Microbiology News : Mar 2020

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Microbiology News : Mar 2020

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

31 Mar 2020 | ClinicalPharmaceutical

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. more...

New SAS Super Pinocchio CR Compressed Air Sampling Device Introduced by Cherwell Laboratories

31 Mar 2020 | Pharmaceutical

Cherwell’s new SAS Super Pinocchio CR compressed air sampling device offers a more convenient way to monitor compressed air for viable particles. more...

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

31 Mar 2020 | Clinical

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. more...

Automated ELISA Systems for COVID-19 Assays

31 Mar 2020 | Clinical

Dynex Technologies, Inc., has announced that it is actively working with leading ELISA test kit manufacturers, distributor partners and end-user Clinical Labs requesting assistance on implementation and automation of novel COVID-19 ELISA tests. more...

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

31 Mar 2020 | Clinical

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. more...

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

30 Mar 2020 | ClinicalOtherPharmaceutical

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. more...

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

30 Mar 2020 | Clinical

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. more...

EUROIMMUN Announce CE-IVD Marking on COVID-19 ELISA Kit Received and qPCR Awaiting Clearance

30 Mar 2020 | Clinical

EUROIMMUN, a Perkin Elmer company, announce CE-marking for its ELISA COVID-19 antibody detection kits. EUROIMMUN has also developed a qPCR kit for detection of SARS-CoV-2. A CE-IVD application has been submitted for this product and is currrently for RUO in EEA but has FDA-EUA. more...

FDA Provides EUA to PerkinElmer for COVID-19 Testing

30 Mar 2020 | Clinical

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. more...

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

30 Mar 2020 | Clinical

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. more...

Fast & Reliable Tracking of Coronavirus Patient Samples

27 Mar 2020 | Clinical

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. more...

Food Manufacturers Can Reduce Time-to-result with Promicol ATP Bioluminescence Rapid Testing

26 Mar 2020 | Food & Beverage

Food manufacturers switching to Promicol ATP bioluminescence rapid testing can improve the relability and efficiency of their quality control, speed up product release, reduce stock holding and increase cash flow. more...

COVID-19 – Accelerate Your PCR Setup

26 Mar 2020 | ClinicalPharmaceutical

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. more...

New SAS Tri-Clover Isolator Head for Microbial Air Sampler from Cherwell Laboratories

25 Mar 2020 | Pharmaceutical

The new SAS Tri-Clover Isolator Head for Microbial Air Sampler available from Cherwell Laboratories allows easier installation within restricted-access barrier systems (RABs) and filling lines for environmental monitoring in grade A environments. more...

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

25 Mar 2020 | ClinicalPharmaceutical

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. more...

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

25 Mar 2020 | Clinical

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. more...

ISO 9308-1: Testing for E. coli and Coliforms in Drinking Water

24 Mar 2020 | Water

Coliforms and E. coli are tested as indicators of drinking water quality. This testing procedure is outlined in the ISO 9308-1 regulation method, updated in 2014 and recently amended in 2016. more...

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

24 Mar 2020 | Clinical

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. more...

MicrosensDx Announces a Portable Coronavirus Testing Kit

24 Mar 2020 | ClinicalPharmaceutical

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. more...

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

24 Mar 2020 | Clinical

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. more...

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

24 Mar 2020 | Clinical

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. more...

CoronaCheck Lateral-Flow Test Manufacturers Confirm Mass-Production Capacity

24 Mar 2020 | Clinical

20/20 BioResponse, a business unit of 20/20 GeneSystems, has announced that it will begin taking orders for its CoronaCheck COVID-19 Rapid Antibody Test Kit. The test provides a result within 15 minutes, and is CE-marked with FDA-EUA in the pipeline. more...

Help AMR Dx Global by Taking this Antimicrobial Resistance Survey

24 Mar 2020 | Clinical

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. more...

Pall Genedisc System - Ready-to-Use, Gold Standard PCR for Food, Water and Biopharmaceuticals

23 Mar 2020 | Food & BeverageWaterPharmaceutical

With applications for food pathogens, water and biopharmaceutical indicator organisms. The Pall Genedisc system uses an all in one cartridge that comes complete with ready to use reagents, automated barcode reading determines the protocol - press the button and go! more...

