Pracownia Diagnostyki Molekularnej

Pracownia Diagnostyki Molekularnej
Leader Janusz J. Stańczak Ph.D.
(4822) 33 55 262
(4822) 33 55 278
e-mail [email protected]
1. Structure
Molecular Diagnostics Laboratory (MDL) consists of three independent units: Clinical
Microbiology, Immunology and Molecular Diagnostics which are located in a new, separate
building. Its organization structure and the transfer of analyzed samples are in accordance with
the latest guidelines published by relevant UE commissions. In the year 2008 a new laboratory
was opened: one of the first clinical laboratories in Poland with Biosafety Level 3, provided for
work with Risk Group 3 organisms.
Molecular Diagnostics Laboratory is an official member of KIDL with the number 0067.
2. Staff members
The leader of MDL is Janusz J. Stańczak, Ph.D., biologist, microbiology and molecular genetics
specialist. The members of the staff are: one senior research assistant and four junior research
assistants with university degree, microbiology and genetics specialists (two of them doing their
Ph.D. studies), five senior medical analysts with college degree, three custodians and one
medical secretary.
All research and technical assistants are very well trained; majority of them fulfilled international
courses and trainings. Their knowledge and expertise is confirmed by personal certificates.
The leader of MDL and his deputy are second degree specialists, research assistants are
trained according to new programme of specialisation.
The majority of research assistants are members of polish and international scientific
committees, i.a. Polish Human Genetics Society, Polish AIDS Scientific Society, European AIDS
Clinical Society and International AIDS Society.
The leader of MDL acts in organising and scientific committees of international symposia; works
also as an abstract reviewer.
SP ZOZ Wojewódzki Szpital Zakaźny, ul. Wolska 37, 00-000 Warszawa, http://www.zakazny.pl
Tel.: (22) 33 55 351-355, Fax: (22) 33 55 226
NIP: 527-21-53-938, REGON: 000297945
Pracownia Diagnostyki Molekularnej
3. Equipment
MDL is equipped with the newest generation systems: two automated DNA sequencers, three
real-time PCR platforms (MDL was the first laboratory in Poland to introduce viral infection
diagnostics based on real-time PCR technique), two automated systems for nucleic acid
extraction, gel documentation system, ultra low temperature freezer, liquid nitrogen storage
system, etc.
All equipment is routinely tested, calibrated and serviced according to manufacturer’s
specifications or GLP guidelines; each system has a log book.
In MDL database MARCEL - designed for registration, documentation and management of the
samples - was implemented.
4. Diagnostic activities
Clinical Microbiology unit provides complete diagnostics of viral, fungal and bacterial infections
(also anaerobic bacteria). In March 2009 molecular diagnostics was expanded by testing for
factors causing atypical pneumonia (Legionella pnumoniae, Chlamydia sp. and Mycoplasma
pneumoniae); same system is used in our laboratory for the detection of HPV infection. The
majority of equipment is automated and computer controlled. The quality of diagnostics is
verified - each year for 7 years now - and confirmed by appropriate certificates with the highest
scores issued by polish Quality Assurance Center in Molecular Diagnostics (CBJ w DM).
Immunology unit performs routine diagnostics and research studies. The main areas of interests
are evaluation of immune system status and the influence of particular infections on its structure
and functionality. Complete immune profile or chosen parameters – in HIV positive patients
usually lymphocyte T CD4+ absolute count and CD4+/CD8+ ratio – can be assessed.
Molecular Diagnostics unit introduces the latest techniques of genetic diagnostics.
The panel of diagnosed viral infections consists of:
HBV – viral load , genotyping,
drug resistance testing
HCV – viral load, genotyping
HGV and TTV – in this case
diagnostics has been stopped after showing low clinical
relevance of this
viruses
HIV – as the only laboratory in
Poland we perform complete diagnostics, including the
viral replication in
cell cultures (for the need of early diagnostics, detecting infection in
newborns of HIV positive mothers or in case of professional exposures) and
drug
resistance testing (nucleotide sequencing) along with subtype
identification
HPV and CMV – qualitative
testing
SP ZOZ Wojewódzki Szpital Zakaźny, ul. Wolska 37, 00-000 Warszawa, http://www.zakazny.pl
Tel.: (22) 33 55 351-355, Fax: (22) 33 55 226
NIP: 527-21-53-938, REGON: 000297945
Pracownia Diagnostyki Molekularnej
In the year 2008 an assay allowing the detection of HLA B*5701 allele was introduced. The
presence of this variant is associated with hypersensitivity to abacavir, one of the drugs used to
inhibit HIV replication.
Using the phylogenetic analysis based on nucleotide sequences and epidemiological data our
laboratory provided evidence for the first case of intentional HIV exposure in Poland.
The techniques used in MDL include: different variants of PCR (RT-PCR, quantitative,
real-time), SDA, hybridisation, DNA sequencing and RFLP.
All routinely performed diagnostics procedures are annually evaluated by appropriate
international quality assurance centers. MDL receives the highest notes – in the year 2007 as
the only laboratory in Europe our center scored maximal number of points.
MDL undergoes international audits on regular basis; the results confirm the compatibility of
organisation and actions with GLP guidelines.
5. Research activities
Molecular Diagnostics Laboratory takes part as the central or regional laboratory in numerous
international clinical studies investigating new drugs and therapeutical vaccines. It was the first
laboratory in Poland monitoring HIV drug resistance (Illumination, SPREAD, Abbott
programme). Currently the laboratory is involved in European HIV Resistance Network (EHR),
Network of Excellence in AIDS Treatment (NEAT) and New Highly Infectious Diseases
Programme (EuroNHID), all funded and coordinated by European Commission.
Our areas of interests are:
mitochondrial toxicity of antiretroviral drugs
the impact of respective drug classes on apoptosis
the characteristics of HCV quasispecies as a prognostic marker of successful HCV
treatment
the changes of HCV genotype patterns
the changes of HIV subtype patterns
genetic basis of long term non-progression among persons infected with HIV
The results of this research are regularly published and presented during scientific meetings.
The employees of MDL are first authors or co-authors of more than 35 original papers or
reviews, more than 50 posters and oral presentations, 6 chapters in books or academic
textbooks and 300 entries in the latest Great Polish Encyclopedia issued by PWN.
SP ZOZ Wojewódzki Szpital Zakaźny, ul. Wolska 37, 00-000 Warszawa, http://www.zakazny.pl
Tel.: (22) 33 55 351-355, Fax: (22) 33 55 226
NIP: 527-21-53-938, REGON: 000297945
Pracownia Diagnostyki Molekularnej
Students from Analytical Department of Warsaw Medical University carry out their Bachelors
Degree and Master of Science Degree in Molecular Diagnostics Laboratory; vacation
internships are also offered to students from different universities.
MDL is EU-supported training center for clinicians, nurses and laboratory staff from Central and
East European countries.
SP ZOZ Wojewódzki Szpital Zakaźny, ul. Wolska 37, 00-000 Warszawa, http://www.zakazny.pl
Tel.: (22) 33 55 351-355, Fax: (22) 33 55 226
NIP: 527-21-53-938, REGON: 000297945