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24 September 2016 | clpmag.com

Molecular Diagnostic Instruments

guide

[ tech ]Cepheid Great Basin Scientific Inc Hologic Inc Qiagen Inc Qiagen Inc Qiagen Inc

Sunnyvale, Calif

(888) 336-2743;

www.cepheid.com

Salt Lake City

(801) 990-1055;

www.gbscience.com

Marlborough, Mass

(781) 999-7453;

www.hologic.com

Germantown, Md

(800) 362-7737;

www.qiagen.com

Germantown, Md

(800) 362-7737;

www.qiagen.com

Germantown, Md

(800) 362-7737;

www.qiagen.com

1. What is the brand name of your

company’s molecular diagnostic

instrument?

GeneXpert system Great Basin PA500. Panther system EZ1 Advanced XL QiaSymphony RGQ MDx Rotor-Gene Q MDx

2. Specify the authorizing agency, type,

and year of the product’s regulatory

authorizations.

FDA 510(k), 2006; TUV CE mark, 2006. CE mark, 2012, 2015, 2016; FDA 510(k),

2012, 2015, 2016.

Years vary, as each assay was

independently approved/cleared/

CE-marked.

CE mark, 2009; FDA PMA, 2014. FDA 510(k), 2014. FDA 510(k), 2010; FDA PMA, 2012.

3. What is the intended use or primary

function of the product?

GeneXpert Dx systems automate and

integrate sample preparation, nucleic

acid amplification, and detection of the

target sequence in simple or complex

samples using real-time polymerase

chain reaction (PCR); GeneXpert Infinity

systems are fully automated, high-

throughput, on-demand, random-access

closed systems that fully integrate the

process required for real-time PCR-based

molecular diagnostic testing.

Definitive diagnosis of infectious disease

and hospital-acquired infections. Diagnosis.

Intended for automated purification

of nucleic acids from up to 14 human

molecular diagnostics samples.

Intended for in vitro diagnostic (IVD) use

in performing FDA-cleared or -approved

nucleic acid testing in clinical laborato-

ries.

Real-time nucleic acid amplification and

detection system that measures signals

from amplified DNA using fluorescent

detection; intended for in vitro diagnos-

tic use with FDA-cleared or -approved

nucleic acid tests in clinical laboratories.

4. What type of specimen/sample does

the product employ? Specimen type dependent on assay. Positive blood culture, preserved stool,

raw stool, and vaginal swab.

Pap (ThinPrep test), plasma, serum, swab

(cervical, endocervical, vaginal), and

urine.

Viral DNA and RNA and bacterial DNA

from cerebrospinal fluid, dried swab

samples, plasma, respiratory samples,

serum, stool, transport media, urine, and

whole blood; genomic DNA from human

whole blood.

Direct qualitative detection of herpes

simplex virus (HSV) 1/2 requires human

oral or genital lesion swabs collected

in M4RT or universal transport media;

detection of Clostridium difficile requires

human liquid or soft stool.

Sample types vary and depend on the

assay being performed.

5. What types of diseases, conditions, or

analytes does the system detect?

Proprietary Xpert test cartridges span

critical infectious disease, healthcare-

associated infections, genetics, oncology,

sexual health, and virology.

Group B Strep, toxigenic C. difficile,

Shiga toxin direct, Shiga toxin-producing

E. coli and E. coli 0157, Staph ID/R

blood culture panel, methicillin-resistant

Staphylococcus aureus, Staphylococcus

aureus, Staphylococcus spp,

Staphylococcus lugdunensis.

Chlamydia trachomatis, hepatitis B virus,

hepatitis C virus, human

immunodeficiency virus 1, human

papillomavirus, Mycoplasma genitalium,

Neisseria gonorrhoeae, and Trichomonas

vaginalis.

Viral nucleic acids purified using the EZ1

DSP virus kit and genomic DNA purified

using the EZ1 DSP DNA blood kit are

ready to use in downstream diagnostic

assays based on enzymatic amplification.

HSV 1/2; C. difficile toxin genes A and B.

Cytomegalovirus (CMV) viral load

quantitation; C. difficile and herpes

simplex virus (HSV) 1/2 qualitative

detection; EGFR and KRAS mutation

detection.

