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News : clinical, Jun 2020

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Special Focus on Choosing the Right Swab

Swabs from MWE for the best results
ATP TestingHygiene MonitoringNorovirus
30 Jun 2020
Capture, maintain and release - that's all a swab has to do but there are a range of different swab materials and different transport systems. Browse through some of the options in our rapidmicrobiology special focus on swabs, covering applications in clinical and food sectors.

Enhanced Performance and High-Throughput Screening up to 384 Samples Simultaneously

GenePro SARS CoV 2 FDA EUA Genecurix
Reverse Transcription PCR (RT-PCR)SARS-CoV-2
30 Jun 2020
The GenePro SARS-CoV-2 RT-PCR test, developed by Gencurix (South Korea), has received FDA-EUA. The kit can work on a varitey of PCR instruments and has been designed to work on 384-well plates, quadrupling standard runs. 

Early Validation Data on COVID-19 Antigen Test Shows Promise Say Developers

AVACTA Affimer COVID 19
Lateral Flow AssaysSARS-CoV-2
30 Jun 2020
Avacta and Cytiva, who are developing a point-of-care COVID-19 antigen detection test, are pleased with early performance data and claim the test can detect the virus' spike protein within the clinical range found in the saliva of COVID-19 patients. 

Free Samples! WESAIL 5 Min CE-Marked IgM/IgG Antibody COVID-19 Test Kit

COVID19 Colloidal Gold IgMIgG antibody test
SARS-CoV-2
29 Jun 2020
WESAIL Biotech launches IgM/IgG Antibody COVID-19 Test Kit with 99% specificity and ≥90% sensitivity. It is used for the qualitative detection of IgM/IgG antibody in human whole blood/serum/plasma samples and indicates recent and previous infections in one single test.

Warning Letters Sent to Risky COVID-19 Antibody Test Kit Suppliers

US FDA COVID 19 Antibody Test
SARS-CoV-2
26 Jun 2020
The US FDA has sent out warning letters to several companies who are illegally marketing COVID-19 serology kits as FDA approved and for also using the FDA logo on kits. FDA are encouraging health care professionals and consumers to report any concerns on quality to the FDA's MedWatch.

To Ask The Correct Question Choose The Correct Swab – Choose MWE!

Swabs for Diagnostics
SwabsSwabs Environmental MonitoringSwabs Virology
25 Jun 2020
Sigma Transwab® & Transwab® - best for bacteriology, Transwab® - the best gel swab, Sigma Transwab® - best for automated platforms, Fecal Transwab® - best for enterics, Sigma Virocult® - best for viruses, Sigma VCM™ - best universal /multi-purpose.

High Quality Swabs for Collection and Transportation of Samples

Swabs for sample collection and transportation
CE-IVDSpecimen TransportSwabs
23 Jun 2020
Alpha Laboratories has the expertise to respond to unique requirements and can help you choose the right swab to preserve your sample and protect your staff. 

Chinese 'Allowed List' of NMPA Approved CE-IVD & US FDA EUA COVID-19 Test Kit Suppliers

Image not available
Lateral Flow AssaysSARS-CoV-2
23 Jun 2020
The China National Medical Products Administration (NMPA) are constantly updating their 'allowed' of COVID-19 test kit vendors who they have given approval for export. You can download the most recent list here. 

Chembio Loses FDA EUA for Antibody Test Due to Higher Than Expected False Results

Image not available
SARS-CoV-2
23 Jun 2020
The US FDA have revoked an EUA given to Chembio for its COVID-19 serology test. Data submitted by Chembio and an independent study found the DPP COVID-19 IgM/IgG System showed a higher rate of false results that outweighed it's benefit to COVID-19 testing regimes. 

LGC SeraCare Expands SARS-CoV-2 Serology Offering with 11-Member, Positive-Patient Performance Panel

AccuSet SARS CoV 2 Performance Panel
SARS-CoV-2Assay Validation
23 Jun 2020
LGC SeraCare has launched AccuSet™ SARS-CoV-2 Performance Panel; an out-of-the-box solution to provide confidence, mitigate sourcing challenges and accelerate antibody assay development, validation, verification and onboarding. 

ChromaCode's High-definition COVID-19 qPCR test is now FDA-EUA

ChromaCode HDPCR COVID 19
Reverse Transcription PCR (RT-PCR)SARS-CoV-2
22 Jun 2020
Chromacode's high-definition multiplex technology is now used to detect SARS-CoV-2. The HDPCR™ SARS-CoV-2 Real-Time PCR Assay is now FDA-EUA, allows high-throughput testing and runs on standard qPCR instruments with no on-site training required. 

