Ospedale di Circolo e Fondazione Macchi, Varese · 14.15 Saluto del Direttore Generale - Walter...
Transcript of Ospedale di Circolo e Fondazione Macchi, Varese · 14.15 Saluto del Direttore Generale - Walter...
Dott. Luigi Ruffo Codecasa, Responsabile Centro Regionale di Riferimento per la
Tubercolosi, Villa Marelli, A.O. Ospedale Niguarda Cà Granda, Milano
Dott. Giorgio Crosta, Dirigente Medico U.O. Pneumologia, A.O. Ospedale di
Circolo e Fondazione Macchi, Varese
Dott. Giovanni Gesu, Direttore Laboratorio Virologia e Microbiologia
A.O. Ospedale Niguarda Cà Granda, Milano
Dott.ssa Ester Mazzola, Dirigente Medico, Laboratorio di Virologia e Microbiologia
A.O. Ospedale Niguarda Cà Granda, Milano
Prof. Luigi Nespoli, Direttore Clinical Pediatrica - Ospedale F. del Ponte, Ospedale
di Circolo e Fondazione Macchi, Varese
Dott. Agostino Rossi, Dirigente Medico, Laboratorio di Microbiologia,
A.O. Ospedale di Circolo e Fondazione Macchi, Varese
Dott.ssa Franca Sambo, Responsabile Servizio di Medicina Preventiva delle
Comunità, ASL Varese
Prof. Antonio Toniolo, Direttore Laboratorio di Microbiologia, Ospedale di Circolo e
Fondazione Macchi, Varese
14.15 Saluto del Direttore Generale - Walter Bergamaschi
14.30 Introduzione scientifica - Antonio Toniolo
14.45 Diffusione della tubercolosi nella Provincia di Varese - Franca Sambo
15.15 La malattia tubercolare: aspetti clinici - Luigi Ruffo Codecasa
15.45 La malattia tubercolare nel paziente pediatrico - Luigi Nespoli
16.15 La malattia tubercolare: epidemiologia e diagnostica - Giorgio Crosta
16.45 Screening immunologico della infezione tubercolare - Giovanni Gesu
17.15 Discussione
17.25 Pausa
17.40 Diagnostica microbiologica e antibiogramma - Agostino Rossi
18.00 Aspetti molecolari: diagnostica, antibiogramma,epidemiologia –
Ester Mazzola
18.25 Discussione e conclusioni
18.45 Compilazione customer satisfaction
One third of the world’s population is infected with organisms of the Mycobacterium tuberculosis complex
Each year:
- Two million people die
- Eight million people are newly infected
22 Countries Account for 80% of Global TB Cases
No estimate
0–999
10,000–99,999
100,000–999,999
1,000,000 or more
1,000–9,999 ITALY
Estimated number of new TB cases (all forms)
WHO CLASSIFICATION OF TB LABS
District-LevelSmear Microscopy
Regional-LevelCulture Laboratories
Central Laboratory -DST for all who
start treatment
CentralCentral
DSTDST
National Reference
Laboratory
Guidance and Standards
• National SOP
– How to do the tests
• NICE guidance
– How to manage the patient
• DH programme
– What service should be delivered
– 3 working groups
TB monitoring and laboratory services
working group
• Surveillance standards
• Standards for laboratory diagnosis
– Current best practice
– Simple and straightforward
– Not replicate or replace the National SOP
Standards to cover
• Samples
• Transfer to laboratory
• Immediate tests
– Microscopy
• Culture, isolation and
identification
• Laboratory facilities and
expertise
• Transport
• Susceptibility testing
• Molecular
fingerprinting/typing
• Notification
• PCR detection of Mtb
• Immunodiagnostic tests
• Histopathology
Samples
• Type of sample
– Sputum (resp. sample), CSF (spinal/para-spinal/intra-cerebral), gastric washings, lymph nodes (tissues), urine, faeces
• Number of samples
– 2 or 3 for sputum? Consecutive days.
– Early morning or any time?
– True LRT specimen
• Documentation
Transfer to laboratory
• Within 24h (or 1 working day, max 48h)
– Minimise overgrowth
– Maintain AFB character
• Potentially infected clinical sample
– Routine procedure
Immediate tests
• Microscopy
– Auramine fluorescent staining
– 6-day service (not on call)
– Perform microscopy and issue result within 24h (1 working
day) of receipt
– Telephone positive result to senior member of clinical
team
– Notify lead TB nurse, lead clinician, CCDC
• Accreditation; IQC programme; satisfactory EQA
performance; staff CPD/peer review
Culture, isolation and identification
• Automated liquid culture on all samples
– Set up within 24h of receipt (6 day service)
– Plus conventional solid culture
• Send all isolates to RCM on day found to be
positive
– Reach RCM within 24h
• Complete identification of most mycobacterial
isolates within 21 days
Identification and reporting
• NAAT (PCR, LCR) or hybridisation gene probe
for MTB complex
– On the day culture shows positive OR
– Within 24h of receipt at RCM
• Other probes and/or phenotypic tests
• Report on day of test to
– Senior member of clinical team
– Lead TB nurse, lead TB clinician, CCDC
Laboratory facilities and expertise
• Safety – Category 3 for culture
– HSE approved
– Contingency plan for accidental dispersal
– Continuity plan for closure
• Accredited
– IQC programme, satisfactory EQA
• Sufficient number – daily service, competence
• Named Consultant and BMS for advice
Transport
• Samples
– Potentially infected samples (routine)
• Positive cultures
– Category A but exemption to treat as B for clinical
and diagnostic purposes
• UN 3373 – marked Diagnostic or Clinical
• P650 packaging
• Do not send by Royal Mail
Susceptibility testing
• Complete within 30 days of initial receipt of clinical
sample for primary agents
– Isoniazid, rifampicin, pyrazinamide, ethambutol
• Takes 10-20 days by liquid proportion (automated) or resistance
ratio
• Molecular detection
– Rifampicin within 24h if MDRTB suspected
– Isoniazid under development
• Done at RCM with accreditation, IQC, EQA
Molecular fingerprinting/typing
• ALL ISOLATES
– 15-loci MIRU-VNTR
• Mycobacterial Interspersed Repetitive Units – Variable
Number Tandem Repeats
– Results to national database
– Other techniques as appropriate
• Done at RCM
Laboratory notification
• HPA
– Via CoSurv from laboratory that identifies a
positive culture
– Confirmation of positive from RCM within 24h (1
working day) of receipt
– RCM reports culture and susceptibility results to
MycobNET within 24h of report to clinician
PCR detection of MTB
• Not routine
• Available from RCM for particular samples
– High suspicion
– Definitive diagnosis deemed to be urgent
– Liaise in advance – Consultany Microbiologist to
RCM
Immunodiagnostic tests
• Interferon γ (QuantiFERON-TB Gold)
• Activated specific T-cells (T-SPOT.TB)
– Standard under development
• Which patients?
• How long should it take?
• Who provides it?
• What do the results mean and who interprets them?
Histopathology
• Report within 3 days of receipt
• Inform the Microbiology service
– Ensure same reporting as for positive microscopy
and culture results
• Send autopsy samples to Microbiology
without formalin!!
• [Role of PCR to be determined]
Implementation of standards
• Local responsibility
– What is done where?
• Microscopy; culture; identification
– What throughput is needed?
– Equipment – cost-effectiveness
– Personnel
• Maintain skills; CPD; peer review
• Named individuals for advice
• Back-up and cover
– IQC, EQA