HIV Testing

Date of current publication: August 4, 2026
Lead author: Benjamin W. Tsoi, MD, MPH
Contributor: Linda Styer, PhD
Writing group: Rona M. Vail, MD, AAHIVS; Sanjiv S. Shah, MD, MPH, AAHIVS; Steven M. Fine, MD, PhD; Joseph P. McGowan, MD, FACP, FIDSA, AAHIVS; Samuel T. Merrick, MD, FIDSA; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Christopher J. Hoffmann, MD, MPH, MSc, FACP; Brianna L. Norton, DO, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: October 3, 2018

This guideline was developed by the New York State Department of Health AIDS Institute (NYSDOH AI) to accomplish the following goals:

• Provide clinicians in New York State with information on HIV testing policies and practices and NYSDOH Wadsworth Center Bloodborne Viruses Laboratory
• Ensure awareness of and access to the standard 3-step HIV testing algorithm recommended by the Centers for Disease Control and Prevention (CDC) and the NYSDOH AI.
• Ensure that clinicians recognize and respond to HIV testing as a gateway to care, such that an HIV diagnosis prompts a referral for HIV treatment and a negative HIV test result prompts a referral for HIV prevention services, including pre- and post-exposure prophylaxis, when appropriate.
• Emphasize that rapid antiretroviral therapy (ART) initiation is the standard of care for all individuals diagnosed with HIV.

Diagnosing HIV: This guideline provides an overview of the screening and diagnostic methods used to accurately diagnose or exclude HIV infection, as outlined in the CDC 2018 Quick reference guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens and Technical update for HIV nucleic acid tests approved for diagnostic purposes and the Association of Public Health Laboratories Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm (also see Figure 2: HIV Laboratory Testing Algorithm in this guideline) APHL 2025; CDC 2023; CDC 2018.

Widespread use of the HIV-1/2 antigen (Ag)/antibody (Ab) immunoassay (formerly known as the “4th-generation” test) can increase the number of people aware of their HIV status, including those who may transmit HIV during acute infection. The 2018 CDC algorithm testing sequence for detecting HIV Ags, Abs, and nucleic acids differs from previous HIV testing recommendations that were based on Ab screening followed by Western blot confirmation CDC 2018. The 2018 algorithm features a specific sequence of tests to provide maximal sensitivity, specificity, and accuracy for HIV detection. This algorithm was further updated in 2023 with the approval of the HIV-1/HIV-2 nucleic acid test for diagnosis CDC 2023.

Initiating ART: The current standard of care for an individual newly diagnosed with HIV is same-day ART initiation. If an individual cannot start ART on the day of diagnosis, then every effort should be made to initiate ART as soon as possible and no later than 30 days after diagnosis.

Accessible and routine HIV testing for all individuals aged 13 years and older is a crucial clinical and public health intervention for people with or at risk of acquiring HIV. HIV testing is not an isolated activity; it is the entry point to the continuum of HIV care and prevention. Table 1, below, provides an overview of HIV testing requirements in New York State. Additional information regarding testing procedures and regulations is available from the NYSDOH Wadsworth Center Bloodborne Viruses Laboratory (phone: 518-474-2163).

The NYSDOH Wadsworth Center Bloodborne Viruses Laboratory provides the following testing services and assistance to clinicians in New York State. All testing for New York State patients and providers is free of charge.

HIV-1/HIV-2 diagnostic testing:

• HIV-1/2 antigen/antibody testing; plasma and serum
• HIV-1/HIV-2 supplemental antibody testing of specimens that are reactive on the initial testing assay
• HIV-1 RNA testing on plasma, serum, and dried blood spots
• HIV-2 nucleic acid testing to detect HIV-2 RNA
• Assistance with inconclusive HIV test results
• Confirmatory testing of dried blood spots using an alternative algorithm for enrolled community-based HIV testing sites unable to collect venous blood
• Website | Phone: 518-474-2163

Pediatric HIV testing:

• HIV-1 RNA testing for all newborns exposed to HIV-1 in New York State
• If the individual submitting the sample indicates that the newborn has been exposed to HIV-2, the Pediatric HIV Testing Service will perform an RT-PCR (reverse transcription polymerase chain reaction) test for qualitative detection of HIV-2 RNA in all samples.
• Website | Phone: 518-486-9605

HIV-2 nucleic acid testing:

• Qualitative HIV-2 RNA testing for diagnosis and quantitative detection of HIV-2 RNA (viral load) in plasma samples for baseline and subsequent monitoring of response to antiretroviral therapy in patients with confirmed HIV-2 infection.
• HIV-2 RNA viral load testing during pregnancy: Contact the lab early in the patient’s pregnancy to discuss the protocol and timing for testing.
• HIV-2 phenotypic and genotypic resistance testing is not offered at the Wadsworth Center or commercially available in the United States.
• Website | Phone: 518-473-6007

The time from HIV infection to detection of the virus depends on the test that is used. Figure 1, below, illustrates the window of detection of HIV infection according to antibody (Ab), antigen (Ag)/Ab combination, and HIV RNA tests. Establishing the exact window period for an initial HIV test is challenging because the precise time of exposure is rarely known. Among individuals using HIV pre-exposure prophylaxis (PrEP) who have breakthrough infections, the exact window period may be even more difficult to define because of partial suppression of viral replication and possible blunted or delayed immune response. Post-exposure prophylaxis (PEP) after an exposure may also alter the time to detection of HIV.

