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User Manual September 2015 Public Health England National
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1. EU states in the WHO Euro region It is also a member of the WHO Global Laboratory Initiative involved with the development of WHO IUATLD strategies for management of mycobacterial diseases and participates in international EQA schemes receiving samples and dispatching to designated regions The NMRL with the ECDC co ordinates the European Reference Laboratory Network for mycobacterial disease NMRL contact details Public opening hours 9 am to 5 15 pm Monday to Friday Main numbers Telephone 020 7377 5895 Fax 020 7539 3459 Melanie Kemp phe gov uk Enquiries NMRL phe gov uk 020 7377 5895 0208 882 2572 Clinical Lead Dr Eliza Alexander 020 7377 5895 Eliza Alexander phe gov uk 0208 882 2572 Enquiries General NMRL phe gov uk 020 7377 5895 Administration 020 7882 2572 Mrs Yen Holicka Office Manager and Finance Yen Holicka phe gov uk Laboratory Manager Ms Nada Ahmed 020 7377 5895 Nada Ahmed phe gov uk 020 7882 2573 Specialist Reference and Molecular Epidemiology Dr Simon Warwick Simon Warwick phe gov uk 020 7377 5895 020 7882 2578 Dr Tim Brown 020 7882 2575 Tim Brown phe gov uk Quantiferon testing Dr Vlad Nikolayevskyy 020 7377 5895 Vlad Nikolayevskyy phe gov uk 020 7882 2578 Safety Officer Mrs Melanie Kemp 020 7377 5895 020 7882 2575 General results enquiries are addressed by our administrative staff initially who will direct clinical and technical enquiries to the appropriate staff There
2. adhered to refer also to the document PHE recognition of Caldicott recommendations e The report must be sent to a safe haven fax machine This means that if the location is in general use consideration must be given to ensuring that unauthorised personnel are unable to read reports accidentally or otherwise Also the room housing the fax machine must be in a secure location which is locked if it is likely to be unattended at the time the fax is sent e Assurance must be sought from the intended recipient of the faxed report in writing that the receiving fax machine is a safe haven If it is essential to fax patient identifiable information to NMRL please speak to the administration office at NMRL who will arrange for someone to receive the fax Our fax machine is a safe haven fax machine e tis a requirement that any recipient of a fax from the NMRL confirms that the fax has been received No faxes will be sent to centres refusing to confirm the safe receipt of faxes Compliance with the Human Tissue Act Submitting tissue samples from deceased people The PHE Microbiology Services is licensed by the Human Tissue Authority HTA Licence number 12459 to store tissues from deceased people for scheduled purposes Post mortem samples are submitted to PHE Microbiology Services by coroners or pathologists for examination to help them determine the cause of death As part of our public health remit we sometimes
3. attention any instances where PID security has been threatened or has broken down Any uses that PID are put to outside the clinical diagnostic services generally allow patient identifiers to have been removed before hand and when PID is used for research purposes the proposals are considered first by the appropriate Ethics Committee All enquiries regarding the security and use of PID should be addressed to the Caldicott Guardian at NURL phe gov uk Key References Wright A Zignol M Van Deun A Falzon D Ruesch Gerdes S Feldman K Hoffner S Drobniewski F Barrera L van Soolingen D Boulabhal F Paramasivan C N Kam KM Mitarai S Jaramillo E Nunn P Raviglione M for The Global Project on Anti Tuberculosis Drug Resistance Surveillance Anti tuberculosis drug resistance in the world 2002 2007 Lancet 2009 May 30 373 9678 1861 73 Ojo O Sheehan S Corcoran GD Okker M Gover K Nikolayevsky V Brown T Dale J Gordon SV Drobniewski F Prentice MB Mycobacterium bovis strains causing smear positive human tuberculosis Southwest Ireland Emerg Infect Dis 2008 Dec 14 12 1931 4 Drobniewski FA V Nikolayevskyy S Hoffner O Pogoryelova D Manissero AJ Ozin The added value of a European Union tuberculosis reference laboratory network analysis of the national reference laboratory activities Euro Surveill 2008 13 12 Kruijshaar ME Watson JM Drobniewski F Anderson C Brown TJ Magee JG Smith EG Story A Abub
