Quantabio RT-qPCR Kit Given Expanded Role in CDC COVID-19 Testing Protocol
|
By LabMedica International staff writers Posted on 09 Jul 2020 |

Illustration
Quantabio’s (Beverly, MA, USA) UltraPlex 1-Step ToughMix has been recognized as part of the expanded emergency use authorization (EUA) for the Centers for Disease Control and Prevention (CDC) COVID-19 testing protocol.
Public health laboratories facing RNA extraction reagent supply shortages are now advised to use the amended protocol, which includes the one-step, reverse transcription and real-time quantitative PCR (RT-qPCR) kit that provides high assay efficiency, sensitivity and specificity in minimal reaction volumes and accelerated thermal cycling rates. The CDC first added Quantabio’s UltraPlex 1-Step ToughMix and qScript XLT 1-Step RT-qPCR ToughMix to its protocol for the 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel in April 2020. Due to the global shortage of nucleic acid extraction reagents, CDC recently amended the EUA protocol to include a heat treatment methodology, using UltraPlex 1-Step ToughMix, as a viable alternative to RNA extraction.
The UltraPlex 1-Step ToughMix is a ready-to-use, single-component, 4X concentrated master mix solution that delivers robust and reliable performance of highly multiplexed RNA detection assays with a wide range of inhibitory starting materials while maintaining very high sensitivity. The UltraPlex 1-Step ToughMix Kit contains all required components for RT-qPCR, except RNA template and, probe and is compatible with all dual-labeled probe chemistries. The simple workflow enables scientists to conduct first-strand cDNA synthesis and PCR amplification in the same, closed tube.
“Over the past seven years, Quantabio has actively supported development of testing protocols for influenza, polio and other infectious diseases,” said Heather Meehan, PhD, Vice President and Head of Quantabio. “Our expertise in enzyme development and large-scale production competencies have now been applied to COVID-19 testing solutions for commercial testing providers, state public health laboratories and molecular diagnostic tools companies in the US and around the world. The UltraPlex 1-Step ToughMix overcomes common PCR inhibitors, delivers superior performance and enables laboratories to continue testing for COVID-19 despite the global reagent supply issues.”
Related Links:
Quantabio
Public health laboratories facing RNA extraction reagent supply shortages are now advised to use the amended protocol, which includes the one-step, reverse transcription and real-time quantitative PCR (RT-qPCR) kit that provides high assay efficiency, sensitivity and specificity in minimal reaction volumes and accelerated thermal cycling rates. The CDC first added Quantabio’s UltraPlex 1-Step ToughMix and qScript XLT 1-Step RT-qPCR ToughMix to its protocol for the 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel in April 2020. Due to the global shortage of nucleic acid extraction reagents, CDC recently amended the EUA protocol to include a heat treatment methodology, using UltraPlex 1-Step ToughMix, as a viable alternative to RNA extraction.
The UltraPlex 1-Step ToughMix is a ready-to-use, single-component, 4X concentrated master mix solution that delivers robust and reliable performance of highly multiplexed RNA detection assays with a wide range of inhibitory starting materials while maintaining very high sensitivity. The UltraPlex 1-Step ToughMix Kit contains all required components for RT-qPCR, except RNA template and, probe and is compatible with all dual-labeled probe chemistries. The simple workflow enables scientists to conduct first-strand cDNA synthesis and PCR amplification in the same, closed tube.
“Over the past seven years, Quantabio has actively supported development of testing protocols for influenza, polio and other infectious diseases,” said Heather Meehan, PhD, Vice President and Head of Quantabio. “Our expertise in enzyme development and large-scale production competencies have now been applied to COVID-19 testing solutions for commercial testing providers, state public health laboratories and molecular diagnostic tools companies in the US and around the world. The UltraPlex 1-Step ToughMix overcomes common PCR inhibitors, delivers superior performance and enables laboratories to continue testing for COVID-19 despite the global reagent supply issues.”