Eclipse period refers to the time following an HIV exposure during which no available HIV test can detect the virus (see Figure 1, below) Stekler, et al. 2023; Spinelli, et al. 2021; CDC 2018; Delaney, et al. 2017; Hoenigl, et al. 2016. The duration of the eclipse period varies depending on characteristics of the infecting virus and the individual Fiebig, et al. 2003. In a study that applied modeling methods to estimate the time from exposure, with subsequent infection, to HIV RNA detection among people not receiving PrEP, the median length of the eclipse period was 11.5 days Delaney, et al. 2017.

Window period refers to the time between HIV exposure and when a test can accurately and consistently detect quantifiable HIV biomarkers. The duration is often given as a range because the time needed for a test to first become positive can vary due to host factors, how much virus was transmitted, transmission route, specimen type, test platform, and use of antiretroviral medication such as HIV PrEP or PEP. In general, HIV tests performed on plasma or serum specimens detect early HIV infection earlier than tests performed on whole blood Masciotra, et al. 2017; Stekler, et al. 2016, and HIV tests performed on whole blood detect early HIV infection earlier than tests performed on oral fluid Stekler, et al. 2016; Stekler, et al. 2013. Instrumented laboratory-based HIV-1/2 Ag/Ab immunoassays are more sensitive for early HIV detection than point-of-care tests. Ag/Ab immunoassays detect HIV-1 and HIV-2 Abs and HIV-1 p24 Ag, which is present during acute HIV before Ab seroconversion (Ab production).

In individuals who acquire HIV while taking PrEP (oral or long-acting injectable), antiretroviral (ARV) medications may partially suppress HIV replication and alter the normal progression of HIV biomarkers. As a result, levels of HIV RNA, HIV DNA, HIV p24 Ag, and HIV Abs may remain near the limits of assay detection, making HIV diagnosis challenging Spinelli, et al. 2021; Lee, et al. 2020. This diagnostic challenge is particularly relevant to individuals who acquire HIV while receiving cabotegravir as part of long-acting injectable PrEP and has been described as long-acting early viral inhibition (LEVI) syndrome Parikh, et al. 2026; Landovitz, et al. 2024. Diagnostic delays may persist for weeks to months after discontinuation of long-acting injectable PrEP. Similarly, very early treatment of acute HIV infection can, uncommonly, result in delayed seroconversion or seroreversion, which may also complicate HIV diagnosis Stekler, et al. 2023; Hare, et al. 2006; Kassutto, et al. 2005.

Each type of HIV test has a different detection window. Choosing the appropriate test and accurately interpreting its results requires an understanding of when each test becomes reliably reactive. A negative result before the detection window has passed cannot rule out HIV infection. To confidently exclude HIV infection, the test must be performed after the end of its detection window (see Table 2, below).

Advances in immunoassay technology have improved the sensitivity and specificity of HIV screening and diagnostic tests, which detect specific infection markers that may be virologic (viral proteins or nucleic acids) or immunologic (Abs produced in response to HIV infection). In 2018, the CDC issued a revised 3-step HIV testing algorithm for HIV diagnostic testing performed on serum and plasma specimens CDC 2018; CDC 2014, and this algorithm was further updated in 2023 with the approval of the HIV-1/HIV-2 RNA NAT for diagnosis of acute HIV CDC 2023. Figure 2, below, outlines the standard 3-step HIV testing algorithm recommended by this committee and the CDC CDC 2023. For information on the testing services and assistance available in New York State, see the guideline section NYSDOH Wadsworth Center Bloodborne Viruses Laboratory Services.

The first test in the algorithm screens for established HIV-1 or HIV-2 infection and acute HIV-1 infection. When requesting HIV diagnostic testing of anyone aged 2 years and older, testing should be ordered from a laboratory that offers an FDA-approved HIV-1/2 Ag/Ab immunoassay as an initial HIV test CDC 2018; CDC 2014. If the initial Ag/Ab immunoassay is reactive, the laboratory will usually follow the recommended algorithm steps to confirm or exclude laboratory evidence of HIV (see Figure 2, above).

HIV-1/2 Ag/Ab immunoassays, formerly known as “4th-generation” immunoassays, detect both immunoglobulin G and M Abs to HIV-1 and HIV-2 plus HIV-1 p24 Ag. These Ag/Ab immunoassays have a distinct advantage over screening tests that detect only Abs. Although Ag/Ab immunoassays cannot detect HIV during the eclipse period, when HIV Ab, Ag, and RNA are not detectable, the ability to identify both HIV-1 p24 Ag and HIV-1/2 Abs in a single screening test enables detection of HIV early in the acute period and throughout established infection, including in HIV controllers.