6. What platform technologies does the

product employ?

Automates and integrates sample

preparation, nucleic acid amplification,

and detection of the target sequence in

simple or complex samples using

real-time polymerase chain reaction.

Chip-based detection, helicase

dependent amplification, and polymerase

chain reaction.

Transcription-mediated amplification

(TMA) uses biochemical reactions to drive

amplification; real-time TMA (RT-TMA) is

utilized for certain assays.

Fully automated nucleic acid purification

using magnetic particles.

Integrated automated nucleic acid

purification and assay setup with manual

transfer for real-time polymerase

chain reaction amplification and

detection; automated result analysis and

interpretation.

Real-time polymerase chain reaction

(PCR) amplifying specific pathogen or

mutation-associated sequence, as well

as a heterologous amplification control

system.

7. Under ideal conditions, what is the

time to first result; how are the test

results made available?

30 to 90 minutes per sample on average;

summarized and detailed test results

data are provided in tabular and graphic

formats.

90 to 120 minutes time to result;

definitive results are reported

electronically.

For TMA-based assays, results are ready

3.5 hours after sample is pipetted (2.5

hours for RT-TMA assays); results are

available in sets of five, every 5 minutes

after first results are completed.

EZ1 DSP virus, 40 minutes for 14-sample

run; EZ1 DSP DNA, 15–20 minutes for

14-sample run.

HSV 1/2 and C. difficile, 380 min for 72

results, including full process controls;

Rotor-Gene AssayManager analysis

interpretation for both applications.

Real-time PCR run times are

assay-specific; C. difficile and HSV 1/2,

110 minutes; CMV, 109 minutes; EGFR

and KRAS, 117 minutes.

8. What are the product’s maximum

capacity and throughput under ideal

conditions?

GeneXpert systems have the capacity to

perform 1−80 tests at the same time;

Infinity 48s: 1,300 tests in 24 hours;

Infinity 80: 2,300 tests in 24 hours.

Random access, on-demand stat testing;

one sample per run.

120 samples on board, 1,000 test

reagent capacity, 750 specimens

processed in 14−16 hours.

14 samples per instrument; up to four

instruments can be connected to an

external computer to simplify data input/

output for a total of 56 samples.

As many as 72 samples, including full

process controls.

As many as 72 samples, including

controls.

9. Briefly describe any automation or

connectivity features or options that

pertain to the product.

Laboratory information system

connectivity; system monitoring and

disease surveillance capabilities; Xpert

tests have internal quality control and

autocalibration; Infinity systems are fully

automated for on-demand processing

and 24/7 robotic sample handling.

Automated self-checks with every run;

internal control with each test cartridge

that monitors all stages of the assay;

error code reporting for any system

failures; analyzers are wi-fi enabled;

support can connect remotely for

additional troubleshooting.

Reagent dispensing verification and

liquid level sensing on all samples and

reagents; positive sample ID with

automated sample barcode scanning.

All processing steps are performed by the

instrument, from piercing reagent

cartridges to nucleic acid elution;

foil-sealed reagent cartridges remain

sealed until instrument door is closed and

protocol run starts, reducing the risk of

contamination.

Fully automated sample purification and

assay setup; Rotor-Gene AssayManager

for automated analysis and data

interpretation; optional QiaLink for

automated data transfer between

QiaSymphony RGQ MDx and laboratory

information management system.

Data security with audit trails, digital

signatures, and user management;

Rotor-Gene Q software or Rotor-Gene

AssayManager software for automated

analysis and data interpretation (assay-

dependent).

10. What types of technical support

are available?

Global service and product support

capabilities include 24/7 phone support,

onsite field service, remote system

monitoring, onsite implementation and

training, and eight global repair centers.

We provide customers with technical

support at no cost, with no service

contracts; toll-free phone and e-mail

support are available; analyzer swapouts

are completed at no charge.

Field application specialists and technical

support hotline.

Technical services for remote support,

and field service and field application

specialists for onsite support.

Technical services for remote support,

and field service and field application

specialists for onsite support.

Technical services for remote support,

and field service and field application

specialists for onsite support.

11. What capabilities, features, or

accessories distinguish this product

from others on the market?

