Virology User Manual
Virology User Manual
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DEPARTMENT OF VIROLOGY
USER MANUAL
Version 17
November 2016
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TABLE OF CONTENTS
MISSION STATEMENT
INTRODUCTION
The Virology Laboratory, University College London Hospitals NHS Foundation Trust is accredited by
Clinical Pathology Accreditation (UK) Limited and performs in excess of 500,000 tests per year. The
department is also licenced by the HTA under the Quality and Safety (tissue and cells) Regulations,
Human Application Sector. In addition to the routinely available tests used to diagnose and monitor
viral infections the assay development group of the department develops and provides novel
molecular diagnostic assays. The Virology Laboratory is an acknowledged reference laboratory for
HIV, hepatitis B, hepatitis C and molecular diagnosis and has a special interest and expertise in:
Medical and laboratory staff are happy to discuss any problems relating to the diagnosis and
management of patients with viral infections and also with any issues about the quality of the service
provided to you.
This manual is intended to enable all users to make best use of the various services provided,
ensuring an accessible, equitable and efficient service.
LOCATION
Health Services Laboratories, Virology Laboratories, are located in buildings at 60 Whitfield Street
and 307 Euston Road.
POSTAL ADDRESS
WORKING HOURS
Routine opening
Monday to Friday 8 am to 8 pm
Saturday and Sunday 9am to 3pm
Specimens cannot be received outside these times without prior arrangement.
Out of hours
Requests for the provision of laboratory testing outside normal working hours may be accommodated
under exceptional circumstances. These should be arranged with the consultant on-call who may be
air-called through the UCLH switchboard (020 3456 7890 / 0845 155 5000).
Consultant advice
Advice on the diagnosis, treatment and containment of viral infections in patients is available at any
time through the 24 hour consultant led on-call service. The consultant providing this cover is always
contactable through the UCLH switchboard (020 3456 7890 / 0845 155 5000).
Diagnostic Services provided by HSL (HSL is a progressive partnership between The Doctors
Laboratory, Royal Free London NHS Foundation Trust (the Royal Free London) and University
College London Hospitals NHS Foundation Trust (UCLH))
On call Consultant via the UCLH Switchboard (020 3456 7890 / 0845 155 5000)
ask for the on-call Virologist (pager 299)
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It is a condition of employment within UCLH that staff observe and comply with the Trust Information
Governance Policy and related policies and procedures when handling personal data in the course of
their work. This includes personal data relating to any patient, employee, customer, client, third party
supplier or agent of UCLH. It is a condition of employment that under no circumstances will such
information be passed on or discussed with any unauthorised person
All users of UCLH data, whether employees, honorary contract holders, third party suppliers or other
employees of partner organizations are subject to the following:
SERVICES AVAILABLE
Please see also table showing diseases and specimens to be collected for virological diagnosis later
in this manual.
Urgent specimens
(1) Pregnant, in recent contact with a case of chickenpox: if there is clear history of chickenpox in
the past, no testing is necessary. Otherwise, please supply details of date of contact and type of
contact (face-to-face / same room for 15 mins / own child).
(2) For all other urgent testing please phone the laboratory so that we can identify your patient’s
specimen. Please include your contact number on the request form.
For suspected viral haemorrhagic fever or SARS or other exotic viruses in a returning traveller:
contact the duty Virologist and Infectious/Tropical Diseases team for discussion as investigating for
these pathogens might have significant infection control implications.
Specimens from patients with a suspected viral haemorrhagic fever (a history of having returned from
West Africa, within 21 days) are HIGH RISK. Contact the on-call Virologist before sending any
specimens to the laboratories. The consultant virologist will advise on the appropriate specimens to
be collected and appropriate transport. High risk specimens must be sent to the laboratory using
appropriate packaging.
Contact Virologist immediately - Air call on call Virologist (pager 299) through UCLH
switchboard (020 3456 7890 / 0845 155 5000).
REQUEST FORMS
Request forms are clearly labelled as “Virology” request forms and have a bag attached for the
specimen. Please send requests for Virology on a separate form from requests going to other
departments. Ideally serology and molecular requests should be sent on separate request forms.
Specimens accompanied by the wrong, or inadequately completed, request form may result in
unnecessary delays.
Three unique patient identifiers are required for accepting a sample for testing in Virology.
These are:
First name with family name + hospital number or NHS number + DOBSamples with a
complete Clinic code – e.g. GUM clinic coding are accepted
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All dataset options defined above must match on both request and sample for acceptance. The
sample is taken as the correct reference of information against which information on forms received
will be compared in the event of minor discrepancies.
Samples may be rejected if the minimum dataset is not provided.