4. is daily cover for clinical and technical issues and asking for a specific named individual may not be the fastest option e g they are on annual leave Complex cases are discussed further internally and the advice returned will often be a product of this discussion not just the opinion of the person answering the call We record the advice given for continuity We must know the identity both of the patient and the caller Summary of Services e Please note that although analyses will generally be provided free to the NHS where a patient specimen is sent a charge will be incurred Non NHS specimens will be charged e Identification of Mycobacterium sp isolates this is provided free to the NHS and is a rapid molecular DNA amplification based identification service e Drug Susceptibility Testing for M tuberculosis complex phenotypic culture based for first line drugs on solid media and rapid liquid culture based for reserve drugs this is provided free to the NHS e Drug Susceptibility Testing for Non Tuberculous Mycobacteria NTM phenotypic culture based testing for clinically significant NTM isolates this is free of charge for patients under 18 years old e Molecular Epidemiological Service e g outbreak investigations laboratory cross contamination provided free to the NHS e Interferon Gamma Release Assay latent TB infection diagnosis e Primary Isolation Service including microscopy and culture e Fastrack PCR Ser
5. not write in this space e The PHE NMRL laboratory advises users where forms are poorly completed Wherever possible the NMRL supports its users by not rejecting referred specimens and cultures e There are four NMRL request forms these are as follows e Mycobacterium Referral Form primary samples and positive cultures N1 e Fastrack Request Form N2 e Molecular Epidemiology Request Form N3 e QuantiFERON TB Gold test N4 e NMRL request forms can be downloaded from the following website https www gov uk government collections national mycobacterium reference laboratory nmrl or ordered pre labelled with the requestor code and address from the PHE LIMS department via e mail Limshelpdesk phe gov uk GUIDANCE ON PACKAGING SAMPLES The PHE has a short film clip to provide guidance for referring laboratories on how to package samples to the required standard http webarchive nationalarchives gov uk 20140722091854 http www hpa org uk ProductsServ ices MicrobiologyPathology MicrobiologicalTestsAndServices cfi40Packagingguidance A small but significant proportion of samples received by the PHE Reference Microbiology Services are poorly or inappropriately packaged This often leads to samples leaking or being damaged during transport therefore posing a serious risk to PHE staff handling them PHE hopes to eliminate this risk by helping laboratories to understand basic packaging requirements The following guidelines are in
6. to sending laboratory within 1 working day NB Minimum CSF volumes are required 0 5 ml We will also culture residual material for maximum sensitivity Samples received before 9 30 am Wednesday results communicated to sending laboratory by Friday NB For paraffin wax blocks the whole wax block must be sent along with a diagram slide indicating the area where AFB granuloma were seen The NMRL pro actively analyses cultures produced at NMRL from patient specimens submitted to our national Fastrack Molecular diagnostic service If we have detected rifampicin resistance mutations predictive of MDRTB we will automatically analyse cultures for first line and reserve drugs at no further cost to the NHS This is a major contribution to our public health role Interferon Gamma Release Assay Quantiferon Assay Clinical and Technical Advice Reports sent out within 10 working days of receipt of sample Incoming calls for clinical and technical advice available Monday Friday 9 00 to 17 00 Key factors affecting specimen performance If a specimen is received at the NMRL which is unsuitable for examination we will endeavour to contact the sender to discuss the problem If a specimen is submitted to NMRL for an investigation that we do not offer we will temporarily archive the sample isolate and issue a report to the sender explaining the reasons for the sample s rejection Reference service The time taken to perform