Laboratory HIV-1/2 Ag/Ab immunoassays (e.g., Abbott ARCHITECT, Bio-Rad Bioplex, Roche Elecysys, and others) are preferred for use in step 1 of the algorithm because of their superior sensitivity in detecting HIV during acute infection. The Determine HIV-1/2 Ag/Ab Combo (Abbott Diagnostics) is the only FDA-approved HIV-1/2 Ag/Ab immunoassay point-of-care screening test. The Determine HIV-1/2 Ag/Ab Combo may be used with serum or plasma (not fingerstick whole blood) when instrumented laboratory testing is not feasible CDC 2017.

No HIV test is perfect at both detecting infection and excluding false results. Because of the serious consequences of missed HIV infection, this HIV testing algorithm begins with a highly sensitive screening test to minimize missed infections, including during early HIV infection. As a result, reactive results are considered preliminary positive and may include false positives; all reactive results require supplemental testing for confirmation. In populations with lower HIV prevalence, a greater proportion of reactive screening tests may represent false positive results.

For more information on laboratory testing in New York State, including FDA-approved tests, see NYSDOH 2024 Guidelines Update for Use of the HIV Diagnostic Testing Algorithm for Laboratories.

Results and next steps: When used for routine HIV screening, a negative initial HIV-1/2 Ag/Ab immunoassay result is referred to as nonreactive. If the initial test result is reactive (preliminary positive), supplemental testing with an HIV-1/HIV-2 Ab differentiation immunoassay (see step 2, below) is performed. When the standard HIV laboratory testing algorithm is followed, laboratory reporting may include the initial HIV test result and, if it is reactive, supplemental testing results.

A sequence of tests, rather than a single test, is recommended to establish a laboratory diagnosis of HIV infection. Full results confirm reactivity and include an HIV-1/HIV-2 Ab differentiation immunoassay that detects and discriminates between HIV-1 and HIV-2 Abs with high specificity. If the supplemental Ab test result is negative or indeterminate, an HIV-1 or HIV-1/HIV-2 RNA NAT (see Step 3: HIV RNA Nucleic Acid Testing, below) can verify acute HIV-1 infection (see Box 1: Reasons for False Positive, False Negative, or Indeterminate HIV Test Results, below).

Point-of-care HIV and supplemental testing: Screening with a point-of-care (POC) HIV test, including when used in community-based or outreach settings, allows individuals to quickly learn their HIV status. A reactive (preliminary positive) result should be provided as soon as possible. Because POC HIV tests can sometimes produce false positive results (see Box 1, below), particularly in populations not at high risk of HIV infection, supplemental testing is required to confirm all reactive results.

If a POC HIV test performed on oral fluid or fingerstick whole blood produces a reactive result, a venipuncture blood specimen should be collected. The CDC recommends confirming all reactive POC HIV test results using the HIV testing algorithm CDC 2018, which begins with a laboratory-based HIV-1/2 Ag/Ab immunoassay. If the Ag/Ab immunoassay result is nonreactive, the POC HIV test result is interpreted as false positive (see Box 1, below), and no further testing is needed. If the immunoassay is reactive, specimen testing should continue according to the HIV testing algorithm.

Instrumented laboratory-based HIV-1/2 Ag/Ab immunoassays are preferred for the first step of the HIV testing algorithm because they are more sensitive for detecting early HIV infection than the Determine HIV-1/2 Ag/Ab Combo POC test. When instrumented laboratory testing is not available, the Determine HIV-1/2 Ag/Ab Combo test performed using serum or plasma specimens may serve as an alternate first step HIV-1/2 Ag/Ab test CDC 2017. In this setting, a reactive result may be followed directly by a supplemental HIV-1/2 Ab differentiation immunoassay. However, when the Determine HIV-1/2 Ag/Ab Combo test is performed on whole blood and yields a reactive result, the CDC recommends confirmatory testing with a laboratory-based HIV-1/2 Ag/Ab immunoassay.

Alternative specimen types may be used for supplemental testing if collecting a venous blood specimen is not possible or practical. The NYSDOH Wadsworth Center Bloodborne Viruses Laboratory offers confirmatory testing of dried blood spot specimens using an alternative algorithm for enrolled community-based HIV screening sites unable to collect venous blood.

For more information, see Appendix > Point-of-Care (Rapid) Screening Tests.

HIV self-testing: The CDC encourages health departments to support HIV self-testing, in which HIV testing is conducted by individuals outside the healthcare setting rather than by trained clinicians, as a means to expand access, especially for populations who face barriers to HIV testing.

Advise patients to only use FDA-approved tests and emphasize that these tests are accurate when used correctly Figueroa, et al. 2018 but that errors in specimen collection, processing, or report interpretation can occur. All individuals with a reactive (preliminary positive) self-test result should seek confirmatory laboratory testing and linkage to care as soon as possible.

