Microbiology News : clinical, Sep 2020
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CCCosmetic/Personal Care
F&BFood & Beverage
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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. more...
Laboratories can achieve stringent biosafety level guidelines, for handling contaminated solutions, using INTEGRA’S VACUSAFE system. more...
COVID-19 or Flu? a rapidmicrobiology Special Focus
29 Sep 2020 | C
In this rapidmicrobiology special focus on testing for COVID-19 and flu, you will find suppliers of diagnostics for Flu and COVID-19, plus swabs and transport media, process controls and a 1-step qPCR kit for your high-throughput test. more...
C4Diagnostics, Bertin Technologies and Enalees have developed the BEC-SARS-CoV-2 test for humans with the Pasteur Institute. The kit is currently for RUO but is now on clinical trial at several sites and C4Diagnostics hope to have CE-IVD at the end of Sept. more...
Seasonal Flu and Coronavirus Identification
28 Sep 2020 | C
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. more...
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. more...
Influenza Virus Research Tools
28 Sep 2020 | C
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. more...
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. more...
Thaw Samples 60% Faster with SPL Guard Florida
25 Sep 2020 | F&BWCOPVCCM
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. more...
Flu Testing During COVID-19
25 Sep 2020 | C
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) more...
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. more...
FDA Clears Antimicrobial Susceptibility Test for P. aeruginosa
24 Sep 2020 | C
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. more...
Asymptomatic People Need to be Tested for COVID-19 says CDC
24 Sep 2020 | C
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. more...
Limit of Detection Data Released for FDA-EUA COVID-19 qPCR Kits
23 Sep 2020 | C
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. more...
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) more...
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. more...
GenMark Diagnostics' new respiratory virus panel, ePlex® RP2, is now CE-marked for the upcoming winter flu and virus season. The kit is designed for use with the ePlex systems and provides rapid results for infections with similar symptoms from a single syndromic assay. more...
Test wastewater for SARS-CoV-2 to establish COVID-19 prevalence in the community; simple test-card designed for on-the-spot testing; strong positives show up in 3 minutes with test set for airports and a quantitative test is CE-marked. more...
Next week's newsletter will highlight products to distinguish between Flu and COVID-19. Find out how you can include your product.. more...
Spanish Firm Announce Ready-to-Use Flu & COVID-19 qPCR Kits
22 Sep 2020 | C
Genetic PCR Solutions™ has developed a qPCR ready-to-use kit that can diagnose for Influenza A & B and can work in tandem with its SARS-CoV-2 test kit,. The kit is currently for research use only (RUO) and has been internally validated using full genomes of influenza. more...
Lepu Medical's simple rapid antigen test card for the detection of SARS-CoV-2 has received CE-marking. The test provides a result in 15 minutes, takes swab specimens from the nasopharynx and oropharyngeal, and darkens in colour with an increase in viral load. more...
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. more...
Rapid 3-Minute COVID-19 Antigen Test Planned for Airports
18 Sep 2020 | C
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. more...
The EURORealTime SARS-CoV-2 from EUROIMMUN provides highly specific detection of SARS-CoV-2 via PCR and can be evaluated fully automatically. The preceding RNA isolation step is automatable using instruments and kits from PerkinElmer. more...
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. more...
WHO Approves Dried Blood Spot Test For HIV-1
16 Sep 2020 | C
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. more...
96-Well Microtiter Plate Reading with BIOMIC V3
16 Sep 2020 | C
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. more...
SARS-CoV-2 IVD Inactivated Whole Virus & Full Process Controls
16 Sep 2020 | C
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. more...
FDA Clears New Influenza A/B & RSV Test
15 Sep 2020 | C
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. more...
UK Begin At-Home COVID-19 Antibody Testing Programme
15 Sep 2020 | C
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. more...
In this week's COVID-19 updates: Validate a COVID-19 molecular test with process and virus controls; UK's Rapid Test Consortium lateral-flow test kit; new FDA cleared Flu A/B and RSV test for work with SARS-CoV-2 test and qPCR tests judged by Limit of Detection (LoD). more...
FDA-EUA COVID-19 Sanger Method Avoids RNA Extraction
15 Sep 2020 | C
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. more...
Fujirebio has now three CE-marked kits for the detection of COVID-19. The most recent kits to obtain certification are the LUMIPULSE fully automated antigen test and the ESPLINE simple cassette test which provides results in 30 minutes. more...
COVID-19 qPCR Kits Ranked by Low Limit of Detection
14 Sep 2020 | C
An article published in Nature Biotechnology has ranked FDA-EUA COVID-19 kits based on their limit of detection (LoD). DiaCarta's QuantiVirus™ SARS-CoV-2 Multiplex has perfomed well in the evaluation alongside Perkin Elmer, Roche and Quest Diagnostics. more...
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. more...
The Eppendorf Move It® is an adjustable space pipette making liquid transfers between tubes to 96 or 386 well plates, easier and safer. more...
This week: Clinical studies show CRISPR test as accurate as qPCR; VTM manufacturer scales-up to meet demand; enormous amount of new CE-IVD rapid antigen test produced; High-affinity neutralizing antibodies available for research & diagnostics and FDA grant EUA for flu & SARS-CoV-2 assay. more...
FDA Authorizes Flu & SARS-CoV-2 Multiplex Assay
07 Sep 2020 | C
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. more...
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. more...
CRISPR COVID-19 Test - Accurate as Gold-Standard PCR Says Study
03 Sep 2020 | C
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. more...
COVID-19 Patient-Derived Neutralizing Antibodies Available
03 Sep 2020 | C
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. more...
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. more...
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 more...
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. more...
Universal Lysis Buffer Included in CE-IVD SARS-CoV-2 Kit
01 Sep 2020 | C
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. more...
PCR Test for HIV-1 & 2 Diagnosis Receives FDA Approval
01 Sep 2020 | C
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. more...
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