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Clinical Laboratory int.

Archive for category: Corona News

Corona News

Molgen Lab

Unlocking the world through monitoring

, 28 March 2022/in Corona News, Editors' Picks, Featured Articles /by panglobal
by Niels Kruize, CCO, MolGen

“Automation and industrialization of COVID-19 PCR-testing will facilitate an immense scale-up of the global PCR-testing capacity. It will allow for a new approach to keep society open: preventive, regular testing (twice per week), which will create green bubbles and get us ahead of the curve” – Niels Kruize, CCO, MolGen

Molgen Lab

Why do we need PCR testing for monitoring?

To get ahead of the curve, we will need to change our methodology of COVID-19 testing. After two years, the pandemic continues to disrupt our way of life through the rise of new variants and outbreaks. The world has experienced several pandemic waves, subsequent lockdowns, and a variety of different policies per country and sometimes even per region. The regular discovery of new variants made us realize that we need to transition from infrequent, symptomatic patient testing, towards a more frequent testing approach, called monitoring. The Omicron variant shows us that the current system is under strain, as vaccines and updates to these vaccines become a pressing requirement to keep pace with new variants popping up. It is becoming clearer by the day that the way out of this pandemic demands us to take an even more pro-active role in testing to prevent the spread of the virus.

In diagnostics, scientists have long been aware that we need to move from incidental and individual diagnostic testing to regular interval testing for monitoring on a much larger scale. Monitoring will be instrumental in keeping our society open. People will be regularly tested (twice per week). This will increase the chance of early detection of a new case of infection before that person becomes infectious and participates in spreading the virus. Being able to then isolate the individual temporarily, will stop the spread of COVID-19 in its tracks or at least significantly slow it down.

At MolGen we are highly motivated to enable this for the world, but it will be instrumental to motivate people to see the need to get tested twice a week. For this to work we will have to lift the barriers to mass PCR-testing and make collecting a sample non-invasive and the costs to governments, employers and individuals far more affordable.

Molgen PurePrep TTR Buffers

How to lift barriers and make mass PCR-testing available and accessible
So how will we take away the public’s reluctance to get tested? We will have to take away the main barriers:

  1. Replace invasive nasal and throat swabs with a non-invasive sample collection method, using a Saliva Collection Kit.
  2. Make sample collection available at home, work, and any other location, instead of having to schedule an appointment at a local sampling location.
  3. Enabling the individual to easily link the sample to the person, without the fear of leaking or abuse of personal data, using our anonymous mobile app.
  4. Decrease the current costs of testing. By industrializing PCR-testing, the costs of a PCR-test will go down, making it suitable for mass monitoring purposes.

Molgen PurePrep TTR

MolGen’s MegaPrep is an innovative solution that contains solutions to all these 4 barriers. By working with leading laboratories across the Netherlands, Europe, and the world, the MegaPrep workflow uses the same principles as any other COVID-19 extraction and PCR detection workflow but is implemented on an industrial scale. A combination of smart innovations in automation and massive parallel PCR can handle much larger amounts of samples in a shorter timeframe at lower cost.

Our Saliva Collection Kit mixes saliva with a stabilization lysis transport buffer. This tube can be either collected in a dropbox or can be sent in a safety bag to a lab where the PCR testing is performed. The barcode on the tube combined with video recording of the sample collection in the MegaPrep will allow for non-invasive, safe & anonymous sample collection.

MegaPrep is handling up to a million samples a day
By making non-invasive testing available every 3-4 days, we are far more likely to detect an infected person before they become infectious. This means testing twice a week, every week. By accommodating this at the workplace, at the gym and in our schools, we can create what I call green bubbles. Monitoring using large scale PCR-testing is the safest way to create and maintain these safe bubbles.
I’m excited about all the possibilities created by MegaPrep. Non-invasive, cost-effective, and sensitive testing. MegaPrep will forge the future of testing and will be a key to unlocking our world.