For more information, see Appendix > Home-Based Tests.

Repeat testing: For sexually active individuals and those with other potential HIV exposure risk factors, including injection drug use, clinicians should conduct an HIV risk assessment at least annually and offer HIV testing based on findings of that assessment or at the patient’s request. For individuals with ongoing or repeated HIV exposure risk factors, including multiple sex partners, an STI diagnosis in the past year, injection drug use, and exchange of sex for money or drugs, clinicians should offer HIV testing every 3 to 6 months, or sooner if acute HIV infection is suspected, for as long as risk remains. Risk factors can change over time and should be reassessed at each visit.

When acute HIV infection is suspected: When very early acute HIV infection is suspected, HIV RNA testing may be warranted. During early acute HIV infection, an HIV-1/2 Ag/Ab immunoassay may return a false negative result because HIV Ag and Abs are not yet present in sufficient quantities for detection, while HIV RNA may already be detectable. If available, clinicians should use an FDA-approved HIV-1/HIV-2 RNA NAT for diagnostic use (e.g., cobas HIV-1/HIV-2 Qualitative). If this test is not available, an FDA-approved HIV-1 RNA NAT should be used. HIV RNA testing is warranted when initiating PrEP and when an individual has:

• A recent high-risk exposure (within the past 10-33 days; median time to HIV RNA detectability is ~11.5 days), or
• Symptoms consistent with acute retroviral syndrome, such as fever, sore throat, rash, myalgia, and lymphadenopathy

When an initial HIV-1/2 Ag/Ab immunoassay (see step 1, above) result is reactive (or repeatedly reactive), the next step in the HIV testing algorithm is to perform a supplemental immunoassay that differentiates HIV-1 and HIV-2 antibodies (see Figure 2, above). There are currently 2 FDA-approved HIV-1/HIV-2 Ab differentiation immunoassays:

• Geenius HIV 1/2 Supplemental Assay (Bio-Rad Laboratories)
• VioOne HIV Profile Supplemental Assay (Avioq)

HIV-1/HIV-2 Ab differentiation immunoassays produce separate results for HIV-1 and HIV-2 antibodies, with each result categorized as reactive, nonreactive, or indeterminate. The individual HIV-1 and HIV-2 results are combined into an overall assay interpretation, such as HIV Antibody Negative, HIV-1 Positive, HIV-1 Indeterminate, etc. Laboratories are required to include the overall assay interpretation on the laboratory report, as per the assay instruction for use. Laboratories should not include individual HIV-1 and HIV-2 results, as they may lead to misinterpretation of the test results. Results listed below refer to the final assay interpretation provided by the HIV-1/HIV-2 Ab differentiation immunoassays.

Reactive: An HIV-1/HIV-2 Ab differentiation immunoassay (step 2) with positive results for HIV-1 or HIV-2 should be interpreted as positive for HIV-1 or HIV-2.

An HIV-1/HIV-2 Ab differentiation immunoassay (step 2) that detects HIV Abs but cannot distinguish between HIV-1 and HIV-2 (untypable) should be treated as presumptive HIV positive. HIV type can be determined by repeating the HIV testing algorithm, starting with step 1, in 2 to 4 weeks or performing HIV-1 or HIV-2 RNA testing. If assistance is needed with this testing, contact the NYSDOH Wadsworth Center Bloodborne Viruses Laboratory.

Nonreactive/indeterminate: If an HIV-1/HIV-2 Ab differentiation immunoassay (step 2) result is nonreactive or indeterminate for any HIV type (HIV, HIV-1, or HIV-2), the next step in the HIV testing algorithm is to perform HIV-1 or HIV-1/HIV-2 RNA testing (see step 3, below) using a test approved for diagnostic purposes (qualitative or quantitative; see Step 3: HIV RNA Nucleic Acid Testing, below).

Acute HIV-1 infection is much more common than HIV-2 infection. Some individuals with acute HIV-1 infection may have HIV indeterminate or HIV-2 indeterminate results on the HIV-1/HIV-2 Ab differentiation immunoassay (step 2), which is why HIV-1 RNA testing is recommended as the third step of the algorithm. If HIV-1 RNA is not detected and the HIV-1/HIV-2 Ab differentiation immunoassay result remains HIV-2 indeterminate or HIV indeterminate, HIV-2 RNA NAT testing should be considered. Alternatively, an HIV-1/HIV-2 RNA test may be performed. If nonreactive, no additional HIV-2 testing is needed.

For more information on laboratory testing in New York State, see NYSDOH 2024 Guidelines Update For Use of the HIV Diagnostic Testing Algorithm for Laboratories.