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

20 Mar 2020 | Clinical

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. more...

Automated Extraction of RNA / DNA From Viruses Increases Testing Capacity

20 Mar 2020 | Clinical

Combined with automation solutions the foodproof^® Magnetic Preparation Kit VI can process up to 480 reactions in a short time, significantly increasing available testing capacity. It is currently being evaluated for COVID-19 detection at various coronavirus testing laboratories. more...

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

19 Mar 2020 | Clinical

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. more...

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

19 Mar 2020 | Clinical

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. more...

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

18 Mar 2020 | Clinical

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. more...

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

18 Mar 2020 | Clinical

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. more...

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

18 Mar 2020 | Clinical

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. more...

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

16 Mar 2020 | Clinical

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. more...

CE-Marked COVID-19 IgM/IgG Lateral-Flow Kit Provides Results in 10-minutes

16 Mar 2020 | Clinical

ERA-BIO has received CE-marking for its 10-minute sample-to-result lateral flow assay for COVID-19. The kit includes two tests, which have over 95% sensitivity and specificity for the IgG and IgM antibodies that are specific for SARS-CoV-2. more...

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

16 Mar 2020 | Clinical

SARSCoV2 full length S protein human ACE2 protein

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.
more...

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

13 Mar 2020 | Clinical

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. more...

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

13 Mar 2020 | Clinical

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. more...

VOYAGER Adjustable Tip Spacing Pipette Saves Labs Time and Money

12 Mar 2020 | Pharmaceutical

Labs can now calculate their return on investment when purchasing a VOYAGER, adjustable tip spacing pipette, using INTEGRA’s ROI calculator. more...

NCIMB Launches Probiotics and Microbial Additive Testing Service

12 Mar 2020 | Food & BeverageMicrobiome

NCIMB has launched a package of services to help probiotics and feed additive manufacturers assess the suitability of candidate strains and comply with European Food Safety Authority guidelines. more...

Microbiologics Introduces SARS-CoV-2 Synthetic RNA

12 Mar 2020 | Clinical

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. more...

Campden BRI runs Industry Survey to Develop new Scoring System to Control Listeria

11 Mar 2020 | Food & Beverage

Campden BRI has begun an industry survey to gain an insight into how much control the food industry has over Listeria. It forms part of a new research project that will deliver new guidelines and controls to help the industry manage this pathogen. more...

Co-Diagnostics Announce Surging Demand for It's CoPrimer™-Based COVID-19 Screening Assay

10 Mar 2020 | Clinical

Co-Diagnostics announce a surging demand for its Logix Smart™ COVID-19 Test Kit. Awarded a 'Technical Advance' accolade in the Journal of Molecular Diagnostics, the CoPrimer™ mismatch reduction technology has been incorporated into their Logix Smart™ COVID-19 qPCR assay. more...

The Most Expensive Test Is the One You Have to Do Twice.

10 Mar 2020 | Pharmaceutical

Charles River’s portfolio of FDA-licensed products for bacterial endotoxin testing is designed to increase data integrity compliance, reduce retest rates, and streamline manufacturing processes, allowing prompt, confident decisions. more...

Special Focus on Endotoxin / Pyrogen Testing

10 Mar 2020 | Pharmaceutical

A rapidmicrobiology special on pyrogen/endotoxin testing - includes pharmacopeial acceptance of rFC tests, how to improve endotoxin testing efficiencies, reduce time-consuming and expensive re-testing and the advantages of Monocyte Activation Testing. PLUS we have a special quiz! more...

Increasing Efficiency in Endotoxin Testing

10 Mar 2020 | Pharmaceutical

Endotoxin Testing can be difficult, time-consuming and associated with multiple re-testing. With new technologies in the market, increasing efficiency in your testing solutions can be easily and “rapidly” implemented. Kevin L. Williams, bioMérieux, explains... more...

Spanish Biotech Company Receive CE-IVD Marking on Two Covid-19 Diagnostic Test Kits

10 Mar 2020 | Clinical

Genomica SAU has received CE-IVD Marking for both of its PCR-based Covid-19 diagnostic kits. The qCovid-19 and the CLART® Covid-19 assays will be made available in China and 30 other countries due to commercial agreements already in place. more...

