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News : clinical, Sep 2020

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Now, You Can Put a Price on (Biological) Safety with Baker's New Cost of Ownership Calculator

the cost of ownership calculator allows you to compare your existing BSC with Bakers new SterilGARD
Biological Safety Cabinets
30 Sep 2020
Baker's new cost of ownership calculator allows you to compare the running costs of your existing biological safety cabinet with those of the SterilGARD® e3 and thus prepare a persuasive argument for your planned investment.

Safe And Efficient Collection And Containment Of Biological Liquid Waste

Vacusafe Aspiration System
Waste Disposal
30 Sep 2020
Laboratories can achieve stringent biosafety level guidelines, for handling contaminated solutions, using INTEGRA’S VACUSAFE system.

Seasonal Flu and Coronavirus Identification

influenza flu a b lateral flow test rapid thermo fisher xpect
InfluenzaLateral Flow AssaysSARS-CoV-2
28 Sep 2020
Influenza and coronavirus are contagious respiratory illnesses. It may be difficult to tell the difference between them because some symptoms are similar and testing may be needed to confirm a diagnosis. 

Is it Flu or is it COVID-19? Test with a Puritan Swab!

Puritan COVID 19 and Inluenza flock swab foam spun polyester tip swab
InfluenzaSwabs
28 Sep 2020
When testing for COVID-19 or flu, whether with a flock, foam or spun polyester tip swab, Puritan delivers reliability. Today, tomorrow and beyond - Puritan produces fine quality specimen collection devices. US made and reliable.

Influenza Virus Research Tools

Sino Biological also offers customized antigen microarray services for influenza studies
Antigen SupplierInfluenzaInfluenza H1N1
28 Sep 2020
Sino Biological launched the world's largest recombinant viral antigen collection, ProVir™. It features 600+HA, NA, and ME antigens from over 300 strains of influenza viruses, including vaccine strains and the pandemic strains.

Novel Molecular Transport Media for Dual COVID-19 and Influenza Sampling

transport media for COVID19 and Flu
InfluenzaSARS-CoV-2Swabs
28 Sep 2020
PrimeStore® MTM (Molecular Transport Medium) is an FDA class 2 & CE-IVD marked sample collection and transportation device for COVID-19, flu A, flu B, HIV and TB which deactivates any viruses present, enabling safe sample handling and subsequent molecular testing. 

Thaw Samples 60% Faster with SPL Guard Florida

fast rack thawing as stand alone or for robotic liquid handler workstation
Liquid HandlingRack Thawing
25 Sep 2020
SPL Guard claims to have developed the "fastest rack thawing solution on the market". The SPL Guard Florida is said to be 60% faster than other instruments on the market and can thaw up to 10 racks in as little as 9 minutes with consistent rate and temperature guaranteeing sample integrity. 

Flu Testing During COVID-19

triage flu and covid
Influenza
25 Sep 2020
Triage influenza and COVID-19 fast with Thermo Scientific™ Xpect™ Flu A&B, a lateral flow assay delivering a clear, easy to read result in 15 minutes from human nasal wash, nasal swab and throat swab specimens. SPECIAL OFFER BUY 4 Kits GET ONE EXTRA! (for U.S. Customers only)

New Reader Quantifies the Level of Viral Load in COVID-19 Infected Patients

iPeak lateral flow reader gives quantitative and qualitative results and offers connectivity
Lateral Flow AssaysLateral Flow ReaderSARS-CoV-2
24 Sep 2020
A breakthrough in lateral flow readers, iPeak® delivers quantitative and qualitative results, interprets IgG, IgM, and Ag tests, is highly sensitive, and offers cyber-secure connectivity, ensuring patient confidentiality.

FDA Clears Antimicrobial Susceptibility Test for P. aeruginosa

Pheno AST for pseudomonas aeruginosa and gram negative bacteremia
Antibiotic SensitivityGram-negative bacteremiaPseudomonas aeruginosa
24 Sep 2020
Accelerate Diagnostics have received clearance from the US FDA for improvements made to its Pheno® antimicrobial susceptibility testing system. These include improvements made for four antibiotics used to treat P. aeruginosa. 

Asymptomatic People Need to be Tested for COVID-19 says CDC

CDC Update on COVID testing
SARS-CoV-2
24 Sep 2020
CDC are now advising asymptomatic people to be tested for COVID-19 after several studies showed asymptomatic people to be positive for COVID-19 and a high incidence of COVID-19 in a 20-29 age group. 

Limit of Detection Data Released for FDA-EUA COVID-19 qPCR Kits

data on limit of detection of covid 19 qpcr rt pcr kits
SARS-CoV-2
23 Sep 2020
The US FDA has released comparative data on 55 molecular COVID-19 tests that are authorized under emergency use legislation. The information supplied are limit of detection (LoD) values and are compared against an FDA standardized sample panel. 