For specimens that are reactive on the initial HIV-1/2 Ag/Ab immunoassay (see step 1, above) and nonreactive or indeterminate on the HIV-1/HIV-2 Ab differentiation immunoassay (see step 2, above), the next step in the HIV testing algorithm is to perform HIV RNA testing using an HIV-1 or HIV-1/HIV-2 RNA NAT that is FDA-approved for diagnostic purposes (see Figure 2, above).

Most laboratories reflex directly to an HIV RNA NAT without requiring an additional test order or new specimen, either by performing the test in-house or referring the specimen to another laboratory.

Interpreting NAT results:

• A reactive HIV-1 or HIV-1/HIV-2 NAT (step 3) result with a nonreactive or indeterminate HIV-1/HIV-2 Ab differentiation immunoassay (see step 2, above) result indicates laboratory evidence of acute HIV-1 or HIV-2 infection, respectively. Clinicians should proceed with clinical evaluation and management.
• A nonreactive HIV-1 or HIV-1/HIV-2 NAT (step 3) result with a nonreactive or indeterminate HIV-1/HIV-2 Ab differentiation immunoassay (see step 2, above) result generally indicates that the reactive initial HIV screening test (see step 1, above) was a false positive and that the patient does not have HIV infection.
  • This result pattern can also occur in individuals taking PrEP or in individuals with HIV who initiated ART early in infection, when seroconversion is delayed or inhibited Smith, et al. 2018. In these situations, history of HIV exposure risk, recent PrEP or ART use, and timing of potential HIV exposures should be assessed to interpret results appropriately and determine whether repeat testing with a fresh blood sample is necessary to rule out very early infection or technical issues. Data suggest that delays in HIV detection can be longer, due to delayed Ab formation, among individuals using injectable cabotegravir (4 to 26 weeks) than those using tenofovir disoproxil fumarate/emtricitabine (1 to 12 weeks) Avelino-Silva, et al. 2024. It is also possible that the viral load will be undetectable because of the antiretroviral activity of cabotegravir.
• If the HIV-1/HIV-2 Ab differentiation immunoassay (see step 2, above) result is repeatedly HIV-2 indeterminate or HIV indeterminate, and the HIV-1 NAT (step 3) is nonreactive, HIV-2 RNA NAT testing should be considered, or the algorithm should be repeated in 2 to 4 weeks starting with step 1. Additional HIV-2 testing is generally unnecessary if an HIV-1/HIV-2 RNA NAT (step 3) result is nonreactive.

HIV-1 and HIV-1/HIV-2 RNA qualitative assays approved for diagnostic use: There are currently 3 FDA-approved NATs for diagnostic use (see Table 3, below). All have low limits of detection (<30 copies/mL) and the ability to detect low levels of all major HIV-1 and HIV-2 groups and HIV-1 subtypes.

Two assays, the Aptima HIV-1 RNA Quant Dx (Hologic) and Alinity m HIV-1RNA (Abbott Molecular), produce both qualitative and quantitative results, and can confirm HIV-1 infection and monitor disease prognosis. The cobas HIV-1/HIV-2 Qualitative (Roche Molecular Systems) assay, which produces a qualitative result only, detects and differentiates HIV-1 RNA and HIV-2 RNA.

HIV infection can be vertically transferred from pregnant individuals with HIV to their infants. Because infants acquire birth-parent antibodies to HIV, HIV RNA testing is performed to diagnose infection in infants. The NYSDOH strongly recommends that all New York State birth facilities use the NYSDOH Wadsworth Center Pediatric HIV Testing Service. The Wadsworth Center uses the Aptima HIV-1 RNA Quant Dx assay (Hologic) and has validated the use of lower specimen volumes and extended specimen stability.

HIV-1 RNA quantitative assays (specifically assays without dual diagnostic and monitoring claims): Quantitative HIV-1 RNA NATs are widely available and approved by the FDA to monitor the prognosis of HIV-1 infection and response to ART. The performance characteristics of the quantitative HIV-1 tests are discussed further in the NYSDOH AI guideline Virologic and Immunologic Monitoring in HIV Care.

Regulatory restrictions may prevent laboratories from reflexing to a quantitative HIV-1 RNA test as part of the diagnostic testing algorithm. Quantitative HIV-1 RNA testing may be separately ordered when acute HIV infection is suspected or upon initiation of PrEP. Although these tests are highly sensitive, they have not been evaluated for HIV diagnosis to the same extent as the 3 HIV RNA NATs that are FDA-approved for diagnostic use. As a result, quantitative HIV-1 RNA NATs may have lower specificity for diagnosing acute HIV infection. Therefore, when one of the 3 FDA-approved diagnostic HIV RNA NATs is available, it should be used instead of a quantitative HIV-1 RNA assay to diagnose acute HIV infection.

If a quantitative HIV-1 RNA is ordered, clinicians should be aware that a low-level viremia (<200 copies/mL) in the absence of serologic confirmation of HIV infection may indicate a false positive test result. Repeat HIV RNA and HIV Ag/Ab testing should be completed. See Box 2, below.

