Reverse transcription polymerase chain reaction

Therma Bright Awaits FDA-EUA Approval From Over 260 AcuVid(TM) Clinical Study Test Results

Thursday, July 22, 2021 - 2:24pm

Negative percent agreement (NPA) is the proportion of comparative/reference method negative results in which the test method result is negative.

Key Points: 
  • Negative percent agreement (NPA) is the proportion of comparative/reference method negative results in which the test method result is negative.
  • "We're excited to share our overall 264 test results from our Brazilian AcuVid Saliva / RT-PCR Test Clinical Study.
  • The additional 201 test results, on top of the initial 63, not only exceed FDA-EUA minimum requirements, but confirms the performance quality and ease-of-use of our AcuVid saliva test.
  • In fact, our complete AcuVid study achieved comparable, and in some cases, better performance results than other leading COVID-19 rapid antigen tests available on today's market," expressed Rob Fia, CEO of Therma Bright.

Twist Bioscience Now Shipping Synthetic RNA Positive Controls for Delta (B.1.617.2) SARS-CoV-2 Variant for Development of Accurate Diagnostic Tests

Thursday, July 22, 2021 - 1:00pm

Rates of vaccinations in many countries have slowed, with COVID cases specific to the Delta variant spiking.

Key Points: 
  • Rates of vaccinations in many countries have slowed, with COVID cases specific to the Delta variant spiking.
  • In March 2020, Twist launched its first 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.
  • For customers interested in alternative variants of SARS-CoV-2, or synthetic RNA or DNA controls for other sequences, Twist can provide custom controls in multiple formats.

Biocept to Participate in Two July Investment Conferences

Monday, July 19, 2021 - 1:00pm

The conference is being held in Newport, R.I. on July 26.

Key Points: 
  • The conference is being held in Newport, R.I. on July 26.
  • Biocept, Inc. develops and commercializes molecular diagnostic assays that provide physicians with clinically actionable information for treating and monitoring patients diagnosed with a variety of cancers.
  • In addition to its broad portfolio of blood-based liquid biopsy assays, Biocept has developed the CNSide cerebrospinal fluid (CSF) assay that detects cancer that has metastasized to the central nervous system.
  • Biocept also is leveraging its molecular diagnostic capabilities to offer nationwide COVID-19 RT-PCR testing to support public health efforts during this unprecedented pandemic.

Quantabio’s UltraPlex 1-Step ToughMix Added to SalivaDirect Emergency Use Authorization Protocol

Monday, July 12, 2021 - 1:03pm

Authorized CLIA-certified laboratories running the SalivaDirect protocol can now use the UltraPlex 1-Step ToughMix, which was designed to increase sensitivity and improve assay performance, especially when dealing with saliva samples that may contain a low copy number of RNA virus.

Key Points: 
  • Authorized CLIA-certified laboratories running the SalivaDirect protocol can now use the UltraPlex 1-Step ToughMix, which was designed to increase sensitivity and improve assay performance, especially when dealing with saliva samples that may contain a low copy number of RNA virus.
  • The addition of the Quantabio UltraPlex 1-Step ToughMix enhances the protocol by enabling scientists to overcome common PCR inhibitors and quantify RNA viruses with high efficiency, sensitivity and specificity using as little as 1 pg of starting material.
  • Being added to the SalivaDirect EUA protocol is another strong validation of the versatility of our UltraPlex 1-Step ToughMix, said Heather Meehan, PhD, Vice President and Head of Quantabio.
  • UltraPlex 1-Step ToughMix is a ready-to-use, one-step, 4X concentrated RT-qPCR master mix that uses probe-based detection methods for real-time PCR.

Eurofins and Rite Aid Launch an Over-the-Counter, FDA-Authorised, at-Home COVID-19 PCR Test in all Rite Aid Locations in the U.S.

Friday, July 9, 2021 - 1:00pm

Eurofins (Paris:ERF), through its empowerDX subsidiary, and Rite Aid announce the launch of an over-the-counter, FDA-authorised[1], at-home COVID-19 PCR Test Kit.

Key Points: 
  • Eurofins (Paris:ERF), through its empowerDX subsidiary, and Rite Aid announce the launch of an over-the-counter, FDA-authorised[1], at-home COVID-19 PCR Test Kit.
  • The at-home COVID-19 nasal PCR kit is among the first over-the-counter at-home test kits for SARS-CoV-2 to receive US Food and Drug Administration Emergency Use Authorization (EUA).
  • The test was developed by Eurofins Viracor , a leading infectious disease testing laboratory, and is based on its FDA EUA authorised SARS-CoV-2 RT-PCR assay.
  • Eurofins CEO, Gilles Martin commented: "We are excited to partner with Rite Aid and launch this at-home COVID-19 testing kit, making access to test kits widely available to people across the U.S through Rite Aids national network.

