Reverse transcription polymerase chain reaction

Combined CDC COVID-19/Influenza Test Amended to Include Promega Maxwell® RSC 48 and CSC 48 Instruments, Maxwell® RSC Viral Total Nucleic Acid Purification Kit

Retrieved on: 
Wednesday, January 13, 2021
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210113005075/en/
    The Promega Maxwell CSC 48 (pictured), Maxwell RSC 48 and Maxwell RSC Viral Total Nucleic Acid Purification Kit are now authorized options for labs running the US Centers for Disease Controls (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.
  • (Photo: Business Wire)
    The Promega Maxwell RSC 48 benchtop instrument is an automated nucleic acid purification platform that processes up to 48 samples simultaneously.
  • The Maxwell RSC Viral Total Nucleic Acid Purification Kit can be used with either instrument to purify viral RNA from SARS-CoV-2 test samples.
  • Maxwell RSC 48, Maxwell CSC 48, Maxwell RSC Viral Total Nucleic Acid Purification Kit and GoTaq Probe 1-Step RT-qPCR System are already included, for emergency use, in the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RTPCR Diagnostic Panel, which tests for COVID-19 only.

Eurofins GeneScan Technologies Announces AOAC PTM Accreditation for the VIRSeek SARS-CoV-2 Detection Workflow on Environmental Surfaces under the AOAC SARS-CoV-2 Emergency Response Validation Program

Retrieved on: 
Monday, January 11, 2021

Eurofins GeneScan Technologies (Paris:ERF) announces that the VIRSeek SARS-CoV-2 Solution has been evaluated and approved by the AOAC Performance Tested MethodsSM (PTM) Program on December 29, 2020 and awarded Emergency Response Validation PTM certification number 122006.

Key Points: 
  • Eurofins GeneScan Technologies (Paris:ERF) announces that the VIRSeek SARS-CoV-2 Solution has been evaluated and approved by the AOAC Performance Tested MethodsSM (PTM) Program on December 29, 2020 and awarded Emergency Response Validation PTM certification number 122006.
  • The VIRSeek SARS-CoV-2 Solution is a comprehensive workflow for the detection of SARS-CoV-2 on environmental surfaces that includes swabbing of environmental surfaces, RNA extraction, analysis by Reverse Transcription PCR (RT-PCR) and evaluation by an advanced algorithm.
  • Recent research has shown that virus contamination of environmental surfaces may lead to viral transfer and therefore an acceleration of outbreaks.
  • The VIRSeek SARS-CoV-2 Solution includes all required reagents for surface sampling and ensures the effective uptake of the virus from various surface types.

Twist Bioscience Supplies Centers for Disease Control and Prevention with Custom SARS-CoV-2 Synthetic RNA Controls

Retrieved on: 
Thursday, January 7, 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 it will supply the U.S. Centers for Disease Control and Prevention (CDC) with a customized version of Twist SARS-CoV-2 Synthetic RNA Controls for use in the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.

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 it will supply the U.S. Centers for Disease Control and Prevention (CDC) with a customized version of Twist SARS-CoV-2 Synthetic RNA Controls for use in the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.
  • Positive controls provide quality control measures for the development, verification, and ongoing validation of both next-generation sequencing (NGS) and reverse transcription-polymerase chain reaction (RT-PCR) assays.
  • In March 2020, 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.
  • Customers purchasing synthetic controls are subject to Twists leading biosecurity screening protocols and applicable laws and regulations.

ShopHQ Offers Exclusive FDA-Authorized, At-Home COVID-19 Tests

Retrieved on: 
Tuesday, January 5, 2021

Based on these characteristics, the Company believes it is strategically situated to capture a meaningful share of this growing marketplace.

Key Points: 
  • Based on these characteristics, the Company believes it is strategically situated to capture a meaningful share of this growing marketplace.
  • iMedias tests are saliva-based, rRT-PCR tests, which are the gold standard in molecular diagnostics and the most accurate type of test for COVID-19.
  • These statements may contain information about our prospects, including anticipated show, event, or product line launches, and involve risks and uncertainties.
  • We caution that actual results could differ materially from those that management expects, depending on the outcome of certain factors.

QuestCap Provides COVID-19 Testing Kits to Kinross Gold’s Russian Operations

Retrieved on: 
Tuesday, January 5, 2021

We look forward to extending this to other businesses that require our complete COVID-19 testing solution.

Key Points: 
  • We look forward to extending this to other businesses that require our complete COVID-19 testing solution.
  • Specifically, QuestCap supplied CMGC with 15 portable RT PCR analyzers, 57,000 RT-PCR tests, and 10,000 Novel Coronavirus (2019-nCoV) IgM/IgG Rapid Antibodytests.
  • Equipment training has been conducted with CMGC employees in Russia with the testing protocols now being implemented.
  • The safety of our workers is of paramount importance, says Claude Schimper, Senior Vice President of Operations, Russia for Kinross Gold.