Is It Bacterial or Viral? - Triage Assay Tested on COVID-19 Symptomatic Patients

Biomarker test for viral and bacterial infections using MxA and CRP
Bacterial & Viral infection BiomarkersInfluenzaSARS-CoV-2
23 Sep 2020
Study results have been released on Lumos Diagnostics' viral and bacterial infection biomarker assay, FebriDx® to assess its potential to rapidly triage patients with symptomatic respiratory infections during the COVID-19 pandemic. (Not available in US)

Quantitative Test Measures Antibodies for SARS-CoV-2 Spike Protein

quantitative antibody test for spike protein of sars cov 2 vaccine evaluation
SARS-CoV-2
22 Sep 2020
Roche has achieved CE-marking for its Anti-SARS-CoV-2 S antibody test that delivers a quantitative measurement of antibodies produced for the spike protein of the virus. The test can be used to evaluate the efficacy of vaccines and plasma donations. 

Get your Product Update in our Special Focus: Is it Flu or COVID-19?

Image not available
InfluenzaSARS-CoV-2
22 Sep 2020
Next week's newsletter will highlight products to distinguish between Flu and COVID-19.  Find out how you can include your product..

First SARS-CoV-2 Neutralizing Antibody Testing Lab For Public Opens in Europe

Neutralizing antibodies testing service
SARS-CoV-2
21 Sep 2020
Innatoss Laboratories have begun testing the general public for SARS-CoV-2 neutralizing antibodies using the GenScript cPass™ test. The test is in 96-well ELISA format and uses the virus's receptor-binding domain is used for detection. 

Rapid 3-Minute COVID-19 Antigen Test Planned for Airports

QIAGen ELLUME rapid antigen test for airports
SARS-CoV-2
18 Sep 2020
QIAGEN has announced it will have its Access Anti-SARS-CoV-2 test available in US and EU markets once authorization is obtained. The test detects the nucleocapsid protein of the virus and can give result of a strong positive in 3 minutes. 

PCR Biosystems Aids Winter Virus Test Development With New Products

one step SARS CoV 2 influenza RSV and winter RNA virus detect plus inhibitor
Assay DevelopmentInfluenzaRespiratory Panel
17 Sep 2020
For those developing diagnostic kits for viruses such as SARS-CoV-2, RSV or influenza, PCR Biosystems has launched RiboShield RNase Inhibitor and qPCRBIO Probe 1-Step Virus Detect – a 4x RT-qPCR kit for highly multiplexed RNA detection assays.

WHO Approves Dried Blood Spot Test For HIV-1

Hologic Aptima Quant Dried Blood Test for HIV 1 With Global Access Initiative
HIV
16 Sep 2020
The World Health Organization has approved Hologic's Aptima® HIV-1 Quant Dx Assay, a dried blood spot test, taken by either finger or heel prick and can be used to monitor viral load, disease progression and to aid in diagnosis of infected infants under 18 months. 

96-Well Microtiter Plate Reading with BIOMIC V3

BIOMIC V3 Automated reader of 96 well microtitre plates from Giles Scientific
LIMSMIC (Minimum Inhibitory ConcentrationSIR Results
16 Sep 2020
Receive MIC & SIR results automatically, instant plate reading for color and turbidity with high-res images and follow CLSI/EUCAST guidelines with the BIOMIC V3 Microbiology System from Giles Scientific. 

SARS-CoV-2 IVD Inactivated Whole Virus & Full Process Controls

SARS CoV 2 COVID Process controls from microbiologics
SARS-CoV-2Assay Validation
16 Sep 2020
Microbiologics’ SARS-CoV-2 IVD Whole Virus and Full Process Controls validate every step of a molecular assay. Uniquely formatted to mimic patient samples in ready-to-use pellets or swabs, they join the broadest portfolio of SARS-CoV-2 and Influenza controls.  

FDA Clears New Influenza A/B & RSV Test

DiaSorin Simplexa RT PCR Test for Influenza RSV
InfluenzaInfluenza H1N1
15 Sep 2020
FDA has authorized the use of DiaSorin's Simplexa Flu A/B & RSV Direct Gen II assay for the upcoming flu season. The test has been validated with over 100 Flu A and Flu B strains, aswell as 2020/21 vaccine strains. It is designed to run on the LIAISON® MDX instrument. 

UK Begin At-Home COVID-19 Antibody Testing Programme

UK antibody home testing kit by rapid test consortium
Lateral Flow AssaysSARS-CoV-2
15 Sep 2020
UK Government has embarked on a national at-home antibody testing programme with an in-house rapid test consortium kit. The lateral-flow kit detects IgG antibodies in the patient's blood and provides a result in 20 minutes and is developed by Abingdon health, Omega, BBI and CIGA. 

