title: 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.
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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Medical Biotechnology, University of Siena, viale Mario Bracci n.16, 53100 Siena, Italy. Electronic address: genny.meini@gmail.com.
authors.forename: Genny
authors.initials: G
authors.lastname: Meini
authors.affiliation: Institute of Pharmacology, Catholic University Medical School, Rome, Italy. Electronic address: cinzia.dellorusso@rm.unicatt.it.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Dello Russo
authors.affiliation: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, c.so Svizzera 164, 10149 Torino, Italy. Electronic address: tiziano.allice@aslto2.piemonte.it.
authors.forename: Tiziano
authors.initials: T
authors.lastname: Allice
authors.affiliation: Hygiene Unit, IRCCS AOU San Martino-IST, Genoa, Italy. Electronic address: renata.barresi@hsanmartino.it.
authors.forename: Renata
authors.initials: R
authors.lastname: Barresi
authors.affiliation: I.N.M.I. Lazzaro Spallanzani, Rome, Italy. Electronic address: roberta.darrigo@inmi.it.
authors.forename: Roberta
authors.initials: R
authors.lastname: D'Arrigo
authors.affiliation: Department of Molecular Medicine, Sapienza University of Rome, Italy. Electronic address: francesca.falasca@uniroma1.it.
authors.forename: Francesca
authors.initials: F
authors.lastname: Falasca
authors.affiliation: Ospedali Riuniti di Foggia, viale Luigi Pinto, 71100 Foggia, Italy. Electronic address: marlip@tiscalinet.it.
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Lipsi
authors.affiliation: IRCCS S. Matteo Hospital, Pavia, Italy. Electronic address: S.Paolucci@smatteo.pv.it.
authors.forename: Stefania
authors.initials: S
authors.lastname: Paolucci
authors.affiliation: Microbiology, Immunology and Virology Unit, IRCCS CRO Aviano National Cancer Institute, via Gallini n.2, Aviano, 33081 PN, Italy. Electronic address: szanussi@cro.it.
authors.forename: Stefania
authors.initials: S
authors.lastname: Zanussi
authors.affiliation: Ospedali Riuniti di Foggia, viale Luigi Pinto, 71100 Foggia, Italy. Electronic address: rantonetti@ospedaliriunitifoggia.it.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Antonetti
authors.affiliation: IRCCS S. Matteo Hospital, Pavia, Italy. Electronic address: f.baldanti@smatteo.pv.it.
authors.forename: Fausto
authors.initials: F
authors.lastname: Baldanti
authors.affiliation: Microbiology, Immunology and Virology Unit, IRCCS CRO Aviano National Cancer Institute, via Gallini n.2, Aviano, 33081 PN, Italy. Electronic address: gbasaglia@cro.it.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Basaglia
authors.affiliation: Hygiene Unit, IRCCS AOU San Martino-IST, Genoa, Italy. Electronic address: bianca.bruzzone@hsanmartino.it.
authors.forename: Bianca
authors.initials: B
authors.lastname: Bruzzone
authors.affiliation: Ospedale Civile Spirito Santo di Pescara, Pescara, Italy. Electronic address: e.polilli@libero.it.
authors.forename: Ennio
authors.initials: E
authors.lastname: Polilli
authors.affiliation: Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, c.so Svizzera 164, 10149 Torino, Italy. Electronic address: valeria.ghisetti@unito.it.
authors.forename: Valeria
authors.initials: V
authors.lastname: Ghisetti
authors.affiliation: I.N.M.I. Lazzaro Spallanzani, Rome, Italy. Electronic address: leopoldo.pucillo@inmi.it.
authors.forename: Leopoldo Paolo
authors.initials: LP
authors.lastname: Pucillo
authors.affiliation: Department of Molecular Medicine, Sapienza University of Rome, Italy. Electronic address: ombretta.turriziani@uniroma1.it.
authors.forename: Ombretta
authors.initials: O
authors.lastname: Turriziani
authors.affiliation: ViiV Healthcare s.r.l, via Fleming 2, 37135 Verona, Italy. Electronic address: antonella.a.pirazzoli@viivhealthcare.com.
authors.forename: Antonella
authors.initials: A
authors.lastname: Pirazzoli
authors.affiliation: Institute of Pharmacology, Catholic University Medical School, Rome, Italy. Electronic address: pnavarra@rm.unicatt.it.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Navarra
authors.affiliation: Department of Medical Biotechnology, University of Siena, viale Mario Bracci n.16, 53100 Siena, Italy. Electronic address: maurizio.zazzi@gmail.com.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Zazzi
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects; D019411:Clinical Laboratory Techniques / Q000379:methods / Q000592:standards*; D015224:Dideoxynucleosides / Q000008:administration & dosage / Q000009:adverse effects; D004342:Drug Hypersensitivity / Q000175:diagnosis* / Q000517:prevention & control; D060005:Genotyping Techniques / Q000379:methods / Q000592:standards*; D015235:HLA-B Antigens / Q000235:genetics*; D006801:Humans; D007558:Italy; D059021:Laboratory Proficiency Testing; D011785:Quality Assurance, Health Care; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D015235:HLA-B Antigens; D000099227:Abacavir; C484830:HLA-B*57:01 antigen
keywords: Abacavir hypersensitivity reaction; External quality assurance; HIV; HLA-B*57:01 testing