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View article: From crisis to routine – Standardization of SARS-CoV-2 genome detection by enhanced EQA schemes in a scientific pandemic network
From crisis to routine – Standardization of SARS-CoV-2 genome detection by enhanced EQA schemes in a scientific pandemic network Open
In the beginning of 2020, the outbreak of the COVID-19 pandemic led to a crisis in which diagnostic methods for the genome detection of SARS-CoV-2 were urgently needed. Based on the very early publication of the basic principles for a diag…
View article: Droplet Digital PCR: A Powerful Tool for Accurate Quantification of Hepatitis D Virus RNA Levels and Verification of Detection Limits
Droplet Digital PCR: A Powerful Tool for Accurate Quantification of Hepatitis D Virus RNA Levels and Verification of Detection Limits Open
Reliable quantification of hepatitis D virus (HDV) RNA levels is necessary for initiating and guiding antiviral treatment. The aim of this work is to develop and validate a digital PCR method for the accurate quantification of HDV RNA, inc…
CCQM-P123 number and geometric property of cells adhered to a solid substrate Open
Main text Several scientific fields, such as cytology, biochemistry, molecular biology and genetics have cells as their direct topic of study. The cell is a fundamental unit of highly technological systems, employed, for example, in the de…
View article: The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing
The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing Open
Background Nucleic acid amplification tests (NAATs) assist in the diagnosis of numerous infectious diseases. They are typically sensitive and specific and can be quickly developed and adapted. Far more challenging is the development of sta…
View article: CCQM-P199: Interlaboratory comparability study of HIV-1 RNA copy number quantification
CCQM-P199: Interlaboratory comparability study of HIV-1 RNA copy number quantification Open
Infection with human immunodeficiency virus (HIV)-1 leads to acquired immunodeficiency syndrome (AIDS) if left untreated. According to UN figures, approximately 39 million people globally were living with HIV in 2022, with 76% of those ind…
View article: CCQM-P199b: Interlaboratory comparability study of SARS-CoV-2 RNA copy number quantification
CCQM-P199b: Interlaboratory comparability study of SARS-CoV-2 RNA copy number quantification Open
Nucleic acid amplification tests including reverse transcription quantitative PCR (RT-qPCR) are used to detect RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of the Coronavirus disease 2019 (COVI…
View article: Correlation of SARS-CoV-2 RNA and nucleocapsid concentrations in samples used in INSTAND external quality assessment schemes
Correlation of SARS-CoV-2 RNA and nucleocapsid concentrations in samples used in INSTAND external quality assessment schemes Open
Objective In routine clinical laboratories, severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection is determined by reverse-transcription PCR (RT-PCR). In the COVID pandemic, a wide range of antigen detection tests were also …
View article: Guidance document describing how rapid near patient (point of care) IVD manufacturers can meet the new IVD EU Regulation 2017/746
Guidance document describing how rapid near patient (point of care) IVD manufacturers can meet the new IVD EU Regulation 2017/746 Open
Guidance document on how commercial stakeholders can meet the meet the IVD EU Regulation 2017/746, the replacement for EU Directive 98/79/EC, Regulation (EU) 2017/746, when considering automated, rapid near patient (point of care) testing …
RNA reference materials with defined viral RNA loads of SARS-CoV-2—A useful tool towards a better PCR assay harmonization Open
SARS-CoV-2, the cause of COVID-19, requires reliable diagnostic methods to track the circulation of this virus. Following the development of RT-qPCR methods to meet this diagnostic need in January 2020, it became clear from interlaboratory…
The performance of human cytomegalovirus digital PCR reference measurement procedure in seven external quality assessment schemes over four years Open
A candidate digital PCR (dPCR)-based reference measurement procedure for quantification of human cytomegalovirus (hCMV) was evaluated in 10 viral load comparison schemes (seven external quality assessment (EQA) and three additional trainin…
View article: An assessment of the reproducibility of reverse transcription digital PCR quantification of HIV-1
An assessment of the reproducibility of reverse transcription digital PCR quantification of HIV-1 Open
Viral load monitoring in human immunodeficiency virus type 1 (HIV-1) infection is often performed using reverse transcription quantitative PCR (RT-qPCR) to observe response to treatment and identify the development of resistance. Traceabil…
Cellular Metrology: Scoping for a Value Proposition in Extra- and Intracellular Measurements Open
The symptomatic irreproducibility of data in biomedicine and biotechnology prompts the need for higher order measurements of cells in their native and near-native environments. Such measurements may support the adoption of new technologies…
Comparison of Volumetric and Bead‐Based Counting of CD34 Cells by Single‐Platform Flow Cytometry Open
Background Over 2,000 people a year in the United Kingdom need a bone marrow or blood stem cell transplant. It is important to accurately quantify the hematopoietic stem cells to predict whether the transplant will be successful in repleni…