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Rapid Testing for HIV

  • Author: Jeffrey Dubin, MD, MBA; Chief Editor: Steven C Dronen, MD, FAAEM  more...
 
Updated: Apr 07, 2015
 

Overview

Early diagnosis of acute human immunodeficiency virus (HIV) infection by rapid HIV testing can help identify patients who may be candidates for antiretroviral treatment, which has been shown to delay the progression to acquired immunodeficiency syndrome (AIDS) and death.[1] Rapid HIV testing may also be useful to quickly confirm HIV status in a patient not known to be HIV positive who presents with an AIDS-defining illness.

The Centers for Disease Control and Prevention (CDC) recommends HIV screening of all US residents aged 13-64 years.[2] The US Preventive Services Task Force recommends screening for ages 15-65 years and for those outside this range with HIV risk factors.[3] This can be completed at any convenient physician encounter, including emergency department visits and even outreach programs utilizing mobile clinic vans to see patients.

Studies have shown that nearly one third of patients screened for HIV by traditional programs with pretest counseling and blood tests that are sent to a central laboratory fail to return for follow-up visits to learn the results.[4] Rapid HIV testing provides the results during the single counseling session. Identification of asymptomatic HIV-positive patients benefits the individual and the public health. Seropositive patients can be referred for treatment and taught about practices that will help reduce the risk of infecting others.[5]

For other discussions on HIV infection, see HIV Disease, Pediatric HIV Infection, and Antiretroviral Therapy for HIV Infection, as well as HIV in Pregnancy.

Patient education

Provide frank, complete, nonjudgmental information on the routes of transmission. Teach HIV-infected patients how to minimize the risk to others.

For patient education information, see the Immune System Center, Sexually Transmitted Diseases Center, and Yeast and Fungal Infections Center, as well as HIV/AIDS, Rapid Oral HIV Test, and Candidiasis (Yeast Infection).

For more information, see the CDC guidelines for HIV Infection: detection, counseling, and referral and revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings.[6, 7]

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Pre- and Post-Test Counseling

Pre- and post-test counseling can be done by nonmedical personnel. Pre-test counseling can be completed via prerecorded video or pamphlet and takes about 1-20 minutes. Counseling protocols and counselor prompt cards are available on the CDC website. Post-testing referrals for counseling patients with positive rapid test results need to be prearranged (dedicated follow-up program).

If HIV seropositivity is expected, patients whose test results are positive with rapid HIV tests should be told they likely have HIV and need further confirmatory testing. If HIV is not likely, a patient with a positive rapid test result should be counseled that he or she may have HIV but that a confirmatory test is necessary. Patients are expected to be anxious after learning rapid HIV test results.

Patients with a high suspicion for acute HIV infection and a probable false-negative rapid HIV test result should have HIV RNA viral load testing done and should be referred for follow-up HIV ELISA testing. Remember that during acute HIV infection, the antibody test ELISA, will usually be negative.

Protect patient confidentiality. Patients may not have informed family members or friends of their risk behaviors or diagnosis.

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Test Settings

Outreach programs can provide rapid HIV testing in the community. Counseling and testing can be completed anywhere. These programs provide an opportunity to identify high-risk patients who otherwise would not seek outpatient testing. Emergency department (ED) testing has the following features:

  • Routine HIV screening of asymptomatic patients and outpatient referral for confirmatory testing and care (routine opt-out screening of ED patients may result in increased numbers of patients tested and identified as HIV positive compared to physician-directed screening [8] )
  • Identification of acute HIV infection with possible ED diagnosis and/or referral for further diagnostics and treatment
  • Confirmation of diagnosis of HIV in patients with AIDS-defining illness, previously not known to be seropositive
  • There are multiple models of HIV screening in the ED. “Opt out” programs, as recommended by the CDC, have the potential to screen the greatest number of patients compared to “opt in” programs, but may be hindered by state laws governing consent to testing and refusal of testing and burden the ED with increased costs of testing. [9] Having a dedicated counselor screen for HIV has been shown to be significantly more successful than provider-based screening; however, there is an added cost to a counselor-based testing program. [10] . Replacing counselors with trained ED technicians has been shown to increase rates of testing. [11] In addition, some sites have found success with novel self-testing kiosks. [12]
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Follow-up

HIV-positive patients should be referred for confirmatory testing and further outpatient treatment as needed. If acute HIV infection is suspected, send a specimen for HIV RNA viral load testing or recommend a repeat HIV test in 4-8 weeks.

Do not discharge patients with newly diagnosed HIV infection without proper follow-up for testing or treatment. Make sure follow-up care has been arranged for patients prior to initiating an HIV screening program.

