Virology - Hepatitis Testing Service (HTS)

The virology hepatitis testing service provides diagnostic tests for Hepatitis A, B, C, D, and E to support the Hepatitis clinics, Liver transplantation and Liver intensive care, as well as GPs and other hospitals.

  • Hepatitis A - HAV Ab (IgG & IgM)
  • Hepatitis B - HBsAg, HBeAg/HBeAb, HBsAb, HBcAb (Total & IgM), HBV DNA, HBV genotype and drug resistance mutation
  • Hepatitis C - HCV Ab. HCV RNA Quantitative, HCV genotype
  • Hepatitis D - HDV Ab (Total & IgM); HDV RNA Quantitative
  • Hepatitis E - HEVAb (IgG & IgM)

Hours of Service

From 9am to 5pm, Monday to Friday.
No routine service is provided outside these hours. The HTS is closed on public holidays.

Clinical Advice

Clinical advice is available during service hours from:

  • Clinical Scientists providing the service at a level commensurate with their seniority and expertise. Please phone 020 3299 3732 and ask for Dr Dazhuang Shang in the first instance
  • Dr Sam Moses (Consultant Virologist and Service Lead for the HTS)
  • Dr Kosh Agarwal (Lead Clinician/Consultant Hepatologist)

Specimen Submission Guidelines

Specimen

All specimens must be labelled with the following:-

  • Patient’s full name and/or unique patient identifier (Hospital number and/or NHS number
  • Date of Birth
  • Sender’s lab reference number (requests external to KCH only)
  • Date of specimen collection
  • Time of specimen collection (desirable)

Request Forms

For Users external to KCH, a fully completed request form must accompany all specimens. Your own locally available request form is acceptable or an HTS request form is available to download HERE

Both electronic and paper requests must match the information on the specimen and must include the following information:

  • Patient’s full name and/or unique patient identifier (Hospital number and/or NHS number)
  • Date of birth
  • Gender
  • Sender’s lab reference number (requests external to KCH only)
  • Sample type (serum/EDTA plasma) (requests external to KCH only)
  • Date of specimen collection
  • Test(s) required
  • A secure postal address to which the results will be sent (results may be sent to a secure email address on prior arrangement with the Lab)
  • A contact telephone/extension number
  • A contact name
  • Relevant clinical information

PLEASE NOTE: specimens or request forms received without the minimum essential identification criteria may be rejected and/or may lead to a delay in reporting. Unlabelled specimens cannot be processed and may be discarded.

Requests that do not meet the above criteria may on occasion be accepted at the discretion of the Service Lead if the samples are regarded as ‘unrepeatable’. Reports will indicate the nature of the problem and any possible consequence of this.

Specimens sent by post or by courier must be in a sealed container, surrounded by sufficient absorbent material to absorb any fluid should a breakage occur, sealed in a plastic bag and placed in an approved outer container which meets current postal or other transport regulations.

The sender is responsible for ensuring that clinical specimens are transported in a way that complies with UK postal, courier or international safety regulations

For further information on the transport of infectious materials please refer to the following web page:

http://www.dft.gov.uk/vca/dangerousgoods/dangerous-goods-offi.asp

Specimen Collection/Processing/Factors Affecting Tests

Patient preparation:

No patient preparation is required

Serology tests:

Fresh whole blood should be left at room temperature to clot. Samples should be separated as soon as possible after collection (within 24 hours). Do not freeze whole blood samples as this can cause haemolysis of the red blood cells which may affect the results of serological assays.

Serum or plasma samples should be stored at 2-8°C for up to 5 days then should be frozen at -20°C or lower until referral. Samples should be frozen and thawed a maximum of three times as multiple freeze-thaw cycles may degrade the target analyte resulting in false negative results or inaccurate quantitation.

Certain assays (e.g. Delta Ab (Total) assay) require serum only – plasma samples are not suitable.

Samples which are grossly haemolysed, hyperlipaemic, heat-inactivated or which contain obvious microbial contamination are not suitable for testing and should not be sent.

Molecular tests:

Serum or EDTA plasma should be separated within 24 hours of collection. Separated samples should be sent as soon as possible or frozen at -20°C or lower until referral.

Multiple freeze-thaw cycles should be avoided as this may result in under-quantification of viral load.

Samples which are grossly haemolysed, hyperlipaemic or which contain obvious microbial contamination are not suitable for testing and should not be sent.

Please note: viral loads may decrease if specimens are not processed and stored appropriately.

Whole (unseparated) blood samples:

Certain tests (e.g. IL-28B (rs12979860)) require whole unseparated blood collected on EDTA. Samples should be sent to the laboratory as soon as possible after collection.