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

09 Mar 2020 | Clinical

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. more...

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

09 Mar 2020 | Clinical

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. more...

COVID-19 CE-Marked Kits Available Now from Pro-Lab Diagnostics

06 Mar 2020 | Clinical

VIASURE CE-marked SARS-CoV-2 Real-Time PCR Detection Kit is now available from Pro-Lab Diagnostics. The kit is designed for the specific identification of the new coronavirus (SARS-CoV-2) in clinical samples and allows 1-96 samples to be tested per assay. more...

Latest Microbiology Newsletter - 3 March 2020

06 Mar 2020 | Clinical

SARS-CoV-2, COVID-19 or 2019-nCoV whichever term you prefer, it's making a big impact on scientific meetings, see our test method guide on swabs and kits, ELISA kit for cooked egg allergen testing and all the latest product news. more...

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

06 Mar 2020 | Clinical

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

Securely Seal Tube Racks with impressiOn

04 Mar 2020 | Food & BeverageClinicalPharmaceuticalMicrobiome

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

Pipettes with True One-Handed Operation Fit into Narrow Containers

04 Mar 2020 | Food & BeverageClinicalPharmaceuticalMicrobiome

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 more...

PyroMAT^® System, a Suitable Solution for the Detection of a Wide Range of Pyrogens

03 Mar 2020 | Pharmaceutical

The PyroMAT™ system is a Monocyte Activation Test solution that uses a monocytic cell line for the detection of pyrogens. It has been demonstrated that this cell line can detect a wide range of pyrogens by using several TLR ligands. more...

Qiagen Streamlines Covid-19 Molecular Workflow with Rapid Swab Analyzer

03 Mar 2020 | Clinical

Qiagen's rapid Covid-19 molecular assay undergoes clinical evaluation in China and France. The QIAstat-Dx instrument analyses a swab and provides results in about one hour, streamlining molecular preparation workflow. more...

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

03 Mar 2020 | Clinical

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. more...

Maintain Sample Integrity with New RNA Complete BCT^™

03 Mar 2020 | Clinical

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

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

03 Mar 2020 | Clinical

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. more...

Thermo Fisher Acquire Qiagen

03 Mar 2020 | Clinical

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. more...

The Compendia Are Ready to Adopt rFC, Are You?

02 Mar 2020 | Pharmaceutical

In this article, Allen L. Burgenson, Global Subject Matter Expert, Lonza Pharma&Biotech – Testing Solutions, reviews how leading pharmacopeias are moving towards acceptance of the use of recombinant Factor C (rFC) for compendial Bacterial Endotoxin Testing (BET). more...

COPAN Streamlines Production to Yield Maximum Output of Viral Transport Kits

02 Mar 2020 | Clinical

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.
more...

Campden BRI to run Campylobacter Seminar

02 Mar 2020 | Food & Beverage

Campden BRI will hold a seminar on 21 April to help the food industry understand how to control Campylobacter more...

New Identity Reflects Microbiologics’ Work on the Frontiers of Health and Safety

02 Mar 2020 | Pharmaceutical

Microbiologics new brand identity reflects the commitment to growth through relentless R & D, as well as the acquisitions of Michigan-based Micromyx in 2019, California-based Virapur in 2017, and Kentucky-based Gibson Bioscience in 2008. more...

WuXi Launch Covid-19 ELISA & NAT Diagnostic Kits

02 Mar 2020 | Clinical

Wuxi Diagnostics has developed two ELISA-method Covid-19 antibody detection kits along with a nucleic acid test (NAT) for the novel coronavirus; providing results in 60 minutes and 2 hours, respectively. more...

BIOTECON Diagnostics Enters Into a Global Supply Agreement with FoodChek Systems Inc.

02 Mar 2020 | Food & Beverage

BIOTECON Diagnostics now supply FoodChek Actero^™ Listeria Elite Enrichment Media which, when used with BIOTECON Diagnostics foodproof^® Listeria, significantly reduces time-to-results whilst improving sensitivity, sample handling, and throughput. more...

Novel Coronavirus SARS-CoV-2 Ag Antigen rapid test kit PEI evaluated and CE-marked on EU Common list

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