Produces accurate results with minimal

risk of contamination; Xpert tests require

<2 minutes of hands-on time; results are

available in approximately 1 hour in any

workflow environment; random access to

batch testing.

Unique business model with no-cost

analyzer, no contracts, and low-cost

assays; Shiga toxin direct test is the

only FDA-cleared standalone molecular

test detecting Shiga toxin-producing

E. coli and E. coli 0157; Staph ID/R

blood culture panel provides species

information, including the pathogenic S.

Lugdunensis, ruling out CoNS infections.

Integrated platform with sample-in,

result-out capacity; random access

allows user to access assay reagents and

samples during processing and sampling

with multiple assays; scheduled and

automated daily maintenance activities.

Optimal ease of use and walkaway

automation; separate computer not

required for operation; operation via

simple display and keypad; handheld

barcode scanner for reading reagent and

sample information; uses preprogrammed

protocols on EZ1 Advanced XL DSP cards

and EZ1 DSP kits for sample processing.

Sample-to-result IVD workflow solution

for performing FDA-cleared or -approved

nucleic acid testing; flexible sample

batching and efficient processing

optimize IVD workflows; reduces hands-

on time; automates data handling; allows

lab-developed tests (when using open

mode).

Up to six excitation sources and six

detection filters (red and HRM channels

are not intended for use with FDA-

cleared or -approved nucleic acid tests),

combined with a short, fixed optical

path; allows use for multiplex reactions;

ensures minimum fluorescence variability

between samples and eliminates the

need for calibration.

clpmag.com | September 2016 25

Cepheid Great Basin Scientific Inc Hologic Inc Qiagen Inc Qiagen Inc Qiagen Inc

Sunnyvale, Calif

(888) 336-2743;

www.cepheid.com

Salt Lake City

(801) 990-1055;

www.gbscience.com

Marlborough, Mass

(781) 999-7453;

www.hologic.com

Germantown, Md

(800) 362-7737;

www.qiagen.com

Germantown, Md

(800) 362-7737;

www.qiagen.com

Germantown, Md

(800) 362-7737;

www.qiagen.com

1. What is the brand name of your

company’s molecular diagnostic

instrument?

GeneXpert system Great Basin PA500. Panther system EZ1 Advanced XL QiaSymphony RGQ MDx Rotor-Gene Q MDx

2. Specify the authorizing agency, type,

and year of the product’s regulatory

authorizations.

FDA 510(k), 2006; TUV CE mark, 2006. CE mark, 2012, 2015, 2016; FDA 510(k),

2012, 2015, 2016.

Years vary, as each assay was

independently approved/cleared/

CE-marked.

CE mark, 2009; FDA PMA, 2014. FDA 510(k), 2014. FDA 510(k), 2010; FDA PMA, 2012.

3. What is the intended use or primary

function of the product?

GeneXpert Dx systems automate and

integrate sample preparation, nucleic

acid amplification, and detection of the

target sequence in simple or complex

samples using real-time polymerase

chain reaction (PCR); GeneXpert Infinity

systems are fully automated, high-

throughput, on-demand, random-access

closed systems that fully integrate the

process required for real-time PCR-based

molecular diagnostic testing.

Definitive diagnosis of infectious disease

and hospital-acquired infections. Diagnosis.

Intended for automated purification

of nucleic acids from up to 14 human

molecular diagnostics samples.

Intended for in vitro diagnostic (IVD) use

in performing FDA-cleared or -approved

nucleic acid testing in clinical laborato-

ries.

Real-time nucleic acid amplification and

detection system that measures signals

from amplified DNA using fluorescent

detection; intended for in vitro diagnos-

tic use with FDA-cleared or -approved

nucleic acid tests in clinical laboratories.

4. What type of specimen/sample does

the product employ? Specimen type dependent on assay. Positive blood culture, preserved stool,

raw stool, and vaginal swab.

Pap (ThinPrep test), plasma, serum, swab

(cervical, endocervical, vaginal), and

urine.

Viral DNA and RNA and bacterial DNA

from cerebrospinal fluid, dried swab

samples, plasma, respiratory samples,

serum, stool, transport media, urine, and

whole blood; genomic DNA from human

whole blood.

Direct qualitative detection of herpes

simplex virus (HSV) 1/2 requires human

oral or genital lesion swabs collected

in M4RT or universal transport media;

detection of Clostridium difficile requires

human liquid or soft stool.