  • Learn more about MolGen at molgen.com
https://clinlabint.com/wp-content/uploads/sites/2/2022/03/Molgen_Lab_02.jpg 1285 2000 panglobal https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png panglobal2022-03-28 12:41:482022-03-28 12:44:07Unlocking the world through monitoring
SARS-CoV-2

IONTAS identifies novel SARS-CoV-2 neutralising antibodies

, 3 May 2021/in Corona News, E-News, Product News /by panglobal

SARS-CoV-2

IONTAS and FairJourney Biologics, leaders in the discovery and optimisation of fully human antibodies, have announced the identification of neutralizing antibodies, which bind to multiple emerging SARS-CoV-2 variants. The results, generated from a combination of phage display technology and B-cell receptor repertoire sequencing of hospitalized COVID-19 patients, have identified potent neutralizing antibodies with distinct mechanisms of action. Based on this approach, the Company has developed a panel of therapeutic candidates.

SARS-CoV-2 virus enters the body as a result of the viral spike protein binding to the ACE2 protein on the surface of lung cells. This interaction is driven by a small region of the spike protein and the majority of antibodies currently undergoing clinical trial bind to this site. However, this site has changed in some of the emerging viral variants, reducing or abolishing the effect of some clinical candidates. Drug candidate antibodies developed by IONTAS to this same site have been shown to retain binding to the emerging variants.

An alternative approach for tackling variants is to target alternative regions of the virus which have a greater degree of conservation, making escape variants less likely. GSK/VIR Biotechnology recently announced a successful Phase 3 trial of such an antibody. VIR-7831 is an antibody which binds to a region of the spike protein which is highly conserved between SARS-CoV-2 and SARS-CoV-1 (A distantly related virus responsible for the outbreak of Severe Acute Respiratory Syndrome in 2003). VIR-7831 has shown an 85% reduction in hospitalisation and death during the COMET-ICE clinical trial.

A sub-set of the IONTAS antibodies, show a similar functionality to VIR-7831, by binding to sites conserved both in the recently emerging SARS-CoV-2 variants as well as to the more distantly related SARS-CoV-1 virus.

Dr John McCafferty, CSO at IONTAS, commented: “The first wave of antibody drugs for treating COVID-19 was focused on achieving maximal neutralization to the original SARS-CoV-2 strain first identified in Wuhan. This led many companies to a target site on the virus which is very effective for neutralization but also prone to genetic change. Second generation drug candidates need to anticipate the emergence of new variants by targeting more conserved sites. IONTAS has identified drug candidates which neutralize by targeting conserved regions of the virus. We now seek partners to help develop these to better position the world in tackling this dreadful disease.”

https://clinlabint.com/wp-content/uploads/sites/2/2021/05/corona.jpg 1280 1920 panglobal https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png panglobal2021-05-03 12:20:212021-05-03 12:20:21IONTAS identifies novel SARS-CoV-2 neutralising antibodies
Erba Mannheim SARS-CoV-2 RT-PCR Assay

ERBA Mannheim launches 2nd generation SARS-CoV-2 RT-PCR Assay with room temperature storage

, 2 February 2021/in Corona News, Product News /by callan

Erba Mannheim SARS-CoV-2 RT-PCR Assay

In response to the ongoing COVID-19 pandemic, Erba Mannheim has launched the ErbaMDx SARS-CoV-2 RT-PCR Kit for detection of SARS-CoV-2.

To overcome challenges in older COVID-19 molecular tests, Erba’s Cambridge(UK)-based development team has engineered a new assay to improve detection and ease of use with a single tube multiplex mastermix, compatible with room-temperature storage and transportation.

The new assay offers 200 copies/ml LoD, using universally trusted gene targets highly specific for SARS-CoV-2 and updated primer sequences to maximise long term performance. Sample types include both nasopharyngeal and oropharyngeal swabs as well as saliva.

