170809 CLP Tech Guide Molecular Diagnostic Instruments

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guide

Alere Inc

BioFire Diagnostics LLC

GenMark Diagnostics Inc

Waltham, Mass
(877) 262-4669
www.alere.com

Salt Lake City
(801) 736-6354
biofiredx.com

Carlsbad, Calif
(760) 448-4300
www.genmarkdx.com

1. What is the brand name of
your company’s molecular
diagnostic instrument?

Alere i Strep A

FilmArray: FilmArray Torch,
FilmArray 2.0, FilmArray EZ

ePlex

2. Specify the authorizing
agency, type, and year of
the product’s regulatory
authorizations.

CLIA waiver, 2015; FDA 510(k),
2015.

FDA 510(k), 2011.

CE mark, 2016; FDA 510(k), 2017.

Molecular Diagnostic
Instruments

3. What is the intended use
or primary function of the
product?

Point-of-care diagnosis of
Streptococcus A.

Diagnostic testing.

Intended to perform in vitro diagnostic multiplex nucleic acid tests
for the simultaneous qualitative
detection and identification of
pathogens by processing singleuse cartridges developed and manufactured by GenMark Diagnostics.

4. What type of specimen/sample does the product employ?

Throat swab.

Cerebrospinal fluid, nasopharyngeal swab, positive blood culture,
stool in Cary Blair medium.

Nasopharyngeal swab.

5. What types of diseases,
conditions, or analytes does
the system detect?

Strep A.

Blood culture identification; meningitis/encephalitis; gastrointestinal
and respiratory infections.

Viral and bacterial nucleic acids
associated with respiratory infection; additional panels in development.

6. What platform technologies
does the product employ?

Isothermal nucleic acid amplification molecular technology.

Polymerase chain reaction.

Electrowetting, eSensor detection,
microarrays, polymerase chain
reaction.

7. Under ideal conditions, what
is the time to first result; how
are the test results made
available ?

First results in 8 minutes or less;
test results are made available via
large display screen.

FilmArray requires 2 minutes of
hands-on time; results are available in about 1 hour. Respiratory
Panel 2 (RP2) results are available
in 45 minutes.

Approximately 1.5 hours.

8. What are the product’s
maximum capacity and
throughput under ideal
conditions?

The Alere i can store 999 patient
test results and 99 quality control
test results; memory allows search
and retrieval; archiving and exporting are available via USB.

One sample per pouch running
unit. The FilmArray platforms offer
scalability from one pouch running
unit to 12 pouch running units. Run
time is 45 to 60 minutes.

Flexible and scalable solution analyzes up to 24 tests per run.

9. Briefly describe any
automation or connectivity
features or options.

The Alere i platform features visual
guides and unidirectional
connectivity to the user’s network.

Integrated sample preparation,
amplification, detection, and analysis; software automatically analyzes the result for each target.

Random access sample-to-answer
solution with fully integrated
nucleic acid extraction, amplification, and detection; single-use, selfcontained cartridge requires no
user-added reagents; bidirectional
laboratory information system
(LIS) interface with result release
controls.

10. What types of technical
support are available?

Technical support is available
online through the Alere website.

24/7 phone technical support;
email technical support.

Onsite training, updates, and repair
services; 24/7 continuous multilingual telephone and email support;
remote support and monitoring.

11. What capabilities, features,
or accessories distinguish
this product from others on
the market?

Delivers molecular results that
detect Strep A in 8 minutes or
less; CLIA waived; uses isothermal
nucleic acid amplification
technology, which does not require
lengthy or complex thermocycling
or DNA purification; delivers
polymerase chain reaction-caliber
results in a broad range of settings;
kit features a compact footprint,
intuitive touchscreen, visual guides,
and unidirectional connectivity to
the user’s network.

Designed to be the new standard
for syndromic infectious disease
molecular diagnostics; integrated
sample preparation, amplification,
detection, and analysis; delivers
accurate results in 45 to 60
minutes.

Streamlines the diagnostic workflow from physician order entry
to release of the final report with
accurate, actionable test results;
intuitive user experience; true sample-to-answer workflow; random,
continuous access; data reporting;
quality control tracking; modular,
scalable design; bidirectional LIS
interface.

