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Screening and diagnostic testing for HIV infection

John G Bartlett, MD
Paul E Sax, MD
Section Editor
Martin S Hirsch, MD
Deputy Editor
Jennifer Mitty, MD, MPH


Nearly 15 percent of HIV-infected persons in the United States remain unaware of their HIV infection, leading to significant morbidity and the risk of further transmission to others. Improved access to HIV testing and new testing algorithms can decrease the number of individuals who present with advanced immunocompromise, enhance the detection of newly infected individuals, and reduce transmission to others.

This topic will address screening and diagnostic testing for HIV infection in adults in clinical care settings. Detailed information about screening for HIV in the blood supply, the diagnosis of HIV infection in children, and the diagnosis of HIV infections in patients presenting with symptoms of acute infection are found elsewhere. (See "Blood donor screening: Laboratory testing", section on 'Infectious disease screening' and "Diagnostic testing for HIV infection in infants and children younger than 18 months" and "Acute and early HIV infection: Clinical manifestations and diagnosis".)


HIV testing should be performed to diagnose HIV in patients with clinical signs and symptoms of acute or chronic infection, as well as those with a possible exposure to HIV. HIV testing should also be incorporated into routine screening of healthy individuals, including pregnant women.

Symptoms of HIV infection — All patients with signs and symptoms of acute or chronic HIV infection should be tested. For patients presenting with clinical manifestations of acute HIV infection, testing for HIV RNA may be needed. A detailed discussion of the clinical manifestations of HIV infection is found elsewhere. (See "The natural history and clinical features of HIV infection in adults and adolescents".)

Possible HIV exposure — Patients who present after a known high-risk exposure to HIV (eg, sexual or percutaneous) should be tested for HIV infection and assessed for post-exposure antiretroviral therapy. Such patients should then have follow-up testing over the course of four to six months (depending upon the type of test that is used). Topic reviews that discuss risk factors for HIV transmission and the use of post-exposure prophylaxis are found elsewhere. (See "HIV infection: Risk factors and prevention strategies", section on 'Risk factors for infection' and "Nonoccupational exposure to HIV in adults" and "Management of healthcare personnel exposed to HIV".)


