THIS IS A CONTROLLED DOCUMENT. DO NOT COPY Area Laboratory Service Organisational Unit: Title: Ref No: Version No: Date Issued: Author: Authorised by: Review date: Location of this Copy : Microbiology Lyme borreliosis users guide MQ022 2.1 07-Jun-2017 Sally Mavin Roger Evans 07-Jun-2018 Microbiology Serology The master copy of this document is held and controlled on ipassport QMS. Document review history is recorded on ipassport.
NATIONAL LYME BORRELIOSIS TESTING LABORATORY USER MANUAL Page 1 of 12
CONTENTS Section Page 1 Introduction 3 2 Contact details and key personnel 3 3 Opening hours 3 4 Service provided 4 4.1 Samples 4 4.2 Laboratory tests 4 4.3 Specialist advice 4 5 Clinical Information 4 6 Specimen and request form labelling 5 7 Specimen transportation 5 8 Charges 6 9 Results and turn around times 6 10 Treatment 6 11 Prevention 6 12 References 6 13 Lyme request form Form MF023 14 Latoratory diagnosis of Lyme borreliosis algorithm 7 Page 2 of 12
1.0 Introduction The National Lyme borreliosis testing laboratory (NLBTL), established in 2003, provides a specialist diagnostic service for Scottish Health Boards and other users by request. In 2014 over 5000 samples were tested at NLBTL. The laboratory is located within the Microbiology department of Raigmore Hospital, Inverness, where testing for Lyme borreliosis has taken place since 1990. The department is accredited by Clinical Pathology Accreditation (UK) Ltd. Lyme borreliosis (formerly Lyme disease) is caused by the spirochaete Borrelia burgdorferi and is endemic in Scotland 2.0 Contact details and key personnel 2.1 Address: Postal address: National Lyme borreliosis testing laboratory Microbiology Department Zone 3, Raigmore Hospital Old Perth Road Inverness IV2 3UJ 2.2 Telephone/ email: Enquiries (09:00-17:00 Monday to Friday) email 2.3 Key personnel: DX address DX6180102-90IV 01463 704206 / 704207 (direct) nhshighland.microbiology@nhs.net Designation Name Telephone Clinical Lead Dr Chin Lim 01463 704206 Consultant Clinical Scientist Dr Roger Evans 01463 705882 Clinical Scientist Dr Sally Mavin 01463 705882 Microbiology Service Manager Dr David Ashburn 01463 704108 3.0 Opening hours 3.1 Core Hours are Monday Friday 9.00am to 5.00pm The department does not operate an out-of-hours service for Lyme borreliosis. Page 3 of 12
4.0 Service provided 4.1 Samples Serology: Please ensure minimum volume is sent to the lab. o o Clotted blood (10ml)/ serum (500μl) CSF (Highland patients: 700μl/ referred patients: 200μl) CSF samples must be accompanied by serum sample taken on the same day and must not be bloody. Referring laboratories: Albumin and IgG levels (and CSF cell counts) should also be provided for CSF/serum pairs to allow calculation of the antibody index to determine intrathecal synthesis of borrelia antibodies PCR: Skin biopsies/ CSF (200μl, after discussion with laboratory)/ joint fluid (200μl) 4.2 Laboratory tests Enzyme Immunoassay (EIA) Immunoblot for confirmation of EIA CSF/serum IgG EIA for neuroborreliosis PCR (PCR samples must be accompanied by serum sample). 4.3 Specialist advice The laboratory can be contacted (as above in 2.0) for clinical enquiries regarding Lyme borreliosis as well as advice regarding specialist testing. 5.0 Clinical Information This is vitally important in deciding how to test a sample and to provide appropriate interpretative comments on results to users. Please give specific symptoms and signs and details of any tick bite/exposure (see NLBTL request form). The BIA position statement on Lyme borreliosis advises that patients with a tick bite and erythema migrans (EM) should be treated accordingly and not tested. Testing is not indicated for asymptomatic patients with a tick bite. 5.1 Early Lyme borreliosis Onset of symptoms 3-30 days following a tick bite/exposure. EM is diagnostic but rash may be atypical. Tender muscles/ joints, pyrexia and lymphadenopathy can also occur. Meningitis/ encephalitis are rare. NB: For patients with suspected early Lyme borreliosis a negative result does not exclude the possibility of Borrelia burgdorferi infection. Failure to detect antibodies is most likely to be due to sample collection prior to detectable antibody development. 5.2 Late Lyme borreliosis Weeks to months after tick exposure. Multiple or single system involvement of skin, joints, heart, brain or peripheral nerves. Page 4 of 12
