Leader Janusz J. Stańczak Ph.D.

(4822) 33 55 261

(4822) 33 55 278

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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.

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

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.

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.

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