The importance of accuracy when completing the form, labelling the specimen, and the
provision of relevant clinical details cannot be over-emphasised. For patient safety reasons,
mislabelled specimens may not be processed.
If a decision is made to accept a sample that does not meet the criteria listed ABOVE a ‘disclaimer’ is
added to the final report explaining the limitations of the test and result issued for the situation.
Please see table for sample type and volumes required for different assays on page 16
COLLECTION OF SPECIMENS
In order to provide you with the best quality results, it is essential that good specimens are collected
properly and at the appropriate time. It is also important that they are transported to the laboratory
without undue delay. This enables the laboratory and the medical staff to provide a meaningful report
and an interpretation relevant to the patient's illness.
Inappropriate specimens or those that are damaged or leaking are liable to be discarded. Should this
occur, every attempt will be made to inform the user that a second specimen may be required.
If unvalidated samples are tested a disclaimer will be added to the final report explaining the
limitations of the test.
Specimen collection
Please ensure that the correct specimen container is used. If unsure which specimen type to examine
or how to collect a particular specimen type, please contact the laboratory (020 344 78994) for advice.
Information for Trust users on the proper collection of blood samples is available here on the
Phlebotomy page on Insight.
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Dry swabs are not appropriate. For genital ulcers, vesicular rash, eye swabs and respiratory swabs.
please use Copan brand swabs which come with their own vial of transport medium in the same
packet and which have a long shelf life at room temperature.
These can be ordered through NHS Logistics; code HHD 116 for the small 1mL container
Use the swab provided: snap off into the bottle and replace cap. Complete patient details
Please use red topped double headed swabs for molecular MRSA screening.
Aptima swabs are available for unisex and self-taken samples. Urine collection kits are also available
for CT/GC molecular tests.
Blood samples collected into EDTA purple capped containers OR EDTA plasma are required for all
molecular testing. Serum and blood samples collected in lithium heparin, or heparin are not suitable
for molecular tests and will be rejected.
For serological tests only a clotted (red top) or SST (yellow top) blood or serum are the samples of
choice. Other blood samples may be rejected.
For most single investigations a minimum volume of 4-5ml of blood is required. Larger
volumes will be needed for multiple investigations or two separate specimens where both
serological and molecular testing is required. Neonatal / paediatric specimens should indicate
the priority tests when small volumes are sent.
Please contact the laboratory for further guidance on specimen volumes if only a small volume is
available.
If sending separated plasma or serum ensure all tubes are clearly labelled as to the contents.
SPECIMEN LABELLING
Complete patient details must be clearly marked on BOTH the request form AND the specimen
container before insertion into the plastic bag and before it is sealed ready for transportation. Do not
use pins or staples as this is hazardous.
The specimen must be labelled with the same patient details as that on the request form.
Please ensure that the full patient name and the date of specimen collection are legible. The sample
is taken as the correct reference of information against which information on forms received will be
compared in the event of minor discrepancies.
The importance of accuracy when completing the form, labelling the specimen, and the
provision of relevant clinical details cannot be over-emphasised. For patient safety reasons,
mislabelled specimens may not be processed.
TRANSPORT OF SPECIMENS
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Specimens should be sent direct to the Virology Specimen Reception at 60 Whitfield Street W1T 4EU
as soon as possible after collection. If there is a transport delay samples should be refrigerated.
Samples older than seven days since collection should be discarded and a repeat collected.
Routine specimens
Routine specimens from UCH should be sent via the pneumatic tube system. Specimens from other
sites, including GPs, should be sent using the regular courier service to 60 Whitfield Street.
Specimens may also be sent by post. Please refer to the Trust policy:
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On rare occasions, the quickest way to get an urgent specimen to the Virology laboratory may be for
a member of ward staff to carry it instead of calling a medical courier. In this situation, staff should
always carry the specimen in a suitable rigid container. Such containers should be available on each
ward. Spare/replacement containers can be obtained from Virology Specimen Reception at 60
Whitfield Street.
The sender is responsible for ensuring the health and safety of any courier or taxi service that
is used to transport specimens to the Clinical Virology laboratory.
If sent by post or by external courier, specimens must be in a sealed container, sealed in a plastic
bag. The primary container must be surrounded by sufficient absorbent packing material to take up
any leakage from the primary container during transit. Bags must then be placed in an approved outer
container which satisfies current postal or other transport regulations.
Guidance on the transporting of specimens, including specimens requiring category A transport when
being transported by road in the UK, may be found at:
[Link]
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Virology cut-off times for processing specimens with a same day turnaround time (TAT).