7. A Post or courier Royal mail WILL accept These guidelines are not intended as a substitute for reading the advice given by DfT and DoH Use the links below for further information https www gov uk shipping dangerous goods overview https www gov uk government organisations department for transport series transporting dangerous goods http www who int ihr publications who hse ihr 2012 12 en http www icao int http www unece org Reporting incidents during transportation that may affect the safety of personnel The NMRL will report to users any leaking containers and improperly packaged parcels Leaking cultures will not be processed by the NMRL users will be informed and a repeat sample requested Repeated offences will be referred to the PHE Safety Committee who may refer to the Health and Safety Executive Labelling and Packaging NMRL All specimens cultures sent to the NMRL must be packed in accordance with IATA regulations 650 602 Label the specimen culture bottle with the name of the patient or unique identifier and the laboratory number The top of the specimen culture bottle must be fixed on firmly so that there is no chance of leakage It may be necessary to use parafilm to ensure that the top remains on tight during transport This will also prevent desiccation of the specimen culture in transit which will compromise successful culture Wrap the bottle in absorbent material and seal insid
8. ae Public Health England Public Health England National Mycobacterium Reference Laboratory amp Regional Centre for Mycobacteriology for South and Southeast England User Manual September 2015 The NMRL is a constituent laboratory of PHE National Infection Services The NMRL is a WHO Supranational Reference Laboratory The NMRL is a lead partner of the European TB Reference Laboratory Network The NMRL is part of the Clinical TB and HIV Group Blizard Institute Barts and the London School of Medicine Queen Mary College Address Postal DX Public Health England PHE MR Unit National Mycobacterium Reference Laboratory DX 6680700 3 Floor Abernethy Building TOWER HAMLETS 93 E 2 Newark Street London El 2AT Tel 44 0 20 7377 5895 Fax 44 0 20 7539 3459 National Mycobacterium Reference Laboratory NMRL The National Mycobacterium Reference Laboratory NMRL is an accredited constituent reference laboratory of the National Infection Service NIS of Public Health England PHE The NMRL is PHE s National Reference Centre and the Regional South and Southeast England Centre for Tuberculosis The principal activities of the NMRL include primary isolation service including microscopy and culture Fastrack PCR Service for detection of M tuberculosis complex and rifampicin and multidrug resistance molecular based rapid identification of Mycobacterium sp isolates drug susceptibility testing for first line and reserve drug
9. akar I Increasing antituberculosis drug resistance in the United Kingdom analysis of National Surveillance Data BMJ 2008 May 31 336 7655 123 1 4 Epub 2008 May 1 Drobniewski F Cobelens F Zellweger JP and KNCV EuroTB Workshop Use of Gamma interferon assays in low and medium prevalence countries in Europe a consensus statement of a Wolfheze Workshop organised by KNCV EuroTB Vilnius Sept 2006 Eurosurveillance 2007 12 7 E070726 2 Dinnes J Deeks J Kunst H Gibson A Cummins E Waugh N Drobniewski F Lalvani A A systematic review of rapid diagnostic tests for the detection of tuberculosis infection Health Technol Assess 2007 Jan 11 3 1 314 Shah NS Wright A Bai GH Barrera L Boulahbal F Martin Casabona N Drobniewski F Gilpin C Havelkov M Lepe R Lumb R Metchock B Portaels F Rodrigues MF Riisch Gerdes S Van Deun A Vincent V Laserson K Wells C Cegielski JP Worldwide emergence of extensively drug resistant tuberculosis Emerg Infect Dis 2007 Mar 13 3 380 7 Drobniewski F Riisch Gerdes S Hoffner S and Subcommittee on Antimicrobial Susceptibility Testing of Mycobacterium tuberculosis of the European Committee for Antimicrobial Susceptibility Testing EUCAST of the European Society of Clinical Microbiology and Infectious Diseases ESCMID Antimicrobial susceptibility testing of Mycobacterium tuberculosis EUCAST document E DEF 8 1 report of the Subcommittee on Antimicrobial Susceptibility Testing of Mycobacteri
10. bacterial identification and drug susceptibility tests is dependent on the receipt of pure viable cultures Cultures that require purification or that cannot be retrieved because they are no longer viable and necessitate a second isolate may increase turnaround time significantly Our approach is to assist you wherever possible by not rejecting contaminated cultures however submitting a second culture is usually the best strategy If an aliquot of a liquid culture is to be sent then a concentrated sample is best Transfer 1 ml of the concentrated sample to a sterile universal or cryovial microcentrifuge tube for transport and store the rest of the sample 1 2 ml at your laboratory