FDA-EUA COVID-19 Sanger Method Avoids RNA Extraction

covid 19 sanger sequencing test is rna extraction free
Next Generation Sequencing (NGS)
15 Sep 2020
Laboratories with Sanger Sequencers can now test for COVID-19 using a newly FDA authorized test. The test is made by BillionToOne and avoids the use of reagents needed for RNA extraction that are prone to shortages. Sanger sequencers can process 4000 of these tests per day. 

SARS-CoV-2: Validate Every Step from Swab to PCR Signal Detection with Microbiologics' Controls

SARS-CoV-2 molecular QC standards
Diagnostic ManufacturingQC Molecular StandardsSARS-CoV-2
11 Sep 2020
Microbiologics' Process Controls and Inactivated Whole Virus controls are available in ready-to-use swab and pellet formats that mimic patient samples to challenge every step of molecular testing, including sample collection and handling.

FDA Authorizes Flu & SARS-CoV-2 Multiplex Assay 

cobas 6800 8800 PCR systems for sars and influenza tests
InfluenzaSARS-CoV-2
07 Sep 2020
Roche has been granted FDA-EUA for its cobas® SARS-CoV-2 & Influenza A/B Test. The  CE-marked test runs on the cobas 6800/8800 systems which provide up to 96 results in about 3 hours and takes nasal or nasopharyngeal swab samples. 

Brazil Approves Finnish SARS-CoV-2 Antibody and Antigen Test Kits 

ANVISA approved rapid antigen and antibody test kits for sars cov 2 from biohit healthcare
Lateral Flow AssaysSARS-CoV-2
04 Sep 2020
Biohit Healthcare's rapid SARS-CoV-2 antigen and antibody tests have been given ANVISA status by the Brazilian Government. The antibody kit is a lateral-flow test, which provides a result in 15 minutes and is already authorized by the US FDA.  

CRISPR COVID-19 Test - Accurate as Gold-Standard PCR Says Study 

Sherlock Bioscience CRISPR SARS-CoV-2 Kit
CRISPRSARS-CoV-2
03 Sep 2020
Sherlock Biosciences has released outstanding results from a pilot study on its  Sherlock™ CRISPR SARS-CoV-2 kit. The analysis was performed at the Dartmouth-Hitchcock Medical Centre and showed high sensitivity  & specificity across a range of viral loads.

COVID-19 Patient-Derived Neutralizing Antibodies Available 

high affinity Neutralizing antibodies for COVID 19 research and diagnostics
AntibodiesAssay DevelopmentSARS-CoV-2
03 Sep 2020
The Absolute Antibody catalog now includes neutralizing antibodies for COVID-19 research and diagnostics. The clones are derived from COVID-19 patients and said to bind to the receptor-binding domain and inhibit the virus from binding to ACE2. 

Clinical Diagnostics Firm Make 40 Million CE-Marked Rapid Antigen Tests Available Each Month

roche launch ce sars cov 2 antigen test for covid 19 diagnosis
SARS-CoV-2
02 Sep 2020
The SARS-CoV-2 Antigen Test from Roche will be officially launched in late September when they will have 40 million tests available per month, with that number to double by the end of the year. The test shows results in 15 minutes and is CE-marked. 

TRINITY V3 Antibiotic Potency Zone Reader for Cylinder-Plate Assays

Trinity V3 Digital Imaging Reader of Antibiotic Potency Zone
Antibiotic SensitivityColony CountersDigital Imaging
02 Sep 2020
TRINITY V3 Antibiotic Potency Zone Reader from Giles Scientific utilizes digital imaging to automate USP & EP cylinder-plate assays.  Complies with 21 CFR Part 11 electronic signature requirements.  An optional colony counting module is available

Viral Transport Medium Manufacturer Now Does Monthly Output Each Day

Teknova Viral Transport Medium for SARS Cov 2 COVID Transport
SARS-CoV-2Specimen Transport
02 Sep 2020
Teknova are now manufacturing 30,000 tubes of viral transport medium with the aid of its flexible automated systems. Teknova's VTM and saline is made and validated according to CDC procedures and under GMP conditions.

Universal Lysis Buffer Included in CE-IVD SARS-CoV-2 Kit 

OpGen sars cov 2 PCR kit with universal lysis buffer
SARS-CoV-2
01 Sep 2020
Curetis (OpGen) has received CE certification for its SARS-CoV-2 PCR assay. The kit includes a PCR-Compatible Universal Buffer (PULB), which they say can help laboratories avoid trying to source RNA extraction kits in short supply. 

PCR Test for HIV-1 & 2 Diagnosis Receives FDA Approval 

roche kit hiv 1 hiv 2 on the cobas 6800 8800 gets FDA approval
HIVQuantitative PCR (qPCR)
01 Sep 2020
The US FDA have approved the Roche cobas® HIV-1/HIV-2  qualitative test, a PCR test with high sensitivity that promises to pick up infections that serology tests would show negative due to lack of antibodies generated. 

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