White Papers

Our white papers are available for download to our partners and associates.

Covid-19 antibody testing of patients admitted to the ICU by a novel, point-of-care assay, and the relationship to survival.

June, 2021
  • Patients admitted to ICU who exhibit a low IgG response to COVID are at greater risk of mortality
  • AgPlus PoC system showed better performance than ELISA and lateral flow at detecting IgG antibodies in patients
  • AgPlus PoC assay had 100% specificity for IgG antibodies to COVID- so no false positive results.
  • Testing of immune response in patients with COVID19 is important in the fight against the pandemic and even more so in monitoring the efficacy of the vaccination programmes.

Benefit of Point of Care testing for Faecal Calprotectin

May 2021
  • Increased compliance with recommendations for testing frequency and treatment adoption
  • Improved clinical outcomes
  • Facilitated patient education and motivation
  • Improved patients’ quality of life
  • Contribute to cost/time savings both for health-care professionals and patients

The role of Clinical Tests in the management of the global pandemic induced by SARS-COV-2

November 2020
  • Inless than 12 months SERS-CoV-2 has infected > 55 million people and has been implicated in the death of >1.3 million.
  • Use of novel gene sequencing and protein expression techniques have rapidly elucidated the genetic structure and the detailed proteomics of the virus.
  • Knowledge of the genetic and protein make-up of the virus has spawned the development of an unprecedented number of both molecular and serological tests to diagnose and monitor the condition throughout the classic disease dynamics of incubation, early, progressive and recovery phases.
  • The main molecular test established for disease diagnosis is based on gene sequencing of the virus using samples obtained by swabbing the upper and/or lower respiratory tract; the key serological test for confirming prior infection and/or monitoring of the condition is based on the measurement of IgG antibodies in patient blood samples.
  • Although much is known of the virus and the condition it induces there remain big gaps in our knowledge relating to infectivity and correlates of protection.
  • The advent of vaccine therapies against SARS-CoV-2 will accelerate the war against this pathogen, tests will still be fundamental to control the management of the disease and especially for surveillance and epidemiological purposes.

The impact of implementing the new In vitro Diagnostic Regulations on SMEs

May 2020
  • From 26 May 2022, all new In vitro Diagnostic products will have to comply with the In vitro Diagnostic Regulations.
  • Certificates issued under the In vitro Diagnostic Directive may be valid up to 27 May 2024.
  • The requirements of the new Regulation relating to post-market surveillance, vigilance, and the registration of economic operators and devices shall apply from the Date of Application.
  • The requirements of the In vitro Diagnostic Regulations need to be fulfilled by the manufacturer.
  • Important challenges for SMEs ahead while implementing IVDR include – not enough designated notified bodies, the volume of technical documentation and constantly updating documentation throughout the lifecycle of the product.

Serum human neutrophil lipocalin: An effective biomarker for diagnosing bacterial infections

January 2020
  • Infectious diseases are a serious threat to global public health, and infections are also a common and costly complication in patients with established diseases.
  • For bacterial infections, antibiotic therapy is an effective strategy, and earlier treatment is optimal.
  • Therefore, it is important to determine the microbiological sources of infections in a timely manner, which is difficult even for experienced physicians.

Human neutrophil lipocalin in fMLP-activated whole blood as a diagnostic means to distinguish between acute bacterial and viral infections

May 2015
  • The distinction between causes of acute infections is a major clinical challenge. Current biomarkers, however, are not sufficiently accurate.
  • Human neutrophil lipocalin (HNL) in serum distinguishes acute infections with high accuracy, but in the emergency setting the assay time should be b15–20 min, which excludes the use of serum samples.
  • The aim was therefore to develop a novel rapid assay principle and test its clinical performance.

Differentiation of Bacterial versus Viral Infection in Acute Respiratory Conditions using a Point of Care Assay to detect Human Neutrophil Lipocalin

November 2018
  • Millions of antibiotic prescriptions are written annually in primary care settings around the world and it is estimated that more than 50% of these prescriptions are unnecessary due to a viral source of infection (Ref 2). Unnecessary antibiotic use has resulted in a global surge in both antibiotic resistance and adverse drug reactions (ADR’s)….
  • A PoC solution would cut costs for the healthcare systems and improve patient outcomes.

The Simultaneous Detection of Two Analytes on the Agilis System Using Silver and Gold Nanoparticles

January 2020
  • AgPlus expands capabilities to measure gold and silver NPs simultaneously on the AgilisTM system.
  • Successful dual detection of two analytes simultaneously.
  • Multiple applications in patient point of care for the dual detection of analytes.
  • Dual detection speeds up diagnosis.

Challenges to Point-of-Care Testing (POCT)

September 2019
  • Point-of-care tests (POCT) offer rapid diagnostic and/or predictive results in real-time thereby facilitating clinical decision making. However, certain issues relating to Performance, Cost Effectiveness, Quality and Connectivity considerations are perceived as barriers to implementation of these technologies.
  • The main performance issues of POCT arise as a result of the small sample size used (≤5μL), the very fast time-to-result (≤15 mins) and the use of Whole Blood with all its cellular and enzymatic Constituents.

Human Neutrophil Lipocalin as a Superior Diagnostic Means To Distinguish between Acute Bacterial and Viral Infections

June 2015
  • AgPlus expands capabilities to measure gold and silver NPs simultaneously on the AgilisTM system.
  • The distinction between causes of acute infections is a major clinical challenge. Current biomarkers, however, are not sufficiently accurate. Human neutrophil lipocalin (HNL) concentrations in serum or whole blood activated by formyl-methionineleucine- phenylalanine (fMLP) were shown to distinguish acute infections of bacterial or viral cause with high accuracy.
  • The aim was therefore to compare the clinical performance of HNL with currently used biomarkers.