Leaking culture samples will not be processed and a report will be issued informing the user of this Primary Service e The specimens to be sent should be as fresh as possible e Nothing should be added to the sample except when the specimen is a small piece of tissue in which case sterile saline or sterile water should be added Do NOT use formalin as this will kill the mycobacteria e Blood samples and Bone Marrow samples minimum volume of 2 ml for culture should be sent in a vacutainer containing lithium heparin Mycobacterial survival is lower in EDTA tubes e We strongly recommend that specimens are refrigerated if any delays in submission to the NMRL are likely e We do not usually perform microscopy on urine specimens we only culture early morning urine
11. e a minigrip bag The NMRL will endeavour to process primary material if leakage occurs but this is likely to compromise the chance of successful culture and we will request the user to send us an additional specimen Leaking cultures will NOT be processed and a repeat sample will be requested Place the specimen culture inside a leak proof plastic container with enough absorbent material to be able to absorb all the contents of the bottle in case of leakage Place the plastic container inside a fibreboard box Place the form between the plastic container and the outer cardboard box DO NOT PLACE IT INSIDE THE PLASTIC CONTAINER In the event of leakage breakage the whole shipment will be destroyed without opening Specimens may be sent by Royal Mail or Courier We recommend that to minimise delays specimens especially those sent for our Fastrack molecular diagnostic service are sent by routine courier e g DX or other specialised courier Please ensure that the courier is able to reach the NMRL before 1700h Cultures can only be sent by courier Faxing and emailing reports containing patients data It is our policy that reports containing patient data should not be sent by routine E mail E mails cannot be relied on to guarantee security of patient data because they can be intercepted by a third party on route unless encrypted In some circumstances NMRL can send results by fax In this case the following conditions must be
12. ending on the organism identified Primary Service Microscopy performed within 1 working day of sample receipt Decontamination and culture of clinical samples on liquid and solid media Culture of blood and bone marrow Incubation of inoculated blood and bone marrow cultures Molecular Epidemiology Service VNTR MIRU analysis Confirmation of rapid fingerprinting by further VNTR MIRU analysis or other appropriate methodology Fastrack Service Rapid PCR service for the detection of M tuberculosis complex and Rifampicin Isoniazid resistance Rapid PCR service for M tuberculosis complex and Rifampicin resistance detection in pulmonary amp CSF samples Rapid PCR service for M tuberculosis complex and rifampicin resistance detection in non pulmonary samples except CSFs Microscopy report sent out within 1 working day Final Negative result reported after 6 weeks or 8 weeks for blood cultures and CSF samples NB Incubation will be continued for up to 12 weeks but a further report is not issued unless culture becomes positive Final report within 4 weeks of receipt of a suitable culture Report telephoned or final written report within 6 weeks of receipt of a suitable culture Appropriate cultures received by 9 30 am analysed daily and results communicated to sending laboratory within 1 working day Appropriate pulmonary amp CSF samples received by 9 30 am analysed daily and results communicated
13. erformance of the GenoType R MTBDRPIlus assay in routine settings a multicenter study Eur J Clin Microbiol Infect Dis 2011 Oct 25 Balabanova Y Tchernyshev V Tsigankov I Maximova S Mikheeva N Fedyukovitch L Kuznetsov S Fedorin I Drobniewski F Analysis of undiagnosed tuberculosis related deaths identified at post mortem among HIV infected patients in Russia a descriptive study BMC Infect Dis 2011 Oct 18 11 276 Faksri K Drobniewski F Nikolayevskyy V Brown T Prammananan T Palittapongarnpim P Prayoonwiwat N haiprasert A Epidemiological trends and clinical comparisons of Mycobacterium tuberculosis lineages in Thai TB meningitis Tuberculosis Edinb 2011 Nov 91 6 594 600 Epub 2011 Sep 14
