Testing devices

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Detection of traumatic brain injury (TBI)

First rapid handheld blood test for concussions receives FDA clearance

Abbott has received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions. The test will run on Abbott's handheld i-STAT Alinity platform. Tests results are available within 15 minutes after plasma is placed in the test cartridge. TBIs, including concussions, are an…

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Frontal part of the nose

Covid-19 Antigen Test: CE Mark for easier sample collection

Siemens Healthineers announced CE mark has been achieved to use anterior nose swab sampling for the Clinitest Rapid Covid-19 Antigen test. This sampling method can be less cumbersome and time consuming for both the provider and the patient. The test is a point-of-care cassette test that does not require laboratory instruments or specialized lab personnel to administer, and it delivers results in…

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Enzyme Linked Immunosorbent Assay

Startup develops breakthrough IgG antibody test for Covid-19

ZTA Biotech, a Budapest-based biotech startup, has developed a Covid-19 antibody (IgG) test using the ELISA protocol. This new detection method represents a great step forward in determining if patients have had a coronavirus infection and if they might still have immunity to the disease. Early results have proven 100% in specificity after testing 280 samples, and 100% sensitivity by testing 260…

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Rapid antigen testing at point of care

AI-assisted SARS-CoV-2 testing: Cooperation for first live project in Munich

Medicus AI announces the successful launch of its first live project under SafePlay, the digital platform supporting rapid antigen testing, which went live in partnership with Roche Diagnostics Germany and 21Dx in Munich this month. Medicus provides operators with a tech-enabled end-to-end solution that supports the logistical aspects of testing, managing the administrative workflow from…

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Digital health

AI test rules out Covid-19 diagnosis within one hour

An Artificial Intelligence test has been shown to be able to rapidly screen patients arriving in Emergency Departments for Covid-19, using clinical information routinely available within the first hour of coming to hospital. Results of the CURIAL study, published in The Lancet Digital Health, show that the AI test correctly predicted the Covid-19 status of 92.3% of patients coming to Emergency…

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New gargle test

Mass spectrometry to improve Covid testing

A UK biotech laboratory has used mass spectrometry in a new approach to coronavirus testing. MAP Sciences developed a gargle test, which collects samples from the back of the throat, and avoids the unpleasant sensation of the current PCR (polymerase chain reaction) swab tests. From there, the sample is tested for coronavirus using mass spectrometry (MS) with high levels of accuracy.

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False positive results

Accuracy of rapid covid test may be lower than previously suggested

The accuracy of a rapid finger-prick antibody test for SARS-CoV-2, the virus responsible for covid-19 infection, may be considerably lower than previously suggested, finds a study published by The BMJ. The results suggest that if 10% of people given the test had previously been infected, around 1 in 5 positive test results would be incorrect (false positive results). These conclusions contrast…

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Using virus particles in exhaled breath

New SARS-CoV-2 test to deliver results in under 5 minutes

Research and innovation hub Imec announced that it has started developing a groundbreaking SARS-CoV-2 test. Unlike current approaches (using blood, saliva, or a nasopharyngeal swab), the new test will identify SARS-CoV-2 virus particles in a person’s exhaled breath. The solution promises the accurate identification of a contagious case in less than five minutes.

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Testing strategy re-evaluated

COVID-19 testing at random? Here's a better idea

As COVID-19 infections begin to rise again, a novel testing strategy proposed by researchers at the University of Oxford at the start of the pandemic has become urgent once again. The strategy aims to bring the virus’s reproduction number (‘R’) down to below 1, by concentrating testing resources on particular groups in the population that are most likely to spread the infection to others,…

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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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