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
Urine-Based Nanosensor Tracks Lung Cancer and Fibrosis Noninvasively
Lung cancer remains difficult to monitor for early progression and treatment resistance, while pulmonary fibrosis continues to pose major challenges for early diagnosis. Clinicians need repeatable, noninvasive... Read more
Blood-Based Alzheimer’s Test Gains CE Mark for Amyloid Pathology Detection
Alzheimer’s disease is the most common cause of dementia, yet confirmatory testing remains invasive and hard to access. Diagnosis currently takes an average of 3.5 years, and about 75% of people with dementia... Read moreMolecular Diagnostics
view channel
Sensitive Protein Marker Aids Diagnosis of Small Cell Prostate Cancer
Accurate identification of aggressive prostate cancer subtypes can be difficult when tumors lose expression of lineage markers used in routine pathology. Small cell carcinoma of the prostate, in particular,... Read more
Rapid Multiplex PCR Test Detects 11 Gastrointestinal Pathogens from Single Sample
Cepheid’s Xpert GI Panel has received CE marking under the In Vitro Diagnostic Medical Devices Regulation (IVDR) and is expected to begin shipping to countries that accept the CE mark in the coming weeks.... Read moreHematology
view channel
Stem Cell Biomarkers May Guide Precision Treatment in Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is an aggressive blood cancer that most often affects older adults and still carries a poor prognosis despite therapeutic advances. Venetoclax-based regimens have improved... Read more
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 moreImmunology
view channel
Routine TB Screening Test May Reveal Immune Aging and Mortality Risk
Immune aging is associated with weaker responses to vaccination, greater risks of infection, and higher levels of inflammation. Leveraging routinely ordered laboratory tests to quantify that responsiveness... Read more
Biomarkers and Molecular Testing Advance Precision Allergy Care
Allergic diseases often present with similar symptoms but can be driven by distinct biological mechanisms, making standardized care inefficient for many patients. Historically, individuals with pollen... Read moreMicrobiology
view channel
Study Finds Hidden Mpox Infections May Drive Ongoing Spread
Mpox continues to circulate despite vaccination, and many cases show no known link to a symptomatic partner. The role of people without symptoms has remained uncertain, limiting clarity on how transmission persists.... Read more
Large-Scale Genomic Surveillance Tracks Resistant Bacteria Across European Hospitals
Antimicrobial resistance (AMR) poses a growing threat to patient safety, with carbapenem-resistant Enterobacterales causing difficult-to-treat infections and leaving clinicians with limited therapeutic options.... Read more
Molecular Urine and Stool Tests Do Not Improve Early TB Treatment in Hospitalized HIV Patients
Tuberculosis is the leading cause of death among people living with HIV, and diagnosis in hospital settings remains difficult. Symptoms are often non-specific, disease can be extrapulmonary, and many patients... Read morePathology
view channel
FDA Clears AI Digital Pathology Tool for Breast Cancer Risk Stratification
Risk assessment at diagnosis is central to guiding therapy for early-stage, hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) invasive breast cancer, where overtreatment... Read more
New AI Tool Reveals Hidden Genetic Signals in Routine H&E Slides
Pathologists worldwide rely on hematoxylin and eosin (H&E) slides to examine tissue architecture, yet these stains do not reveal the underlying molecular activity that often drives disease.... Read moreTechnology
view channel
Point-of-Care Testing Enhances Health Literacy and Self-Management in Chronic Disease
Limited access to general practitioners and pathology services can delay diagnosis and monitoring for people in regional and remote communities. Rapid, on-the-spot testing can shorten turnaround times... Read more
Fully Automated Sample-to-Insight Workflow Advances Latent TB Testing
Latent tuberculosis remains a substantial testing workload for clinical laboratories as screening programs expand. Despite this growth, only about 40% of testing has shifted from traditional skin tests... Read moreIndustry
view channel
AI-Powered Multi-Functional Analyzer Wins German Innovation Award
Hematology services are increasingly delivered across distributed care settings, where limited staffing and complex workflows can extend turnaround times. Advanced morphology review still often depends... Read more









