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

Genny Meini, Cinzia Dello Russo, Tiziano Allice, R. Barresi, Roberta D'Arrigo, Franceses Falasca, Maria Rosaria Lipsi, Stefania Paolucci, Stefania Zanussi, Raffaele Antonetti, Fausto Baldanti, Giancarlo Basaglia, B. Bruzzone, Ennio Polilli, Valeria Ghisetti, Leopoldo Paolo Pucillo, Ombretta Turriziani, Antonella Pirazzoli, P. Navarra, Maurizio Zazzi

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1-3
Number of pages3
JournalJournal of Clinical Virology
Volume78
DOIs
Publication statusPublished - May 1 2016

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Virology
Italy
Clinical Laboratory Services
HLA-B57 antigen
Polymerase Chain Reaction
Pharmacogenetics
DNA
Point Mutation
Blood Transfusion
Hypersensitivity
Alleles
HIV
Pharmacology

Keywords

  • Abacavir hypersensitivity reaction
  • External quality assurance
  • HIV
  • HLA-B*57:01 testing

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Cite this

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. / Meini, Genny; Russo, Cinzia Dello; Allice, Tiziano; Barresi, R.; D'Arrigo, Roberta; Falasca, Franceses; Lipsi, Maria Rosaria; Paolucci, Stefania; Zanussi, Stefania; Antonetti, Raffaele; Baldanti, Fausto; Basaglia, Giancarlo; Bruzzone, B.; Polilli, Ennio; Ghisetti, Valeria; Pucillo, Leopoldo Paolo; Turriziani, Ombretta; Pirazzoli, Antonella; Navarra, P.; Zazzi, Maurizio.

In: Journal of Clinical Virology, Vol. 78, 01.05.2016, p. 1-3.

Research output: Contribution to journalArticle

Meini, G, Russo, CD, Allice, T, Barresi, R, D'Arrigo, R, Falasca, F, Lipsi, MR, Paolucci, S, Zanussi, S, Antonetti, R, Baldanti, F, Basaglia, G, Bruzzone, B, Polilli, E, Ghisetti, V, Pucillo, LP, Turriziani, O, Pirazzoli, A, Navarra, P & Zazzi, M 2016, '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', Journal of Clinical Virology, vol. 78, pp. 1-3. https://doi.org/10.1016/j.jcv.2016.02.020
Meini, Genny ; Russo, Cinzia Dello ; Allice, Tiziano ; Barresi, R. ; D'Arrigo, Roberta ; Falasca, Franceses ; Lipsi, Maria Rosaria ; Paolucci, Stefania ; Zanussi, Stefania ; Antonetti, Raffaele ; Baldanti, Fausto ; Basaglia, Giancarlo ; Bruzzone, B. ; Polilli, Ennio ; Ghisetti, Valeria ; Pucillo, Leopoldo Paolo ; Turriziani, Ombretta ; Pirazzoli, Antonella ; Navarra, P. ; Zazzi, Maurizio. / 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. In: Journal of Clinical Virology. 2016 ; Vol. 78. pp. 1-3.
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AU - Russo, Cinzia Dello

AU - Allice, Tiziano

AU - Barresi, R.

AU - D'Arrigo, Roberta

AU - Falasca, Franceses

AU - Lipsi, Maria Rosaria

AU - Paolucci, Stefania

AU - Zanussi, Stefania

AU - Antonetti, Raffaele

AU - Baldanti, Fausto

AU - Basaglia, Giancarlo

AU - Bruzzone, B.

AU - Polilli, Ennio

AU - Ghisetti, Valeria

AU - Pucillo, Leopoldo Paolo

AU - Turriziani, Ombretta

AU - Pirazzoli, Antonella

AU - Navarra, P.

AU - Zazzi, Maurizio

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N2 - 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.

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