We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
RANDOX LABORATORIES

Download Mobile App





New Stool-Based Assay Detects SARS-CoV-2 Genetic Material in Donor Stool Using RT-PCR

By LabMedica International staff writers
Posted on 06 Oct 2021
Print article
Illustration
Illustration

A new custom-made SARS-CoV-2 assay has enabled a stool bank to resume patient Fecal Microbiota Transplantation (FMT) treatment distribution and ease supply chain disruptions.

CosmosID, Inc. (Germantown, MD, USA), a microbiome laboratory services company, has provided a testing solution to OpenBiome (Cambridge, MA, USA) which was left with freezers full of processed donor stool samples that could not be released until tested for the SARS-CoV-2 virus. Using the new custom-made testing solution named CosmosID, the stool bank is now able to quickly screen and distribute the stored treatments to patients across the US who suffer from recurrent C. difficile infection.

The custom CosmosID test was implemented by OpenBiome after review by the US Food and Drug Administration (FDA) which has earlier issued a series of safety alerts on the risk of transmitting SARS-CoV-2 via FMT. CosmosID detects SARS-CoV-2 genetic material in donor stool using reverse transcription polymerase chain reaction (RT-PCR) - the same molecular technique used in COVID-19 diagnostic testing. OpenBiome can now test its large inventory of FMT treatments manufactured after December, 2019, which had largely been previously ineligible for distribution per the FDA safety alerts. The test allows OpenBiome to restore its supply chain of FMT treatments and once again make them widely available to patients. In order to successfully develop the test, CosmosID leveraged its scientific team's particular expertise in molecular techniques for analyzing stool samples. The team also flexibly adapted to the changing regulatory requirements during the validation process.

"Our team has extensive experience using next-generation sequencing technologies to analyze gut microbiomes for many different applications – including detecting the presence of disease-causing microbes. We welcomed this collaboration with OpenBiome to come up with a quick and easy test for their banked stool samples, which helps them continue their work," said Manoj Dadlani, CEO of CosmosID.

"CosmosID brought a solutions-oriented mindset to the challenge — they were creative, pragmatic, and proactive, and were utterly committed to the goal of making sure that patients would maintain safe access to fecal transplantation. It has been terrific to collaborate with them on this solution for patients and public health," added Carolyn Edelstein, Executive Director of OpenBiome.

"Rigorous donor screening is critical to enhancing safety and enabling access to FMT for patients with C. difficile who have exhausted all treatment options," said Majdi Osman, Chief Medical Officer at OpenBiome. "Until now, the challenges of directly testing for SARS-CoV-2 in stool have significantly limited physicians' abilities to treat patients with C. difficile infection," he says. "Screening our inventory using the stool-based assay developed by CosmosID will allow thousands of patients to get much-needed treatment for C. difficile infection. For these patients, an FMT is a chance to recover from a debilitating infection and return to a normal life."

Related Links:
CosmosID, Inc. 
OpenBiome 

Gold Supplier
COVID-19 Real Time RT-PCR Kit
respiraScreen 1
New
Handheld β-Ketone and Glucose Analyzer
STAT-Site WB Analyzer
New
High Throughput Molecular Testing Solution
Panther Scalable Solutions
New
Respiratory Multiplex RT-PCR Kit
Respiratory Multiplex RT-PCR Kit

Print article

Channels

Clinical Chem.

view channel
Image: Simoa is an ultra-sensitive immunoassay technology that allow detection of proteins and nucleic acids at lowest possible levels (Photo courtesy of Quanterix)

Plasma Amyloid-β 42/40 Assays Compared in Alzheimer Disease

Blood-based tests for brain amyloid-β (Aβ) pathology are needed for widespread implementation of Alzheimer disease (AD) biomarkers in clinical care and to facilitate patient screening and monitoring of... Read more

Molecular Diagnostics

view channel
Image: The QuikRead go iFOBT is an immunochemical fecal immunochemical test for detection and quantification of human hemoglobin in feces in case of suspected bleeding from the lower gastrointestinal tract (Photo courtesy of Aidian)

Fecal Immunochemical Tubes Sourced to Analyze Gut Microbiome for CRC

Colorectal cancer (CRC) is a challenging public health problem which successful treatment depends on the stage at diagnosis. Recently, CRC-specific microbiome signatures have been proposed as a marker... Read more

Hematology

view channel
Image: Bone marrow aspirate from a patient with peripheral T-cell lymphoma (Photo courtesy of Peter Maslak, MD)

Mutation Analysis Links Angioimmunoblastic T-Cell Lymphoma to Clonal Hematopoiesis

Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoid tumors and encompass peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and... Read more

Immunology

view channel
Image: The BD LSRFortessa X-20 Cell Analyzer can be configured with up to five lasers to detect up to 20 parameters simultaneously to support ever increasing demands in multicolor flow cytometry (Photo courtesy of BD Biosciences)

Highly Multiplexed Cell Surface Protein Analyzed Via Flow Cytometry

Modern immunologic studies increasingly requires high-dimensional analyses to understand the complex milieu of cell types that comprise the tissue microenvironments of disease. One of the cornerstones... Read more

Pathology

view channel
Image: Characteristic bronchoalveolar lavage findings of diffuse alveolar hemorrhage (Photo courtesy of Peter C. Bauer, MD)

Bronchoalveolar Lavage Cell Pattern Determined for Diffuse Alveolar Hemorrhage

Diffuse alveolar hemorrhage (DAH) is a clinicopathological syndrome that describes the accumulation of intra-alveolar red blood cells originating from the alveolar capillaries. DAH can induce severe respiratory... Read more

Industry

view channel
Image: GastroPanel Quick Test (Photo courtesy of Biohit Healthcare)

Biohit’s Innovative GastroPanel Quick Test Receives CE Mark

Biohit Healthcare’s (Helsinki, Finland) GastroPanel Quick Test, the latest innovation in its unique GastroPanel product family, is now CE marked. The GastroPanel Quick Test is intended for diagnosing... Read more
Copyright © 2000-2021 Globetech Media. All rights reserved.