Division of Microbiology and Infectious Diseases (DMID)

The Lab-in-a-Tube: A Rapid Influenza Molecular Diagnostic Platform

Effectively treating infectious diseases depends on the ability to correctly diagnose them. For highly contagious diseases such as influenza, an accurate and speedy diagnosis is crucial. Several antiviral drugs are most effective when taken within two days of getting sick, and with the threat of a potential influenza pandemic, healthcare providers must be able to rapidly and accurately diagnose influenza.

Currently, most influenza strains go undiagnosed or are identified in a laboratory miles from a doctor’s office. If the strain is diagnosed, the time between a throat swab and a final read out can be days, if not weeks. Recognizing the need for an improved influenza diagnostic, NIAID supported IQuum's Lab-in-a-Tube (Liat) platform—a highly sensitive sample-to-result tool that can detect and differentiate influenza A and B strains near-patient in approximately 20 minutes. The Liat Influenza A/B Assay is currently the only test that has equivalent or better sensitivity and specificity as existing lab-based nucleic acid tests, while substantially matching the time-to-result and ease-of-use of rapid immunoassays.

NIAID Genome Sequencing Crucial for Creating Lab-in-a-Tube

DMID has supported the early, mid, and late stage development of the Lab-in-a-tube since 2003. The Division’s resources for basic research played a critical role in the product’s early development. Influenza genome sequences were generated by the NIAID-funded  Genomic Sequencing Center at the J. Craig Venter Institute and made available through the National Center for Biotechnology Information and NIAID Influenza Research Database. These sequences facilitated the design of the assay. Following basic research success, a collection of NIAID small business and partnership awards supported the development of the Liat platform from the prototype through the current version of the diagnostic platform.

In response to the emergence of the 2009 H1N1 strain, NIAID awarded a grant to support the continued development of a multiplex influenza assay diagnostic platform and enabled the company to immediately incorporate the identification of the 2009 H1N1 strain into their tool. The result, the Liat Influenza A/2009 H1N1 Assay, rapidly detected the 2009 H1N1 virus,. The Liat Assays and accompanying Analyzer have received Food and Drug Administration clearance.

Liat System May Expand to New Diagnostics

Building upon the success of the Liat Influenza A/B Assay and 2009 H1N1 Assay, NIAID is providing additional funding to IQuum to expand its diagnostic research. In addition to influenza, IQuum has received funding to develop diagnostic assays, including that for dengue and HIV viral load.