170809 CLP Tech Guide Molecular Diagnostic Instruments

2017-08-22

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26 August/September 2017 | clpmag.com

tech

guide

Molecular Diagnostic

Instruments

Alere Inc BioFire Diagnostics LLC GenMark Diagnostics Inc Hamilton Robotics Luminex Corp Roche Diagnostics

Waltham, Mass

(877) 262-4669

www.alere.com

Salt Lake City

(801) 736-6354

biofiredx.com

Carlsbad, Calif

(760) 448-4300

www.genmarkdx.com

Reno, Nev

(775) 858-3000

www.hamiltoncompany.com

Austin, Texas

(512) 219-8020

www.luminexcorp.com

Indianapolis

(800) 852-8766

go.roche.com/itmatters

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 VeriSeq NIPT Microlab Star Aries Cobas Liat polymerase chain

reaction (PCR) system

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.

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.

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 diag-

nostic multiplex nucleic acid tests

for the simultaneous qualitative

detection and identification of

pathogens by processing single-

use cartridges developed and man-

ufactured by GenMark Diagnostics.

Noninvasive prenatal testing

(NIPT).

The in vitro diagnostic (IVD) plat-

form 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.

4. What type of specimen/sam-

ple does the product employ? Throat swab.

Cerebrospinal fluid, nasopharyn-

geal swab, positive blood culture,

stool in Cary Blair medium.

Nasopharyngeal swab. Maternal whole blood. 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.

5. What types of diseases,

conditions, or analytes does

the system detect?

Strep A.

Blood culture identification; menin-

gitis/encephalitis; gastrointestinal

and respiratory infections.

Viral and bacterial nucleic acids

associated with respiratory infec-

tion; additional panels in develop-

ment.

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.

6. What platform technologies

does the product employ?

Isothermal nucleic acid amplifica-

tion molecular technology. Polymerase chain reaction.

Electrowetting, eSensor detection,

microarrays, polymerase chain

reaction.

Polymerase chain reaction (PCR)-

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

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 avail-

able in about 1 hour. Respiratory

Panel 2 (RP2) results are available

in 45 minutes.

Approximately 1.5 hours.

Up to 96 samples from sample

accession to report in approxi-

mately 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 min-

utes for Strep A.

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 export-

ing 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 ana-

lyzes up to 24 tests per run.

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 instru-

ment for a total of 12 samples

per run.

Over 20,000 results can be stored;

one assay/test can be run at a

time.

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 analy-

sis; software automatically ana-

lyzes the result for each target.

Random access sample-to-answer

solution with fully integrated

nucleic acid extraction, amplifica-

tion, and detection; single-use, self-

contained cartridge requires no

user-added reagents; bidirectional

laboratory information system

(LIS) interface with result release

controls.

The automated next-generation

sequencing system is preconfig-

ured and qualified to work with

Illumina’s NIPT reagents, con-

sumables, 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 informa-

tion system via HL7 interface and

through other third-party data

management systems that offer a

driver for the Cobas Liat.

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 multilin-

gual telephone and email support;

remote support and monitoring.

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.

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 work-

flow from physician order entry

to release of the final report with

accurate, actionable test results;

intuitive user experience; true sam-

ple-to-answer workflow; random,

continuous access; data reporting;

quality control tracking; modular,

scalable design; bidirectional LIS

interface.

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 environ-

ment; uses internal barcode scan-

ning and other advanced features

to minimize operator errors; two

independent magazinemod-

uleseach support from one to six

cassettes, allowing for both stat

and batch testing.

The only RT-PCR system CLIA-

waived 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.

clpmag.com | August/September 2017 27

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

March

Laboratory software and

information technologies

April/May

Microbiology systems

and tools

June

Anatomic and digital

pathology instruments