Comparative evaluation of three FDA-approved HIV Ag/Ab combination tests using a genetically diverse HIV panel and diagnostic specimens

Journal of Clinical Virology

Volumn 92, Issue , 2017, Pages 62-68

  Qiu, Xiaoxing ^a   Sokoll, Lori ^b   Yip, Paul ^c   Elliott, Debra J ^b   Dua, Renu ^b   Mohr, Phaedre ^b   Wang, Xiao Yan ^c   Spencer, Megan ^c   Swanson, Priscilla ^a   Dawson, George J ^a   Hackett, John ^a  

^a ABBOTT LABORATORIES   (United States)

^b DEPARTMENT OF PATHOLOGY   (United States)

^c UNIVERSITY HEALTH NETWORK   (Canada)

Author keywords

Acute HIV infection; Clinical specificity; Genetic diversity; HIV antigen and antibody combination test

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; HUMAN IMMUNODEFICIENCY VIRUS ANTIGEN;

ACUTE HIV INFECTION; ANTIGEN DETECTION; ARTICLE; CHEMILUMINESCENCE IMMUNOASSAY; COMPARATIVE STUDY; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; FOOD AND DRUG ADMINISTRATION; GENETIC VARIABILITY; GENOTYPE; HIV CLIA KIT; HIV TEST; HUMAN; IMMUNOASSAY; IMMUNOASSAY ANALYZER; LIMIT OF DETECTION; MULTIPLEX FLOW IMMUNOASSAY; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; SEROCONVERSION; VIRUS ISOLATION; BLOOD; DEVICES; DIAGNOSTIC KIT; DIAGNOSTIC TEST APPROVAL; EVALUATION STUDY; GENETIC VARIATION; GENETICS; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 2; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOLOGY; ISOLATION AND PURIFICATION; MASS SCREENING; PROCEDURES; SERODIAGNOSIS; UNITED STATES; VIROLOGY; VIRUS LOAD;

AIDS SERODIAGNOSIS; DIAGNOSTIC TEST APPROVAL; GENETIC VARIATION; HIV ANTIBODIES; HIV ANTIGENS; HIV INFECTIONS; HIV-1; HIV-2; HUMANS; MASS SCREENING; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VIRAL LOAD;

EID: 85019373193     PISSN: 13866532     EISSN: 18735967     Source Type: Journal    
DOI: 10.1016/j.jcv.2017.05.005     Document Type: Article

References (39)

