First external quality assurance program of the Italian HLA-B*57:01 Network assessing the performance of clinical virology laboratories in HLA-B*57:01 testing

J Clin Virol. 2016 May:78:1-3. doi: 10.1016/j.jcv.2016.02.020. Epub 2016 Feb 23.

Abstract

Background: Since the HLA-B*57:01 allele is strongly associated with abacavir hypersensitivity reaction, testing for the presence of HLA-B*57:01 is mandatory before administration of abacavir. While HLA-B*57:01 testing is usually provided by pharmacogenetics, genetics or blood transfusion services, clinical virology laboratories can be an optimal opportunity for HLA-B*57:01 testing since they receive blood samples for routine HIV monitoring and have the expertise for convenient and less expensive PCR-based point mutation assays.

Objectives: The Italian HLA-B*57:01 Network gathers accredited clinical virology laboratories offering HLA-B*57:01 testing in Italy with the aim to share protocols, test new methods, develop and maintain external quality assurance (EQA) programs.

Study design: A panel of 9HLA-B*57:01-positive and 16HLA-B*57:01-negative frozen blood samples were blindly distributed to 10 units including 9 clinical virology laboratories and one reference pharmacology laboratory. Each laboratory was free to use its own routine method for DNA extraction and HLA-B*57:01 testing.

Results: DNA was extracted by automated workstations in 6 units and by manual spin columns in 4. Eight units used the Duplicα Real Time HLA-B*57:01 kit by Euroclone and two units used two different PCR homemade protocols. All the 10 units correctly identified all the 25 samples.

Conclusions: The first HLA-B*57:01 EQA program run in Italy showed that clinical virology units are equipped and proficient for providing HLA-B*57:01 testing by inexpensive assays easy to integrate into their routine.

Keywords: Abacavir hypersensitivity reaction; External quality assurance; HIV; HLA-B*57:01 testing.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • Clinical Laboratory Techniques / methods
  • Clinical Laboratory Techniques / standards*
  • Dideoxynucleosides / administration & dosage
  • Dideoxynucleosides / adverse effects
  • Drug Hypersensitivity / diagnosis*
  • Drug Hypersensitivity / prevention & control
  • Genotyping Techniques / methods
  • Genotyping Techniques / standards*
  • HLA-B Antigens / genetics*
  • Humans
  • Italien
  • Laboratory Proficiency Testing*
  • Quality Assurance, Health Care

Substances

  • Anti-HIV Agents
  • Dideoxynucleosides
  • HLA-B Antigens
  • HLA-B*57:01 antigen
  • abacavir