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Literature review current through: Sep 2016. | This topic last updated: Sep 8, 2016.
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  1. Workowski KA, Bolan GA, Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015; 64:1.
  2. Centers for Disease Control and Prevention (CDC). HIV testing among men who have sex with men--21 cities, United States, 2008. MMWR Morb Mortal Wkly Rep 2011; 60:694.
  3. Frieden TR, Foti KE, Mermin J. Applying Public Health Principles to the HIV Epidemic--How Are We Doing? N Engl J Med 2015; 373:2281.
  4. Centers for Disease Control and Prevention (CDC). Previous HIV testing among adults and adolescents newly diagnosed with HIV infection - National HIV Surveillance System, 18 jurisdictions, United States, 2006-2009. MMWR Morb Mortal Wkly Rep 2012; 61:441.
  5. Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 dependent areas, 2012. Available at http://www.cdc.gov/hiv/pdf/surveillance_report_vol_19_no_3.pdf (Accessed on March 21, 2016).
  6. Hall HI, An Q, Tang T, et al. Prevalence of Diagnosed and Undiagnosed HIV Infection--United States, 2008-2012. MMWR Morb Mortal Wkly Rep 2015; 64:657.
  7. World Health Organization.Consolidated guidelines on HIV testing services. July 2015 http://apps.who.int/iris/bitstream/10665/179870/1/9789241508926_eng.pdf?ua=1&ua=1.
  8. Walensky RP, Paltiel AD, Losina E, et al. The survival benefits of AIDS treatment in the United States. J Infect Dis 2006; 194:11.
  9. Grinsztejn B, Hosseinipour MC, Ribaudo HJ, et al. Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis 2014; 14:281.
  10. TEMPRANO ANRS 12136 Study Group, Danel C, Moh R, et al. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med 2015; 373:808.
  11. INSIGHT START Study Group, Lundgren JD, Babiker AG, et al. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med 2015; 373:795.
  12. Samji H, Cescon A, Hogg RS, et al. Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One 2013; 8:e81355.
  13. Marcus JL, Chao CR, Leyden WA, et al. Narrowing the Gap in Life Expectancy Between HIV-Infected and HIV-Uninfected Individuals With Access to Care. J Acquir Immune Defic Syndr 2016; 73:39.
  14. Centers for Disease Control and Prevention. HIV surveillance report. Diagnosis of HIV infection and AIDS in the United States and dependent areas, 2009. http://www.cdc.gov/hiv/surveillance/resources/reports/2009report/pdf/2009SurveillanceReport.pdf.
  15. Losina E, Schackman BR, Sadownik SN, et al. Racial and sex disparities in life expectancy losses among HIV-infected persons in the united states: impact of risk behavior, late initiation, and early discontinuation of antiretroviral therapy. Clin Infect Dis 2009; 49:1570.
  16. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365:493.
  17. Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS 2006; 20:1447.
  18. Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006; 55:1.
  19. Klein D, Hurley LB, Merrill D, et al. Review of medical encounters in the 5 years before a diagnosis of HIV-1 infection: implications for early detection. J Acquir Immune Defic Syndr 2003; 32:143.
  20. Qaseem A, Snow V, Shekelle P, et al. Screening for HIV in health care settings: a guidance statement from the American College of Physicians and HIV Medicine Association. Ann Intern Med 2009; 150:125.
  21. Moyer VA on behalf of the U.S. Prentive Services Task Force. Screening for HIV: U.S. Preventive services task force recommendation statement. Ann Intern Med 2013.
  22. Hutchinson AB, Farnham PG, Duffy N, et al. Return on public health investment: CDC's Expanded HIV Testing Initiative. J Acquir Immune Defic Syndr 2012; 59:281.
  23. Paltiel AD, Weinstein MC, Kimmel AD, et al. Expanded screening for HIV in the United States--an analysis of cost-effectiveness. N Engl J Med 2005; 352:586.
  24. Sanders GD, Bayoumi AM, Sundaram V, et al. Cost-effectiveness of screening for HIV in the era of highly active antiretroviral therapy. N Engl J Med 2005; 352:570.
  25. Walensky RP, Weinstein MC, Kimmel AD, et al. Routine human immunodeficiency virus testing: an economic evaluation of current guidelines. Am J Med 2005; 118:292.
  26. Paltiel AD, Walensky RP, Schackman BR, et al. Expanded HIV screening in the United States: effect on clinical outcomes, HIV transmission, and costs. Ann Intern Med 2006; 145:797.
  27. Long EF, Brandeau ML, Owens DK. The cost-effectiveness and population outcomes of expanded HIV screening and antiretroviral treatment in the United States. Ann Intern Med 2010; 153:778.
  28. Branson BM. To screen or not to screen: is that really the question? Ann Intern Med 2006; 145:857.