1. [1] Centers for Disease Control and Prevention. CDC Features: June 27 is National HIV Testing Day, http://www.cdc.gov/features/hivtesting/. Accessed September 20, 2016.
2. [2] Centers for Disease Control and Prevention (CDC). Challenges in HIV Prevention NCHHSTP Newsroom. http://www.cdc.gov/nchhstp/newsroom/docs/factsheets/challenges-508.pdf. Accessed September 20, 2016.
3. [3] Centers for Disease Control and Prevention (CDC), National HIV testing day and new testing recommendations. MMWR. Morb. Mortal. Wkly. Rep., 63, 2014, 537.
4. [4] Pandori, M.W., Hackett, J. Jr, Louie, B., Vallari, A., Dowling, T., Liska, S., Klausner, J.D., Assessment of the ability of a fourth-generation immunoassay for human immunodeficiency virus (HIV) antibody and p24 antigen to detect both acute and recent HIV infections in a high-Risk setting. J. Clin. Microb. 47 (2009), 2639–2642, 10.1128/JCM.00119-09.
5. [5] Stekler, J.D., Swenson, P.D., Coombs, R.W., Dragavon, J., Thomas, K.K., Catherine Brennan, A.C.A., Devare, S.G., Wood, R.W., Golden, R.W., HIV testing in a high incidence population: is antibody testing alone good enough?. Clin. Infect. Dis. 49 (2009), 444–453, 10.1086/600043.
6. [6] Eshleman, S.H., Khaki, L., Laeyendecker, O., Piwowar-Manning, E., Johnson-Lewis, L., Husnik, M., Koblin, B., Coates, T., Chesney, M., Vallari, A., Devare, S.G., Hackett, J. Jr., Detection of individuals with acute HIV-1 infections using the ARCHITECT HIV Ag/Ab Combo assay. J. Acquir. Immune Defic. Syndr. 52 (2009), 121–124, 10.1097/QAI.0b013e3181ab61e1.
7. [7] Chavez, P., Wesolowski, L., Patel, P., Delaney, K., Michele Owen, S., Evaluation of the performance of the abbott ARCHITECT HIV Ag/Ab combo assay. J. Clin. Virol. 52:Suppl.1 (2011), S51–S55, 10.1016/j.jcv.2011.09.010.
8. [8] Taylor, B.S., Sobieszczyk, M.E., McCutchan, F.E., Hammer, S.M., The challenge of HIV-1 subtype diversity. N. Engl. J. Med. 358 (2008), 1590–1602, 10.1056/NEJMra0706737.
9. [9] Korber, B., Gaschen, B., Yusim, K., Thakallapally, R., Kesmir, C., Detours, V., Evolutionary and immunological implications of contemporary HIV-1 variation. Br. Med. Bull. 58 (2001), 19–42.
10. [10] Gao, F., Bailes, E., Robertson, D.L., Chen, Y., Rodenburg, C.M., Michael, S.F., Cummins, L.B., Arthur, L.O., Peeters, M., Shaw, G.M., Sharp, P.M., Hahn, B.H., Origin of HIV-1 in the chimpanzee Pan troglodytes troglodytes. Nature 397 (1999), 436–441.
11. [11] Gaudy, C., Moreau, A., Brunet, S., Descamps, J.M., Deleplanque, P., Brand, D., Barin, F., Subtype B human immunodeficiency virus (HIV) type 1 mutant that escapes detection in a fourth generation immunoassay for HIV infection. J. Clin. Microbiol. 42 (2004), 2847–2849.
12. [12] Zouhair, S., Roussin-Bretagne, S., Moreau, A., Brunet, S., Laperche, S., Maniez, M., Barin, F., Harzic, M., Group O human immunodeficiency virus type 1 infection that escaped detection in two immmunoassays. J. Clin. Microbiol. 44 (2006), 662–665.
13. [13] Ly, T.D., Plantier, J.C., Leballais, L., Gonzalo, S., Lemée, V., Laperche, S., The variable sensitivity of HIV Ag/Ab combination assays in the detection of p24 Ag according to genotype could compromise the diagnosis of early HIV infection. J. Clin. Virol. 55 (2012), 121–127, 10.1016/j.jcv.2012.06.012.
14. [14] Pyne, M.T., Hackett, J. Jr, Holzmayer, V., Hillyard, D.R., Large-scale analysis of the prevalence and geographic distribution of HIV-1 non-B variants in the United States. J. Clin. Microbiol. 51 (2013), 2662–2669, 10.1128/JCM. 00880-13.
15. [15] Semaille, C., Barin, F., Cazein, F., Pillonel, J., Lot, F., Brand, D., Plantier, J.C., Bernillon, P., Le Vu, S., Pinget, R., Desenclos, J.C., Monitoring the dynamics of the HIV epidemic using assays for recent infection and serotyping among new HIV diagnoses: experience after 2 years in France. J. Infect. Dis. 196 (2007), 377–383.
16. [16] Parry, J.V., Murphy, G., Barlow, K.L., Lewis, K., Rogers, P.A., Belda, F.J., Nicoll, A., McGarrigle, C., Cliffe, S., Mortimer, P.P., Clewley, J.P., National surveillance of HIV-1 subtypes for England and Wales: design, methods, and initial findings. J. Acquir. Immune Defic. Syndr. 26 (2001), 381–388.
17. [17] Vercauteren, J., Wensing, A.M.J., van de Vijver, D.A.M.C., Alvert, J., Balotta, C., Hamouda, O., Kücherer, C., Struck, D., Schmit, J.C., Asjö, B., Bruckova, M., Camacho, R.J., Clotet, B., Coughlan, S., Grossman, Z., Horban, A., Korn, K., Kostrikis, L., Nielsen, C., Paraskevis, D., Poljak, M., Puchhammer-Stöckl, E., Riva, C., Ruiz, L., Salminen, M., Schuurman, R., Sonnerborg, A., Stanekova, D., Stanojevic, M., Vandamme, A.M., Boucher, C.A., Transmission of drug-resistant HIV-1 is stabilizing in Europe. J. Infect. Dis. 200 (2009), 1503–1508.
18. [18] Berg, M.G., Yamaguchi, J., Alessandri-Gradt, E., Tell, R.W., Plantier, J.-C., Brennan, C.A., A pan-HIV strategy for complete genome sequencing. J. Clin. Microbiol. 54 (2016), 868–882, 10.1128/JCM.02479-15.
