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BD MAX™ USERS DISCUSS NAATWORK DEVELOPMENTS AND SUCCESSES A report from the 2013 BD MAX™ User Meeting in Frankfurt, Page 3
BREAKING DOWN DIAGNOSTICS BARRIERSAn interview with Dr. Paul VerhoevenPage 5
WINNING THE BATTLE AGAINST CLOSTRIDIUM DIFFICILE INFECTIONSAn interview with Dave ThomasPage 6
2013 Vol. 1
MOLECULAR BACTERIOLOGY SHOWS ADVANCES IN DIAGNOSTIC SPEED, ACCURACY AND PATIENT CAREPage 4
Advancing molecular diagnostics
LETTER FROM THE EDITOR
AN INDUSTRY TRANSFORMED
More than 50 molecular diagnostics experts recently gathered in Frankfurt for the first BD MAX™
User Meeting. Through presentations, a poster session and informal networking they shared
experiences and best practices. Every day, professionals around the world are rapidly advancing
molecular infectious disease diagnostics. The conference confirmed this exciting trend.
One participant shared his conclusion on diagnosing bacterial gastroenteritis: “We have been
using a suboptimal gold standard for years. For me, culture should, in this domain, clearly be
replaced by molecular.” It is a statement that illustrates the significant transformation that is
taking place in microbiology laboratories worldwide right now. This BD newsletter intends to
help chronicle and spread the trends and successes in molecular diagnostics. We look forward
to hearing your thoughts and feedback on this first issue of NAATWORK News.
ABOUT NAATWORK NEWS
Editorial staff: Dominique Clarysse ([email protected])
Leila Smith ([email protected])
Dominique Clarysse
2 NAATWORK NEWS
BD DiagnosticsTullastrasse 8-1269126 HeidelbergGermanyTel. (49) 6221 305 0Fax. (49) 6221 305 [email protected]/europe/ds/
BD, BD Logo and all other trademarks are the property of Becton, Dickinson and Company. ©2013 BD Becton Dickinson GmbH - General Manger: Roland Pfleger - Registered Office Heidelberg - Commercial Register: Mannheim HRB 330 707
DON’T MISS IT!
NAATWORK Café is a tour of events, also available as webinars, that engage clinical laboratory
professionals in a discussion on the future of molecular diagnostics. Find out more on page 7.
NAATWORK
3 NAATWORK NEWS
The first BD MAX™ User Meeting held in Frankfurt on June 5
and 6 provided a forum for more than 50 new and expert users
of BD MAX™, supported by BD representatives. According to
Mike Nugent, Global Marketing Manager with BD Diagnostics,
the goal of the User Meeting was to share and network:
“Laboratories all over Europe are doing exciting work using
the BD MAX™. The meeting allowed them to share their research
and successful protocols. The result was better than expected.
Our participants showed boundless interest and involvement.”
One of the recurring topics during the post-presentation feedback
sessions: a call for collaboration and coordination with clinicians
and hospital infection prevention teams.
PRESENTATIONS ON HAI:
Paul Smits, Slotervaart Ziekenhuis Amsterdam:
Why BD MAX™? Sharing the experience of a first line user
Paul Verhoeven, University Hospital of Saint-Etienne:
First evaluation of the BD MAX™ StaphSR assay for
the detection of MRSA strains carrying the mecC gene
PRESENTATIONS ON RESPIRATORY DISEASES:
Kate Templeton, Royal Infirmary of Edinburgh:
A comparative evaluation of the Diagenode Multiplex
PCR kit on the BD MAX™ versus routine in-house
assay used to diagnose Bordetella pertussis
PRESENTATIONS ON ENTERIC DISEASES:
Eric Claas, Leiden University Medical Centre:
Diagnosing viral gastroenteritis: is there a role for BD MAX™?
