Reverse transcription polymerase chain reaction

Novel SARS CoV-2 Saliva Collection Devices Address COVID-19 Testing Challenges, Improving Lab Efficiency and PCR Test Performance

Retrieved on: 
Tuesday, January 26, 2021

GenTegra, LLC, a Pleasanton, California-based company , announced today a study on the development and characterization of two novel COVID-19 saliva sample collection tube devices.

Key Points: 
  • GenTegra, LLC, a Pleasanton, California-based company , announced today a study on the development and characterization of two novel COVID-19 saliva sample collection tube devices.
  • https://www.medrxiv.org/content/10.1101/2021.01.20.20243782v1
    The GenTegra GTR-STM and direct-into-PCR GenTegra GTR-STMdk saliva sample collection tubes are the only devices that eliminate dilution of virus levels in saliva samples, while providing a safe and convenient means to transport saliva samples at ambient conditions.
  • The dried transport media formulation in both of these devices incorporates the companys Active Chemical Protection (ACP) technology to provide substantial improvements in SARS-CoV-2 viral RNA stability, and RT-PCR process efficiency for COVID-19 saliva testing.
  • Direct-into-PCR, GTR-STMdk eliminates the need for expensive and time consuming RNA extraction, improving the turnaround time for reporting test results.

Dante Labs £30M investment in Cambridge will support global COVID-19 sequencing surveillance program

Retrieved on: 
Tuesday, January 26, 2021

CAMBRIDGE, United Kingdom, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Dante Labs announced today a 30M investment in the United Kingdom to run a global surveillance programme of the new variants of the SARS-CoV-2 virus, starting with a hardware and analytical capacity of 50,000 RNA samples per week.

Key Points: 
  • CAMBRIDGE, United Kingdom, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Dante Labs announced today a 30M investment in the United Kingdom to run a global surveillance programme of the new variants of the SARS-CoV-2 virus, starting with a hardware and analytical capacity of 50,000 RNA samples per week.
  • As the SARS-CoV-2 virus mutates, few companies have the skills and expertise to offer both RT-PCR molecular diagnostics and full RNA sequencing.
  • In 2020, Dante Labs successfully leveraged its ImmensaGenome Platform to support COVID-19 testing at scale, with immediate results.
  • Dante Labs built Immensaas a smart software platform that uses machine learning to advance the interpretation of the human genome with every analysis.

Fluidigm Receives CE-IVD Mark for Its Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay for COVID-19

Retrieved on: 
Thursday, January 21, 2021

The Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab, and the companys clinical studies for submission demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.

Key Points: 
  • The Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab, and the companys clinical studies for submission demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.
  • In the first phase of the pandemic, we served the European market via home-brew laboratory COVID-19 tests.
  • We anticipate offering the Advanta Dx SARS-CoV-2 RT-PCR Assay for as little as 5 euros per test, based on volume and other factors.
  • Fluidigm continually conducts in silico analyses to determine the effectiveness of the Advanta Dx Assay design to detect SARS-CoV-2.

ERBA Mannheim Launches 2nd Generation SARS-CoV-2 RT-PCR Assay with room temperature storage

Retrieved on: 
Thursday, January 21, 2021

LONDON, Jan. 21, 2021 /PRNewswire/ -- In response to the ongoing COVID-19 pandemic, Erba today launched the ErbaMDx SARS-CoV-2 RT-PCR Kit for detection of SARS-CoV-2.

Key Points: 
  • LONDON, Jan. 21, 2021 /PRNewswire/ -- In response to the ongoing COVID-19 pandemic, Erba today launched the ErbaMDx SARS-CoV-2 RT-PCR Kit for detection of SARS-CoV-2.
  • To overcome challenges in older COVID-19 molecular tests, Erba's Cambridge(UK)-based development team has carefully engineered a new assay to improve detection and ease of use with a single tube multiplex mastermix, compatible with room-temperature storage and transportation.
  • The new assay offers 200 copies/ml LoD, using universally trusted gene targets highly specific for SARS-CoV-2 and updated primer sequencesto maximise long term performance.
  • Erba Mannheim is a global company focused on delivering innovative, affordable and sustainable diagnostic solutions to labs everywhere.