14. irements regarding disposal or returning tissue samples if requested by the sending coroner or pathologist PHE Microbiology Services recognition of Caldicott recommendations The recommendations of the Caldicott report 1997 have been adopted by the Public Health England PHE These recommendations relate to the security of patient identifying data PID and the uses to which they are put The PHE observes Caldicott guidance in handling PID and has an overall Caldicott Guardian who is the Director of Health Protection and Medical Director who reports through the Information Governance and Caldicott functions and onwards to the National Executive The PHE Microbiology Services has a Caldicott guardian who advises the Director of Microbiology Services on confidential issues and is responsible for monitoring the physical security of PID in all parts This also applies to the transfer of results of investigations to and from PHE Microbiology Services whether by mail services telephone or fax The value of safe haven arrangements or other means of the sender and receiver information identifying themselves to each other before data is transferred is emphasised The PHE is anxious to audit the security of its PID in collaboration with its customers Customers are invited to review our arrangements in conjunction with individual laboratory directors and or the Caldicott Guardian Customers are also asked to draw to the Caldicott Guardian s
15. ith no or incomplete request forms a fixed administrative charge of 14 35 will be applied Internal Recharging NHS PHE External Recharging Outside of outbreak investigations we do not analyse non NHS PHE cultures without prior agreement Please note all above prices are subject to VAT SPECIMEN AND SAMPLE SUBMISSION GUIDELINES All Specimens MUST be labelled with the following 1 Surname Forename or other Unique Patient Identifier 2 Sender s Sample Number 3 Date of Birth Request Forms MUST match and include the above information on the sample the list below And the Name and contact information of requester telephone number vital for urgent requests 4 Tests required 5 Sample type 6 Specimen Isolation site 7 Date of dispatch 8 NHS Number 9 Sex 10 Date and time of collection of specimen 11 Relevant clinical information Request Forms to accompany specimens cultures e Please ensure the appropriate NMRL request from is fully completed for the sample being submitted with the required information as stated above 1 11 as well as the correct telephone number particularly for Fastrack requests e Each sample must be accompanied by an individual request from even if more than one sample is submitted from the same patient e Please complete the forms in BLACK or BLUE pens NOT RED or any other colour e The space marked For NMRL Use only is intended for use by NMRL staff Please do
16. need to retain these samples for the purpose of public health monitoring which is defined as a scheduled purpose within the Human Tissue Act 2004 Further analysis of these samples may help determine the cause of an outbreak due to an infectious disease or may allow identification of new strains of infectious agents at a later date Obtaining consent to remove store and use human tissues for a scheduled purpose is one of the underlying principles of the Human Tissue Act PHE Microbiology Services receives post mortem samples from Coroners post mortems or from NHS establishments across the UK and therefore we are not in a position to either seek consent ourselves or have arrangements in place to confirm that the requirements of the Act have been complied with by the sender We would ask coroners and pathologists who send post mortem samples to PHE Microbiology Services to provide us with details of consent and would also ask that consent includes retention of the samples for the purpose of public health monitoring When tissue samples from deceased people are received at the PHE Microbiology Services they are retained securely and confidentiality is maintained in compliance with Caldicott principles as are all samples received at this centre It is normal practice for tissue samples from the deceased to be disposed of in the same way that all others clinical samples we receive are disposed of However we will adhere to any specific requ
