title: HIV testing updates and challenges: when regulatory caution and public health imperatives collide.
abstract: Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25 years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster turnaround times for test results. These play an important role in identifying HIV infection during the highly infectious acute phase, which has implication for both patient management and public health interventions to control the spread of HIV. Access to these developments, however, is often delayed by the regulatory apparatus for approval and oversight of HIV testing in the USA. This article summarizes recent developments in HIV diagnostic testing technology, outlines their implications for clinical management and public health, describes current systems of regulatory oversight for HIV testing in the USA, and proposes alternatives that could expedite access to improved tests as they become available.
authors: Scientific Affairs LLC, Eldorado Drive NE, Atlanta, GA, 30345, USA, BBranson@ScientificAffairs.us.
authors: Bernard M
authors: BM
authors: Branson
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods* / Q000639:trends; D042241:Early Diagnosis; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D011634:Public Health; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
references: J Clin Microbiol. 2009 Aug;47(8):2639-42
references: 19535523
references: PLoS One. 2014 Mar 06;9(3):e86461
references: 24603442
references: J Clin Virol. 2011 Dec;52 Suppl 1:S63-6
references: 21995932
references: Antimicrob Agents Chemother. 1993 May;37(5):1037-42
references: 7685994
references: J Clin Virol. 2011 Dec;52 Suppl 1:S23-7
references: 21993309
references: J Clin Virol. 2013 Dec;58 Suppl 1:e123-6
references: 23994111
references: Transfusion. 2003 Oct;43(10):1428-32
references: 14507275
references: J Mol Diagn. 2005 Feb;7(1):2-7
references: 15681468
references: PLoS One. 2013 Dec 12;8(12):e80629
references: 24349007
references: Arch Intern Med. 2010 Jan 11;170(1):66-74
references: 20065201
references: J Acquir Immune Defic Syndr. 2009 Sep 1;52(1):121-4
references: 19506484
references: J Clin Virol. 2011 Dec;52 Suppl 1:S35-40
references: 22018662
references: MMWR Morb Mortal Wkly Rep. 2011 Jul 29;60(29):985-8
references: 21796096
references: Am J Med. 1997 May 19;102(5B):117-24; discussion 125-6
references: 9845513
references: J Clin Virol. 2011 Dec;52 Suppl 1:S71-6
references: 22005551
references: AIDS. 2006 Aug 1;20(12):1655-60
references: 16868447
references: PLoS Med. 2012;9(7):e1001232
references: 22802728
references: J Clin Microbiol. 2008 May;46(5):1588-95
references: 18322061
references: J Med Microbiol. 2008 Oct;57(Pt 10):1228-33
references: 18809550
references: AIDS. 2013 Jul 17;27(11):1687-95
references: 23807269
references: J Clin Virol. 2011 Dec;52 Suppl 1:S17-22
references: 21981983
references: J Infect Dis. 2012 Dec 15;206(12):1946-7; author reply 1949-50
references: 23045630
references: J Infect Dis. 2006 Sep 15;194(6):725-33
references: 16941337
references: Antimicrob Agents Chemother. 2009 Sep;53(9):3611-9
references: 19470514
references: J Clin Virol. 2013 Dec;58 Suppl 1:e85-91
references: 24342484
references: J Infect Dis. 2010 Oct 15;202 Suppl 2:S270-7
references: 20846033
references: J Clin Virol. 2010 May;48(1):40-3
references: 20211580
references: AIDS. 2007 Aug 20;21(13):1723-30
references: 17690570
references: J Infect Dis. 2010 Apr 15;201 Suppl 1:S7-15
references: 20225950
references: J Clin Virol. 2013 Dec;58 Suppl 1:e104-7
references: 24342468
references: Commun Dis Rep CDR Rev. 1992 Oct 9;2(11):R128-30
references: 1284932
references: J Virol Methods. 2007 Jul;143(1):86-94
references: 17395277
references: J Clin Virol. 2014 Dec;61(4):623-4
references: 25453336
references: Implement Sci. 2011 Jun 10;6:62
references: 21663655
references: MMWR Morb Mortal Wkly Rep. 2013 Jun 21;62(24):489-94
references: 23784012
references: J Infect Dis. 2007 Apr 1;195(7):951-9
references: 17330784
references: J Acquir Immune Defic Syndr. 2013 Jul;63 Suppl 2:S187-99
references: 23764635
references: Curr Opin HIV AIDS. 2010 Jul;5(4):283-90
references: 20543602
references: J Clin Microbiol. 2003 May;41(5):2153-5
references: 12734265
references: AIDS Clin Care. 2003 Mar;15(3):19-23, 30
references: 12685418
references: J Clin Virol. 2011 Dec;52 Suppl 1:S41-4
references: 21995935
references: Clin Infect Dis. 2009 Aug 1;49(3):444-53
references: 19538088
references: JAMA. 1998 Nov 18;280(19):1699-701
references: 9832003
references: J Infect Dis. 2008 Sep 1;198(5):687-93
references: 18662132
references: PLoS Pathog. 2013 Mar;9(3):e1003211
references: 23516360
references: JAMA Intern Med. 2013 Mar 25;173(6):475-6
references: 23529554
references: Clin Infect Dis. 2010 Dec 1;51(11):1334-42
references: 21039219
references: J Clin Virol. 2014 Aug;60(4):399-401
references: 24932737
references: J Infect Dis. 2010 Apr 15;201 Suppl 1:S52-8
references: 20225947
references: J Clin Virol. 2013 Dec;58 Suppl 1:e119-22
references: 24342471
references: J Clin Virol. 2013 Dec;58 Suppl 1:e97-e103
references: 24113294
references: MMWR Morb Mortal Wkly Rep. 2002 Nov 22;51(46):1051-2
references: 12487529
references: N Engl J Med. 2011 May 19;364(20):1943-54
references: 21591946
references: AIDS. 2006 Aug 1;20(12):1597-604
references: 16868440
references: MMWR Recomm Rep. 2005 Nov 11;54(RR-13):1-25; quiz CE1-4
references: 16280973
references: J Clin Virol. 2013 Dec;58 Suppl 1:e108-12
references: 24342469
references: MMWR Suppl. 1989 Jul 21;38(7):1-7
references: 2501638
references: J Clin Virol. 2011 Dec;52 Suppl 1:S67-9
references: 21995933
references: J Clin Microbiol. 2014 Sep;52(9):3377-83
references: 25031444
references: Transfusion. 1997 Mar;37(3):352-4
references: 9122912
references: J Infect Dis. 2004 May 15;189(10):1785-92
references: 15122514
references: J Clin Virol. 2013 Dec;58 Suppl 1:e92-6
references: 24342485
references: J Infect Dis. 2012 Jan 1;205(1):87-96
references: 22180621
references: AIDS. 2003 Sep 5;17(13):1871-9
references: 12960819
references: MMWR Morb Mortal Wkly Rep. 2009 Nov 27;58(46):1296-9
references: 19940835
references: MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4
references: 16988643
references: J Clin Virol. 2013 Dec;58 Suppl 1:e54-8
references: 23911678
references: MMWR Morb Mortal Wkly Rep. 2008 Jun 20;57(24):660-5
references: 18566566
references: J Clin Virol. 2013 Dec;58 Suppl 1:e113-8
references: 24342470
references: J Clin Microbiol. 2014 Jan;52(1):103-7
references: 24153130