Sample volume requirements:

Please see pages for the required test(s) on the ‘Tests Provided’ table for information on minimum serum/plasma volumes required for each test.

Samples may be rejected if:

  • They are the incorrect sample type for required test(s)
  • They have leaked in transit
  • They are of insufficient volume*
  • They are grossly haemolysed, hyperlipaemic, heat-inactivated or contain obvious microbial contamination
  • The information on the request form and sample do not match or if there is insufficient information on either the sample or form
  • The specimen has not been processed/stored appropriately prior to referral or if there is a significant delay in specimen receipt

* where appropriate low volume samples may be tested at a dilution; reports will indicate the potential effect of this on assay sensitivity

If a specimen is rejected the referring laboratory will be notified of the rejection and the reason(s) why by telephone.

Authorised patient reports will be printed and delivered by post. Printed reports include results for the last four samples on the patient.

Results may be emailed to a secure email address on prior arrangement with the Laboratory.

For requests internal to KCH placed electronically, results will be available via EPR. Printed patient reports are available on request.

External Quality Assessment (EQA):

The HTS participates in all available schemes relevant to our test portfolio. These include schemes run by the UK National External Quality Assurance Scheme (NEQAS) and Quality Control for Molecular Diagnostics (QCMD). Details of participation in specific schemes are available on request.

Internal Quality Assessment (IQA):

The quality of our Service is also monitored by our IQA re-test scheme. This involves the selection of previously tested and reported samples for anonymised/blind re-testing. After re-testing, the results for IQA samples are unblinded and are assessed against the originally reported results. Any inconsistencies are fully investigated and, where appropriate, corrective measures are implemented.

EQA and IQA performance outcomes are discussed at monthly HTS Lab Meetings and monthly Quality Meetings.

Terms of Payment

Invoices are issued monthly. Our Services are provided based on agreement with the Referring Laboratory that payment will be received within 30 days from the date of the invoice.

All requests external to KCH must be accompanied by written acceptance of charges for testing for testing and a clear indication of the person and/or department to whom the invoice should be sent.

For further information on KCH Liver Pathology Services please refer to the Liver Pathology User Handbook

Contact
Dazhuang Shang
Tel. +44 (0)20 3299 3732
Fax: +44 (0)20 3299 3955
Email: kch-tr.LiverHTS@nhs.net
Lead Clinician: Dr. Kosh Agarwal

Our Team


URGENT TESTS
Call us on +44 (0)20 3299 3732 to discuss any urgent test request(s).

Tests Provided

TestTurnaround *
HAV Ab (IgM)2 working days
HAV Ab (Total)2 working days
HBsAg2 working days
HBsAb2 working days
HBsAg Confirmatory5 working days
HBsAg Quantitative3 working days
HBeAg2 working days
HBeAb2 working days
HBcAb (IgM)2 working days
HBcAb2 working days
HBV DNA Quantitative4 working days
HBV Drug Resistance Mutation10 working days
HBV Genotype10 working days
HBV Genotype + Drug Resistance Mutation10 working days
HCV Ab2 working days
HCV Genotype5 working days
HCV RNA Quantitative3 working days
Delta Ab (Total)5 working days
Delta Ab (IgM)10 working days
HDV RNA Quantitative5 working days
HEV Ab (IgM)5 working days
HEV Ab (IgG)5 working days
HEV RNA15 working days

For further information on any of the above tests please contact the Laboratory directly

Minimum sample requirements include sufficient volume for repeat testing in the event of assay failure. Smaller volumes may be sent at Sender’s discretion.

* Turnaround is based on single test per sample, where multiple tests are requested on a sample the turnaround time of the sample is likely to be that of the test with the longest turnaround time.

Requests for Additional Tests

Time Limits and Retention of Specimens

If additional testing is required on a sample previously sent to the HTS, please contact the Lab directly. Specimens are normally retained for several years after analysis but further testing may not be possible due to insufficient sample volume, specimen viability or other factors. The HTS will be able to advise on the suitability of the original specimen for further testing.

Sample Referral

When required, samples will be referred for testing to external accredited referral laboratories.

Where it is not possible to determine HCV genotype in-house and for qualitative HEV RNA and Q80K testing samples will be referred to:

Micropathology Ltd.
University of Warwick Science Park,
Venture Centre, Sir William Lyons Road,
Coventry,
CV4 7EZ
United Kingdom

For HEV RNA quantitation samples will be referred to:

Public Health England Virus Reference Department
61 Colindale Avenue, London
NW9 5EQ