17. ontrol J Epidemiol Community Health 2010 Apr 64 4 373 6 Epub 2010 Mar 15 Mitchell SL Seoudi N Hutchison DCS Drobniewski FA Multidrug resistant tuberculosis resistance dates to first and second line antituberculosis drugs in the UK in 2008 2009 and the role of rapid molecular tests for drug resistance Thorax 2010 Sep 29 Moore JE Kruijshaar ME Ormerod P Drobniewski F Abubakar I Increasing reports of non tuberculous mycobacteria in England Wales and Northern Ireland 1995 2006 BMC Public Health 2010 Oct 15 10 612 Martineau AR Peter M Timms Graham H Bothamley Alleyna P Claxton Geoffrey E Packe John C Moore Gillon Mathina Darmalingam Robert N Davidson Thomas C Stokes Heather J Milburn Lucy V Baker Stefan Lozewicz Richard D Barker Nicholas J Woodward Yasmeen Hanifa Kamrul Islam Timothy R Venton Korina E Barnes Christopher J Mullett Anna K Coussens Clare M Rutterford Charles A Mein Geraint R Davies Robert Wilkinson Vladyslav Nikolayevskyy Francis A Drobniewski Sandra M Eldridge Christopher J Griffiths High dose vitamin D3 during intensive phase treatment of pulmonary tuberculosis a double blind randomised controlled trial Lancet 2011 Jan 15 377 9761 242 50 Stone MJ Brown TJ Drobniewski FA Human Mycobacterium bovis infection in London and southeast England J Clin Microbiol 2011 Nov 9 Mironova S Pimkina E Kontsevaya I Nikolayevskyy V Balabanova Y Skenders G Kummik T Drobniewski F P
18. re is sent by the sending laboratory directly NMRL Price List April 2015 March 2016 METHODS REQUEST NHS PHE PRICE per isolate sample NI SC CI PRICE per isolate sample NON NHS PRICE per isolate sample Identification of submitted cultures and first line drug testing on solid media no charge if within the remit of the PHE ID and Sensitivity 0 66 24 88 32 Reserve drugs for DST Extra Sensitivities 0 49 68 66 24 Molecular epidemiology of TB cultures Molecular Epidemiology 0 41 95 55 20 Non Tuberculous Mycobacteria NTM DST ID and Sensitivity 58 00 58 00 75 00 Primary specimen receipt and inoculation into standard solid and liquid culture medium Culture 36 43 36 43 49 68 Blood bone marrow Standard liquid culture Culture 36 43 36 43 49 68 Fastrack PCR identification of M tuberculosis complex and molecular rifampicin testing includes culture of residential material and identification of resulting cultures Fastrack 137 16 137 16 198 12 Quantiferon Gold for diagnosis of latent infection and active tuberculosis based on purchase of 10 tests at a time IGRA 45 72 45 72 45 72 NOTE Where samples are unsuitable for testing leaking incorrect container unlabelled specimen or are submitted w
19. s and molecular epidemiological typing and support of outbreak investigations contact tracing Interferon Gamma Release Assays for detection of latent infection and diagnosis are also carried out The NMRL initiated the first national molecular detection and drug resistance service for patient specimens and with centres in Germany Estonia and Russia developed and initiated new rapid liquid culture analyses for reserve drugs susceptibility testing DST The NMRL provides comprehensive molecular epidemiological typing and analyses of outbreaks Our activities support surveillance activity for TB in the UK The NMRL is based in the Blizard Institute of Barts and the London School of Medicine Queen Mary College where it forms part of the Clinical TB and HIV Group The Group s research interests relate to all aspects of tuberculosis and other mycobacterial diseases respiratory infections and HIV particularly its interaction with TB we focus on disease diagnosis the molecular epidemiology of TB and HIV understanding drug resistance and disease tropisms and broader public health problems posed by these diseases both in the UK and overseas We have staff working on collaborative national and international clinical laboratory and public health topics relating to TB The NMRL is a WHO Supranational Reference Laboratory for M tuberculosis DST together with centres in Germany Sweden and Belgium it co ordinates EQA for DST across the EU and non
20. specimens e Ifyou wish to send samples of non human origin please contact the NMRL clinical staff before sending Fastrack Service This is our rapid national molecular diagnostic service for primary samples and positive cultures to detect MTBC and rifampicin resistance and isoniazid resistance in cultures only Ideal specimens are smear positive primary specimens or a positive culture Other specimens have lower sensitivities for detection see Sam et al Emerging Infectious Diseases 2006 12 752 9 Seudi et al Thorax 2012 67 361 367 Generally smear positive samples are more likely to be successfully analysed as they have a higher Acid Fast Bacilli AFB load As part of Fastrack the NMRL pro actively analyses specimens shown to be rifampicin resistance for isoniazid resistance and any resulting cultures from specimens containing MTBC with rifampicin isoniazid resistant mutations predictive of MDRTB are pro actively analysed for first line and reserve drugs at no further cost to the NHS We see this as a major contribution to our public health role for clinical management and limitation of the further development and spread of drug resistant TB In general dilutional fluid samples e g CSF pleural fluid ascites etc have much lower sensitivities the minimum amount of CSF that will be examined is 0 5ml not supernatant However submitting the largest possible volume of CSF and other fluids will increase the sensitivity Please submi