For more information on laboratory testing in New York State, see NYSDOH 2024 Guidelines Update For Use of the HIV Diagnostic Testing Algorithm for Laboratories.

For more information on laboratory testing in New York State, see NYSDOH 2024 Guidelines Update For Use of the HIV Diagnostic Testing Algorithm for Laboratories.

The U.S. Food and Drug Administration FDA has approved several HIV screening tests as Clinical Laboratory Improvements Act (CLIA)-waived tests, which allows a test to be performed in nonlaboratory, point-of-care (POC) settings. The FDA categorizes tests as CLIA-waived if they can use unprocessed specimens (whole blood or oral fluid), are easy to use, and have little risk of an incorrect result (see Centers for Disease Control and Prevention [CDC] CLIA Certificate of Waiver). CLIA-waived tests may be used for initial HIV testing when it is not possible or practical to collect blood by venipuncture to submit to a clinical laboratory. These POC tests are single-use test devices that can produce results within 30 minutes and are often referred to as rapid tests. Currently, POC HIV screening tests may only be used as initial screening tests; they are an alternative option when HIV testing according to the standard algorithm is not possible or practical. Reactive results on these tests require follow-up confirmatory testing.

Table A1, below, lists the characteristics of each of the 7 current FDA-approved POC HIV screening tests. Result interpretation is typically performed visually without instrumentation; the appearance of a line or circle in the appropriate area indicates a reactive result. The devices include a built-in procedural control that produces the expected appearance for a valid test result.

Although some POC HIV screening tests have been designed for POC use, clinical laboratories also use these tests for HIV screening when a quick result is needed or the laboratory’s overall testing volume is low. Depending on the device and its specific approval, laboratories may perform POC screening tests using serum, plasma, or whole blood specimens collected by venipuncture. Each of the POC HIV screening tests is restricted to the body fluid(s) that it was designed to analyze (see Table A1, below). All CLIA-waived HIV screening tests may be used with plasma or serum specimens; however, laboratories processing these specimen types with CLIA-waived tests require a moderate- or high-complexity laboratory permit. The additional steps and instrumentation needed to process blood to plasma and serum add complexity to the test procedure; therefore, these tests are classified as moderate-complexity for serum and plasma specimens Hurt, et al. 2017.

POC screening tests employ various technologies, and some devices are more sensitive for early detection than others. The Determine HIV-1/2 antigen/antibody (Ag/Ab) Combo (Abbott Diagnostics) is distinguished by its ability to detect both HIV-1 p24 Ag and HIV-1 and HIV-2 Abs. Studies conducted by the CDC show that the Determine HIV-1/2 Ag/Ab Combo is capable of detecting HIV infection 1 to 2 weeks earlier than all other FDA-approved POC screening tests but is less sensitive than the laboratory HIV-1/2 Ag/Ab immunoassays Masciotra, et al. 2013.

Aside from the Determine HIV-1/2 Ag/Ab Combo, all other FDA-approved POC screening tests only detect HIV Abs and so are less sensitive for identifying acute HIV. These detect HIV Abs 6 to 12 days later than enzyme immunoassays (EIAs) Masciotra, et al. 2013; Masciotra, et al. 2011.

HIV self-testing allows individuals to collect a specimen and test themselves for HIV at home. Product instructions guide users through specimen collection and result interpretation, and manufacturers offer online support for questions about test use. Self-tests are screening tests; reactive results require confirmatory laboratory testing using the standard HIV diagnostic algorithm (see guideline section HIV Testing With the Standard 3-Step Algorithm).

Currently, 2 types of FDA-approved HIV self-tests are available for purchase over the counter:

Oral fluid self-tests:

• Use a mouth swab to collect a specimen.
• Provide results in approximately 20 minutes.
• Example: OraQuick HIV Self-Test (OraSure Technologies)
• For additional information about oral fluid testing, see guideline section Alternative HIV Tests: Oral and Urine Specimens, below.

Fingerstick whole blood self-tests:

• Use a small blood sample to collect a specimen.
• Provide results in approximately 1 minute.
• Example: INSTI HIV Self Test (bioLytical Laboratories)

A limited number of FDA-approved assays may be performed on body fluids other than blood for HIV diagnostic testing. Advantages to oral fluid and urine specimens include noninvasive sample collection in settings where phlebotomy is not available and reduced risk of occupational exposure to infectious agents. Disadvantages include reduced sensitivity and specificity of the test methods FDA 2009; FDA 2004.

Oral fluid specimens: Oral fluid is not saliva but oral mucosal transudate (OMT) obtained by swabbing the gums. Though Abs are detectable in OMT, they are present at concentrations 800- to 1,000-fold lower than those found in serum, plasma, or fingerstick whole blood.

The only FDA-approved EIA for use on oral fluid specimens is the Avioq HIV-1 Microelisa System (Avioq), which may be performed on OMT specimens collected using the OraSure HIV-1 Oral Fluid Collection Device (OraSure Technologies). Reactive results must be confirmed.

