Department

Microbiology

Preferred Sample Type

Hepatitis B genotypic resistance testing

Suitable Specimen Types

  • EDTA Whole Blood
2ml plasma

Turnaround Time

14 days

Sample Stability

Freshly drawn specimens (whole blood) may be held at 2 to 30°C for up to 6 hours prior to centrifugation.
Plasma samples are stored for 2 years at -20°C.

Hepatitis B genotypic resistance testing

General Information

Genotypic HBV resistance testing is the current recommended method for determining drug resistance in HBV infection. Genotypic resistance data provides information on the presence/absence of drug resistance mutations, which is used as a predictor of virological response to therapy. This aids clinical decisions regarding therapy changes. Choosing the most appropriate therapy regime improves patient management and reduces the cost of care.

The methodology for genotypic HBV resistance testing involves extraction of DNA, amplification of the polymerase gene using a nested PCR, population sequencing, sequence analysis and resistance interpretation.

 

Patient Preparation

For taking blood samples we recommend that users follow either their local protocols or “The Royal Marsden Manual of Clinical Nursing Procedures”.

Lavender  top blood (EDTA) sample

  • Sufficient blood for the test should be drawn into lavender topped (EDTA) vacuum tubes
  • Invert tube 8–10 times.

The Hepatitis B genotypic resistance request form is available from the following link HBV GENOTYPIC RESISTANCE REQUEST FORM

Specifications

  • EQA Scheme?: Yes
  • EQA Status: QCMD

The laboratories at Heartlands Hospital, Good Hope Hospital and Solihull Hospital form part of the services provided by University Hospitals Birmingham and are UKAS (United Kingdom Accreditation Service) accredited to the ISO 15189:2012 standard. For a list of accredited tests and other information please visit the UKAS website using the following link: https://www.ukas.com/find-an-organisation/

  • Heartlands, Good Hope and Solihull Hospital pathology laboratories are a UKAS accredited medical laboratory No.8217
  • United Kingdom Health Security Agency laboratory is a UKAS accredited medical laboratory No.8213

Tests not appearing on the UKAS Schedule of Accreditation currently remain outside of our scope of accreditation. However, these tests have been validated to the same high standard as accredited tests and are performed by the same trained and competent staff.

For further test information, please visit the test database: http://www.heftpathology.com/frontpage/test-database.html.

Protection of personal information - Laboratory Medicine comply with the Trust Data Protection policy and have procedures in place to allow the Directorate and its employees to comply with the Data Protection act  1998 and associated best practice and guidance.

For further information contact Louise Fallon, Quality Manager, 0121 424 1235

UKAS HEFT