Cut for time for Results
Specimen type Assay
processing available
Respiratory PCR
Respiratory specimen (Influenza, RSV, ParaFlu, 11.00 16.30
Metapneumovirus, Adenovirus)
Gastro PCR
Faeces (Norovirus, Rotavirus, 11.00 16.30
Adenovirus)
COMMUNICATION OF RESULTS
Electronic reports are exported to downstream systems (to CDR for UCLH, to CELLMA for
Mortimer Market and Archway clinics, and for General Practitioners to GPLINKS, GPPORTAL and
the Community Browser).
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Automatic electronic faxing of reports is used for some requestors and this is set up within the
Laboratory Information System.
Non-electronic reports are printed twice a day and are dispatched by post Monday to Friday.
All clinically relevant and urgent positive results are telephoned out to our users by one of the medical
staff. For reasons of confidentiality, results are only faxed to “safe-haven fax numbers”.
MEDICAL ADVICE
Advice on the diagnosis, treatment and containment of viral infections in patients is available at any
time through the 24 hour consultant led on-call service. The consultant providing this cover is always
contactable through the UCLH switchboard (020 3456 7890 / 0845 155 5000).
A variety of key factors impact upon the uncertainty of results of virological testing.
Pre testing
Outside factors that can affect the outcome of investigations include the delay from specimen
collection to testing and sample storage conditions prior to and during transport to the laboratory. For
quantitative molecular testing in particular, a significant delay in transit to the laboratory may result in
inaccurate estimation of viral loads.
Note that if a patient has recently received a blood transfusion or blood products, this can result in
misleading antibody test results.
Copan swabs should be used and placed in viral transport medium. Swabs in bacterial transport
medium will not be tested.
Whole bloods should be sent to the laboratory to arrive within a maximum of 72 hours of being taken.
If sending is likely to be delayed, whole bloods may be separated and stored as plasma/serum prior to
transportation. This should be performed as soon as possible after collection.
Plasma or serum samples may be stored at 2-8C for no longer than 7 days. They should be frozen at
-20C or below if being stored longer. Repeated freeze-thaw cycles may reduce assay sensitivity.
Note that EDTA blood is the sample of choice for molecular assays, clotted or heparinised specimens
have not been validated and may give rise to erroneous results. If unvalidated samples are tested a
disclaimer will be added to the final report explaining the limitations of the test.
Urine samples for CT/GC testing should be kept refrigerated to prevent the overgrowth of bacteria
which may interfere with the result.
Testing
Results from specimens that are heat inactivated, haemolysed, and lipaemic or heavily bacterially
contaminated may not be accurate. Such specimens may be unsuitable for testing and should not be
sent.
Small volume samples:
Small volume urgent or precious samples may be diluted and tested at the discretion of the
laboratory. Diluting samples may compromise the accuracy of PCR. A repeat sample may
be requested if clinically indicated
- The maximum dilution allowed for a viral loads is 1:5 , For very small volume samples, an
“insufficient” comment will be issued.
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Post testing
All results must be interpreted with reference to clinical information. In many cases clinical comments
will be provided with results but it may not be possible to properly interpret results where clinical
information has not been provided with the request. Medical staff are available in the laboratory during
working hours and on-call (out of hours) to discuss cases and provide guidance on the diagnosis and
management of infectious diseases.
The absence of detectable markers does not necessarily exclude the possibility of infection,
especially in the early acute phase.
QUALITY ASSURANCE
The laboratory is accredited with CPA/UKAS. . For full details please refer to the UKAS website
[Link] The laboratory is
currently working towards meeting the requirements of ISO15189 and is due an inspection under
these standards in 2016. See appendix 1 for a copy of the current CPA certificate.
The results sent out by this laboratory are of the highest possible quality. To this end we have a
Quality Management System (QMS) that meets CPA/UKAS standards. The laboratory also
participates in various inter laboratory comparison schemes including the UK National External
Quality Assessment Scheme (UKNEQAS) and Quality Control for Molecular Diagnostics (QCMD) for
a wide range of virological investigations. Where tests performed are not covered by UKNEQAS or
QCMD, alternative sources of EQA material or exchange of samples with other laboratories is used to
provide external quality assurance. See appendix 2 for a copy of all EQA schemes and interlaboratory
comparisons the laboratory participates in. Our results and ongoing performance are available for
inspection.
An annual User Survey is undertaken to receive feedback on the service and to review testing profiles
and indicate where improvements to the overall service may be made.
COMPLAINTS
If you wish to make a complaint, please contact the Virology General Manager or Consultant Virologist
and your complaint will be dealt with promptly.