The only FDA-approved POC screening tests for use on oral fluid specimens are the OraQuick ADVANCE POC HIV-1/2 Antibody Test (OraSure Technologies) and Chembio DPP HIV 1/2 Assay (Chembio Diagnostic Systems). The tests detect both HIV-1 and HIV-2 Abs but cannot distinguish between them. These tests are CLIA-waived and may be used with oral fluid specimens in POC and nonclinical testing sites. For more information, see Table A1, above.

Urine specimens: HIV-1 Abs may be detected in urine. Only 1 screening test and 1 Western blot are FDA-approved for use with urine specimens. Although urine specimens are commonly used for HIV testing in situations such as insurance company testing, HIV tests for urine specimens do not offer adequate sensitivity or specificity for general diagnostic use and should be avoided. Both nonreactive and reactive results of urine HIV testing should be confirmed with standard serologic testing, starting with an HIV-1/2 Ag/Ab immunoassay.

Date of current publication: August 8, 2023
Lead authors: Jessica Rodrigues, MS; Jessica M. Atrio, MD, MSc; and Johanna L. Gribble, MA
Writing group: Steven M. Fine, MD, PhD; Rona M. Vail, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: August 8, 2023

Throughout its guidelines, the New York State Department of Health (NYSDOH) AIDS Institute (AI) Clinical Guidelines Program recommends “shared decision-making,” an individualized process central to patient-centered care. With shared decision-making, clinicians and patients engage in meaningful dialogue to arrive at an informed, collaborative decision about a patient’s health, care, and treatment planning. The approach to shared decision-making described here applies to recommendations included in all program guidelines. The included elements are drawn from a comprehensive review of multiple sources and similar attempts to define shared decision-making, including the Institute of Medicine’s original description [Institute of Medicine 2001]. For more information, a variety of informative resources and suggested readings are included at the end of the discussion.

The benefits to patients that have been associated with a shared decision-making approach include:

• Decreased anxiety [Niburski, et al. 2020; Stalnikowicz and Brezis 2020]
• Increased trust in clinicians [Acree, et al. 2020; Groot, et al. 2020; Stalnikowicz and Brezis 2020]
• Improved engagement in preventive care [McNulty, et al. 2022; Scalia, et al. 2022; Bertakis and Azari 2011]
• Improved treatment adherence, clinical outcomes, and satisfaction with care [Crawford, et al. 2021; Bertakis and Azari 2011; Robinson, et al. 2008]
• Increased knowledge, confidence, empowerment, and self-efficacy [Chen, et al. 2021; Coronado-Vázquez, et al. 2020; Niburski, et al. 2020]

Collaborative care: Shared decision-making is an approach to healthcare delivery that respects a patient’s autonomy in responding to a clinician’s recommendations and facilitates dynamic, personalized, and collaborative care. Through this process, a clinician engages a patient in an open and respectful dialogue to elicit the patient’s knowledge, experience, healthcare goals, daily routine, lifestyle, support system, cultural and personal identity, and attitudes toward behavior, treatment, and risk. With this information and the clinician’s clinical expertise, the patient and clinician can collaborate to identify, evaluate, and choose from among available healthcare options [Coulter and Collins 2011]. This process emphasizes the importance of a patient’s values, preferences, needs, social context, and lived experience in evaluating the known benefits, risks, and limitations of a clinician’s recommendations for screening, prevention, treatment, and follow-up. As a result, shared decision-making also respects a patient’s autonomy, agency, and capacity in defining and managing their healthcare goals. Building a clinician-patient relationship rooted in shared decision-making can help clinicians engage in productive discussions with patients whose decisions may not align with optimal health outcomes. Fostering open and honest dialogue to understand a patient’s motivations while suspending judgment to reduce harm and explore alternatives is particularly vital when a patient chooses to engage in practices that may exacerbate or complicate health conditions [Halperin, et al. 2007].

Options: Implicit in the shared decision-making process is the recognition that the “right” healthcare decisions are those made by informed patients and clinicians working toward patient-centered and defined healthcare goals. When multiple options are available, shared decision-making encourages thoughtful discussion of the potential benefits and potential harms of all options, which may include doing nothing or waiting. This approach also acknowledges that efficacy may not be the most important factor in a patient’s preferences and choices [Sewell, et al. 2021].

Clinician awareness: The collaborative process of shared decision-making is enhanced by a clinician’s ability to demonstrate empathic interest in the patient, avoid stigmatizing language, employ cultural humility, recognize systemic barriers to equitable outcomes, and practice strategies of self-awareness and mitigation against implicit personal biases [Parish, et al. 2019].

Caveats: It is important for clinicians to recognize and be sensitive to the inherent power and influence they maintain throughout their interactions with patients. A clinician’s identity and community affiliations may influence their ability to navigate the shared decision-making process and develop a therapeutic alliance with the patient and may affect the treatment plan [KFF 2023; Greenwood, et al. 2020]. Furthermore, institutional policy and regional legislation, such as requirements for parental consent for gender-affirming care for transgender people or insurance coverage for sexual health care, may infringe upon a patient’s ability to access preventive- or treatment-related care [Sewell, et al. 2021].

