Rapid Testing for HIV 

  • Author: Jeff Dubin, MD; Chief Editor: Steven C Dronen, MD, FAAEM   more...
 
Updated: Jul 15, 2011
 

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] 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.[3] 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.[4]

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.[5, 6]

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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[7] )
  • 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
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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 6 rapid HIV tests (see Table 1, below).[8] All FDA-approved kits have been shown to perform similarly.[9] 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.

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

FDA-Approved Rapid HIV TestOraQuick AdvanceUni-Gold RecombigenClearview Stat-Pak and CompleteReveal G-3Multispot
Specimen NeededOral swab or blood (fingerstick)Whole blood



(fingerstick)



Whole blood



(fingerstick)



Serum



plasma



Serum



plasma



Turnaround Time (minutes) 201015310
CLIA* RequirementWaivedWaivedWaivedRequiredRequired
*CLIA (Clinical Laboratory Improvement Amendment) "waived" means testing does not have to be done by certified laboratory staff.



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

Jeff Dubin, MD  Medical Director, Emergency Department, Washington Hospital Center; Assistant Professor, Department of Emergency Medicine, Georgetown University School of Medicine

Jeff Dubin, MD is a member of the following medical societies: American Academy of Emergency Medicine

Disclosure: Nothing to disclose.

Specialty Editor Board

Ronald A Greenfield, MD  Professor, Department of Internal Medicine, University of Oklahoma College of Medicine

Ronald A Greenfield, MD is a member of the following medical societies: American College of Physicians, American Federation for Medical Research, American Society for Microbiology, Central Society for Clinical Research, Infectious Diseases Society of America, Medical Mycology Society of the Americas, Phi Beta Kappa, Southern Society for Clinical Investigation, and Southwestern Association of Clinical Microbiology

Disclosure: Pfizer Honoraria Speaking and teaching; Gilead Honoraria Speaking and teaching; Ortho McNeil Honoraria Speaking and teaching; Abbott Honoraria Speaking and teaching; Astellas Honoraria Speaking and teaching; Cubist Honoraria Speaking and teaching; Forest Pharmaceuticals Speaking and teaching

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

Disclosure: Medscape Salary Employment

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 Progressor, 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 Association for Oncology, Southern Clinical Neurological Society, and 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 and Society for Academic Emergency Medicine

Disclosure: Nothing to disclose.

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

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

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

  6. 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.

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

  8. FDA-approved rapid HIV antibody screening tests. Centers for Disease Control and Prevention. Available at http://1.usa.gov/iB5YeN. Accessed July 8, 2011.

  9. Delaney KP, Branson BM, Uniyal A, et al. Evaluation of the Performance Characteristics of 6 Rapid HIV Antibody Tests. Clin Infect Dis. Jan 2011;52(2):257-63. [Medline].

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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 Rapid HIV Tests
FDA-Approved Rapid HIV TestOraQuick AdvanceUni-Gold RecombigenClearview Stat-Pak and CompleteReveal G-3Multispot
Specimen NeededOral swab or blood (fingerstick)Whole blood



(fingerstick)



Whole blood



(fingerstick)



Serum



plasma



Serum



plasma



Turnaround Time (minutes) 201015310
CLIA* RequirementWaivedWaivedWaivedRequiredRequired
*CLIA (Clinical Laboratory Improvement Amendment) "waived" means testing does not have to be done by certified laboratory staff.



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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