Nikhil Vazirani, MD of Erba, said: “We are proud and excited to add a highly sensitive RT-PCR test to our growing range of immunoassay and molecular solutions. The new ErbaMDx SARS-CoV-2 test perfectly complements our successful COVID-19 IgG and IgM ELISA assays to offer customers a state-of-the-art molecular test in addition to antibody testing which will offer clinicians valuable insight into the immune response to infection or vaccination.”

The CE-marked kit will be available through Erba’s global distribution network.

Erba Mannheim, established in over 100 countries, focusses on delivering innovative, affordable and sustainable diagnostic solutions to labs everywhere. The Erba group uses a combination of cutting-edge R&D in 4 continents with efficient low-cost manufacturing to make diagnostic technologies accessible in all resource settings.

  • For more information, visit: https://covid19.erbamannheim.com/
https://clinlabint.com/wp-content/uploads/sites/2/2021/02/erba.jpg 1321 1984 callan https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png callan2021-02-02 09:17:062021-02-02 16:00:58ERBA Mannheim launches 2nd generation SARS-CoV-2 RT-PCR Assay with room temperature storage

Read more

#diagnostics, Clinical, 18 January 2021/in Corona News, E-News, No Category, Product News /by panglobal

ZTA Biotech, a Budapest-based biotech startup has announced the breakthrough development of 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 COVID-19 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 samples of recovered and symptomatic patients.

Read more

https://clinlabint.com/wp-content/uploads/sites/2/2021/01/ZTA-photo.png 497 903 panglobal https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png panglobal2021-01-18 10:35:362021-01-18 14:42:02Biotech Team Develops ELISA Protocol for COVID-19 IgG Antibody Detection

Siemens Healthineers molecular Fast Track Diagnostics SARS-CoV-2 Assay test kit available for use in Europe

, 26 August 2020/in Corona News, Featured Articles /by 3wmedia

Siemens Healthineers molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit is ready for immediate rollout for diagnostic use in Europe. This follows registration of the test kit for diagnostic use with the Luxembourg Ministry of Health. The test kit was released for research use only (RUO) on April 2, 2020.
The test has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity. Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed. Up to 32 patient samples can be analysed per kit.
The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May 2020. The FTD SAR-CoV-2 Assay can be run in laboratories simultaneously with FTD Respiratory Pathogens 21 and FTD FLU/HRSV, molecular syndromic testing panels from Siemens Healthineers that identify a wide range of pathogens that can cause acute respiratory infections.
Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers, commented: “Having our molecular assay available for diagnostic use throughout the European Union is a major step forward in our contribution to the fight against the global pandemic. I am grateful for the work and achievement of our Siemens Healthineers teams under difficult circumstances, and I hope our clinical test will help the healthcare professionals who are working on the frontlines of the pandemic and those affected by COVID-19.”
The company is also working to expand its infectious disease testing capabilities to address the COVID-19 pandemic in other areas of diagnostics. On April 23, the company announced it is developing a SARS-CoV-2 serology assay to detect IgM and IgG antibodies in blood, helping indicate whether a person has developed immunity against SARS-CoV-2.
Siemens Healthineers anticipates availability of the total antibody test by late May 2020. Planned expanded production in the company’s Walpole, Massachusetts manufacturing facility will accommodate more than 25 million tests per month in June and beyond. The company is pursuing Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) as well as the CE Mark.
The test will be available on the Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour and will enable a result in just 14 minutes. In addition, the serology test also is expected to be available on the company’s expansive installed base of ADVIA Centaur XP and XPT analysers, which deliver up to 240 tests per hour, with a result in 18 minutes. Availability of this test on these industry leading platforms ensures more patients are tested in a shorter time.

https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 0 0 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:39:122021-01-08 11:33:06Siemens Healthineers molecular Fast Track Diagnostics SARS-CoV-2 Assay test kit available for use in Europe

