In-vitro diagnostics company Universal Diagnostics (UDX) announced promising new data for its investigational blood-based lung cancer test. The data, presented at the IASLC 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC20), held virtually 28th-31st January 2021, used methylation status measurement of the tumour-derived portion from…
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…
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…
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…
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…
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…
The U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both Covid-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC Covid-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for Covid-19 +Flu by individuals who are suspected of respiratory viral infection consistent…
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.
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…
Merck announced a collaboration with Mammoth Biosciences Inc. for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test.
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.
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,…
EKF Diagnostics, the global in vitro diagnostics company, announces that it has added a novel viral transport media for the safe sample handling and testing of multiple infectious diseases from a single swab to its product range.
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…
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…
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…
To develop and manufacture COVID-19 test kits in massive quantities was not part of their 2020 business plans. Yet, as the epidemic evolved into a global pandemic, the urgent need for diagnostic and antibody SARS-CoV-2 test kits triggered an unprecedented scramble among medical manufacturers.
A new diagnostic test can detect the RNA of SARS-CoV-2, the virus that causes COVID-19, in urine, blood, saliva or mouth swab samples in just 30 to 45 minutes, according to a new study in the open-access journal PLOS ONE by Laura Lamb of the Beaumont Health System, Michigan, USA, and colleagues.
European photonics scientists are developing an ultrasensitive laser sensor that detects coronavirus at the earliest point of infection from a saliva or nasal swab in minutes.
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.
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…
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…
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…
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.
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…