ERBA Mannheim Launches 2nd Generation SARS-CoV-2 RT-PCR Assay with room temperature storage

Retrieved on: 
Thursday, January 21, 2021

LONDON, Jan. 21, 2021 /PRNewswire/ -- In response to the ongoing COVID-19 pandemic, Erba today launched the ErbaMDx SARS-CoV-2 RT-PCR Kit for detection of SARS-CoV-2.

Key Points: 
  • LONDON, Jan. 21, 2021 /PRNewswire/ -- In response to the ongoing COVID-19 pandemic, Erba today launched the ErbaMDx SARS-CoV-2 RT-PCR Kit for detection of SARS-CoV-2.
  • To overcome challenges in older COVID-19 molecular tests, Erba's Cambridge(UK)-based development team has carefully engineered a new assay to improve detection and ease of use with a single tube multiplex mastermix, compatible with room-temperature storage and transportation.
  • The new assay offers 200 copies/ml LoD, using universally trusted gene targets highly specific for SARS-CoV-2 and updated primer sequencesto maximise long term performance.
  • Erba Mannheim is a global company focused on delivering innovative, affordable and sustainable diagnostic solutions to labs everywhere.

Eurofins launches new tests and massive capacity for detecting and monitoring new variants of SARS-CoV-2

Retrieved on: 
Friday, January 15, 2021

Currently, strains of concern include the B.1.1.7 variant, first identified in the United Kingdom, and the B.1.351 variant, first identified in South Africa.

Key Points: 
  • Currently, strains of concern include the B.1.1.7 variant, first identified in the United Kingdom, and the B.1.351 variant, first identified in South Africa.
  • Furthermore, this RT-PCR test maintains very high sensitivity in the detection of variants such as B.1.1.7 and B.1.351.
  • Eurofins ability to produce and distribute primers and probes, and commercial PCR kits, additionally benefits the speed of development of new assays.
  • With over 50,000 staff across a network of more than 800 laboratories in over 50 countries, Eurofins companies offer a portfolio of over 200,000 analytical methods.

Twist Bioscience Begins Shipping of Synthetic RNA Controls for UK Variant Strain of SARS-CoV-2

Retrieved on: 
Thursday, January 14, 2021

Twist Bioscience Corporation (Nasdaq: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced that it has started shipping its new synthetic RNA reference controls, which includes the new variant strain of SARS-CoV-2 identified in the United Kingdom.

Key Points: 
  • Twist Bioscience Corporation (Nasdaq: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced that it has started shipping its new synthetic RNA reference controls, which includes the new variant strain of SARS-CoV-2 identified in the United Kingdom.
  • In March, Twist launched synthetic SARS-CoV-2 RNA distinct reference sequences as positive controls for the development of both next-generation sequencing (NGS) and reverse transcription-polymerase chain reaction (RT-PCR) assays to test for SARS-CoV-2.
  • The Twist synthetic controls are designed based on specific SARS-CoV-2 variants, cover the full viral genome and are sequence-verified.
  • Customers purchasing synthetic controls are subject to Twists leading biosecurity screening protocols and applicable laws and regulations.

PerkinElmer SARS-CoV-2 RT-PCR Assay Receives FDA EUA for Asymptomatic Testing

Retrieved on: 
Thursday, January 14, 2021

For asymptomatic carriers, diagnostic testing is essential to identify infected individuals, and thereby provides a better chance of getting infectious individuals into isolation to avoid spreading the disease further.

Key Points: 
  • For asymptomatic carriers, diagnostic testing is essential to identify infected individuals, and thereby provides a better chance of getting infectious individuals into isolation to avoid spreading the disease further.
  • Moreover, based on comparative data released by the FDA , the PerkinElmer test kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay.
  • PerkinElmers RT-PCR assay originally obtained FDA EUA in the spring of 2020.
  • Previously, the FDA issued EUA to allow sample pooling with the PerkinElmer New Coronavirus Nucleic Acid Detection Kit to increase the number of individuals who can be tested without increasing resources.