pneumoniae demonstrate excellent (≥95%) overall concordance for serotype and antimicrobial susceptibility testing results across six laboratories. IMPORTANCE: Arctic populations experience several social and physical challenges that lead to the increased spread and incidence of invasive diseases. The International Circumpolar Surveillance (ICS) program was developed to monitor five invasive bacterial diseases in Arctic countries and territories. Each ICS organism has a corresponding interlaboratory quality control (QC) program for laboratory-based typing, to ensure the technical precision and accuracy of reference testing services for these regions, and identify and correct potential problems. Here, we describe the results of the ICS Streptococcus pneumoniae QC program, from 2009 to 2020. Excellent overall concordance was achieved for serotype and antimicrobial susceptibility testing results across six laboratories. Ongoing participation in these QC programs ensures the continuation of quality surveillance systems within Arctic populations that experience health disparities.

Interlaboratory Comparison of Antibody-Free LC-MS/MS Measurements of C-peptide and Insulin.

BACKGROUND: The enhanced precision and selectivity of liquid chromatography-tandem mass spectrometry (LC-MS/MS) makes it an attractive alternative to certain clinical immunoassays. Easily transferrable work flows could help facilitate harmonization and ensure high-quality patient care. We aimed to evaluate the interlaboratory comparability of antibody-free multiplexed insulin and C-peptide LC-MS/MS measurements. METHODS: The laboratories that comprise the Targeted Mass Spectrometry Assays for Diabetes and Obesity Research (TaMADOR) consortium verified the performance of a validated peptide-based assay (reproducibility, linearity, and lower limit of the measuring interval [LLMI]). An interlaboratory comparison study was then performed using shared calibrators, de-identified leftover laboratory samples, and reference materials. RESULTS: During verification, the measurements were precise (2.7% to 3.7%CV), linear (4 to 15 ng/mL for C-peptide and 2 to 14 ng/mL for insulin), and sensitive (LLMI of 0.04 to 0.10 ng/mL for C-peptide and 0.03 ng/mL for insulin). Median imprecision across the 3 laboratories was 13.4% (inter-quartile range [IQR] 11.6%) for C-peptide and 22.2% (IQR 20.9%) for insulin using individual measurements, and 10.8% (IQR 8.7%) and 15.3% (IQR 14.9%) for C-peptide and insulin, respectively, when replicate measurements were averaged. Method comparison with the University of Missouri reference method for C-peptide demonstrated a robust linear correlation with a slope of 1.044 and r2 = 0.99. CONCLUSIONS: Our results suggest that combined LC-MS/MS measurements of C-peptide and insulin are robust and adaptable and that standardization with a reference measurement procedure could allow accurate and precise measurements across sites, which could be important to diabetes research and help patient care in the future.

An active-learning laboratory focused on critical care topics.

BACKGROUND AND PURPOSE: To describe an active-learning laboratory on critical care topics including advanced cardiac life support (ACLS), rapid sequence intubation (RSI), and toxicology and its effect on students' knowledge, skills, and confidence. EDUCATIONAL ACTIVITY AND SETTING: Third year pharmacy students (n = 88) participated in a critical care focused laboratory with four stations focused on ACLS review, ABBOJECTⓇ syringe assembly, ACLS simulations, RSI cases, and toxicology. Prior to the critical care focused skills laboratory, students completed an optional assessment composed of six confidence and eight knowledge questions. After the laboratory, students completed the same confidence and knowledge assessment. Descriptive statistics assessed pre/post-assessment responses. Paired pre/post-assessment Likert data were analyzed using the Wilcoxon signed-rank test and paired pre/post-test multiple choice responses were analyzed using the McNemar test. FINDINGS: Of the 88 students in the cohort, 76 students completed both the pre/post-assessments (response rate: 86.4%). Students demonstrated a significant increase in their overall knowledge and confidence scores on the post-assessment. All students successfully assembled an ABBOJECTⓇ syringe. The majority of respondents rated the critical care laboratory as excellent or good with regards to how enjoyable and effective the activity was to help understand critical care topics. SUMMARY: A hands-on, active-learning laboratory devoted to teaching and reinforcing common critical care concepts allowed students to gain knowledge and confidence regarding ACLS, RSI, and toxicology.

How reliable are test results from 17 laboratories on the basis of EN 1500 for a hand rub based on 80% (w/w)?