AMSBIO Launch Better Specific-Antibody Binding COVID-19 Products

AMSBio SARS CoV 2 Spike Protein Research
Assay DevelopmentSARS-CoV-2
22 Jun 2020
Adding to its ever-expanding COVID-19 portfolio which includes recombinant proteins, antibodies, inhibitor screening kits, ​AMSBIO has launched a new range of SARS-CoV-2 Spike Protein Products to be used in immunocapture, cell-stimulating, flow cytometry applications, ELISA assays and biopanning.

Quidel Receives Amended FDA-EUA for Rapid Antigen COVID-19 Diagnostic Assay 

Quidel SOFIA COVID FDA EUA Antigen
Lateral Flow AssaysSARS-CoV-2
18 Jun 2020
Quidel's Sofia® SARS Antigen FIA, the first FDA-Emergency Use Authorized COVID-19 Antigen test, is now allowed to run on both of Quidel's Point-of-Care instruments; the Sofia 1 & 2. The instruments provide a result within 15 minutes. 

New Leap Forward for SARS-CoV-2 Detection - Designed for Ultra Sensitive, High Throughout Testing

High Sensitivity qPCR 1Step COVID-19
Reverse Transcription PCR (RT-PCR)SARS-CoV-2
16 Jun 2020
PCR Biosystems' 4x RT-qPCR kit enables ultra-sensitive, high-throughput detection of viral RNA sequences, the new kit allows users to add more sample to their reactions to boost analytical sensitivity, even when working with small volume reactions.

Beckman Coulter Ramps Up Capacity for CE-IVD COVID-19 Antibody Test

Access IgG COVID 19 CE mark Beckman Coulter
SARS-CoV-2
15 Jun 2020
Beckman Coulter has received CE-marking for its Access SARS-CoV-2 IgG assay. The serology test detects IgG antibodies targeting the receptor-binding domain of the spike protein and has confirmed 100% sensitivity and 99.8% specificity. Beckman Coulter can now manufacture 30 million tests per month. 

ALS Expands A2LA Scope to Cover COVID-19 Surface Testing

ALS A2LA COVID 19 Surface testing
Environmental Monitoring
15 Jun 2020
ALS, the international provider of lab services, has added surface testing for SARS-COV-2 to its US labs. ALS is one of the first to be accredited for this type of test by A2LA. The customer swabs their surfaces and sends this on to A2LA for testing. 

IDEXX's Medical Diagnostics Company Receives EU and US Authorization for SARS-CoV-2 Test 

OPTI IDEXX COVID 19 RT PCR CE EUA
SARS-CoV-2
12 Jun 2020
OPTI Medical Systems (IDEXX Laboratories) has received CE-marking for its FDA-EUA OPTI® SARS-CoV-2 RT-PCR test kit. OPTI Medical was also awarded FDA-EUA for OPTI DNA/RNA Magnetic Bead Kit for nucleic acid extraction: Allowing OPTI to provide labs with a complete COVID-19 testing solution. 

Illumina Receives First FDA-EUA for a Seq-Based COVID-19 Diagnostic Test

Illumina COVIDSeq FDA EUA
Next Generation Sequencing (NGS)SARS-CoV-2
12 Jun 2020
The Illumina COVIDSeq™ Test is the first sequencing-based method to detect SARS-CoV-2 awarded EUA from the US FDA. It allows high-throughput testing, accommodating up to 3,072 samples per run on the NovaSeq™ 6000 Sequencing System & returns results in 24 hours. 

TBG's COVID-19 Test Portfolio Now Includes Rapid Antibody & FDA-EUA qPCR Kits

ExProbe SARS-CoV-2 TBG FDA EUA
SARS-CoV-2
12 Jun 2020
TBG Diagnostics Ltd (TDL), a global molecular diagnostics company with its manufacturing hub based in Taiwan, has been awarded US FDA-EUA for its CE-marked ExProbe™ SARS-CoV-2 Test Kit. TDL also has a CE-marked SARS-CoV-2 IgG/IgM Rapid Test Kit with a result turnaround of 15 minutes.

Video Introduces Don Whitley Scientific’s Contract Microbiology Labs

Don Whitley Contract Lab
Antimicrobial Resistance (AMR)GLPMIC (Minimum Inhibitory Concentration
11 Jun 2020
This new DWS video presents an introduction to their GLP compliant contract microbiology research laboratories, providing services from routine analysis/quality control to substantial research and development programmes.