Terumo BCT’s Mirasol shows efficacy against SARS-COV-2 in plasma and platelets

, 26 August 2020/in Corona News, Featured Articles /by 3wmedia

Data from a new study suggests that a medical device that uses vitamin B2 and ultraviolet light for treating human blood products is effective against the virus that causes COVID-19. The study results, generated by Terumo BCT in collaboration with researchers from Colorado State University, have been accepted for publication by Vox Sanguinis, a peerreviewed medical journal covering hematology. While there is no evidence that blood transfusions transmit COVID-19, some blood centres are using Mirasol to treat platelets and plasma as an additional layer of safety. Some healthcare providers also treat convalescent plasma with Mirasol. The International Society for Blood Transfusion (ISBT) Global Blood Safety Working Party recommends, where feasible, pathogen inactivation of plasma to control residual risks of transfusion transmitted infection diseases and to allay concern about possible superinfections with SARS-CoV-2.
Using riboflavin (vitamin B2) and ultraviolet light, Mirasol is designed to reduce the pathogen load of various disease-causing agents such as viruses, parasites and bacteria in blood products before they are transfused to patients. Mirasol also inactivates white blood cells to help reduce certain transfusion reactions.
Mirasol is CE marked for platelets, plasma and whole blood and is in routine use in more than 20 countries throughout Europe, the Middle East, Africa, Asia and Latin America. The system is not approved for sale in the U.S. and Canada.

https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 0 0 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:39:122021-01-08 11:33:06Terumo BCT’s Mirasol shows efficacy against SARS-COV-2 in plasma and platelets

BIOVENDOR‘S COVID-19 PORTFOLIO!

, 26 August 2020/in Corona News, Featured Articles /by 3wmedia
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/AD_CLI_BIOVENDOR.jpg 1469 1000 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:39:122021-01-08 11:33:09BIOVENDOR‘S COVID-19 PORTFOLIO!

New molecular diagnostic test for COVID-19 (SARS-CoV-2)

, 26 August 2020/in Corona News, Featured Articles /by 3wmedia
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/AD_CLI_RANDOX.jpg 1401 1000 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:39:122021-01-08 11:33:12New molecular diagnostic test for COVID-19 (SARS-CoV-2)

COVID-19 – ANTIBODY & MOLECULAR TESTING SOLUTIONS

, 26 August 2020/in Corona News, Featured Articles /by 3wmedia
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/AD_NOVATEC.jpg 1415 1000 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:39:122021-01-08 11:33:04COVID-19 – ANTIBODY & MOLECULAR TESTING SOLUTIONS

Siemens starts worldwide shipping of total antibody test for COVID-19

, 26 August 2020/in Corona News, E-News /by 3wmedia

Siemens Healthineers announced late May that it is now shipping worldwide its laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood. The test received the CE mark and data has demonstrated 100 percent sensitivity and 99.8 percent specificity. The total antibody test allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.
The US FDA has issued an Emergency Use Authorization (EUA) for its laboratory-based total antibody test.
Siemens says it is prepared to ramp up production as the pandemic evolves with capacity exceeding 50 million tests per month across its platforms starting in June.
The antibody test is now available on the largest installed base in the U.S. and one of the largest in the world with 20,000 Siemens Healthineers systems installed worldwide. This includes the Atellica Solution immunoassay analyser, which can run up to 440 tests per hour and enables a result in just 10 minutes. By detecting both IgM and IgG antibodies, the test provides a clearer clinical picture over a longer period of time as the disease progresses.
The antibody test also is available on the company’s installed base of ADVIA Centaur XP and XPT analysers, which can test up to 240 samples per hour, with a result in 18 minutes.
Importantly, the test detects antibodies to a key spike protein on the surface of the SARS-CoV-2 virus, which binds the virus to cells with a distinct human receptor found in lungs, heart, multiple organs and blood vessels. Studies indicate that certain (neutralizing) antibodies to the spike protein can disarm SARS-CoV-2, presumably by interfering with the ability of the virus to bind, penetrate and infect human cells. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.

https://clinlabint.com/wp-content/uploads/sites/2/2020/08/CLI-siemens_antibody-scaled.jpg 1416 2560 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:31:372021-01-08 11:07:50Siemens starts worldwide shipping of total antibody test for COVID-19
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