In the following sections you will find details of the different diagnostic tests available in our lab, the
specimen required and the turnaround time for results. The tests are presented in the following
groups:
Hepatitis viruses (hepatitis A, hepatitis B, hepatitis C, delta and hepatitis E viruses)
Retroviruses (HIV-1, HIV-2, HTLV)
Herpes viruses (CMV, EBV, herpes simplex virus, VZV, HHV-6 & 7, KSHV [aka HHV8])
Exotic/tropical viruses (including arboviruses, dengue, West Nile virus, Lassa fever virus,
Avian influenza H5N1)
Other viruses (or infective agents for which routine testing is performed in the Virology
laboratory) in alphabetical order, including lyme and syphilis testing
Screening profiles (Antenatal, Occupational Health, Needlestick donor and Needlestick
recipient screening batteries)
Molecular MRSA results are normally reported within the same working day if received by
2:30pm
Chlamydia/GC molecular results are normally available with 48 hours of receipt of specimen
Other reference laboratory investigations
Turnaround times in all the following tables are defined as the number of working days
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(Monday to Sunday) from receipt of the specimen to result authorisation and availability on IT.
Original blood specimens are retained for approximately one week. Plasma from ante-natal booking
blood specimens, needlestick related specimens and aliquots from specimens for molecular tests are
retained for 2 years. Within this time frame, additional tests can be requested on these specimens by
telephone or fax. The corresponding period of retention for urine, swab and stool specimens is 3
weeks. Documentation for Donor and Recipient samples are stored for 10 and 30 years respectively,
in line with HTA regulations .
REFERENCE LABORATORIES
Samples may be referred to Reference laboratories for more specific tests where routine testing at
UCLH is not provided. These are listed throughout the tables on the following pages.
If an investigation you require is not listed in the following tables, please call the virology department
for advice. We will receive the specimen in our laboratory and refer it to the most appropriate
reference facility.
Turnaround times for the different tests vary. Please consult with the laboratory if specific information
re turnaround times is required. Further information may be obtainable direct from the individual
reference laboratories. Full addresses of the reference laboratories used and their other contact
details are available on request.
OTHER SEROLOGY
HEPATITIS VIRUSES
VIRUS TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME
Hepatitis A Hepatitis A IgG + IgM Clotted blood Daily (Mon – Sun) 1-2 working days
All serological markers including anti-HBs Clotted blood Daily (Mon – Sun) 1-2 working days Same day if urgent
HBsAg quantitation EDTA blood On request 2-7 working days
Hepatitis B HBV DNA quantification
EDTA blood Daily (Mon – Fri) 3-7 working days
(with or without “e” markers: please specify)
HBV genotyping/resistance testing EDTA blood Twice weekly (Mon & Weds) 5-10 working days
Antibody Clotted blood Daily (Mon – Sun) 1-2 working days Same day if urgent
Hepatitis C HCV RNA detection/quantification EDTA blood Daily (Mon – Fri) 3-7 working days
HCV genotyping (including resistance) EDTA blood Twice weekly (Mon & Weds) 5-10 working days
Delta virus (HDV) serology screen Clotted blood Weekly 7-10 working days
Hepatitis D
HDV RNA detection / quantification EDTA blood Fortnightly 5-20 working days
Antibody Clotted blood Weekly 7-10 working days
Hepatitis E
HEV RNA EDTA blood Monthly / On request 15 working days
RETROVIRUSES
VIRUS TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME
“HIV test” (antibody / antigen detection) Clotted blood Daily (Mon - Sun) 1-2 working days Same day if urgent
HIV-1 RNA (viral load) EDTA blood 4-5 times / week 2-5 working days
HIV-1 genome (DNA and RNA) EDTA blood Weekly (Mon) 2-6 working days
HIV-1 and 2
HIV-1 resistance testing EDTA blood Twice weekly (Mon & Weds) 3-9 working days
HIV-2 RNA (viral load) EDTA blood Fortnightly 5-20 working days
HIV-2 genome (DNA and RNA) EDTA blood Fortnightly 5-20 working days
HTLV-1 and 2 IgG screening Clotted blood Daily (Mon – Sun) 1-3 working days
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HERPESVIRUSES If the specimen type is not specified contact the Medical Virologist