INTRODUCTION: A ring trial organized by the Association of Applied Hygiene (VAH) on the bactericidal efficacy of an ethanol-based hand rub was carried out in 17 laboratories according to EN 1500 with the aim of describing the variability of test results and fulfilment of the methodological acceptance criteria. METHOD: As a test product, a hand rub based on 80% ethanol (w/w) was tested in comparison with the reference alcohol (60% iso-propanol, v/v) in a crossover design. After pre-washing and contamination following the norm, hands were treated either with the reference alcohol (2 × 3 mL for 2 × 30 s) or the test product (3 mL in 30 s). Post-decontamination values were determined immediately after the rub-in period. Validated neutralizers were used. The arithmetic means of all individual log10 pre-values, post-values and reduction values were calculated per laboratory. Non-inferiority was assumed when the Hodges-Lehmann 97.5% confidence limit was <0.6 in comparison with the reference. A z-score was calculated to determine the laboratory performance. RESULTS: Two laboratories did not meet the acceptance criteria and were excluded from the analysis. The bactericidal efficacy of the test product was non-inferior to the reference product in four laboratories and not non-inferior in 11 laboratories. The z-score for the Hodges-Lehmann 97.5% confidence limit indicated a satisfactory performance in all laboratories. CONCLUSION: We consider the EN 1500 test method to be robust in terms of the variability of test results. For products of borderline efficacy, the evaluation should be based on more than one test.

Evaluation of Malaria Microscopy Diagnostic Performance at 40 Public Health Facilities in Abidjan, Côte d'Ivoire in 2020.

PURPOSE: Microscopic diagnosis of Giemsa-stained thick and thin blood films remained the gold standard laboratory method for the diagnosis of malaria. In this context, we felt it was important to conduct this evaluation with 40 public medical biology laboratories (MBLs) in the Abidjan 1 health region that perform blood parasitology tests to improve their implementation process. METHODS: This descriptive and analytical study took place in July 2020 and involved participating laboratories (PLs) from the public sector in Abidjan. A set of 3 blood smear slides of variable parasite densities (PDs) with assigned values (AVs) of parasite densities and assigned Plasmodium species was used. The criterion for establishing the parasite density compliance interval was assigned values of ± 25%, and the performance rates were compared to the 80% recommended by the WHO for the African region. RESULTS: Nearly a quarter (11/40) of the participating laboratories had a compliance rate greater than 80%, including 10 with a performance of 100% for the ability to identify parasites. Regarding identifying plasmodial species, a concordance rate of 100% was obtained for slide 1 for Plasmodium falciparum, while this rate was 20% for slide 2 for Plasmodium ovale. For parasite densities < 200/µl, 87.5% of the participating laboratories (PLs) had a performance rate lower than 80%, while 95% of these PLs had a performance rate higher than 80% for parasitaemia > 2000/µl. CONCLUSIONS: There is a need to strengthen adapted to low parasitaemia, to improve the biological confirmation of malaria in Côte d'Ivoire.

A Nationwide Network of Health AI Assurance Laboratories.

Importance: Given the importance of rigorous development and evaluation standards needed of artificial intelligence (AI) models used in health care, nationwide accepted procedures to provide assurance that the use of AI is fair, appropriate, valid, effective, and safe are urgently needed. Observations: While there are several efforts to develop standards and best practices to evaluate AI, there is a gap between having such guidance and the application of such guidance to both existing and new AI models being developed. As of now, there is no publicly available, nationwide mechanism that enables objective evaluation and ongoing assessment of the consequences of using health AI models in clinical care settings. Conclusion and Relevance: The need to create a public-private partnership to support a nationwide health AI assurance labs network is outlined here. In this network, community best practices could be applied for testing health AI models to produce reports on their performance that can be widely shared for managing the lifecycle of AI models over time and across populations and sites where these models are deployed.

Safety climate in Pakistani universities' laboratories: an assessment of individual factors.

Objectives. Current research aims to identify factors that affect the occupational safety climate in university laboratories despite their perception as low-risk areas compared to industrial environments. Methods. A safety climate survey was conducted in science laboratories across various engineering universities in Pakistan. The survey questionnaire was administered to 406 personnel, and a quantitative method for analysis was selected to examine the socio-demographic variables. A 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) was used to perceive responses from participants. Additionally, a scale reliability test was conducted, and multivariate analysis of variance was performed to determine the relationship between selected dependent and independent variables. Results. The study found an overall safety climate score of 3.16 ± 0.55, indicating a moderate to high perception of safety on a scale of 1-5. Parameters such as role in the laboratory, departments/disciplines, accident experience and safety training significantly affected the safety climate score, while gender, age group, duration in university and accident witnessing did not. Conclusion. Upper management involvement, safety communication and direct supervision are crucial for improving the safety climate of university laboratories. The study recommends the consideration of the identified significant safety climate dimensions in laboratory safety policy-making at academic institutes.