Health equity: Adapting a shared decision-making approach that supports diverse populations is necessary to achieve more equitable and inclusive health outcomes [Castaneda-Guarderas, et al. 2016]. For instance, clinicians may need to incorporate cultural- and community-specific considerations into discussions with women, gender-diverse individuals, and young people concerning their sexual behaviors, fertility intentions, and pregnancy or lactation status. Shared decision-making offers an opportunity to build trust among marginalized and disenfranchised communities by validating their symptoms, values, and lived experience. Furthermore, it can allow for improved consistency in patient screening and assessment of prevention options and treatment plans, which can reduce the influence of social constructs and implicit bias [Castaneda-Guarderas, et al. 2016].

Clinician bias has been associated with health disparities and can have profoundly negative effects [FitzGerald and Hurst 2017; Hall, et al. 2015]. It is often challenging for clinicians to recognize and set aside personal biases and to address biases with peers and colleagues. Consciously or unconsciously, negative or stigmatizing assumptions are often made about patient characteristics, such as race, ethnicity, gender, sexual orientation, mental health, and substance use [Avery, et al. 2019; van Boekel, et al. 2013; Livingston, et al. 2012]. With its emphasis on eliciting patient information, a shared decision-making approach encourages clinicians to inquire about patients’ lived experiences rather than making assumptions and to recognize the influence of that experience in healthcare decision-making.

Stigma: Stigma may prevent individuals from seeking or receiving treatment and harm reduction services [Tsai, et al. 2019]. Among people with HIV, stigma and medical mistrust remain significant barriers to healthcare utilization, HIV diagnosis, and medication adherence and can affect disease outcomes [Turan, et al. 2017; Chambers, et al. 2015], and stigma among clinicians against people who use substances has been well-documented [Stone, et al. 2021; Tsai, et al. 2019; van Boekel, et al. 2013]. Sexual and reproductive health, including strategies to prevent HIV transmission, acquisition, and progression, may be subject to stigma, bias, social influence, and violence.

In addition to the references cited below, the following resources and suggested reading may be useful to clinicians.

References

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Avery JD, Taylor KE, Kast KA, et al. Attitudes toward individuals with mental illness and substance use disorders among resident physicians. Prim Care Companion CNS Disord 2019;21(1):18m02382. [PMID: 30620451]

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Castaneda-Guarderas A, Glassberg J, Grudzen CR, et al. Shared decision making with vulnerable populations in the emergency department. Acad Emerg Med 2016;23(12):1410-16. [PMID: 27860022]

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Coulter A, Collins A. Making shared decision-making a reality: no decision about me, without me. 2011. https://www.kingsfund.org.uk/sites/default/files/Making-shared-decision-making-a-reality-paper-Angela-Coulter-Alf-Collins-July-2011_0.pdf

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KFF. Key data on health and health care by race and ethnicity. 2023 Mar 15. https://www.kff.org/racial-equity-and-health-policy/report/key-data-on-health-and-health-care-by-race-and-ethnicity/ [accessed 2023 May 19]

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Niburski K, Guadagno E, Abbasgholizadeh-Rahimi S, et al. Shared decision making in surgery: a meta-analysis of existing literature. Patient 2020;13(6):667-81. [PMID: 32880820]

Parish SJ, Hahn SR, Goldstein SW, et al. The International Society for the Study of Women’s Sexual Health process of care for the identification of sexual concerns and problems in women. Mayo Clin Proc 2019;94(5):842-56. [PMID: 30954288]

Robinson JH, Callister LC, Berry JA, et al. Patient-centered care and adherence: definitions and applications to improve outcomes. J Am Acad Nurse Pract 2008;20(12):600-607. [PMID: 19120591]

Scalia P, Durand MA, Elwyn G. Shared decision-making interventions: an overview and a meta-analysis of their impact on vaccine uptake. J Intern Med 2022;291(4):408-25. [PMID: 34700363]

Sewell WC, Solleveld P, Seidman D, et al. Patient-led decision-making for HIV preexposure prophylaxis. Curr HIV/AIDS Rep 2021;18(1):48-56. [PMID: 33417201]

Stalnikowicz R, Brezis M. Meaningful shared decision-making: complex process demanding cognitive and emotional skills. J Eval Clin Pract 2020;26(2):431-38. [PMID: 31989727]

Stone EM, Kennedy-Hendricks A, Barry CL, et al. The role of stigma in U.S. primary care physicians’ treatment of opioid use disorder. Drug Alcohol Depend 2021;221:108627. [PMID: 33621805]

Tsai AC, Kiang MV, Barnett ML, et al. Stigma as a fundamental hindrance to the United States opioid overdose crisis response. PLoS Med 2019;16(11):e1002969. [PMID: 31770387]

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