News : clinical, Mar 2020

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News : clinical, Mar 2020

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Sartorius Aid Development of 1^st Vaccine Candidate against SAR-CoV-2 to Enter Clinical Trials

31 Mar 2020

CanSinoBIO and the Institute of Bioengineering saved time during development by using Sartorius’ BIOSTAT^® STR single-use bioreactor system for the upstream preparation of the recombinant vaccine.

SeraCare Produce High-Titre SARS-CoV-2 Stocks to Aid Global Diagnostic Assay Development

Assay Development SARS-CoV-2

31 Mar 2020

LGC's SeraCare Life Sciences is expanding production of their novel COVID-19 reference materials to include high titer stocks that serve as a valuable tool for diagnostic manufacturers.

MicrosensDx COVID-19 Point-of-Care Test: Safe, Fast and Easy to Use

SARS-CoV-2

31 Mar 2020

MicrosensDx has announced the launch its fast and safe RapiPrep^®COVID-19 molecular test for research use in the detection of RNA from the SARS-Cov-2 virus in sputum, throat and nose swab. A CE-marked version is expected in April.

AIRBIO DUO A Stationary and Portable, 2 Aspirating Heads, Air Sampler from ORUM INTERNATIONAL

Air Sampling Automation Cleanroom

30 Mar 2020

With dual heads, and bluetooth connectivity, the TRIO.BAS^™microbial air sampler from Orum International is ideally suited for applications where a large number of tests are performed in different environments whilst meeting quality standards and QM/GMP.

Bruker Partners With Primer Design to Distribute Genesig® CE-IVD & FDA-EUA COVID-19 qPCR Kit

Quantitative PCR (qPCR)SARS-CoV-2

30 Mar 2020

The Genesig® COVID-19 qPCR assay has been validated on Bruker-Hain's GenoXtract 12 DNA/RNA extraction system and the GenoXtract (GXT) automated nucleic acid extraction devices. It is CE-IVD, and FDA EUA marked. Bruker is now distributing this product on behalf of makers Primer Design.

FDA Provides EUA to PerkinElmer for COVID-19 Testing

Reverse Transcription PCR (RT-PCR)SARS-CoV-2

30 Mar 2020

PerkinElmer has announced that the FDA has provided EUA for the Company’s New Coronavirus RT-PCR test. The kit which detects ORF1ab and N genes is also CE-IVD marked.

Instant Results from Abbott's COVID-19 Point-of-Care Test

SARS-CoV-2

30 Mar 2020

Abbott's FDA-EUA marked COVID-19 test can provide positive results in 5 minutes and negative results in 13 minutes. The test takes nasal, throat or nasopharyngeal specimens, and detects the RdRp gene in the viral RNA. Abbott says they will be able to produce 5 million tests a month.

Fast & Reliable Tracking of Coronavirus Patient Samples

SARS-CoV-2

27 Mar 2020

The Ziath DataPaq™ Mirage Rack Scanner accepts all SBS-format tube racks, easy scanning of coded sample tubes, even when wearing cryoprotective or anti-contamination clothing, with easy set-up, straight out of the box, with only a few minutes needed to install the application software.

COVID-19 – Accelerate Your PCR Setup

Automation Liquid Handling Multichannel Pipettes

26 Mar 2020

INTEGRA’s Australian distributor, BioTools, has partnered with Sullivan Nicolaides Pathology to support COVID-19 testing using the ASSIST PLUS pipetting robot, helping the team to increase sample processing capacity and fast track COVID-19 assay development while reducing manual processing.

Extensive Range of SARS-CoV-2 Reagents Available from Sino Biological

Antibodies Assay Development Recombinant Proteins

25 Mar 2020

Sino Biological, with branches in China, US and Germany, have released a comprehensive portfolio of reagents for SARS-CoV-2 vaccine and therapeutic antibody development. The one-stop-shop produces everything in-house and is a leader in recombinant protein manufacture.

bioMérieux's BioFire Defense Announce FDA-EUA Marking on SARS-CoV-2 Test

Reverse Transcription PCR (RT-PCR)SARS-CoV-2

25 Mar 2020

bioMérieux's BioFire Defense subsidiary has received FDA-EUA for its BioFire® COVID-19 test. It is a multiplexed real-time RT-PCR test that runs on FilmArray® 2.0 and FilmArray Torch® systems and can provide a result in approximately 50 minutes.

Meridian Bioscience Provides Free Samples of qPCR Mixes for COVID-19 Assay Developers

Assay Development Diagnostic Manufacturing SARS-CoV-2

24 Mar 2020

Meridian Bioscience, Inc. has announced it is making free samples, of the company’s proprietary technologies, available to developers and manufacturers of molecular assays for COVID-19 detection.