21. t as much of these fluids as possible you can never submit too much Lysed blood or heavily bloodstained samples can interfere with PCR based reactions DNA in specimens requesting molecular tests may degrade if stored for too long before referral Paraffin wax blocks can be examined but sensitivity is lower than that for fresh tissue In these cases the whole wax block must be sent along with a diagram slide indicating the area where AFB granuloma were seen to aid sampling This will be returned to the sender on completion of the Fastrack analysis Interferon Gamma release Assa Blood should be collected in the tubes provided follow instructions and incubated within 16 hours of collection at 37 C for 16 24 hours before sending Samples must reach NMRL within 72 hours of removal from incubation If sent before incubation please clearly indicate as such on the form Contact tracing case meeting We are frequently asked to attend case meetings or via teleconference for complex patients and larger contact tracing investigations in institutions such as schools prisons and health care institutions We will try and assist where possible but requests with less than 1 2 working days notice of the meeting are unlikely to be feasible Referral of specimens cultures No specimens or cultures are referred to other laboratories If other investigations are required at another laboratory then it is strongly recommended that a further specimen cultu
22. tance in the United Kingdom Emerging Infectious Diseases 2006 12 5 752 9 Drobniewski F A Balabanova Y Nikolayevsky V Ruddy M Kuznetzov SI Zakharova SM Melentyev AS Fedorin IM Drug resistant tuberculosis clinical virulence and the dominance of the Beijing strain family in Russia JAMA 2005 293 2726 2731 N Seoudi S Mitchell T Brown F Dashti A K Amin F A Drobniewski Rapid molecular detection of tuberculosis and rifampicin drug resistance retrospective analysis of a national UK molecular service over the last decade Thorax 2012 67 361 367 Bamford AR Crook AM Clark JE Nademi Z Dixon G Paton JY Riddell A Drobniewski F Riordan A Anderson ST Williams A Walters S Kampmann B Comparison of interferon gamma release assays and tuberculin skin test in predicting active tuberculosis TB in children in the UK a paediatric TB network study Arch Dis Child 2010 Mar 95 3 180 6 Epub 2009 Oct 8 Brown T Nikolayevskyy V Velji P Drobniewski F Associations between Mycobacterium tuberculosis strains and phenotypes Emerg Infect Dis 2010 Feb 16 2 272 80 Reddy S Brown T Drobniewski F Detection of Mycobacterium tuberculosis from paraffin embedded tissues by INNO LiPA Rif TB assay retrospective analyses of PHE Mycobacterium Reference Unit data J Med Microbiol 2010 May 59 Pt 5 563 6 Epub 2010 Feb 4 Anderson C Story A Brown T Drobniewski F Abubakar I Tuberculosis in UK prisoners a challenge for c
23. tended to cover the transport of clinical samples from humans or cultures of micro organisms isolated from such samples to another laboratory for diagnostic or other clinical testing within the U K where the micro organisms suspected of causing the disease are all either Hazard groups 2 3 or 4 The terms Category A and Category B are limited to classifying samples microbial cultures being transported to another laboratory Sample Description Packaging Requirement Category A samples are known or suspected to contain a Assign to UN2814 Humans Packaging microbial agent with the following definition an infectious Instructions P1620 Supporting documentation as substance which is transported in a form that if exposure to per ADR it occurs is capable of causing permanent disability life Transport as category A ADR licensed courier threatening or fatal disease to humans or animals see indicative list The majority are Hazard Group 3 or 4 For practical reasons to allow referral reference services to Assign UN3373 Packaging instruction PI650 continue a limited number of Category A agents have Send by courier Royal mail will NOT accept exempted from being transported as Category A These are Vero cytotoxin producing Escherichia coli VTEC Mycobacterium tuberculosis and Shigella dysenteriae 1 Category B samples are those that do not meet the Assign UN3373 Packaging instruction P1650 definitions of Category