6.0 Specimen and request form labelling 6.1 For the safety of patients and staff, the NHS Highland Area Laboratory Service operates a strict specimen acceptance policy (full copy is available on request). 6.2 Specimens may be submitted either using a referring laboratory s own request form or with the NLBTL request form (found in Appendix A at the end of this user manual). However both the request form (or letter) and sample must be labelled with a minimum of three pieces of information to allow unequivocal identification of the patient: MINIMUM DATA SET Request form Sample Patient s surname (1) Patient s surname (1) Patient s forename(s) Patient s forename(s) CHI number (2) CHI number (2) Date of birth (not Date of birth (not age) age) (1) Or accepted coded identifier (e.g. soundex code, NaSH number) (2) Where the CHI number is not available a third point of identification (e.g. address) must be provided. In addition, please ensure the request form includes: Name and location of sender (or details of where the final report should be sent if different) Specimen type Date and time of collection Associated clinical information 6.3 Specimens that do not conform to the minimum data set will NOT be processed by the laboratory. 6.4 The department will reject specimens that present a Health & Safety hazard to staff (e.g. leaking specimens, contamination of specimen containers external surfaces), inappropriate and insufficient specimens. 7.0 Specimen transportation 7.1 Samples must be appropriately packaged and transported in accordance with current regulations. 7.2 If unsure of the current regulations please contact the laboratory for advice. 7.3 Please ensure that packages contain sufficient absorbent material to contain all liquid. 7.4 Please ensure request forms are placed between the plastic container and cardboard outer and not with the sample inside the plastic container. 7.5 Samples should be sent to the laboratory via Royal Mail or DX courier to the address shown in section 2.1. 7.6 NHS Highland users should use appropriate transport within NHS Highland and should refer to the NHS Highland transport policy on the intranet re. specifications for delivery. Page 5 of 12
8.0 Charges Samples received from referring laboratories and private patients are subject to charge; prices are reviewed annually and are available on request. 9.0 Results and turn around times Serology PCR Urgent requests Within 10 working days Within 7 working days Please contact the laboratory Results are returned by Royal Mail to the address on the request form. 10.0 Treatment Treatment of Lyme borreliosis can be dependent upon the clinical presentation. Often specialist advice should be sought. However, in some circumstances treatment options are straightforward: 10.1 Early Lyme borreliosis Erythema migrans or spreading rash after tick bite/exposure: Oral doxycycline (100mg bd for 14 days), amoxicillin (500mg tds for 14 days). Dosage for amoxicillin is for adults only and will need adjustment for children. Doxycycline is preferred over amoxicillin if no contraindication. Avoid doxycycline in children under 12 years, pregnancy and breastfeeding. If these antibiotics are contraindicated then seek specialist advice. Neuroborreliosis: seek specialist advice. 10.2 Late Lyme borreliosis Lyme arthritis: Oral doxycycline (100mg bd for 28 days). If not responding seek specialist advice. Skin, neurological and other late forms of disease seek specialist advice. Further information on treatment can be found in the NHS Highland formularly (http://intranet.nhsh.scot.nhs.uk/clinical/formulary/hjf/highland%20formulary.pdf) 11.0 Prevention When visiting areas inhabited by ticks regular checks should be made and any ticks removed as soon as possible (and within 24 hours). An insect repellent may also be used. Light coloured clothing makes it easier to spot ticks before they may attach. 12.0 References The epidemiology, prevention, investigation and treatment of Lyme borreliosis in United Kingdom patients: a position statement by the British Infection Association. J Inf (2011) 62,329-339 Health Protection Scotland: http://www.hps.scot.nhs.uk/pubs/detail.aspx?id=1823 NHS Highland intranet (available to NHS Highland only): http://intranet.nhsh.scot.nhs.uk/org/dhs/ssu/medical_diagnosticsdivision/labor atories/raigmore/microbiology/pages/default.aspx 13.0 Lyme request form Electronic copy available on NHS Highland intranet and HPS website (as above). Page 6 of 12
14.0 Laboratory diagnosis of Lyme borreliosis algorithm Overleaf Page 7 of 12
Laboratory diagnosis of Lyme borreliosis algorithm (NHS Highland) Erythema migrans (EM) or spreading rash with tick exposure within 6/12 of symptom onset Atypical rash or non specific symptoms (excluding neuroborreliosis) presenting within 6/12 of symptom onset Lyme arthritis (ie. clinical arthritis, not just arthropathy) Neuroborreliosis Presentation with >6/12 non specific symptoms Send serum for serology Positive Negative Repeat serology (if within 8/52 onset) Positive Negative at > 8/52 post symptom onset Send serum for serology Positive Negative Send serum for serology Seek specialist advice. Consider LP Send serum for serology Positive Negative Treat. Lyme disease serology not required. Treat as for EM Treat. Consider synovial fluid for PCR Treat/ seek specialist advice Seek alternative diagnosis Seek alternative diagnosis Page 8 of 12