Marijo Parcina, University Hospital Bonn:
Quick analysis of bacterial diarrhea with BD MAX™
PRESENTATIONS ON USER-DEVELOPED PROTOCOLS:
Alexander Dalpke, University Hospital Heidelberg:
Development & validation of a UDP for Pneumocystis
Ingrid Op Den Buijs, PAMM Veldhoven:
Development & validation of mycobacterium complex assay
BD MAX™ USERS DISCUSS NAATWORK DEVELOPMENTS AND SUCCESSES A report from the 2013 BD MAX™ User Meeting in Frankfurt
2013 BD MAX™ FRANKFURT USER MEETING PRESENTATIONS
NAAT UPDATE
During the two-day meeting, participants shared their findings using BD MAX™
for the detection of infectious organisms such as MRSA, Clostridium difficile,
Bordetella pertussis, Noro- and Rotavirus, TB complex, ... and many more.
Additionally, Courtney Stelling, R&D Manager with BD,
introduced a Total Nucleic Acid Reagents Suite.
Molecular testing has the potential to significantly improve
the three most important performance criteria of a bacteriological
lab: speed, accuracy and patient care. Although new technologies
address the issues that have traditionally hampered its wide-
spread implementation, molecular diagnostics still has to find
its place in today’s lab.
SPEED AND ACCURACY
Highly accurate, quantitative molecular measurements have been
developed over the years. These molecular techniques offer
independence from laborious cultivation techniques for fastidious
organisms. Molecular tests often also provide the benefits of
improved sensitivity and speed to reportable results.
For laboratories that work with in-house, user-developed assays,
the flexibility of target gene selection allows for the swift
formulation of new diagnostic procedures. Furthermore,
with the rapidly progressing developments in sequencing,
genomic information on new pathogens can be available
within days. This allows for quick adaptation of diagnostic
procedures, as illustrated by the handling of the recent EHEC
outbreak in northern Germany.
In the future, a better characterization of virulence factors within
facultative pathogenic bacteria will be possible based on the
availability of large amounts of genome data. Molecular tests
will help determine the clinical meaning of a positive test result.
PATIENT CARE
Bacteriological results have a significant impact on patient care,
confirming the presence or absence of a bacterial infection.
Molecular tests are especially valuable in delivering a rapid
diagnostic or to verify infections when conventional procedures
can’t. Detection of multi-resistant bacteria also helps the selection
of appropriate treatment strategies and to avoid the spread
of infections.
THE BACTERIOLOGICAL LAB RE-INVENTED
Whereas the advantages of molecular diagnostics are significant,
a number of technical and organizational challenges must
be addressed in order to facilitate the implementation of
molecular testing.
Traditionally, test series in molecular bacteriology are often small,
which hampers cost-effective use of automated high-throughput
platforms. Moreover, commercially available assays were often
validated for one specific device, which led to problems when
combining assays or which made it necessary to operate different
machines. This dual challenge is met by technical solutions that
are currently available in the market. These solutions combine
and fully automate molecular diagnostics but leave the flexibility
of running small series and in-house assays.
Integrated but open platforms meet our demands best.
These devices reduce staff requirements and expand availability
of molecular diagnostics in a microbiology lab setting, without
cutbacks in consultant quality and bacteriology expertise.
They also give the labs the option of using one machine or
technical platform for different assays.
(Continued on page 7)
MOLECULAR BACTERIOLOGY SHOWS ADVANCES IN DIAGNOSTIC SPEED, ACCURACY AND PATIENT CARE Prof. Dr. med. Alexander H. Dalpke
NAAT TRENDS
4 NAATWORK NEWS
Dr. Paul Verhoeven is a BD MAX™ pioneer. As an early adopter
of NAAT, his team at the University Hospital of Saint-Etienne
was keen to start using the BD MAX™ in 2011.
“For a university hospital like ours, the open platform of the BD
MAX™ is an important advantage. The BD MAX™ offers the
possibility to develop our own assays targeting pathogen and gene
coding for antimicrobial resistance that emerges and spreads
very quickly. For example, it was easy to adapt a multiplex PCR
assay for the detection of methicillin resistant Staphylococcus
aureus strains carrying the mecC gene.”