BioGX Receives FDA EUA for a Novel, High-Throughput, Direct Sample RT-PCR Test for COVID-19

Friday, July 2, 2021 - 3:45pm

Xfree COVID-19 is acomplete test lyophilized in a single tube, for extraction-free, direct sample addition real-time RT-PCR testing.

Key Points: 
  • Xfree COVID-19 is acomplete test lyophilized in a single tube, for extraction-free, direct sample addition real-time RT-PCR testing.
  • Matthew Beckman, Ph.D., Director of Laboratory Services at GENETWORx said, "The staff at GENETWORx has been very pleased with the performance of the BioGX Xfree COVID-19 test.
  • BioGX test is very simple to use while providing increased quality assurance of well-by-well monitoring of the PCR reaction.
  • The test is already in use in several laboratories and costs $7-12 per sample depending on its use as direct sample addition or with extracted sample.

“Replace bogus PCR tests to avoid unnecessary Coronavirus lockdowns,” Urges Milford Molecular Diagnostics Director Dr. Sin Hang Lee

Monday, June 21, 2021 - 3:00pm

The current Coronavirus chaos is largely caused by phony PCR tests marketed as RT-qPCR assays, explained Dr.

Key Points: 
  • The current Coronavirus chaos is largely caused by phony PCR tests marketed as RT-qPCR assays, explained Dr.
  • Sin Hang Lee, director of Milford, Connecticut-based Milford Molecular Diagnostics ( www.dnalymetest.com ), in an article titled qPCR is not PCR, Just as a Straightjacket is not a Jacket - The Truth Revealed by SARS-CoV-2 False-Positive Test Results.
  • Now, even the general public is aware that RT-qPCR assays are generating numerable false-positive and false-negative test results, he said.
  • Both false-positive and false-negative RT-qPCR test results contributed to the current Coronavirus pandemic, said Dr. Lee.

Roche SARS-CoV-2 molecular test granted first FDA Emergency Use Authorization for PCR testing of both symptomatic and asymptomatic individuals at the point of care

Friday, June 18, 2021 - 4:30pm

This singleplex test is the first real-time reverse transcriptase polymerase chain reaction (RT-PCR) test that can identify SARS-CoV-2 infection within 20 minutes.

Key Points: 
  • This singleplex test is the first real-time reverse transcriptase polymerase chain reaction (RT-PCR) test that can identify SARS-CoV-2 infection within 20 minutes.
  • The cobas SARS-CoV-2 test is the first RT-PCR test that screens within 20 minutes both asymptomatic and symptomatic persons, enabling quick, informed decisions at the point of care.
  • We are pleased that we can now provide a test to enable healthcare professionals to identify both asymptomatic and symptomatic infected individuals at the point of care," said Ian Parfrement, Head of Point of Care for Roche Diagnostics Solutions.
  • "Preventing further spread of the virus is crucial for public health and the continued safe reopening of our communities worldwide."

Roche SARS-CoV-2 molecular test granted first FDA Emergency Use Authorization for PCR testing of both symptomatic and asymptomatic individuals at the point of care

Friday, June 18, 2021 - 4:30pm

This singleplex test is the first real-time reverse transcriptase polymerase chain reaction (RT-PCR) test that can identify SARS-CoV-2 infection within 20 minutes.

Key Points: 
  • This singleplex test is the first real-time reverse transcriptase polymerase chain reaction (RT-PCR) test that can identify SARS-CoV-2 infection within 20 minutes.
  • The cobas SARS-CoV-2 test is the first RT-PCR test that screens within 20 minutes both asymptomatic and symptomatic persons, enabling quick, informed decisions at the point of care.
  • We are pleased that we can now provide a test to enable healthcare professionals to identify both asymptomatic and symptomatic infected individuals at the point of care," said Ian Parfrement, Head of Point of Care for Roche Diagnostics Solutions.
  • "Preventing further spread of the virus is crucial for public health and the continued safe reopening of our communities worldwide."

ECDC supports EU/EEA Member States in rapid detection of SARS-CoV-2 variants

Thursday, June 17, 2021 - 4:03pm

It is the key to identifying variants, as well as monitoring their spread in communities and populations.

Key Points: 
  • It is the key to identifying variants, as well as monitoring their spread in communities and populations.
  • The WGS services under the HERA Incubator include shipping of samples, laboratory sample preparation, sequencing and basic sequence analysis support.
  • In 2021, ECDC and the European Commission have made available EUR27000000 for outsourced WGS services.
  • National WGS and/or RT-PCR infrastructure support programme for EU/EEA public health authorities

    A sizeable and coordinated infrastructure investment in public health laboratories will allow Member States to develop a significant and cost-effective SARS-CoV-2 variant screening system.