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Table: FDA-Approved Rapid HIV Tests

The US Food and Drug Administration (FDA) has approved a number of Clinical Laboratory Improvement Amendment (CLIA)–waived rapid HIV tests (see Table 1).[13] These tests assess for HIV antibodies with an enzyme-linked immunosorbent assay (ELISA). Sensitivity and specificity are greater than 99%. Results are reported as reactive or nonreactive.

The FDA-approved kits have been shown to perform similarly,[14] with the exception of the Determine HIV test, which is a fourth-generation test that also detects p24 antigen, increasing the ability to detect very early infection.[15]

Table 1. FDA-Approved CLIA-Waived Rapid HIV Tests (Open Table in a new window)

Test Name Specimen Needed Turnaround Time (minutes) Median Days from Infection to Detection**
OraQuick Advance Oral swab or blood (fingerstick or venipuncture) 20 34
Uni-Gold Recombigen Whole blood



(fingerstick or venipuncture)



10 32
Clearview Stat-Pak and Complete Whole blood



(fingerstick or venipuncture)



15 30
INSTI HIV Fingerstick whole blood < 2 24
Determine HIV Whole blood



(fingerstick or venipuncture)



20 17
Chembio DPP Fingerstick whole blood 15 28
*CLIA (Clinical Laboratory Improvement Amendment) "waived" means testing does not have to be done by certified laboratory staff.



** Median days to detect infection is based on the estimated days from first infection that the test first detects the HIV infection, which includes the approximately 10-day period from initial infection to detection of HIV-1 RNA.[15]



Note: If the rapid test is reactive, confirm the result with Western blot or immunofluorescent assay (IFA). Western blot results are reported as positive, negative, or indeterminate. Indeterminate tests result from nonspecific reactions of HIV-negative sera with some HIV proteins. If the result is indeterminate, repeat the ELISA test in 1 month.



Nonreactive tests in patients with a strong likelihood of acute HIV infection should be followed up with a virologic test such as HIV RNA assay (viral load). Viral load is very high (>100,000 copies/mL) in acute HIV infection. If virologic test is positive, repeat antibody testing in 3 months after seroconversion.



False-positive and false-negative tests do occur with rapid testing. Positive predictive value is lower in populations with low HIV prevalence, so there will be relatively more false-positive tests in these groups with very low HIV risk factors.



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Contributor Information and Disclosures
Author

Jeffrey Dubin, MD, MBA Chair, Department of Emergency Medicine, MedStar Washington Hospital Center; Associate Professor of Clinical Emergency Medicine, Georgetown University School of Medicine

Jeffrey Dubin, MD, MBA is a member of the following medical societies: American Academy of Emergency Medicine, American College of Emergency Physicians, Society for Academic Emergency Medicine

Disclosure: Nothing to disclose.

Specialty Editor Board

Francisco Talavera, PharmD, PhD Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Received salary from Medscape for employment. for: Medscape.

Eric L Weiss, MD, DTM&H Medical Director, Office of Service Continuity and Disaster Planning, Fellowship Director, Stanford University Medical Center Disaster Medicine Fellowship, Chairman, SUMC and LPCH Bioterrorism and Emergency Preparedness Task Force, Clinical Associate Professor, Department of Surgery (Emergency Medicine), Stanford University Medical Center

Eric L Weiss, MD, DTM&H is a member of the following medical societies: American College of Emergency Physicians, American College of Occupational and Environmental Medicine, American Medical Association, American Society of Tropical Medicine and Hygiene, Physicians for Social Responsibility, Southeastern Surgical Congress, Southern Oncology Association of Practices, Southern Clinical Neurological Society, Wilderness Medical Society

Disclosure: Nothing to disclose.

Chief Editor

Steven C Dronen, MD, FAAEM Chair, Department of Emergency Medicine, LeConte Medical Center

Steven C Dronen, MD, FAAEM is a member of the following medical societies: American Academy of Emergency Medicine, Society for Academic Emergency Medicine

Disclosure: Nothing to disclose.

References
  1. [Guideline] Department of Health and Human Services. January 10, 2011; 1-174. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. AIDSinfo. Available at http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. Accessed: July 8, 2011.

  2. CDC HIV/AIDS Science facts: CDC releases revised HIV testing recommendations in healthcare settings. Centers for Disease Control and Prevention. Available at http://1.usa.gov/mWm8Ol. Accessed: July 8, 2011.

  3. accessed 6/27/13. http://www.uspreventiveservicestaskforce.org/uspstf13/hiv/hivfinalrs.htm#summary.