“In the last year, we have assessed the BD MAX™ Cdiff assay
detecting the toxin B gene of Clostridium difficile disease
screening. In collaboration with reference laboratories in several
European countries, we have participated in the evaluation of
the BD MAX™ Staph SR assay for the detection of the new
MRSA strain carrying the mecC gene. The results presented at
the last ASM general meeting illustrate that the BD MAX™
scores high on specificity, sensitivity and reliability.”
“We have worked in collaboration with BD for the optimization
of the open system reagents. We are now considered a BD MAX™
expert center. Right now, we use our own assays almost exclusively
for the detection of Bordetella pertussis and parapertussis;
Panton-Valentine leukocidin of Staphylococcus aureus; along with
Bartonella and viruses. The BD MAX™ permits an excellent
reactivity of the lab and leads to a slight cost-efficient benefit.”
“Historically, culture testing for pertussis has been slow and insen-
sitive. NAAT has been found more effective in the diagnosis of
pertussis syndrome. Using the BD MAX™, our lab technicians
only spend about 20 minutes on a test. This means we can
now perform testing on a daily basis, instead of once or twice
a week. As children who enter the ER with symptoms of
whooping cough have to stay in the hospital until a diagnosis
is made, this faster detection time has had a significant impact
on the quality and efficiency of our patient care.”
“I believe that NAAT can play a crucial role in these types of time
savings as hospital labs experience ever more pressure to provide
results quickly. NAAT simply is much faster than traditional culture
testing, often with a direct impact on the quality of care.”
Dr. Paul Verhoeven (MD), University Hospital of Saint-Etienne, France
BREAKING DOWN DIAGNOSTICS BARRIERS An interview with Dr. Paul Verhoeven, University Hospital of Saint-Etienne, France
NAAT INTERVIEW
5 NAATWORK NEWS
The BD MAX™ Open System Reagent (OSR) DNA Suite
fully launched in January 2013. This collection of six
new products enables each lab to develop their own
protocols and assays on the BD MAX™.
In February, BD introduced the second assay developed
through a partnership with Diagenode. In April, the CE-
marked enteric viral assay for the detection of Norovirus and
Rotavirus developed through this partnership with Diageno-
de was complemented by a BD-developed enteric bacterial
panel. This qualitative IVD test detects the top four bacterial
organisms causing 95% of bacterial enteric infections.*
On April 9, BD announced FDA clearance for the BD
MAX™ Clostridium difficile assay. It is the third FDA-
cleared BD MAX™ assay.
Also in April, BD shipped the first and only automated
molecular assay the detection of carbapenem-resistant
Enterobacteriaceae (CRE).
In September and October, BD launched two assays with
eXTended Detection Technology, an improved assay design
for identification of Staphylococcus aureus and MRSA.
BD MAX™ UPDATE
* N
ew E
ngla
nd J
ourn
al o
f M
edic
ine;
200
4; 3
50: 3
8-47
.
Dave Thomas and his team in the microbiology lab of the North
Hampshire Hospital NHS Foundation Trust have been using BD
MAX™ since September 2012 to detect flu strains, Clostridium
diffi cile and Norovirus organisms. The hospital has achieved
great success in fighting Clostridium difficile epidemics using
NAAT-based diagnostics, recording a 64 percent decrease in
patients diagnosed with Clostridium difficile infections after
their implementation. “NAAT has had a significant impact on
our diagnostic quality and our ability to control outbreaks.
I believe molecular is the way forward,” says Thomas.
LAB ORGANIZATION
“Finding skilled personnel and limited weekend staffing have
been long-standing challenges for us. Both factors affect
preparation and processing times and thus the time we need
to produce results. The BD MAX™ is easy to use, so the tests don’t
have to be done by experts. With just thirty minutes of training
and a few days of supervised work, everyone in the lab can use
the BD MAX™. It also produces results faster, often saving us
hours or even days. This allows us to contribute to more efficient
bed and patient management. We can start a test at the end of
a workday or even a workweek and leave it to run. When you
are dealing with a fast-spreading Norovirus outbreak and limited
isolation options, that offers a significant advantage.”
“The BD MAX™ has become an integral part of our workday.