24. tification is not possible by the above method Isoniazid rifampicin ethambutol pyrazinamide Ofloxacin moxifloxocin Amikacin kanamycin prothionamide capreomycin Linezolid PAS this is performed rarely and the exact correlation with clinical efficacy is unclear Streptomycin only tested on request Rapid growers Cotramoxazole Linezolid Ciprofloxacin Moxifloxacin Cefoxitin Amikacin Doxycycline Clarithromycin and Tobramycin Imipenem Slow growers Clarithromycin Ethambutol Rifampicin For cultures received before 9 30 am within 1 working day All other cultures are processed the following day A report sent out within 2 working days of culture receipt A report sent out within 2 3 weeks of culture receipt A report sent out within 2 3 weeks of request for these sensitivities Identification of rifampicin resistance or MDRTB in referred cultures The NMRL pro actively analyses cultures produced at NMRL from patient specimens submitted to our national Fastrack Molecular diagnostic service If rifampicin resistance mutations are detected predictive of MDRTB we will automatically analyse cultures for first line and reserve drugs A report sent out within 2 3 weeks of request for these sensitivities or identification of XDRTB A report sent out within 1 2 weeks of culture receipt A report sent out within 2 3 weeks of culture receipt Please note the antibiotic panel tested for NTM will vary dep
25. um tuberculosis of the European Committee for Antimicrobial Susceptibility Testing EUCAST of the European Society of Clinical Microbiology and Infectious Diseases ESCMID Clin Microbiol Infect 2007 Dec 13 12 1144 56 Nikolayevskyy VV Brown TJ Bazhora YI Asmolov AA Balabanova YM Drobniewski FA Molecular epidemiology and prevalence of mutations conferring rifampicin and isoniazid resistance in Mycobacterium tuberculosis strains from the southern Ukraine Clin Microbiol Infect 2007 13 129 38 Drobniewski FA Hoffner S Rusch Gerdes S Skenders G Thomsen V Recommended standards for modern tuberculosis laboratory services in Europe Eur Respir J 2006 28 5 903 909 Drobniewski F Balabanova Y Zakamova E Nikolayevskyy V Fedorin I Rates of Latent Tuberculosis in Health Care Staff in Russia PLoS Med 2007 Feb 13 4 2 e55 Gopaul KK Brown TJ Gibson AL Yates MD and Drobniewski FA Progression towards an improved DNA amplification based typing technique in the study of Mycobacterium tuberculosis epidemiology J Clin Microbiol 2006 44 2492 2498 Kruuner A Yates MD Drobniewski FA Evaluation of MGIT 960 based antimicrobial testing and determination of critical concentrations of first and second line antimicrobial drugs with drug resistant clinical strains of Mycobacterium tuberculosis J Clin Microbiol 2006 Mar 44 3 811 8 Sam IC Drobniewski F More P Kemp M and Brown T Mycobacterium tuberculosis and rifampin resis
26. vice molecular detection of M tuberculosis complex and rifampicin resistance or multi drug resistance in primary specimens and cultures respectively e Clinical and Technical Advice e Clinical Advice for case and outbreak investigation and management e Computerised database on laboratory confirmed cases e Archived collection of Mycobacterium isolates for epidemiological analysis e Training e Research and Development For further information concerning services or matters of interest visit the PHE web site at https www gov uk government organisations public health england Services Available For further information and advice on these services please call 020 7377 5895 Samples cultures cannot be received after 17 15 Please note all turnaround times are dependent upon the receipt of a pure culture containing sufficient bacteria for analysis At least 90 of all samples will be available at the Turnaround times listed below We endeavour to assist laboratories by treating contaminated cultures to purify mycobacteria rather than returning them to the sender Reference Service Identification of cultures of AFB M tuberculosis First Line Sensitivities Reserve Drugs Additional Reserve Drugs Non tuberculous Mycobacteria Rapid identification of M tuberculosis complex and some common Non Tuberculous Mycobacteria NTM using molecular techniques DNA sequencing and phenotypic tests are performed when iden
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