Appendix: Document Lyme borreliosis users guide Appendix Links Please note: links are only correct at time of printing next if type == Linked to Controlled Document - Document: MF023: Lyme request form v1.0 (Authorised) Document Revision History Authorised on 07-Jun-2017 16:54 by Roger Evans Authorised version 2.1 - Authorised RE 7/6/17. The following users will be notified when a review is due for this document: Roger Evans, Sally Mavin Document was scheduled to be released on 2017-06-07 Superseded on 07-Jun-2017 16:54 by Roger Evans Version 2.0 superseded by version 2.1 Draft Created on 23-May-2017 14:24 by Sally Mavin Reason: Amendments required, in particular, extra information re. CSF testing and antibiotic treatment Superseded on 02-Jun-2016 15:57 by Roger Evans Version 1.2 superseded by version 2.0 Authorised on 02-Jun-2016 15:57 by Roger Evans Authorised version 2.0 - Authorised 2/6/16. The following users will be notified when a review is due for this document: Sally Mavin Draft Created on 14-Apr-2016 16:28 by Sally Mavin Reason: requires updating Superseded on 25-Feb-2015 14:00 by Roger Evans Version 1.1 superseded by version 1.2 Page 9 of 12
Appendix: Document Lyme borreliosis users guide Authorised on 25-Feb-2015 14:00 by Roger Evans Authorised version 1.2 - Read 25/2/15 RE. The following users will be notified when a review is due for this document: Roger Evans, Sally Mavin Draft Created on 02-Feb-2015 15:09 by Sally Mavin Reason: Document Reviewed on 02-Feb-2015 15:08 by Sally Mavin Review date set to 29-Feb-2016 - review. The following users will be notified when a review is due for this document: Roger Evans, Sally Mavin. This document was originally due for review on 31-Dec-2014. Superseded on 19-Dec-2013 16:47 by Susan McDonagh Version 1.0 superseded by version 1.1 Authorised on 19-Dec-2013 16:47 by Susan McDonagh Authorised version 1.1 -. The following users will be notified when a review is due for this document: Roger Evans, Sally Mavin Pending tasks were closed with reason: Reviews received verbally Review Task Completed on 26-Sep-2013 15:16 by Jean Chatterton (Inactive) Jean Chatterton completed task, "" Review Task Completed on 27-Jun-2013 13:28 by David Ashburn David Ashburn completed task, "" Review Task Completed on 20-Jun-2013 13:10 by Emma Watson Emma Watson completed task, "" Change Requested on 20-Jun-2013 12:28 by Roger Evans Roger Evans requested a change: "1. I have a picture/clip art of ticks and a dark field microscopy picture of Borrelia. 2. Page 4, Sectin 5.2. Change STRL to NLBTL (Section 2.2). 3. Page 5 Section 6.0. last sentence. Change Section 7,1 to Section 10.1. " Page 10 of 12
Appendix: Document Lyme borreliosis users guide Change Requested on 18-Jun-2013 16:34 by Sally Mavin Sally Mavin requested a change: " " 1. photo - better one can be found on T drive/lyme/pictures/borrelia 2. 5.2 - contact the laboratory (not STRL) for advice 3. 6.0 - please give specific symptoms and signs, date of onset and information on any tick bites/exposure 4. 7.0 - E1 standard implies that we need to mention sample volumes. We require 200µl CSF/joint fluid for PCR, 100µl serum (preferably 500µl),?10ml clotted blood 5. E1 standard implies we need a list of key factors which are known to affect the performance of the test or interpretation of results. Perhaps we need to consider putting in a section outlining what a positive, indeterminate or negative result means. i.e. negative result does not rule out infection if sample has been taken early (<8wks) or if antibiotic therapy has been given, therefore a repeat sample should be requested. Likewise, a positive result only indicates that the patient has evidence of infection at some time. If an indeterminate result is obtained a repeat sample should be taken etc etc Change Requested on 13-Jun-2013 15:08 by Susan McDonagh Susan McDonagh requested a change: "Track changes on - new upload required? Going out with ipassport front page - if so, pagination is one page out. 2.2 Telephone availability given as 09:00-17:30 but phones currently not answered in office after 17:15.? whether still the same with new staff. 2.2 / 3.1 Core hours given as Mon-Fri, but Saturday also included in phone info. Bullet points: should these be sub numbers? " Peer Review Requested on 07-Jun-2013 16:09 by David Ashburn Peer Review tasks were assigned to the following users: David Ashburn, Jean Chatterton, Roger Evans, Sally Mavin, Susan McDonagh, Emma Watson. This review is to be completed by 14-Jun-2013 Draft Created on 07-Jun-2013 11:11 by David Ashburn Reason: Review following CPA non-conformance of toxoplasma user manual Authorised on 16-May-2013 11:52 by David Ashburn Authorised version 1.0 -. The following users will be notified when a review is due for this document: Sally Mavin Creation on 15-May-2013 11:11 by David Ashburn New Document created Page 11 of 12
Appendix: Document Lyme borreliosis users guide Authorisation This document was securely signed and authorised by Roger Evans on 07-Jun-2017 Page 12 of 12