Sample types vary and depend on the

assay being performed.

5. What types of diseases, conditions, or

analytes does the system detect?

Proprietary Xpert test cartridges span

critical infectious disease, healthcare-

associated infections, genetics, oncology,

sexual health, and virology.

Group B Strep, toxigenic C. difficile,

Shiga toxin direct, Shiga toxin-producing

E. coli and E. coli 0157, Staph ID/R

blood culture panel, methicillin-resistant

Staphylococcus aureus, Staphylococcus

aureus, Staphylococcus spp,

Staphylococcus lugdunensis.

Chlamydia trachomatis, hepatitis B virus,

hepatitis C virus, human

immunodeficiency virus 1, human

papillomavirus, Mycoplasma genitalium,

Neisseria gonorrhoeae, and Trichomonas

vaginalis.

Viral nucleic acids purified using the EZ1

DSP virus kit and genomic DNA purified

using the EZ1 DSP DNA blood kit are

ready to use in downstream diagnostic

assays based on enzymatic amplification.

HSV 1/2; C. difficile toxin genes A and B.

Cytomegalovirus (CMV) viral load

quantitation; C. difficile and herpes

simplex virus (HSV) 1/2 qualitative

detection; EGFR and KRAS mutation

detection.

6. What platform technologies does the

product employ?

Automates and integrates sample

preparation, nucleic acid amplification,

and detection of the target sequence in

simple or complex samples using

real-time polymerase chain reaction.

Chip-based detection, helicase

dependent amplification, and polymerase

chain reaction.

Transcription-mediated amplification

(TMA) uses biochemical reactions to drive

amplification; real-time TMA (RT-TMA) is

utilized for certain assays.

Fully automated nucleic acid purification

using magnetic particles.

Integrated automated nucleic acid

purification and assay setup with manual

transfer for real-time polymerase

chain reaction amplification and

detection; automated result analysis and

interpretation.

Real-time polymerase chain reaction

(PCR) amplifying specific pathogen or

mutation-associated sequence, as well

as a heterologous amplification control

system.

7. Under ideal conditions, what is the

time to first result; how are the test

results made available?

30 to 90 minutes per sample on average;

summarized and detailed test results

data are provided in tabular and graphic

formats.

90 to 120 minutes time to result;

definitive results are reported

electronically.

For TMA-based assays, results are ready

3.5 hours after sample is pipetted (2.5

hours for RT-TMA assays); results are

available in sets of five, every 5 minutes

after first results are completed.

EZ1 DSP virus, 40 minutes for 14-sample

run; EZ1 DSP DNA, 15–20 minutes for

14-sample run.

HSV 1/2 and C. difficile, 380 min for 72

results, including full process controls;

Rotor-Gene AssayManager analysis

interpretation for both applications.

Real-time PCR run times are

assay-specific; C. difficile and HSV 1/2,

110 minutes; CMV, 109 minutes; EGFR

and KRAS, 117 minutes.

8. What are the product’s maximum

capacity and throughput under ideal

conditions?

GeneXpert systems have the capacity to

perform 1−80 tests at the same time;

Infinity 48s: 1,300 tests in 24 hours;

Infinity 80: 2,300 tests in 24 hours.

Random access, on-demand stat testing;

one sample per run.

120 samples on board, 1,000 test

reagent capacity, 750 specimens

processed in 14−16 hours.

14 samples per instrument; up to four

instruments can be connected to an

external computer to simplify data input/

output for a total of 56 samples.

As many as 72 samples, including full

process controls.

As many as 72 samples, including

controls.

9. Briefly describe any automation or

connectivity features or options that

pertain to the product.

Laboratory information system

connectivity; system monitoring and

disease surveillance capabilities; Xpert

tests have internal quality control and

autocalibration; Infinity systems are fully

automated for on-demand processing

and 24/7 robotic sample handling.

Automated self-checks with every run;

internal control with each test cartridge

that monitors all stages of the assay;

error code reporting for any system

failures; analyzers are wi-fi enabled;

support can connect remotely for

additional troubleshooting.

Reagent dispensing verification and

liquid level sensing on all samples and

reagents; positive sample ID with

automated sample barcode scanning.