MicrosensDx Announces a Portable Coronavirus Testing Kit

LAMP/Isothermal Amplification SARS-CoV-2

24 Mar 2020

MicrosensDx RapiPrep^® system enables highly sensitive coronavirus (SARS-CoV-2) detection in less than 25 minutes from taking a sample to test result. The portable, desktop kit will be used initially in scientific laboratories involved in vaccine and therapeutic research and development.

Xpert® Xpress SARS-CoV-2 Point-of-Care Test Is Granted FDA-EUA

SARS-CoV-2

24 Mar 2020

Cepheid has received FDA-EUA on its Xpert Xpress SARS-CoV-2 Point-of-Care test which can provide a result within approximately 45 minutes. The test targets multiple regions of the viral genome will run on the GeneXpert Systems. Shipping expected to begin this week.

Bio-Rad's Droplet Digital PCR Finds Patients Positive after qPCR Results showed Negative

Droplet Digital PCR SARS-CoV-2

24 Mar 2020

Bio-Rad Laboratories has reported findings on two studies carried out where its Droplet Digital PCR System has shown higher sensitivity and precision than standard molecular tests and has even shown patients positive for COVID-19 after qPCR had shown negative.

Help AMR Dx Global by Taking this Antimicrobial Resistance Survey

Antibiotic Resistance Antimicrobial Resistance (AMR)

24 Mar 2020

The EU funded AMR Dx Global project is asking stakeholders for information (anonymous) on their own interaction with AMR rapid diagnostics with the aim of improving its current state across the continent.

Microbiologics Introduces the First SARS-CoV-2 RNA CE-IVD Control

QC Molecular Standards SARS-CoV-2

20 Mar 2020

As the need for COVID-19 testing continues to increase, Microbiologics is launching a SARS-CoV-2 IVD control in its popular Helix Elite™ line of molecular standards. The new IVD control provides the N1, N2, & N3 gene targets in an easy-to-use format.

Antibody Test Strip for Rapid COVID-19 Diagnosis Receives CE-Mark

Lateral Flow Assays SARS-CoV-2

19 Mar 2020

SureScreen's Lateral-flow COVID-19 IgG/IgM Rapid Test Cassette has received CE-marking. A drop of patient's serum is placed on a cassette, and by the aid of capillary action is moved through specific anti-human antibodies which bind to SARS-CoV-2 antibodies and show a coloured line.

Hamilton Prioritizes High-Throughput COVID-19 Automated Testing Workstations for US and Europe

SARS-CoV-2 Workstations

19 Mar 2020

Hamilton Company has announced the launch of their two new automated workstations, which can use any COVID-19 assay and also that they are prioritizing orders related to COVID-19 testing for the US and Europe.

US Health Service Grants Qiagen Funding to Speed up COVID-19 Test-Cartridge FDA-Approval

SARS-CoV-2

18 Mar 2020

Qiagen moves one step closer to having its QIAstat-Dx Respiratory SARS-CoV-2 Panel test kit approved by the US FDA after receiving more than half a million dollars from the US Department of Health. The one-hour sample to result, molecular-based test runs on the QIAstat-DX system.

Bio-Rad's SARS-CoV-2 Standards For COVID-Assay Validation Are Now Available in US

QC Molecular Standards SARS-CoV-2

18 Mar 2020

The Bio-Rad SARS-CoV-2 standard contains synthetic COVID-19 RNA transcripts and human genomic DNA, allowing laboratories to test the entire process of a molecular assay including extraction, amplification, and detection of the virus.

Korean KH Medical RADI COVID-19 Kit Receives CE-Marking

Diagnostic Manufacturing SARS-CoV-2

18 Mar 2020

KH Medical has announced that it's RADI COVID-19Real-Time PCR Detection Kit has received CE-IVD marking. The kit is used for the qualitative detection of SARS-CoV-2 in human nasal swab or sputum by using RADI Prep Plus and RADI Real-Time PCR system and all major thermocyclers.

Thermo Fisher's Taqman COVID-19 Diagnostic Kit Receives FDA Emergency Use Authorization

SARS-CoV-2

16 Mar 2020

ThermoFisher has received US FDA Emergency Use Authorization (EUA) for its Taqman COVID-19 Diagnostic Detection Kit. The kit has three targets in the novel coronavirus; ORF1ab, S protein and N protein, and can provide results within 4 hours.