We run Clostridium difficile tests every single day and Norovirus
and flu testing as needed. That is where good coordination
with the hospital’s Control & Infection team comes in,
especially during outbreaks.”
ACCURACY
North Hampshire Hospital NHS Foundation Trust was the first
hospital in the UK to use BD NAAT as its primary means of testing
for Clostridium difficile. After switching to NAAT, the hospital
reduced its rolling three-month average case numbers from 4.67
to 1.66, a 64 percent decline.
“For us, PCR is the only reliable Clostridium difficile test. While it
is more expensive per test, you only need one. The assays are
simple to perform and can provide a result within hours. This allows
us to provide better patient care and to exceed our case number
objectives. The financial consequences are significant as well,
as each Clostridium difficile infection case avoided saves thousands
of pounds,” says Thomas.
THE FUTURE
“Molecular testing has given us significant advances in terms
of diagnostic quality and our ability to control outbreaks. I am
particularly impressed with its real-time results, accuracy and ease
of use. There is a lot of growth-based bacteriology testing that
can move to molecular testing, for example in gram negative
resistance mechanisms such as CRE (carbapenem-resistant
Enterobacteriaceae). I truly believe molecular is the way forward.”
Dave Thomas, General Microbiology Lab Manager, North Hampshire Hospital NHS Foundation Trust, UK
WINNING THE BATTLE
AGAINST CLOSTRIDIUM
DIFFICILE INFECTIONSAn interview with Dave Thomas,
North Hampshire Hospital
NHS Foundation Trust, UK
NAAT INTERVIEW
6 NAATWORK NEWS
(Continued from page 4)
Molecular diagnostics have the reputation of being less automated,
laborious methods. To reduce hands-on time, decrease personnel
occupation and facilitate molecular detection, all of the steps
in molecular diagnostics have been automated to some degree
only. Nucleic acid extraction can be done by automated systems
that are available for different sample numbers. Amplification and
detection is most often combined into one step and done by
realtime amplification techniques. Yet, despite those improve-
ments, the different steps are still isolated and most of the
platforms must be combined in some kind of modular manner.
As a result, molecular methods still require specific infrastructure
and expert staff, limiting their 24/7 availability. As patients’
hospital stays steadily decrease, low turnaround times for
bacteriology tests are an absolute must. Offering molecular
tests only five days a week or only once a week to increase
series sizes will likely no longer meet future demands.
To deal with these challenges while maximizing the benefits
of molecular testing, a future division seems likely between
assays that can be run on fully automated, all-in-one devices
by less trained staff at any time and the classical molecular
techniques that address more sophisticated diagnostic questions.
Prof. Dr. med. Alexander H. Dalpke, Dept. of Infectious Diseases, Medical Microbiology and Hygiene, Heidelberg University, Germany
NAAT TRENDS
7 NAATWORK NEWS
NAAT EDUCATION
NAATWORK Café is a tour of events, also available as webinars, that engage clinical laboratory professionals in a discussion on the future of molecular diagnostics.
UPCOMING NAATWORK CAFÉS Check out and register for upcoming webinars:
http://laboratory-manager.advanceweb.com/webinar/
webinar.aspx?rid=784
MISSED A NAATWORK CAFÉ? All presentations are available online:
http://www.bd.com/ds/learningCenter/presentations/
NAATWork.asp
PAST NAATWORK CAFÉ TOPICS: • Advances in the diagnosis of Clostridium difficile infection:
how molecular diagnostic methods are changing clinical practice and improving patient care
• Antibiotic resistance in healthcare-associated infections: how your laboratory can address the challenges of MRSA and carbapenem-resistant organisms
• Proven ways to boost molecular lab performance by blending lean and automation
• Enteric pathogens: algorithms, applications, and advantages of molecular diagnostics
• TV or not TV? Should screening for T. vaginalis be routine?
• Pre-surgical screening to prevent SSIs: a collaborative effort between the lab and Infection Control
NAATWORK
A longer version of this article previously appeared in Practical Patient Care; 2012; 9: 45.
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