All processing steps are performed by the

instrument, from piercing reagent

cartridges to nucleic acid elution;

foil-sealed reagent cartridges remain

sealed until instrument door is closed and

protocol run starts, reducing the risk of

contamination.

Fully automated sample purification and

assay setup; Rotor-Gene AssayManager

for automated analysis and data

interpretation; optional QiaLink for

automated data transfer between

QiaSymphony RGQ MDx and laboratory

information management system.

Data security with audit trails, digital

signatures, and user management;

Rotor-Gene Q software or Rotor-Gene

AssayManager software for automated

analysis and data interpretation (assay-

dependent).

10. What types of technical support

are available?

Global service and product support

capabilities include 24/7 phone support,

onsite field service, remote system

monitoring, onsite implementation and

training, and eight global repair centers.

We provide customers with technical

support at no cost, with no service

contracts; toll-free phone and e-mail

support are available; analyzer swapouts

are completed at no charge.

Field application specialists and technical

support hotline.

Technical services for remote support,

and field service and field application

specialists for onsite support.

Technical services for remote support,

and field service and field application

specialists for onsite support.

Technical services for remote support,

and field service and field application

specialists for onsite support.

11. What capabilities, features, or

accessories distinguish this product

from others on the market?

Produces accurate results with minimal

risk of contamination; Xpert tests require

<2 minutes of hands-on time; results are

available in approximately 1 hour in any

workflow environment; random access to

batch testing.

Unique business model with no-cost

analyzer, no contracts, and low-cost

assays; Shiga toxin direct test is the

only FDA-cleared standalone molecular

test detecting Shiga toxin-producing

E. coli and E. coli 0157; Staph ID/R

blood culture panel provides species

information, including the pathogenic S.

Lugdunensis, ruling out CoNS infections.

Integrated platform with sample-in,

result-out capacity; random access

allows user to access assay reagents and

samples during processing and sampling

with multiple assays; scheduled and

automated daily maintenance activities.

Optimal ease of use and walkaway

automation; separate computer not

required for operation; operation via

simple display and keypad; handheld

barcode scanner for reading reagent and

sample information; uses preprogrammed

protocols on EZ1 Advanced XL DSP cards

and EZ1 DSP kits for sample processing.

Sample-to-result IVD workflow solution

for performing FDA-cleared or -approved

nucleic acid testing; flexible sample

batching and efficient processing

optimize IVD workflows; reduces hands-

on time; automates data handling; allows

lab-developed tests (when using open

mode).

Up to six excitation sources and six

detection filters (red and HRM channels

are not intended for use with FDA-

cleared or -approved nucleic acid tests),

combined with a short, fixed optical

path; allows use for multiplex reactions;

ensures minimum fluorescence variability

between samples and eliminates the

need for calibration.

Upcoming

Tech Guides

Each month, CLP invites

leading IVD manufacturers

and clinical laboratory

suppliers to complete a

standarized topic-specific

questionnaire highlighting

their products.

Below is a preview of

topics that will appear in

future issues of CLP:

OCTOBER

Hematology

Analyzers

NOVEMBER

Lab and Patient

Safety Products

DECEMBER

Buyer’s Guide

To be considered

for inclusion, contact

associate editor

Elaine Sanchez Wilson at

ewilson@allied360.com

26 September 2016 | clpmag.com

Molecular Diagnostic Instruments

guide

[ tech ]Qiagen Inc Randox Biosciences Vela Diagnostics USA Inc

Germantown, Md

(800) 362-7737;

www.qiagen.com

Crumlin, UK

(866) 472-6369;

www.randox.com

Singapore

(877) 593-7528;

www.veladx.com

1. What is the brand name of your

company’s molecular diagnostic

instrument?

GeneReader NGS system Evidence Investigator Sentosa SQ301 (120 V) with Sentosa SQ

reporter software

2. Specify the authorizing agency, type,

and year of the product’s regulatory

authorizations.

N/A CE mark, 2009. FDA 510(k), 2014; assays are for

research use only.

3. What is the intended use or primary

function of the product?

For research use only; target enrichment

panels designed with the cancer research

lab in mind.

A semiautomated, benchtop biochip

analyzer that offers complete patient

profiling.

