Microbiologics Launches IVD Process Controls and Inactivated Whole Virus Controls for SARS-CoV-2 Testing
|
By HospiMedica International staff writers Posted on 11 Sep 2020 |
|
Illustration
Microbiologics, Inc. (Saint Cloud, MN, USA) has further expanded its comprehensive portfolio of SARS-CoV-2 molecular QC standards by launching IVD Process Controls and Inactivated Whole Virus Controls to meet the complex research and diagnostic challenges of the COVID-19 pandemic.
The Process Controls and Inactivated Whole Virus controls are available in ready-to-use swab and pellet formats that mimic patient samples to challenge every step of molecular testing, including sample collection and handling. Featuring a matrix of human epithelial lung cells, each control performs like a true sample within the nucleic assay procedure. By mimicking the patient sample format and performance, these controls challenge not only assays, but also processes and techniques.
The IVD controls each provide a complete validation for extraction, amplification, and detection within a molecular assay. The Inactivated Whole Virus Controls contain the entire SARS-CoV-2 genome in a non-infectious state confirmed by a validated assay. The Process Controls provide diagnostically relevant gene sequences (Orf1ab/RdRP/S/E/ORF8/M/N gene regions) to match multiple diagnostic protocols. The synthetic RNA within the Process Controls is encapsulated in a phage protein envelope to validate the extraction process. Lyophilized for stability and convenience, these controls can be shipped without dry ice.
“In the era of Emergency Use Authorization, quality control becomes more important than ever, putting everything to a critical test, in some cases even assay design, helping to remove flawed tests from the market,” said Aaron Fisk, VP of Microbiologics Virology Center. “Yet the diversity in gene targets and different collection processes have also made quality control more challenging than ever. These new controls provide broad, yet simplified QC solutions for SARS-CoV-2 testing.”
“The global response to COVID-19 depends on the accuracy and speed of testing,” Fisk stressed. “As the diagnostic landscape continues to change, these new SARS-CoV-2 controls provide some much-needed simplicity and confidence in the assays we depend upon test after test, day after day.”
Related Links:
Microbiologics, Inc.
The Process Controls and Inactivated Whole Virus controls are available in ready-to-use swab and pellet formats that mimic patient samples to challenge every step of molecular testing, including sample collection and handling. Featuring a matrix of human epithelial lung cells, each control performs like a true sample within the nucleic assay procedure. By mimicking the patient sample format and performance, these controls challenge not only assays, but also processes and techniques.
The IVD controls each provide a complete validation for extraction, amplification, and detection within a molecular assay. The Inactivated Whole Virus Controls contain the entire SARS-CoV-2 genome in a non-infectious state confirmed by a validated assay. The Process Controls provide diagnostically relevant gene sequences (Orf1ab/RdRP/S/E/ORF8/M/N gene regions) to match multiple diagnostic protocols. The synthetic RNA within the Process Controls is encapsulated in a phage protein envelope to validate the extraction process. Lyophilized for stability and convenience, these controls can be shipped without dry ice.
“In the era of Emergency Use Authorization, quality control becomes more important than ever, putting everything to a critical test, in some cases even assay design, helping to remove flawed tests from the market,” said Aaron Fisk, VP of Microbiologics Virology Center. “Yet the diversity in gene targets and different collection processes have also made quality control more challenging than ever. These new controls provide broad, yet simplified QC solutions for SARS-CoV-2 testing.”
“The global response to COVID-19 depends on the accuracy and speed of testing,” Fisk stressed. “As the diagnostic landscape continues to change, these new SARS-CoV-2 controls provide some much-needed simplicity and confidence in the assays we depend upon test after test, day after day.”
Related Links:
Microbiologics, Inc.
Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
Gold Member
SARS-CoV-2 Pooling Test
Extensive SARS-CoV-2 Pooling
Silver Member
Compact 14-Day Uninterrupted Holter ECG
NR-314P
New
Enterprise Imaging & Reporting Solution
Syngo Carbon
Latest COVID-19 News
Channels
Artificial Intelligence
view channel
AI-Powered Algorithm to Revolutionize Detection of Atrial Fibrillation
Atrial fibrillation (AFib), a condition characterized by an irregular and often rapid heart rate, is linked to increased risks of stroke and heart failure. This is because the irregular heartbeat in AFib... Read more
AI Diagnostic Tool Accurately Detects Valvular Disorders Often Missed by Doctors
Doctors generally use stethoscopes to listen for the characteristic lub-dub sounds made by heart valves opening and closing. They also listen for less prominent sounds that indicate problems with these valves.... Read more
Critical Care
view channel
Machine Learning Tool Identifies Rare, Undiagnosed Immune Disorders from Patient EHRs
Patients suffering from rare diseases often endure extensive delays in receiving accurate diagnoses and treatments, which can lead to unnecessary tests, worsening health, psychological strain, and significant... Read more
On-Skin Wearable Bioelectronic Device Paves Way for Intelligent Implants
A team of researchers at the University of Missouri (Columbia, MO, USA) has achieved a milestone in developing a state-of-the-art on-skin wearable bioelectronic device. This development comes from a lab... Read more
First-Of-Its-Kind Dissolvable Stent to Improve Outcomes for Patients with Severe PAD
Peripheral artery disease (PAD) affects millions and presents serious health risks, particularly its severe form, chronic limb-threatening ischemia (CLTI). CLTI develops when arteries are blocked by plaque,... Read more
AI Brain-Age Estimation Technology Uses EEG Scans to Screen for Degenerative Diseases
As individuals age, so do their brains. Premature aging of the brain can lead to age-related conditions such as mild cognitive impairment, dementia, or Parkinson's disease. The ability to determine "brain... Read moreSurgical Techniques
view channel
Porous Gel Sponge Facilitates Rapid Hemostasis and Wound Healing
The kidneys are essential organs that handle critical bodily functions, including waste elimination and blood pressure regulation. Often referred to as the silent organ because they typically do not manifest... Read more
Novel Rigid Endoscope System Enables Deep Tissue Imaging During Surgery
Hyperspectral imaging (HSI) is an advanced technique that captures and processes information across a given electromagnetic spectrum. Near-infrared hyperspectral imaging (NIR-HSI) has particularly gained... Read more
Robotic Nerve ‘Cuffs’ Could Treat Various Neurological Conditions
Electric nerve implants serve dual functions: they can either stimulate or block signals in specific nerves. For example, they may alleviate pain by inhibiting pain signals or restore movement in paralyzed... Read more
Flexible Microdisplay Visualizes Brain Activity in Real-Time To Guide Neurosurgeons
During brain surgery, neurosurgeons need to identify and preserve regions responsible for critical functions while removing harmful tissue. Traditionally, neurosurgeons rely on a team of electrophysiologists,... Read morePatient Care
view channel
First-Of-Its-Kind Portable Germicidal Light Technology Disinfects High-Touch Clinical Surfaces in Seconds
Reducing healthcare-acquired infections (HAIs) remains a pressing issue within global healthcare systems. In the United States alone, 1.7 million patients contract HAIs annually, leading to approximately... Read more
Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization
An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more
Game-Changing Innovation in Surgical Instrument Sterilization Significantly Improves OR Throughput
A groundbreaking innovation enables hospitals to significantly improve instrument processing time and throughput in operating rooms (ORs) and sterile processing departments. Turbett Surgical, Inc.... Read more
Health IT
view channel
Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients
Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more
Strategic Collaboration to Develop and Integrate Generative AI into Healthcare
Top industry experts have underscored the immediate requirement for healthcare systems and hospitals to respond to severe cost and margin pressures. Close to half of U.S. hospitals ended 2022 in the red... Read more
AI-Enabled Operating Rooms Solution Helps Hospitals Maximize Utilization and Unlock Capacity
For healthcare organizations, optimizing operating room (OR) utilization during prime time hours is a complex challenge. Surgeons and clinics face difficulties in finding available slots for booking cases,... Read more
AI Predicts Pancreatic Cancer Three Years before Diagnosis from Patients’ Medical Records
Screening for common cancers like breast, cervix, and prostate cancer relies on relatively simple and highly effective techniques, such as mammograms, Pap smears, and blood tests. These methods have revolutionized... Read morePoint of Care
view channel
Critical Bleeding Management System to Help Hospitals Further Standardize Viscoelastic Testing
Surgical procedures are often accompanied by significant blood loss and the subsequent high likelihood of the need for allogeneic blood transfusions. These transfusions, while critical, are linked to various... Read more
Point of Care HIV Test Enables Early Infection Diagnosis for Infants
Early diagnosis and initiation of treatment are crucial for the survival of infants infected with HIV (human immunodeficiency virus). Without treatment, approximately 50% of infants who acquire HIV during... Read more
Whole Blood Rapid Test Aids Assessment of Concussion at Patient's Bedside
In the United States annually, approximately five million individuals seek emergency department care for traumatic brain injuries (TBIs), yet over half of those suspecting a concussion may never get it checked.... Read more
New Generation Glucose Hospital Meter System Ensures Accurate, Interference-Free and Safe Use
A new generation glucose hospital meter system now comes with several features that make hospital glucose testing easier and more secure while continuing to offer accuracy, freedom from interference, and... Read moreBusiness
view channel
Johnson & Johnson Acquires Cardiovascular Medical Device Company Shockwave Medical
Johnson & Johnson (New Brunswick, N.J., USA) and Shockwave Medical (Santa Clara, CA, USA) have entered into a definitive agreement under which Johnson & Johnson will acquire all of Shockwave’s... Read more