COVID-19 - Recomb Proteins and Antibodies for Developing Antiviral Drugs, Vaccines and Diagnostics

SARS-CoV-2

16 Mar 2020

Research materials to help develop SARS-CoV-2 antiviral drugs, vaccines and diagnostics including full length S protein, S1 protein and human ACE2 protein, antibodies, ACE2 expression plasmids, RNAi, CRISPR knockout & activation kits.

CE-Marked BD Max^™VIASURE COVID-19 RT-PCR Test Now Available

SARS-CoV-2

13 Mar 2020

Certest Biotec's VIASURE SARS-CoV-2 RT-PCR Detection Kit that runs on BD MAX™ System has received CE-marking and is now available in Europe. This COVID-19 diagnostic kit targets the S-gene and is offered in lyophilised format.

Roche cobas SARS-CoV-2 Test is Now CE-IVD and FDA-EUA Approved

SARS-CoV-2

13 Mar 2020

Roche announce US FDA EUA and CE-IVD approval for its cobas SARS-CoV-2 Test. The test can be run on cobas 6800/8800 Systems and has a time to result of three hours.

Microbiologics Introduces SARS-CoV-2 Synthetic RNA

Diagnostic Manufacturing QC Molecular Standards SARS-CoV-2

12 Mar 2020

As COVID-19 continues to spread, Microbiologics has responded with synthetic SARS-CoV-2 sub-genomic RNA material to assist in the development of diagnostic assays. An IVD control for SARS-CoV-2 will soon be available in Microbiologics’ Helix Elite™ line of molecular controls.

Pinpoint's Low-Cost Handheld Covid-19 Aptamer-based Diagnostic Device in Development

Diagnostic Manufacturing SARS-CoV-2

09 Mar 2020

A low-cost handheld Covid-19 diagnostic device is currently in development at Pinpoint Science laboratories. The nanosensor aptamer-based instrument will allow anyone, anywhere to perform the test and have a result in 30 seconds.

FDA Recruit Covid-19 3rd-party Kit Manufacturers to Meet Demand

SARS-CoV-2

09 Mar 2020

FDA announces CDC's 3rd-party Covid-19 diagnostic kit manufacturers could have 4 million additional kits available by the end of this week. With current estimates, 2.1 million tests would translate to 850,000 Americans able to undergo testing.

Veredus Laboratories Lab-on-Chip Test to Diagnose Covid-19

SARS-CoV-2

06 Mar 2020

Veredus Laboratories have launched its HSA-approved commercially available VereCoV™ Detection Kit for In-vitro diagnostic (IVD) use to diagnose COVID-19 in Singapore.

Securely Seal Tube Racks with impressiOn

Liquid Handling

04 Mar 2020

The Ziath impressiOn sets a new industry leading benchmark for high integrity, cost effective sealing of single use SBS format tube racks.

Pipettes with True One-Handed Operation Fit into Narrow Containers

Liquid Handling Liquid Handling in Microplates

04 Mar 2020

The BRAND^® Transferpette^® S line of air displacement pipettes are designed to be truely operational with one hand, plus the slimmer shaft fits even narrow vessels and tip cones are designed to fit most brands of quality pipette tips - volume ranges from 0.1 µL to 10 mL

CLIA Labs Can Test for Covid-19 Without EUA say FDA

SARS-CoV-2

03 Mar 2020

The FDA has permitted CLIA certified laboratories to perform Covid-19 testing with diagnostic kits that have yet to receive emergency use authorization (EUA) but have been validated, to expedite the testing process nationwide.

Maintain Sample Integrity with New RNA Complete BCT^™

Blood Culture Sample Collection

03 Mar 2020

Now available in the UK from Alpha Laboratories Ltd, RNA Complete BCT offers a much more convenient workflow process than alternative blood collection tubes.

FDA Entrusts Longhorn's Viral Transport Medium To Protect Suspected SARS-CoV-2 Samples

SARS-CoV-2 Swabs with Transport Medium

03 Mar 2020

The FDA has said that if Covid-19 diagnostic kit manufacturers are applying for EUA, then they should use Longhorn Vaccines and Diagnostics PrimeStore MTM® viral transport medium, which will allow the kits to be used in CLIA labs while EUA application is being reviewed.

Thermo Fisher Acquire Qiagen

Antibiotic Stewardship

03 Mar 2020

QIAGEN has a strong presence in molecular diagnostics with a product portfolio focused on infectious disease and other growth opportunities. The combined company will accelerate the development of higher-specificity, faster and more comprehensive tests.

COPAN Streamlines Production to Yield Maximum Output of Viral Transport Kits

Swabs with Transport Medium

02 Mar 2020

COPAN has responded to the surge in demand for viral transport kits for the collection of upper respiratory samples, including COVID-19 by streamlining its production capacity.

News : clinical, Mar 2020

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