Combines simple chemistry and

semiconductor technology to translate

chemical signals into digital information.

4. What type of specimen/sample does

the product employ?

For use with formalin-fixed, paraffin-

embedded and liquid biopsy sample

types.

Bronchoalveolar lavage fluid, formalin-

fixed paraffin-embedded tissue, fresh and

frozen tissues, nasopharyngeal swab,

serum, urine, urogenital swab, whole

blood.

Formalin-fixed, paraffin-embedded

tissue; plasma; serum.

5. What types of diseases, conditions, or

analytes does the system detect?

Designed for the identification of single

nucleotide variants (SNVs) and indels

associated with breast, colorectal, lung,

melanoma, and ovarian cancers; by the

end of the year detection of copy number

variants (CNVs) will also be possible,

along with additional targeted gene

panels focusing on lung cancer and

BRCA-associated variants.

KRAS, BRAF, PIK3CA array (research use

only); cardiac array; familial

hypercholesterolemia arrays; respiratory

multiplex array; STI multiplex array.

Oncology: colorectal cancer, melanoma,

non-small cell lung cancer, thyroid

cancer; virology: hepatitis C virus

genotyping, human immunodeficiency

virus genotyping.

6. What platform technologies does the

product employ? Next-generation sequencing (NGS).

Biochip microarray coupled with multiplex

polymerase chain reaction (PCR) priming

technology; uses chemiluminescence as

detection signal.

Next-generation sequencing (NGS).

7. Under ideal conditions, what is the

time to first result; how are the test

results made available?

From sample preparation to final report

takes 5 days (<8 hours hands-on time);

the report is presented in an interactive

graphical and tabular format.

One full batch can be run in less than

3.5 hours, generating 1,080 test results

(KRAS/BRAF/PIk3CA array).

Sample to report in about 2 days,

requiring about 2.5 hours of hands-on

time; results provide a summary of

variants in an automatically generated

report.

8. What are the product’s maximum

capacity and throughput under ideal

conditions?

The system is capable of processing

between 10 and 40 samples in either a

parallel or a staggered manner,

depending on the number of flow cells

loaded.

Generates 1,080 test results in

210 minutes using the familial

hypercholesterolaemia array, which

equates to 2,160 tests per day (two full

batch runs) or 10,800 test results per

week.

Oncology: up to 7 samples per run;

virology: up to 15 samples per run.

9. Briefly describe any automation or

connectivity features or options that

pertain to the product.

All steps of the workflow offer either

complete or partial automation;

integrated software enables sample

tracking and connection to a

laboratory information management

system; automated data analysis and

interpretation is performed with a

customized informatics pipeline.

Barcode scanning of samples;

unidirectional laboratory information

management enabled; semiautomated

testing; full Levy-Jennings capabilities;

troubleshooting guide.

IT connectivity to laboratory information

system; sample traceability throughout

the workflow; one system control and

one extraction control with each run;

NGS-specific QC metrics.

10. What types of technical support

are available?

24/7 phone support and service

agreements; different support levels are

available.

Software-generated support;

technical support helpline; regional

technical support offered globally; regular

system checks to assure the operator of

optimal system performance.

Local service and support team

approachable by e-mail and telephone;

instrument certification services include

all functional tests and calibrations

required for installation, operational, and

performance qualification of the

instrument.

11. What capabilities, features, or

accessories distinguish this product

from others on the market?

The complete NGS workflow is designed

to take the user from sample preparation

to generation of a comprehensive report;

the inventive turntable design of the

GeneReader platform makes it possible to

sequence multiple samples in a parallel

or staggered manner.

Allows consolidation of immunoassay and

molecular diagnostics with protein and

DNA-based biochips; broad CE marked

multiplex array for sexually transmitted

infections; offers comprehensive bacterial

and viral respiratory infection testing in a

single multiplex PCR reaction; high

sensitivity, by combining PCR priming

technology and biochip hybridization of

amplified product to spatially tethered

probes.

Enables increased accuracy in variant

calling with minimal sample input for

targeted sequencing; reports are easy to

read, without the need for a

bioinformatician; complete end-to-end

workflow from sample extraction and

NGS library prep to automated reporting;

LIS connectivity for traceabiity of sample

identification.