LGC eBook - 2017 - 13

Accelerating Science Using Integrated PCR Tools * PCR Shows Off Its Clinical Chops

platform, the cobas Liat ("laboratory in a
tube"), is manufactured by Roche Molecular
Systems. The system employs nucleic acid
purification and state-of-art PCR-based assay
chemistry to enable POC sites to rapidly
provide lab-quality results.

In May 2015, Roche Molecular Systems announced
that its cobas Liat Strep A assay received a CLIA waiver.
This clinic-ready assay can detect Streptococcus
pyogenes (group A ß-hemolytic streptococcus)
DNA in throat swabs by targeting a segment of the
S. pyogenes genome.

13

| GENengnews.com

The cobas Liat Strep A Assay detects
Streptococcus pyogenes (group A
β-hemolytic streptococcus) DNA by
targeting a segment of the S. pyogenes
genome. The operator transfers an aliquot
of a throat swab sample in Amies medium
into a cobas Liat Strep A Assay tube, scans
the relevant tube and sample identification
barcodes, and then inserts the tube into
the analyzer for automated processing and
result interpretation. No other operator
intervention or interpretation is required.
Results are ready in approximately 15
minutes.
According to Shuqi Chen, Ph.D., vp of pointof-care R&D at Roche Molecular Systems,
clinical studies of the cobas Liat Strep A

Assay demonstrated 97.7% sensitivity when
the test was used at CLIA-waived, intendeduse sites, such as physicians' offices. In
comparison, rapid antigen tests and
diagnostic culture have sensitivities of 70%
and 81%, respectively (according to a 2009
study Tanz et al. in Pediatrics).
The cobas Liat Assay preserved the same
ease-of-use and rapid turnaround as the
rapid antigen tests. It addition, it provided
significantly faster turnaround than the
lab-based culture test, which can take
24-48 hours.
A CLIA waiver was announced for the cobas
Liat Strep A Assay in May 2015. CLIA waivers
have been submitted for cobas Liat flu
assays, and Roche intends to extend the
assay menu.
POC tests are also moving into field
applications. Coyote Bioscience has
developed a novel method for one-step
gene testing without nucleic acid extraction
http://www.GENengnews.com
LGC eBook - 2017

Table of Contents for the Digital Edition of LGC eBook - 2017