  29. Lyons MS, Lindsell CJ, Ruffner AH, et al. Randomized comparison of universal and targeted HIV screening in the emergency department. J Acquir Immune Defic Syndr 2013; 64:315.
  30. Leber W, McMullen H, Anderson J, et al. Promotion of rapid testing for HIV in primary care (RHIVA2): a cluster-randomised controlled trial. Lancet HIV 2015; 2:e229.
  31. Castel AD, Greenberg AE, Befus M, et al. Temporal association between expanded HIV testing and improvements in population-based HIV/AIDS clinical outcomes, District of Columbia. AIDS Care 2014; 26:785.
  32. Myers JE, Braunstein SL, Shepard CW, et al. Assessing the impact of a community-wide HIV testing scale-up initiative in a major urban epidemic. J Acquir Immune Defic Syndr 2012; 61:23.
  33. Suthar AB, Ford N, Bachanas PJ, et al. Towards universal voluntary HIV testing and counselling: a systematic review and meta-analysis of community-based approaches. PLoS Med 2013; 10:e1001496.
  34. Centers for Disease Control and Prevention (CDC). Laboratory Testing for the Diagnosis of HIV Infection:Updated Recommendations. http://www.cdc.gov/hiv/pdf/hivtestingalgorithmrecommendation-final.pdf (Accessed on July 07, 2014).
  35. Cornett JK, Kirn TJ. Laboratory diagnosis of HIV in adults: a review of current methods. Clin Infect Dis 2013; 57:712.
  36. Smith MK, Rutstein SE, Powers KA, et al. The detection and management of early HIV infection: a clinical and public health emergency. J Acquir Immune Defic Syndr 2013; 63 Suppl 2:S187.
  37. Nasrullah M, Wesolowski LG, Meyer WA 3rd, et al. Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm. AIDS 2013; 27:731.
  38. Torian LV, Eavey JJ, Punsalang AP, et al. HIV type 2 in New York City, 2000-2008. Clin Infect Dis 2010; 51:1334.
  39. 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 2013; 62:489.
  40. Centers for Disease Control and Prevention (CDC). HIV-2 Infection Surveillance--United States, 1987-2009. MMWR Morb Mortal Wkly Rep 2011; 60:985.
  41. Hoenigl M, Graff-Zivin J, Little SJ. Costs per Diagnosis of Acute HIV Infection in Community-based Screening Strategies: A Comparative Analysis of Four Screening Algorithms. Clin Infect Dis 2016; 62:501.
  42. Centers for Disease Control and Prevention (CDC). Identification of HIV-1 group O infection--Los Angeles county, California, 1996. MMWR Morb Mortal Wkly Rep 1996; 45:561.
  43. Zouhair S, Roussin-Bretagne S, Moreau A, et al. Group o human immunodeficiency virus type 1 infection that escaped detection in two immmunoassays. J Clin Microbiol 2006; 44:662.
  44. Weber B, Orazi B, Raineri A, et al. Multicenter evaluation of a new 4th generation HIV screening assay Elecsys HIV combi. Clin Lab 2006; 52:463.
  45. Yeom JS, Jun G, Chang Y, et al. Evaluation of a new fourth generation enzyme-linked immunosorbent assay, the LG HIV Ag-Ab Plus, with a combined HIV p24 antigen and anti-HIV-1/2/O screening test. J Virol Methods 2006; 137:292.
  46. Plantier JC, Leoz M, Dickerson JE, et al. A new human immunodeficiency virus derived from gorillas. Nat Med 2009; 15:871.
  47. Farzadegan H, Polis MA, Wolinsky SM, et al. Loss of human immunodeficiency virus type 1 (HIV-1) antibodies with evidence of viral infection in asymptomatic homosexual men. A report from the Multicenter AIDS Cohort Study. Ann Intern Med 1988; 108:785.
  48. Spivak AM, Sydnor ER, Blankson JN, Gallant JE. Seronegative HIV-1 infection: a review of the literature. AIDS 2010; 24:1407.
  49. Ellenberger DL, Sullivan PS, Dorn J, et al. Viral and immunologic examination of human immunodeficiency virus type 1-infected, persistently seronegative persons. J Infect Dis 1999; 180:1033.
  50. Liu P, Jackson P, Shaw N, Heysell S. Spectrum of false positivity for the fourth generation human immunodeficiency virus diagnostic tests. AIDS Res Ther 2016; 13:1.
  51. Peters PJ, Westheimer E, Cohen S, et al. Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population. JAMA 2016; 315:682.
  52. Branson BM, Stekler JD. Detection of acute HIV infection: we can't close the window. J Infect Dis 2012; 205:521.
  53. Burke DS, Brundage JF, Redfield RR, et al. Measurement of the false positive rate in a screening program for human immunodeficiency virus infections. N Engl J Med 1988; 319:961.
  54. MacDonald KL, Jackson JB, Bowman RJ, et al. Performance characteristics of serologic tests for human immunodeficiency virus type 1 (HIV-1) antibody among Minnesota blood donors. Public health and clinical implications. Ann Intern Med 1989; 110:617.
  55. Kleinman S, Busch MP, Hall L, et al. False-positive HIV-1 test results in a low-risk screening setting of voluntary blood donation. Retrovirus Epidemiology Donor Study. JAMA 1998; 280:1080.