  4. Greenwald JL, Burstein GR, Pincus J, Branson B. A rapid review of rapid HIV antibody tests. Curr Infect Dis Rep. 2006 Mar. 8(2):125-31. [Medline].

  5. Centers for Disease Control and Prevention. Rapid HIV testing. Available at http://www.cdc.gov/hiv/topics/testing/rapid/. Accessed: July 8, 2011.

  6. [Guideline] Workowski KA, Berman S. Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17. 59:1-110. [Medline].

  7. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. National Guideline Clearinghouse. Available at http://1.usa.gov/pZOrYB. Accessed: March 25, 2009.

  8. Haukoos JS, Hopkins E, Conroy AA, et al. Routine opt-out rapid HIV screening and detection of HIV infection in emergency department patients. JAMA. 2010 Jul 21. 304(3):284-92. [Medline].

  9. Waxman, MJ et al. Ethical, financial, and legal considerations to implementing emergency department HIV screening: a report from the 2007 conference of the national emergency department testing consortium. Annals of Emergency Medicine. 2013. Vol 58(1):S33-S43.

  10. Walensky, RP et al. Counselor-versus provider-based HIV screening in the emergency department: results from the universal screening for HIV infection in the emergency room (USHER) randomized controlled trial. Annals of Emergency Medicine. 2013. Vol 58(1), Supplement:S126-S132.

  11. Egan DJ, Nakao JH, VanLeer PM, Pati R, Sharp VL, Wiener DE. Increased rates of rapid point-of-care HIV testing using patient care technicians to perform tests in the ED. Am J Emerg Med. 2014 Jun. 32(6):651-4. [Medline].

  12. Gaydos CA, Solis M, Hsieh YH, Jett-Goheen M, Nour S, Rothman RE. Use of tablet-based kiosks in the emergency department to guide patient HIV self-testing with a point-of-care oral fluid test. Int J STD AIDS. 2013 Sep. 24(9):716-21. [Medline].

  13. Centers for Disease Control and Prevention. Rapid HIV tests suitable for use in non-clinical settings (CLIA-waived). Available at http://www.cdc.gov/hiv/pdf/testing_ListNonClinicalSettings.pdf. Accessed: March 27, 2015.

  14. Delaney KP, Branson BM, Uniyal A, Phillips S, Candal D, Owen SM, et al. Evaluation of the performance characteristics of 6 rapid HIV antibody tests. Clin Infect Dis. 2011 Jan 15. 52(2):257-63. [Medline].

  15. Centers for Disease Control and Prevention. Advantages and disadvantages of different types of FDA-approved HIV immunoassays used for screening by generation and platform. Available at http://goo.gl/oJDMOX. Accessed: March 27, 2015.

 
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Electron microscopy of human immunodeficiency virus (HIV)–1 virions. Courtesy of CDC/Dr. Edwin P. Ewing, Jr.
Table 1. FDA-Approved CLIA-Waived Rapid HIV Tests
Test Name Specimen Needed Turnaround Time (minutes) Median Days from Infection to Detection**
OraQuick Advance Oral swab or blood (fingerstick or venipuncture) 20 34
Uni-Gold Recombigen Whole blood



(fingerstick or venipuncture)



10 32
Clearview Stat-Pak and Complete Whole blood



(fingerstick or venipuncture)



15 30
INSTI HIV Fingerstick whole blood < 2 24
Determine HIV Whole blood



(fingerstick or venipuncture)



20 17
Chembio DPP Fingerstick whole blood 15 28
*CLIA (Clinical Laboratory Improvement Amendment) "waived" means testing does not have to be done by certified laboratory staff.



** Median days to detect infection is based on the estimated days from first infection that the test first detects the HIV infection, which includes the approximately 10-day period from initial infection to detection of HIV-1 RNA.[15]



Note: If the rapid test is reactive, confirm the result with Western blot or immunofluorescent assay (IFA). Western blot results are reported as positive, negative, or indeterminate. Indeterminate tests result from nonspecific reactions of HIV-negative sera with some HIV proteins. If the result is indeterminate, repeat the ELISA test in 1 month.



Nonreactive tests in patients with a strong likelihood of acute HIV infection should be followed up with a virologic test such as HIV RNA assay (viral load). Viral load is very high (>100,000 copies/mL) in acute HIV infection. If virologic test is positive, repeat antibody testing in 3 months after seroconversion.



False-positive and false-negative tests do occur with rapid testing. Positive predictive value is lower in populations with low HIV prevalence, so there will be relatively more false-positive tests in these groups with very low HIV risk factors.



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