19. [19] Brennan, C.A., Bodelle, P., Coffey, R., Devare, S.G., Golden, A., Hackett, J. Jr, Harris, B., Holzmayer, V., Luk, K.C., Schochetman, G., Swanson, P., Yamaguchi, J., Vallari, A., Ndembi, N., Ngansop, C., Makamche, F., Mbanya, D., Gurtler, L.G., Zekeng, L., Kaptue, L., The prevalence of diverse HIV-1 strains was stable in Cameroonian blood donors from 1996 to 2004. J. Acquir. Immune Defic. Syndr. 49 (2008), 432–439, 10.1097/QAI.0b013e31818a6561.
20. [20] Vallari, A., Bodelle, P., Ngansop, C., Makamche, F., Ndembi, N., Mbanya, D., Kaptué, L., Gürtler, L.G., McArthur, C.P., Devare, S.G., Brennan, C.A., Four new HIV-1 group N isolates from Cameroon: prevalence continues to be low. AIDS Res. Hum. Retroviruses 26 (2010), 109–115, 10.1089/aid.2009.0178.
21. [21] Yamaguchi, J., Bodelle, P., Vallari, A.S., Coffey, R., McArthur, C.P., Schochetman, G., Devare, S.G., Brennan, C.A., HIV infections in northwestern Cameroon: identification of HIV type 1 group O and dual HIV type 1 group M and group O infections. AIDS Res. Hum. Retroviruses 20 (2004), 944–957.
22. [22] Vallari, A., Holzmayer, V., Harris, B., Yamaguchi, J., Ngansop, C., Makamche, F., Mbanya, D., Kaptué, L., Ndembi, N., Gürtler, L., Devare, S., Brennan, C.A., Confirmation of putative HIV-1 group P in Cameroon. J. Virol. 85 (2011), 1403–1407, 10.1128/JVI.02005-10.
23. [23] Abbott Diagnostics, Product Package Insert. ARCHITECT HIV Ag/Ab Combo. 2010, Abbott Diagnostics, Abbott Park, IL, USA.
24. [24] Siemens Healthcare Diagnostics, Product Package Insert. ADVIA Centaur HIV Ag/Ab Combo (CHIV). 2015, Siemens Healthcare Diagnostics, Tarrytown, NY, USA.
25. [25] Bio-Rad Laboratories, Product Package Insert. BioPlex 2200 System HIV Ag-Ab. 2015, Bio-Rad Laboratories, Hercules, CA, USA.
26. [26] Commission decision on common technical specifications for in vitro diagnostic medical devices. Off. J. Eur. Commun. L131 (2002), 17–30.
27. [27] Commission decision on common technical specifications for in vitro diagnostic medical devices. Off. J. Eur. Commun. L39 (2009), 3–49.
28. 1, Böni, J., Schüpbach, J., Generation of a recombinant Gag virus-like-particle panel for the evaluation of p24 antigen detection by diagnostic HIV tests. PLoS One, 24(9(10)), 2014, e111552, 10.1371/journal.pone.0111552.
29. [29] Hemelaar, J., Gouws, E., Ghys, P.D., Osmanov, S., WHO-UNAIDS Network for HIV Isolation and Characterization, Global trends in molecular epidemiology of HIV-1 during 2000–2007. AIDS 25 (2011), 679–689.
30. [30] S. Lou, C.J. Hunt, J.G. Konrath, X. Qiu, J.W. Scheffel, J.D. Tyner., (2004). Monoclonal antibodies to human immunodeficiency virus and uses thereof. Patent US 6, 818, 392 B2.
31. [31] Mühlbacher, A., Schennach, H., van Helden, J., Hebell, T., Pantaleo, G., Bürgisser, P., Cellerai, C., Permpikul, P., Rodriguez, M.I., Eiras, A., Alborino, F., Cunningham, P., Axelsson, M., Andersson, S., Wetlitzky, O., Kaiser, C., Möller, P., de Sousa, G., Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay. Med. Microbiol. Immunol. 202 (2013), 77–86, 10.1007/s00430-012-0250-5.
32. [32] Masciotra, S., Performance evaluation of two recently FDA-Approved Ag/Ab combo assays in early HIV-1 infections. 2016 HIV Diagnostics Conference, 2016.
33. [33] Speers, D., Phillips, P., Dyer, J., Combination assay detecting both human immunodeficiency virus (HIV) p24 antigen and anti-HIV antibodies opens a second diagnostic window. J. Clin. Microbiol. 43 (2005), 5397–5399.
34. [34] Niederhauser, C., Ströhle, A., Stolz, M., Müller, F., Tinguely, C., The risk of a second diagnostic window with 4th generation HIV assays: two cases. J. Clin. Virol. 45 (2009), 367–369, 10.1016/j.jcv.2009.05.027.
35. [35] George, C.R., Robertson, P.W., Lusk, M.J., Whybin, R., Rawlinson, W., Prolonged second diagnostic window for human immunodeficiency virus type 1 in a fourth-generation immunoassay: are alternative testing strategies required?. J. Clin. Microbiol. 52 (2014), 4105–4108, 10.1128/jcm.01573-14.
36. [36] Centers for Disease Control and Prevention (CDC), Detection of acute HIV infection in two evaluations of a new HIV diagnostic testing Algorithm—United States, 2011–2013. MMWR. Morb. Mortal. Wkly. Rep. 62 (2013), 489–494.
37. [37] Bennett, B., Neumann, D., Fordan, S., Villaraza, R., Crowe, S., Gillis, L., Performance of the new HIV-1/2 diagnostic algorithm in Florida's public health testing population: a review of the first five months of utilization. J. Clin. Virol. 58:Suppl. 1 (2013), e29–33, 10.1016/j.jcv.
38. [38] Malm, K., von Sydow, M., Andersson, S., Performance of three automated fourth-generation combined HIV antigen/antibody assays in large-scale screening of blood donors and clinical samples. Transfus. Med. 19 (2009), 78–88, 10.1111/j.1365-3148.2009.00907.
39. [39] Salmona, M., Delarue, S., Delaugerre, C., Simon, F., Maylin, S., Clinical evaluation of BioPlex 2200 HIV Ag-Ab, an automated screening method providing discrete detection of HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody. J. Clin. Microbiol. 52 (2014), 103–107, 10.1128/JCM.02460-13.