According to a recent press release, Rheonix is pursuing a rapid Zika Virus diagnostic test. Lablogatory recently discussed this test with the senior vice president for scientific and clinical affairs at Rheonix.
Lablogatory: I understand this test is a so-called “self-confirming” assay; it corroborates serological results with a molecular confirmation. Can you tell readers a bit about the methodology behind this?
Richard Montagna, PhD, FACB: It works much like the “dual assay” for HIV that we recently developed. Using microfluidics, the sample will be split between two sections of the same cartridge. One section will test for antibodies in a methodology similar to ELIZA. The other section will use LAMP technology to lyse, extract, purify, and amplify Zika-specific RNA sequences.
Lab: Sounds efficient! How long do you anticipate the assay will take to run?
RM: We expect it would take less than an hour to perform. Using our existing equipment base, we anticipate the capacity to perform 24 tests in an hour.
Lab: Given the timeline of the impending outbreak, will you seek Emergency Use Authorization (EUA) from the FDA?
RM: Once development is complete, we’ll discuss EUA with the FDA to determine if that approach is feasible.