VIRUS TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME
Daily (Mon – Sun for IgG
CMV IgG + IgM Clotted blood 1-2 working days
Mon- Fri for IgM)
On demand (Contact Medical
CMV IgG avidity EDTA blood 2 working days
Virologist)
Cytomegalovirus
(CMV) CMV DNA qualitative detection EDTA blood,
CSF, urine, 3 times/week (Mon, Weds,
(This test has replaced CMV DEAFF test and 2-3 working days
broncho-alveolar Fri)
CMV culture) lavage
CMV DNA quantification EDTA blood Twice weekly (Tues & Thurs) 2-7 working days
EBV IgG antibodies Clotted blood Weekly (Weds) 3-8 working days
EBV IgM Clotted blood Weekly (Thurs) 3-8 working days
Epstein Barr Virus
(EBV) 3 times / week (Mon, Weds,
EBV DNA qualitative detection CSF 2-3 working days
Fri)
EBV DNA quantification EDTA blood Twice weekly (Tues & Thurs) 2-7 working days
Serology (usually not helpful) Reference lab test (PHE,
Clotted blood 15 working days
Please telephone to discuss Colindale)
Herpes Simplex Swabs: Daily (Mon - Fri)
(HSV) HSV-1 and 2 DNA detection (This test has Swab in VTM,
Other (e.g. CSF):
replaced both tissue culture and EM of vesicle CSF, broncho- 2-3 working days
fluid) alveolar lavage 3 times / week (Mon,
Weds, Fri)
3 times / week (Urgent 2-6 working days
VZV IgG screen Clotted blood
samples on demand) Same day if urgent
VZV IgM (Rarely useful: CSF or swab of On demand if clinically
Varicella Zoster skin/mucosal lesion for VZV-DNA detection is EDTA blood indicated: contact Medical 2-6 working days
Virus usually more helpful) Virologist
(VZV) Swabs: Daily (Mon - Fri)
Swab in VTM, Other (e.g. CSF):
VZV DNA detection Up to 5 working days
CSF 3 times / week (Mon,
Weds, Fri)
Human Herpes Reference lab test (PHE,
HHV6 & HHV7 DNA detection CSF 15 working days
viruses 6 & 7 Colindale)
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SCREENING
BATTERY TESTS SPECIMEN FREQUENCY OF TEST TURNAROUND TIME
Antenatal screen HBsAg, HIV, syphilis & Rubella IgG EDTA blood Daily (Mon – Sun) 1-2 working days Same day if urgent
Occupational Health May include: HBsAg, anti-HBs, Daily (Mon – Sun) except
Clotted blood 2-3 working days Same day if urgent
Screen Rubella IgG, VZV IgG & Measles IgG for VZV IgG (5 times / week )
Needlestick / sharps
HBsAg, HIV, anti-HCV, syphilis Clotted blood Daily (Mon – Sun) 1 working day
DONOR screen
These baseline samples are archived. They are only tested in the event
Needlestick / sharps
Save sample EDTA blood that a follow-up test on the individual shows them to have an infection
RECIPIENT
that might have been acquired from the sharps injury.
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OTHER VIRUSES (OR INFECTIVE AGENTS FOR WHICH ROUTINE TESTING IS PERFORMED IN THE VIROLOGY LABORATORY) IN ALPHABETICAL ORDER
VIRUS / AGENT TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME
16S PCR 16S rDNA identification of bacterial pathogens Tissue Weekly 5-7 working days
Faecal adenovirus (serotypes 40 & 41) DNA Daily (Mon – Sat) if
Faeces 1-2 working days
detection by PCR required
Adenovirus DNA detection by PCR Nasopharyngeal aspirate / throat
Daily (Mon – Sat) if
(This test has replaced direct washing, conjunctival swab in 1-2 working days
7 required
Adenovirus immunofluorescence and tissue culture) VTM
EDTA blood. Stem cell transplant
patients only. (For other Twice Weekly (Tues &
Adenovirus DNA quantification 2-7 working days
patients/specimens contact the Thurs)
on-call Virologist)
Anti-Streptolysin O ASO EDTA Blood Daily (Mon – Fri) 1-2 working days
3 times / week (Mon,
BK virus BKV DNA detection Urine 2-3 working days
Weds, Fri)
EDTA blood Daily (Mon – Fri) 1-2 working days
Brucella Reference lab test
Confirmatory testing
(BRU, Liverpool)
1. For first catch urine (FCU),
transport to laboratory ideally
within 48 hours (unless placed
directly in to Aptima Urine
transport media, GUM ONLY).
2. Specimens older than 7 days
Chlamydia and cannot be processed. 1-3 working days
CT/GC NAAT screen Daily (Mon – Fri)
Gonorrhoea 3. Specimens usually retained Same day if urgent
for 7 days after testing.
4. Unisex/self-taken vaginal
swabs routinely available for
GUM Clinic specimens. All
other users by local
arrangement.
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Appendix 1
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Appendix 2
EQA schemes subscribed to by the Department of Clinical Virology at UCLH