Roche's FDA-EUA COVID-19 Test Predicts a 'Cytokine Storm' 

Roche Elecsys IL-6 test FDA EUA
Biological Indicators
10 Jun 2020
Roche has received FDA-EUA for its Elecsys IL-6 test that warns clinicians their patients are at risk of severe inflammatory response due to COVID-19. The test measures levels of biomarker interleukin 6 (IL-6), which at high levels is known as a 'Cytokine Storm', that can be fatal.

Is it Clean? Be Sure. ATP Testing & Sanitation

Clinical Setting
ATP TestingDisinfectant TestingSARS-CoV-2
09 Jun 2020
Fast and easy way to monitor the success of cleaning and disinfection procedures with MVP ICON® system.

FDA Publish Performance Evaluation of EUA COVID-19 Antibody Tests

FDA EUA COVID Antibody CDC Perfomance
SARS-CoV-2
09 Jun 2020
The US CDC, in collaboration with NIH, BARDA, FDA & DoD has performed evaluation studies on FDA- EUA COVID-19 Antibody test kits. Links to supplier pages with contact info, news articles and instruction booklets are provided on this page. 

Eurofins Technologies Launch COVID-19 Total Antibody ELISA Assay 

Image not available
ELISASARS-CoV-2
09 Jun 2020
Eurofins Technologies announces the launch of INgezim COVID 19 DR kits, a serology-based total antibody (IgG, IgA and IgM) detection ELISA assay (open platform) for indirect diagnostic of past exposure to COVID-19.With an incubation time of 75 minutes and no requirement for sample pre-dilution.

Omega Bio-tek’s New Viral RNA Extraction Kit for COVID-19

OMEGA COVID 19 Mag Bind
Assay DevelopmentSARS-CoV-2
09 Jun 2020
Omega Bio-tek Launches a New Viral RNA Extraction Kit for COVID-19 Testing with Production Capacity for 6 Million Tests A Month. The new magnetic bead-based extraction kit is adaptable to most liquid handling platforms for scalable, high-throughput purification.

How to Detect SARS-CoV-2 Aerosols Using Environmental Air Sampler

CORIOLIS SARS CoV 2 Air Sampler
Air SamplingSARS-CoV-2
08 Jun 2020
As the world moves into the next phase of COVID-19 pandemic control the challenging task of re-opening public spaces without compromising public safety requires science-based surety. Bertin Technologies can help with the Coriolis Air Sampler + RT-PCR platform that collects and detects SARS-CoV-2.

Alpha Labs' COVID-19 Swabs Can Be Used with Alternative VTM

Alpha Swabs COVID19
Specimen TransportSwabs
05 Jun 2020
Alpha lab's swabs meet UK Government guidelines for COVID-19 sampling. They are manufactured in ISO class 8 or higher cleanroom conditions, under an ISO:13485 accredited quality system, certified free of PCR inhibitors, human DNA, RNase, DNase and pyrogens and sterilized by irradiation or EtO. 

COVID-19: Sigma Virocult®- the VTM You Can Trust

MWE COVID19 Sigma Virocult VTM
SwabsSwabs with Transport Medium
05 Jun 2020
MWE's Virocult® medium has shown to be completely reliable on molecular platforms, whether PCR or antigen, as well as the gold standard cell culture methods. A recent study shows it's possible to test directly from Sigma Virocult® medium using RT-qPCR without extraction.

Making COVID-19 ELISA Testing Safer and Easier with Convenient Buffer Removal

COVID-19 ELISA
ELISASARS-CoV-2
05 Jun 2020
As the SARS-CoV-2 virus matures within the community, serology testing has ramped up. ELISA kits are a mainstay in clinical laboratory and this aspiration system can avoid unneccesary mistakes and is simple and ready-to-use. 

FDA EUA for 3DMed Automated Nucleic Acid Extraction System and Associated Kits

ANDiS350 Nucleic Acid Extraction System
Quantitative PCR (qPCR)SARS-CoV-2
05 Jun 2020
When the ANDiS®350 Nucleic Acid Extraction System is used with 3DMed's 2019-nCov nucleic acid detection kits (ANDiS SARS-CoV-2 and Influenza A&B RT-qPCR Detection Kit and ANDiS SARS-CoV-2 RT-qPCR Detection Kit), the detection sensitivity will be higher and the results more accurate.

Reliable Tracking for Large-Scale COVID-19 Testing Labs

Ziath COVID 19 test trace isolate
SARS-CoV-2
02 Jun 2020
To assist labs involved with the essential RT-PCR assay part of the “test, trace and isolate” strategy for dealing with the SARS-CoV-2 virus pandemic – Ziath has introduced two optimized packages for reliable tracking of patient samples submitted for Coronavirus (COVID-19) testing.

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