26 August/September 2017 | clpmag.com

Hamilton Robotics

Luminex Corp

Roche Diagnostics

Reno, Nev
(775) 858-3000
www.hamiltoncompany.com

Austin, Texas
(512) 219-8020
www.luminexcorp.com

Indianapolis
(800) 852-8766
go.roche.com/itmatters

VeriSeq NIPT Microlab Star

Aries

Cobas Liat polymerase chain
reaction (PCR) system

For in vitro diagnostic use; not
FDA cleared; Illumina assay kit is
CE marked.

CE mark, 2015; FDA 510(k), 2015.

FDA 510(k), 2014.

Noninvasive prenatal testing
(NIPT).

The in vitro diagnostic (IVD) platform performs nucleic acid-based
tests in clinical laboratories.

In vitro diagnostic test for
detection of influenza A/B virus,
respiratory syncytial virus (RSV),
and Strep A bacteria.

Variable depending upon the
assay.

Throat swab and 1 mL of Liquid
Amies medium for Strep A;
nasopharyngeal swab and 3 mL
of universal transport media for
influenza A/B, and influenza A/B
and RSV.

Fetal chromosome abnormalities.

IVD tests are available for
Bordetella, C. difficile, Group B
Streptococcus, herpes simplex
virus 1 and 2, influenza A and B
virus, and respiratory syncytial
virus.

Influenza A/B, RSV, and Strep A.

March
Laboratory software and
information technologies

Polymerase chain reaction (PCR)free whole-genome sequencing.

Polymerase chain reaction.

Real-time (RT) PCR.

Up to 96 samples from sample
accession to report in approximately 1 day.

Requires minimal upfront sample
processing of approximately 5
minutes and less than 2 hours
from sample in to result out.

20 minutes for influenza A/B, and
influenza A/B and RSV; 15 minutes for Strep A.

April/May
Microbiology systems
and tools

48−96 samples per batch, eight
individual channels.

Has six channels, and can run up
to six samples per module. There
are two modules in each instrument for a total of 12 samples
per run.

Over 20,000 results can be stored;
one assay/test can be run at a
time.

The automated next-generation
sequencing system is preconfigured and qualified to work with
Illumina’s NIPT reagents, consumables, and analysis software
during plasma isolation, library
prep, quantification, and sample
pooling.

Aries is fully integrated, and
performs nucleic acid extraction,
amplification, and analysis on the
same instrument.

Roche’s Cobas IT 1000 can be
used as a data management
system; Cobas Liat can connect
directly to a laboratory information system via HL7 interface and
through other third-party data
management systems that offer a
driver for the Cobas Liat.

Installation, training,
post-installation.

Complete maintenance and field
service support is available.

Toll-free customer support
number; onsite implementation
support as needed; web-based
self-serve support.

VeriSeq NIPT Microlab Star is
configured and optimized for
Illumina’s VeriSeq NIPT workflow,
and uses a single tube of maternal
whole blood drawn as early as
10 weeks gestation; the PCR-free
protocol decreases risks of error
associated with amplification
procedures, reduces time required
for sample preparation, and
simplifies the workflow.

Sample-to-answer system
designed to deliver laboratory
performance, increase laboratory
efficiency, and fit seamlessly into
today’s Lean laboratory environment; uses internal barcode scanning and other advanced features
to minimize operator errors; two
independent magazine modules each support from one to six
cassettes, allowing for both stat
and batch testing.

The only RT-PCR system CLIAwaived for testing influenza A/B,
influenza A/B and RSV, and Strep
A in 20 minutes or less; no
confirmation of negative results is
required; approximately 1 minute
of hands-on time and the ability to
walk away while test runs.

Maternal whole blood.

UPCOMING
TECH GUIDES
Each month, CLP invites
IVD manufacturers and
clinical laboratory suppliers
to complete a standardized
topic-specific questionnaire
highlighting their products.
Below is a preview of topics
that will appear in future
print issues of CLP.
October
Hematology analyzers
November-December
Lab and patient safety
products
January/February
Lab and point-of-care
glucose monitors

June
Anatomic and digital
pathology instruments
and tools
Urinalysis assays and
instruments
To be considered for
inclusion, contact associate
editor Elaine Sanchez Wilson
at ewilson@medqor.com.

clpmag.com | August/September 2017 27