  56. Sax PE, The Most Common Question About the New HIV Testing Algorithm, Answered. HIV and ID Observations. http://blogs.jwatch.org/hiv-id-observations/index.php/new-hiv-testing-algorithm-great-not-perfect-nothing/2016/09/04/http://blogs.jwatch.org/hiv-id-observations/index.php/new-hiv-testing-algorithm-great-not-perfect-nothing/2016/09/04/ (Accessed on September 08, 2016).
  57. Cooper CJ, Metch B, Dragavon J, et al. Vaccine-induced HIV seropositivity/reactivity in noninfected HIV vaccine recipients. JAMA 2010; 304:275.
  58. Erickson CP, McNiff T, Klausner JD. Influenza vaccination and false positive HIV results. N Engl J Med 2006; 354:1422.
  59. Jackson JB, MacDonald KL, Cadwell J, et al. Absence of HIV infection in blood donors with indeterminate western blot tests for antibody to HIV-1. N Engl J Med 1990; 322:217.
  60. Loussert-Ajaka I, Ly TD, Chaix ML, et al. HIV-1/HIV-2 seronegativity in HIV-1 subtype O infected patients. Lancet 1994; 343:1393.
  61. Schable C, Zekeng L, Pau CP, et al. Sensitivity of United States HIV antibody tests for detection of HIV-1 group O infections. Lancet 1994; 344:1333.
  62. The United States Centers for Disease Control and Prevention. Advantages and disadvantages of FDA-approved HIV immunoassays used for screening by test format and CLIA complexity. http://www.cdc.gov/hiv/pdf/testing/hiv-tests-advantages-disadvantages.pdf (Accessed on October 28, 2015).
  63. Marrazzo JM, del Rio C, Holtgrave DR, et al. HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society-USA Panel. JAMA 2014; 312:390.
  64. Jaspard M, Le Moal G, Saberan-Roncato M, et al. Finger-stick whole blood HIV-1/-2 home-use tests are more sensitive than oral fluid-based in-home HIV tests. PLoS One 2014; 9:e101148.
  65. Centers for Disease Control and Prevention. Home tests. http://www.cdc.gov/hiv/testing/hometests.html (Accessed on May 02, 2016).
  66. 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 2009; 19:78.
  67. Centers for Disease Control and Prevention. FDA-approved HIV screening tests for laboratory use only. http://www.cdc.gov/hiv/pdf/testing/hiv-tests-laboratory-use.pdf (Accessed on October 27, 2015).
  68. Centers for Disease Control and Prevention. Alere Determine HIV-1/2 Ag/Ab combo information sheet for testing programs. http://www.cdc.gov/hiv/pdf/testing/hiv-tests-laboratory-use.pdf (Accessed on December 16, 2014).
  69. Masciotra S, Luo W, Youngpairoj AS, et al. Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast. J Clin Virol 2013; 58 Suppl 1:e54.
  70. Duong YT, Mavengere Y, Patel H, et al. Poor performance of the determine HIV-1/2 Ag/Ab combo fourth-generation rapid test for detection of acute infections in a National Household Survey in Swaziland. J Clin Microbiol 2014; 52:3743.
  71. Conway DP, Holt M, McNulty A, et al. Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population. PLoS One 2014; 9:e94062.
  72. Pilcher CD, Louie B, Facente S, et al. Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco. PLoS One 2013; 8:e80629.
  73. Malloch L, Kadivar K, Putz J, et al. Comparative evaluation of the Bio-Rad Geenius HIV-1/2 Confirmatory Assay and the Bio-Rad Multispot HIV-1/2 Rapid Test as an alternative differentiation assay for CLSI M53 algorithm-I. J Clin Virol 2013; 58 Suppl 1:e85.
  74. Centers for Disease Control and Prevention. FDA-Approved HIV supplemental tests for laboratory use only. http://www.cdc.gov/hiv/pdf/testing/supplemental-hiv-tests-laboratory-use.pdf (Accessed on October 05, 2015).
  75. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 2003; 17:1871.
  76. Daar ES, Little S, Pitt J, et al. Diagnosis of primary HIV-1 infection. Los Angeles County Primary HIV Infection Recruitment Network. Ann Intern Med 2001; 134:25.
  77. Fiscus SA, Pilcher CD, Miller WC, et al. Rapid, real-time detection of acute HIV infection in patients in Africa. J Infect Dis 2007; 195:416.
  78. http://www.cdc.gov/hiv/policies/law/states/index.html (Accessed on March 01, 2016).
  79. Stanley B, Fraser J, Cox NH. Uptake of HIV screening in genitourinary medicine after change to "opt-out" consent. BMJ 2003; 326:1174.
  80. Bozzette SA. Routine screening for HIV infection--timely and cost-effective. N Engl J Med 2005; 352:620.
  81. Bradley H, Hall HI, Wolitski RJ, et al. Vital Signs: HIV diagnosis, care, and treatment among persons living with HIV--United States, 2011. MMWR Morb Mortal Wkly Rep 2014; 63:1113.
  82. Shah M, Risher K, Berry SA, Dowdy DW. The Epidemiologic and Economic Impact of Improving HIV Testing, Linkage, and Retention in Care in the United States. Clin Infect Dis 2016; 62:220.
  83. De Cock KM, Bunnell R, Mermin J. Unfinished business--expanding HIV testing in developing countries. N Engl J Med 2006; 354:440.