OraSure’s OMNIgene®·ORAL Device Included in EUA Amendment Granted to 3B BlackBio Biotech India for SARS-CoV-2 Test

Retrieved on: 
Wednesday, December 23, 2020

The 3B BlackBio Biotech SARS-CoV-2 assay, combined with OMNIgeneORAL, facilitates the detection of nucleic acid from SARS-CoV-2 samples using highly sensitive quantitative PCR technology.

Key Points: 
  • The 3B BlackBio Biotech SARS-CoV-2 assay, combined with OMNIgeneORAL, facilitates the detection of nucleic acid from SARS-CoV-2 samples using highly sensitive quantitative PCR technology.
  • 3B BlackBio Biotech aims at fulfilling the current demand of higher testing and has stepped up its production capacity for RT-PCR kit for SARS-CoV-2 detection.
  • 3B BlackBio Biotech, a subsidiary of Kilpest India Limited (a publicly traded company), is a leading Indian manufacturer of molecular diagnostic kits.
  • 3B BlackBio Biotech has supplied over 5.5 million tests to over 400 satisfied customers all across India.

LumiraDx Receives Authorization by Switzerland´s Federal Office of Public Health Showing Excellent Positive Agreement of its Microfluidic Antigen Test with RT-PCR for Point of Care COVID-19 Testing

Retrieved on: 
Monday, December 21, 2020

The test achieved 98.4-100% positive agreement and 99% negative agreement compared to RT-PCR.

Key Points: 
  • The test achieved 98.4-100% positive agreement and 99% negative agreement compared to RT-PCR.
  • The LumiraDx SARS-CoV-2 Antigen Test is to be used with the LumiraDx Platform and detects antigen nucleocapsid protein from nasal or nasopharyngeal swabs with accurate qualitative results in 12 minutes.
  • "LumiraDx is pleased to achieve regulatory and reimbursement authorization in Switzerland," said LumiraDx Chief Commercial Officer David Walton.
  • High sensitivity antigen testing at the point of care enables fast and accurate identification of infectious patients."

EUROIMMUN Receives CE Mark for New PCR Test to Differentiate Between COVID-19 and Flu

Retrieved on: 
Monday, December 14, 2020

It expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu.

Key Points: 
  • It expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu.
  • Validation efforts revealed very high agreement of results obtained with the EURORealTime test and those obtained with reference PCR tests for SARS-CoV-2 and influenza A/B.
  • The assay is compatible with common real-time PCR thermal cyclers, while the EURORealTime Analysis Software allows for reliable and standardized evaluation of the test results.
  • The EURORealTime SARS-CoV-2/Influenza A/B assay complements PerkinElmers PKamp Respiratory SARS-CoV-2 RT-PCR Panel that previously received the CE mark.

RESOLUTE 2.0 COVID-19 TEST KIT FIRST TO RECEIVE SINGAPORE HEALTH SCIENCES AUTHORITY’S APPROVAL FOR DEEP THROAT SALIVA TESTING

Retrieved on: 
Thursday, December 10, 2020

Advanced MedTech Holdings (AMTH), a global medical technology leader headquartered in Singapore, announced today that the RESOLUTE 2.0 test kit has become the first RT-PCR COVID-19 test to be authorised by Singapores Health Sciences Authority (HSA) for deep-throat saliva (DTS) SARS-CoV-2 testing.

Key Points: 
  • Advanced MedTech Holdings (AMTH), a global medical technology leader headquartered in Singapore, announced today that the RESOLUTE 2.0 test kit has become the first RT-PCR COVID-19 test to be authorised by Singapores Health Sciences Authority (HSA) for deep-throat saliva (DTS) SARS-CoV-2 testing.
  • DTS collection only requires patients to draw out saliva from deep within their throat and spit into a specimen bottle.
  • It is an industry-first direct multiplex RT-PCR COVID-19 test kit co-developed by A*STAR and DSO National Laboratories, manufactured and distributed by AMTH.
  • The kit offers an additional option and flexibility for COVID-19 testing in the community to suit screening and diagnostic requirements.

Genotox Laboratories Announces MyTruthTest At Home Covid-19 Test Kits

Retrieved on: 
Thursday, December 3, 2020

AUSTIN, Texas, Dec. 3, 2020 /PRNewswire/ --Genotox Laboratories, an Austin, Texas based company, has announced the launch of MyTruthTest At Home COVID-19 Test Kits with 24-hour turnaround on RT-PCR test results, in most cases.

Key Points: 
  • AUSTIN, Texas, Dec. 3, 2020 /PRNewswire/ --Genotox Laboratories, an Austin, Texas based company, has announced the launch of MyTruthTest At Home COVID-19 Test Kits with 24-hour turnaround on RT-PCR test results, in most cases.
  • Genotox Laboratories is a world class CLIA-certified laboratory that has processed over one million clinical test results in its 8 years in business.
  • Genotox Laboratories was founded in 2012 by Matthew McCarty, MD, when he became aware of the growing need for enhanced medication monitoring and personalized medicine.
  • Genotox Laboratories is devoted to providing healthcare professionals and patients with accurate, dependable, and actionable clinical laboratory results.