Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing.

In response to the COVID-19 pandemic, the National Institute of Standards and Technology released a synthetic RNA material for SARS-CoV-2 in June 2020. The goal was to rapidly produce a material to support molecular diagnostic testing applications. This material, referred to as Research Grade Test Material 10169, was shipped free of charge to laboratories across the globe to provide a non-hazardous material for assay development and assay calibration. The material consisted of two unique regions of the SARS-CoV-2 genome approximately 4 kb nucleotides in length. The concentration of each synthetic fragment was measured using RT-dPCR methods and confirmed to be compatible with RT-qPCR methods. In this report, the preparation, stability, and limitations of this material are described.

Characterization of a SARS-CoV-2 spike protein reference material.

Development of diagnostic testing capability has advanced with unprecedented pace in response to the COVID-19 pandemic. An undesirable effect of such speed is a lack of standardization, often leading to unreliable test results. To assist the research community surmount this challenge, the National Research Council Canada has prepared a SARS-CoV-2 spike protein reference material, SMT1-1, as a buffered solution. Value assignment was achieved by amino acid analysis (AAA) by double isotope dilution liquid chromatography-tandem mass spectrometry (LC-ID-MS/MS) following acid hydrolysis of the protein, in combination with ultraviolet-visible spectrophotometry (UV-Vis) based on tryptophan and tyrosine absorbance at 280 nm. Homogeneity of the material was established through spectrophotometric absorbance readings at 280 nm. Transportation and long-term storage stabilities were assessed by monitoring relative changes in oligomeric state by size-exclusion liquid chromatography (LC-SEC) with UV detection. The molar concentration of the spike protein in SMT1-1 was 5.68 ± 0.22 µmol L-1 (k = 2, 95% CI), with the native trimeric form accounting for ~ 94% of the relative abundance. Reference mass concentration and mass fraction values were calculated using the protein molecular weight and density of the SMT1-1 solution. The spike protein is highly glycosylated which leads to analyte ambiguity when reporting the more commonly used mass concentration. After glycoprotein molar mass determination by LC-SEC with multi-angle light scattering detection, we thus reported mass concentration values for both the protein-only portion and intact glycoprotein as 0.813 ± 0.030 and 1.050 ± 0.068 mg mL-1 (k = 2), respectively.

Food Safety Assessment: Overview of Metrological Issues and Regulatory Aspects in the European Union

The safety of the food we consume has a direct impact on individual and population health and affects the economic growth of the region where food safety is practised and enhanced. The central goal of the European Commission’s Food Safety policy is to ensure a high level of protection of human health covering the whole supply chain. In recent years, great attention has been paid to food testing and the application of metrological tools to support food safety. The global food market and national and international food safety regulations have created a huge demand for the measurement traceability and comparability of analytical results that are independent of time or space boundaries. This review provides an overview of the European food safety policy and regulation, with a focus on the measurement-related elements of the European Union (EU) food law. It also highlights how the application of analytical techniques, with particular reference to separation approaches, and metrological tools can ensure the control of certain contaminants that nowadays represent the main challenges for food safety (e.g., mycotoxins, nanoparticles, emerging and process contaminants). METROFOOD-RI-Infrastructure for promoting metrology in food and nutrition is therefore described in this context. This European research infrastructure has been developed and is being implemented in the frame of the European Strategy Forum on Research Infrastructures (ESFRI) to support metrology in food and nutrition and establish a strategy allowing reliable and comparable analytical measurements in food across the entire process line, from primary producers to consumers, and making data findable, accessible, interoperable, and reusable (FAIR).

Strategic Priorities of the Scientific Plan of the European Research Infrastructure METROFOOD-RI for Promoting Metrology in Food and Nutrition.

The pan-European distributed Research Infrastructure for Promoting Metrology in Food and Nutrition (METROFOOD-RI) has evolved in the frame of the European Strategy Forum on Research Infrastructures (ESFRI) to promote high-quality metrology services across the food chain. The METROFOOD-RI comprises physical facilities and electronic facilities. The former includes Reference Material plants and analytical laboratories (the 'Metro' side) and also experimental fields/farms, processing/storage plants and kitchen-labs (the 'Food' side). The RI is currently prepared to apply for receiving the European Research Infrastructure Consortium (ERIC) legal status and is organised to fulfil the requirements for operation at the national, European Union (EU) and international level. In this view, the METROFOOD-RI partners have recently reviewed the scientific plan and elaborated strategic priorities on key thematic areas of research in the food and nutrition domain to which they have expertise to contribute to meet global societal challenges and face unexpected emergencies. The present review summarises the methodology and main outcomes of the research study that helped to identify the key thematic areas from a metrological standpoint, to articulate critical and emerging issues and demands and to structure how the integrated facilities of the RI can operate in the first five years of operation as ERIC.

Editorial

The first two Technical Articles are outstanding studies of the crystal structures of a pharmaceutical and an inorganic “Laves” C15 phase along with its magnetic properties. The third Technical Article, “Continuous Series of Symmetric Peak Profile Functions Determined by Standard Deviation and Kurtosis” by Dr. Takashi Ida, is of particular interest to me due to my prior profile modeling work and the development of standard reference materials (several decades ago) on computer modeling of PXRD profile shapes and addressing the shift in position and shape of diffraction profiles due to instrumental aberrations. The International Report provides an excellent summary of the meeting, exhibitors, invited talks, contributed talks, poster sessions, and provided means for virtual social activities.

Nucleic Acid Testing of SARS-CoV-2.

The coronavirus disease 2019 (COVID-19) has caused a large global outbreak. It is accordingly important to develop accurate and rapid diagnostic methods. The polymerase chain reaction (PCR)-based method including reverse transcription-polymerase chain reaction (RT-PCR) is the most widely used assay for the detection of SARS-CoV-2 RNA. Along with the RT-PCR method, digital PCR has emerged as a powerful tool to quantify nucleic acid of the virus with high accuracy and sensitivity. Non-PCR based techniques such as reverse transcription loop-mediated isothermal amplification (RT-LAMP) and reverse transcription recombinase polymerase amplification (RT-RPA) are considered to be rapid and simple nucleic acid detection methods and were reviewed in this paper. Non-conventional molecular diagnostic methods including next-generation sequencing (NGS), CRISPR-based assays and nanotechnology are improving the accuracy and sensitivity of COVID-19 diagnosis. In this review, we also focus on standardization of SARS-CoV-2 nucleic acid testing and the activity of the National Metrology Institutes (NMIs) and highlight resources such as reference materials (RM) that provide the values of specified properties. Finally, we summarize the useful resources for convenient COVID-19 molecular diagnostics.

Progress with the work program of ISO/REMCO during 2020.

The 43rd meeting of the Reference Material Committee of ISO, ISO/REMCO, that was scheduled to take place in Milan, Italy, from 30 June to 3 July 2020 with Accredia, the Italian accreditation body and INRIM, the Italian Metrology Institute as the hosts, was cancelled due to the COVID-19 pandemic. This report shares the details of the important decision that was taken by the ISO Technical Management Board (TMB) in December 2020 to transform ISO/REMCO into an ISO technical committee, ISO/TC 334, Reference materials. The background that led to the decision is provided as well as the implications of the decision for the future of the development of guidance for the production and use of reference materials. The report also gives an update on the progress with the work program of the committee during the past year and the strategy for the future work of the committee.