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
Siemens Adds CE-Marked Capillary Claims for 24 Assays on Atellica Analyzers
Venous blood draws can be challenging in patients with difficult veins, needle phobia, or limited blood volume, and they can slow collection in busy services. Core laboratories also face pressure to expand... Read more
Preoperative Blood Test Predicts Colorectal Cancer Recurrence and Metastasis
Cancer cells require large amounts of nutrients to grow and proliferate, and amino acids support key processes including protein formation, energy production, and DNA synthesis. Colorectal cancer is marked... Read moreMolecular Diagnostics
view channel
Blood Gene Expression Fluctuates More Than Expected Over Time
Blood-based gene expression is widely used to explore disease biology, but temporal variability can complicate interpretation of single time-point measurements. Seasonal shifts, time of day, and subclinical... Read more
Genomic Test Helps Early Breast Cancer Patients Avoid Chemotherapy
Adjuvant chemotherapy decisions in early breast cancer can expose many patients to toxicities without clear benefit when clinical factors alone do not precisely predict recurrence risk. Clinicians therefore... Read more
Residual Disease Test Predicts Merkel Cell Carcinoma Recurrence Earlier Than Antibody Assay
Merkel cell carcinoma is a rare, aggressive skin cancer with a substantial risk of relapse, occurring in about 40% of patients. Surveillance remains challenging because widely used serologic monitoring... Read moreHematology
view channel
Spectral Flow Cytometry Assay Enhances MRD Detection in Multiple Myeloma
imal residual disease (MRD) monitoring is pivotal in multiple myeloma, where persistent malignant plasma cells drive relapse risk and help guide therapy decisions. In the United States, approximately 202,000... Read more
New Marker Helps Detect Aggressive Multiple Myeloma Earlier
Multiple myeloma is an incurable malignancy of plasma cells and the second most common blood cancer worldwide, with more than 188,000 new cases each year. Although therapies have advanced, most patients... Read moreImmunology
view channel
Antibody Profiling Identifies Preclinical Inflammatory Bowel Disease Years Before Diagnosis
Inflammatory bowel disease often develops after a prolonged symptom-free period, complicating timely recognition and clinical intervention. Limited understanding of immune activity during this silent phase... Read more
Ultrasensitive Blood Test Detects Sjögren’s Signature Years Before Diagnosis
Sjögren’s disease is a common autoimmune condition that can be difficult to recognize early, leading to delayed diagnosis and persistent symptom burden. It affects around half a million people in the UK... Read more
New Assays Expand Cytokine Testing for Transplant and Immunocompromised Patients
Eurofins Viracor has introduced three plasma-based assays—CXCL9 (Test Code 33607), CXCL10 (Test Code 33609), and interleukin-18 (IL-18) (Test Code 33611)—expanding its immunology testing menu for transplant... Read moreMicrobiology
view channel
Expanded Diagnostics and Therapies Target Rising Gonorrhea Resistance
Drug-resistant Neisseria gonorrhoeae is straining current treatment protocols and elevating the risk of complications across sexual health services. More than 500,000 cases are reported each year in the... Read more
New Rapid Ebola Antigen Test Detects Infection at Point of Care
A serious Ebola epidemic centered in the Democratic Republic of the Congo has caused hundreds of deaths and triggered a global public health emergency, with cases also reported in Uganda.... Read more
Syndromic GI Panel Detects Cyclospora for Rapid Case Confirmation
U.S. health authorities have reported a rapid increase in cyclosporiasis since May 2026, with more than 1,600 confirmed infections and thousands of additional suspected cases under investigation.... Read more
Rapid Panel Identifies Gram-Negative Pathogens and Resistance Markers in Bloodstream Infections
Bloodstream infections require rapid identification of causative pathogens and resistance mechanisms to guide effective therapy. Delays in profiling gram-negative organisms, which are frequently associated... Read morePathology
view channel
AI Digital Pathology Platform Standardizes IHC Scoring in Breast Cancer
Breast cancer diagnostic workflows increasingly depend on accurate quantification of immunohistochemical biomarkers to guide therapy selection, yet manual scoring can be variable and time-consuming.... Read more
Digital Pathology Tool Predicts Breast Cancer Outcomes and Therapy Response
Breast cancer prognosis often depends on microscopic assessment of tumor architecture, a process that can be subjective and lead to variable predictions across patient groups. Quantitative measures that... Read moreTechnology
view channel
Training Device Improves Accuracy of Pooled Molecular Diagnostics
High-throughput molecular diagnostics have transformed infectious disease detection, but many workflows remain difficult to execute accurately without extensive training. Sample pooling can cut per‑test... Read more
New CE-Certified Software Advances Whole-Genome Cancer Testing
European hospitals are increasingly using comprehensive tumor genomics to guide therapy, but routine whole genome sequencing (WGS) requires validated, regulation-compliant workflows. A newly CE-certified... Read more
National Rare Disease Registry Standardizes Genetic and Clinical Data for Coordinated Care
Rare diseases collectively impose a significant clinical burden despite their individual rarity, often involving multisystem presentations and prolonged diagnostic journeys. Limited specialist expertise... Read moreIndustry
view channel
Collaboration Advances Extracellular Vesicle-Based Tests for Neurodegenerative Diseases
NanoSomiX, Inc. and Beckman Coulter Diagnostics announced a collaboration to explore the development of next-generation immunoassays for neurodegenerative diseases using extracellular vesicles (EVs).... Read more









