COPAN UniVerse™ Facilitates Newly Announced Streamlined Approach for Pooled Serial Screening Testing Programs
April 21, 2021 | Murrieta, CA
On April 20th, 2021, the U.S. Food and Drug Administration (FDA) recently announced further steps to facilitate the emergency use authorization (EUA) of tests for pooling anterior nasal specimens from asymptomatic individuals in serial testing programs (FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing Programs | FDA).
UniVerse™ revolutionizes up front sample processing for molecular diagnostics automatically managing accessioning, labeling, vortexing, and aliquoting into assay tubes and 96-well plates. It supports pooled testing via two methodologies: (a) multiple patient samples pooled into one secondary tube, and (b) multiple patient swabs into a single specimen tube, like PodSwab™.
UniVerse™ fully LIS interfaced, it increases laboratory throughput with complete traceability, reliability and accuracy. Previously authorized SARS-CoV-2 tests can now be used for pooled specimen screening when tested at least once per week as part of a serial testing program without prospective FDA review. To utilize this approach, the EUA holder must submit a notification to FDA with validation data and pooling procedures as part of a self-certification step.
Pooling can be an efficient approach for a serial COVID-19 testing program by increasing testing accessibility and significantly increasing testing capacity. For persons without symptoms and with no known exposure to COVID-19, increased access to testing will assist back-to-school and back-to-work initiatives, as well as assist communities to begin a return to normal.
UniVerse™ is a fully automated instrument for molecular specimen preparation from COPAN. The system increases productivity while decreasing operational cost and allows valuable human resources to be re-deployed to higher level tasks. The system is also capable of pooling specimens, either by the pooling of liquid specimens, or sampling from pooled swab specimens, with complete traceability in case any person would need to be retested. With this streamlined approach to add pooled serial screening for COVID 19 and the desire to return to in person learning or go back to work, the need for a robotic, fully LIS integrated system is crucial to manage the test volume.
“As trends towards specimen pooling screens continue to emerge, the importance of tracking and tracing, and minimizing manual, transposition and transcriptions errors, will be amplified. The UniVerse™ can deliver on flawless up-front specimen processing as we move to pooling specimens in greater numbers in order to return to ‘normal’” stated Norman Sharples, CEO of COPAN Diagnostics, Inc.
About COPAN Diagnostics, Inc.
With a reputation for innovation, COPAN Diagnostics is part of COPAN Group, the leading manufacturer of collection and transport systems in the world. COPAN’s collaborative approach to pre-analytics has resulted in Flocked Swabs, ESwab™, UTM Universal Transport Medium®, and laboratory automation, WASP® and WASPLab®. COPAN carries a range of microbial sampling products, inoculation loops, and pipettes. For more information, visit www.copanusa.com