#testing devices

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Review sheds doubt

Major flaws in evidence base for COVID-19 antibody tests found

Major weaknesses exist in the evidence base for COVID-19 antibody tests, finds a review of the latest research published by The BMJ. The evidence is particularly weak for point-of-care tests (performed directly with a patient, outside of a laboratory) and does not support their continued use, say the researchers. Serological tests to detect antibodies against COVID-19 could improve diagnosis and…

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COVID-19 diagnostics

SARS-CoV-2 IgG antibody test receives FDA Emergency Use Authorization

Beckman Coulter announced that its Access SARS-CoV-2 IgG assay has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA). Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S., and has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark. The…

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UK experts raise concerns

COVID-19 antibody tests: Not a game-changer after all?

A group of senior clinical academics and physicians are concerned about the rapid roll out of COVID-19 antibody testing in England and are publicly questioning how good the tests are - or even what they mean. In a letter to The BMJ, they argue that there is currently no valid clinical reason for large scale testing, test performance has not yet been adequately assessed, and testing risks…

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Volunteering against the coronavirus

Scientists on Standby portal to support COVID-19 testing recruitment

Scientists on Standby has been rapidly conceptualised and launched in response to the COVID-19 crisis and in anticipation of the increasing pressure on UK diagnostic testing laboratories and facilities in the coming weeks and months. The portal enables scientists with relevant skills and experience to volunteer their time, expertise and support for COVID-19 screening and testing.

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New sensor tech

A more reliable way to early detect lung tumours

People who are at high risk of developing lung cancer, such as heavy smokers, are routinely screened with computed tomography (CT), which can detect tumors in the lungs. However, this test has an extremely high rate of false positives, as it also picks up benign nodules in the lungs. Researchers at the Massachussetts Institute of Technology (MIT) have now developed a new approach to early…

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IgM/IgG identification

Coronavirus antibody test in development

In response to the global COVID-19 pandemic, Beckman Coulter announced that it is developing assays to identify IgM and IgG antibodies to the coronavirus or SARS-CoV-2. The assays will be designed for use on any of its high-throughput Access family of immunoassay systems, including the Access 2 and DxI series installed globally. Research has shown that after infection with SARS-CoV-2, viral…

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Blood gas testing

Aiding COVID-19 efforts: FDA clearance for blood gas analyzer

Siemens Healthineers announced that its latest critical care testing solution, the RapidPoint 500e Blood Gas Analyzer, has received clearance from the U.S. Food and Drug Administration (FDA), and is now available in the U.S., Europe and countries requiring the CE mark. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to…

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COVID-19 diagnostics

Corona 'pool testing' increases worldwide capacities many times over

Researchers at the German Red Cross Blood Donor Service in Frankfurt headed by Professor Erhard Seifried, and the Institute for Medical Virology at the University Hospital Frankfurt at Goethe University headed by Professor Sandra Ciesek succeeded in developing a procedure that makes it possible to immediately and dramatically increase worldwide testing capacities for detecting SARS-CoV-2.

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RT-PCR for COVID-19

First of 3 diagnostic tests for SARS-CoV-2 coronavirus available

Biotechnology company bioMérieux, a world leader in the field of in vitro diagnostics, is announcing the forthcoming launch of 3 different tests to address the COVID-19 epidemic and to meet the different needs of physicians and health authorities in the fight against this emerging infectious disease. bioMérieux has finalized the development of the SARS-CoV-2 R-Gene test. This real-time PCR test…

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Fixed DNA Molecule Array

World’s fastest DNA testing method created

A group of scientists from Vilnius University have developed the world’s fastest DNA testing method, reducing DNA testing costs by 90%. It identifies changes in chromosomes, genes, or proteins to determine a genetic condition or eliminate the chance of the formation or passing on of a gene-based disorder amongst humans and animals. At present, the sole method of genetic testing is the DNA…

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Diagnostics

Heat it and read it

You’re sweating and feverish and have no idea why. Fortunately, Sandia National Laboratories scientists have built a device that can pinpoint what’s wrong in less than an hour. Unlike most medical diagnostic devices which can perform only one type of test — either protein or nucleic acid tests — Sandia’s SpinDx can now perform both. This allows it to identify nearly any cause of…

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Testing technology

Vitamin D testing: LC-MS outperforms immunoassays

In recent years, clinicians have increasingly focused on vitamin D deficiency. Studies show that previous reference values – particularly for Vitamin D3 – were most probably set too high. Liquid chromatography with mass spectrometry (LC-MS) can help achieve more precise measurements of vitamin D levels than previously established immunoassay procedures, explains Dr Torsten Binscheck-Domass,…

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Mobile cMyC analysis

The future POCT heart attack test

Experts report that a new blood test to diagnose heart attacks could be carried out on a hand-held device in the not-too-distant future. The test, devised by a team at Kings College London, uses similar technology to the troponin test, but instead analyses cardiac myosin-binding protein C (cMyC). In research presented at the British Cardiovascular Society conference in Manchester, UK, this June,…

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Sepsis treatment

Bedside testing can prevent antibiotic-induced hearing loss in new-borns

More than a million neonatal deaths worldwide each year are estimated to be due to sepsis. In the UK there are approximately 90,000 admissions to neonatal intensive care units per year. Nearly all these patients receive antibiotic therapy during their hospital stay, but babies with a specific genetic change can suffer irreversible hearing loss as a result. Now, in a collaboration between…

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Laboratory operations

Atellica NEPH 630 System now available

Siemens Healthineers announced its Atellica NEPH 630 System is now available to laboratories. The Atellica NEPH 630 System is a low- to mid-volume nephelometric protein testing solution that simplifies laboratory operations by unifying instrument, assay, IT connectivity and remote service disciplines to deliver advancements in protein testing.

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Clinical trial

A simple breath test could evolve breast cancer diagnostics

The University of Southern California (USC) Norris Comprehensive Cancer Center is actively recruiting for a clinical trial that is researching the effectiveness of a breath test for breast cancer diagnostics. The BreathLink device, manufactured by Menssana Research, Inc., captures a two-minute sample of a patient’s breath and provides immediate results on whether there are indications of breast…

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