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
Study Links Saliva-Based Epigenetic Signals to OCD Treatment Outcomes
Obsessive-compulsive disorder (OCD) causes unwanted, recurring thoughts and repetitive behaviors that can severely disrupt daily life. Exposure-based psychotherapy is among the most effective treatments,... Read more
New One-Step Syphilis Test Could Enable Earlier Detection and Faster Treatment
Syphilis can be difficult to diagnose because its symptoms may resemble other diseases and appear and disappear without treatment. Undetected infection can continue causing harm, spread to partners and... Read moreMolecular Diagnostics
view channel
Streamlined Genetic Testing Speeds Pediatric Immune Disorder Diagnosis
Children with genetic immune conditions can develop life-threatening illness, unusual infections, or autoimmune problems before the underlying cause is identified. More than 500 of these rare disorders... Read more
Clinical Trial Evaluates Liquid Biopsy for Early-Stage Breast Cancer Detection
Breast cancer screening relies primarily on mammography, but abnormal findings can lead to additional imaging, biopsy, or repeat imaging after six months, creating anxiety and potentially delaying treatment... Read more
RNA-Based Test Predicts Immunotherapy Response in Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) represents the largest U.S. patient population eligible for immune checkpoint inhibitor therapy. Treatment selection often relies on PD-L1 expression, but a single protein... Read more
Modeling Study Shows Blood-Based CRC Screening Could Prevent More Deaths Than Stool Tests
Colorectal cancer (CRC) screening depends on patient participation and completion of follow-up colonoscopy after an abnormal noninvasive result. Access barriers can make both steps difficult, particularly... Read moreHematology
view channel
New Myelofibrosis Guidelines Recommend Expanded Genetic Testing at Diagnosis
Myelofibrosis is a rare, life-threatening blood cancer affecting up to six per 100,000 people. The disease causes scarring in the bone marrow, limiting the production of healthy blood cells and potentially... Read more
Handheld Point-of-Care Test Aims to Enable Rapid Coagulation Assessment in Trauma
Severe blood loss and inadequate tissue oxygenation are leading causes of preventable death after traumatic injury. Blood products are essential in trauma care, but cold-chain storage, short shelf life,... Read moreImmunology
view channel
Immune Profiling Initiative Aims to Improve Bone Marrow Analysis in Leukemia
Acute myeloid leukemia (AML) is an aggressive blood cancer in which assessing disease burden after therapy can help guide clinical evaluation. Patients with measurable residual disease (MRD) after treatment... Read more
Immune Profiling Identifies Early Maternal Autoantibodies Linked to Preterm Birth Risk
A typical pregnancy lasts about 40 weeks, but labor begins prematurely in roughly one in 10 pregnancies. Preterm birth is the leading cause of newborn death worldwide, yet its underlying causes and which... Read more
Longitudinal Blood Testing Reveals Changes in Allergen Sensitization During Childhood
Food allergy is a major childhood health concern, and distinguishing persistent risk from transient sensitization can guide clinical decisions. Specific IgE antibodies may be detectable even when a child... Read moreMicrobiology
view channel
Molecular Panel Gains WHO Emergency Use Listing to Support Ebola Outbreak Response
The ongoing Ebola Bundibugyo outbreak in the Democratic Republic of the Congo and neighboring countries has become one of the largest outbreaks of this Ebola virus species recorded to date.... Read more
Rapid Host-Response Test Aims to Predict Corticosteroid Benefit in Sepsis
Sepsis and severe infections are difficult to treat because patients with similar clinical presentations may have very different underlying immune responses. Corticosteroids are commonly used in severe... Read morePathology
view channel
Molecular Testing Refines Barrett’s Esophagus Progression Risk Beyond Biopsy Findings
Barrett’s esophagus is a precancerous condition associated with increased risk of esophageal adenocarcinoma. Routine endoscopic biopsy findings guide surveillance and therapy, but histopathology may not... Read more
Updated Digital Pathology Platform Expands AI Integration for Cancer Diagnosis
Digital pathology is reshaping how laboratories manage case review, image analysis, and collaboration. As diagnostic workflows become more complex, pathology teams need platforms that can support digital... Read moreTechnology
view channelLaser-Based Swab Analysis Shows Promise for Detecting Disease-Linked Odor Patterns
Disease-related changes in volatile organic compounds can alter body odor, producing measurable patterns in exhaled breath and bodily fluids. Current analytical methods can be complex, time-consuming,... Read more
Laser-Enhanced Assay Boosts Sensitivity for Colorectal Cancer Biomarker Detection
Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. Early detection remains critical, but cancer biomarkers can produce only faint... Read moreIndustry
view channel
Hologic to Broaden Breast Cancer Testing Portfolio Through Reveal Genomics Acquisition
Hologic (Marlborough, MA, USA) has signed a definitive agreement to acquire Reveal Genomics (Barcelona, Spain), a precision oncology company developing genomic diagnostic tests to help personalize cancer treatment.... Read more