Related Links:
Quantabio
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants
Channels
Clinical Chemistry
view channel
Blood Test Detects Testicular Cancer Missed by Standard Markers
Testicular cancer most often affects adolescents and young adults and is highly treatable when found early. Diagnosis can be difficult when tumors do not produce sufficient levels of standard blood-based... Read more
Routine Blood Tests Identify Biomarkers Linked to PTSD
Post-traumatic stress disorder (PTSD) is associated with a range of chronic physical health conditions and affects multiple organ systems. Clinical laboratories routinely measure blood analytes that reflect... Read moreMolecular Diagnostics
view channel
CRISPR-Based Test Identifies Multiple Respiratory Viruses Simultaneously
Respiratory virus co-circulation complicates differential diagnosis, as overlapping symptoms can obscure etiology. Multiplex testing typically depends on multiple enzymes or fluorophores and multistep... Read more
Multi-Omic Assay Predicts Recurrence and Radiation Benefit in Early Breast Cancer
Early-stage invasive breast cancer is frequently managed with breast-conserving surgery followed by adjuvant radiation therapy, but the magnitude of benefit from radiation varies among patients.... Read more
Portable Test Detects Tuberculosis from Tongue Swabs in 30 Minutes
Despite decades of effective drug regimens, tuberculosis remains the leading cause of death from an infectious disease, driven in part by limited access to accurate, rapid testing. Conventional diagnostics... Read more
Blood Test Receives FDA Breakthrough Status to Differentiate Schizophrenia and Bipolar Disorder
Differentiating schizophrenia from bipolar I disorder in symptomatic patients is challenging because early presentations often overlap. Current diagnostic pathways rely heavily on subjective assessments... Read moreHematology
view channel
Advanced CBC-Derived Indices Integrated into Hematology Platforms
Diatron, a STRATEC brand, has introduced six advanced hematological indices on its Aquila, Aquarius 3, and Abacus 5 hematology analyzers. The new Research Use Only (RUO) indices include Neutrophil-to-Lymphocyte... Read more
Blood Test Enables Early Detection of Multiple Myeloma Relapse
Bone marrow biopsies remain central to diagnosing and monitoring multiple myeloma, yet the procedure is painful, invasive, and often repeated over time. Older patients—who represent most new cases—can... Read moreImmunology
view channel
Finger-Prick Lateral Flow Test Detects Sepsis Biomarkers at Point of Care
Sepsis remains a time-critical condition in which rapid risk assessment is often hindered by reliance on centralized laboratory testing. The global burden is substantial, with an estimated 166 million... Read more
Study Highlights Low Sensitivity of Current Lyme Tests in Early Infection
Accurate laboratory diagnosis of early Lyme disease remains challenging because serologic responses may be limited soon after infection. Missed detection at this stage can delay evaluation and management... Read moreMicrobiology
view channel
Rapid Antigen Biosensor Detects Active Tuberculosis in One Hour
Tuberculosis remains a major global health challenge and continues to drive significant morbidity and mortality. The World Health Organization’s 2024 global report cites it as the leading cause of death... Read more
Oral–Gut Microbiome Signatures Identify Early Gastric Cancer
Early detection of gastric cancer could be advanced by scalable screening strategies using minimally invasive sampling. Saliva collection is noninvasive and cost-effective, supporting wider adoption... Read morePathology
view channel
New Tissue Mapping Approach Identifies High-Risk Form of Diabetic Kidney Disease
Diabetic kidney disease is a leading cause of chronic kidney disease and end-stage kidney disease, affecting 20%–40% of people with diabetes and more than 107 million individuals worldwide as of 2021.... Read more
Multimodal AI Tool Predicts Genetic Alterations to Guide Breast Cancer Treatment
PIK3CA mutations are key biomarkers for selecting phosphoinositide 3-kinase (PI3K)–targeted therapies in breast cancer, yet access to molecular testing can be inconsistent and costly. Conventional polymerase... Read moreTechnology
view channel
Microfluidic Single-Cell Assay Predicts Breast Cancer Risk
Risk stratification for breast cancer remains imprecise, as population-based models and breast density can over- or underestimate individual risk, potentially leading to over- or under-screening.... Read more








