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HIV Testing in the United States

Key Facts

  • HIV testing is integral to HIV prevention, treatment, and care. Knowledge of one’s HIV status is important for preventing the spread of disease, yet 15% of people with HIV do not know they are infected. Studies show that those who learn they are HIV positive modify their behavior to reduce the risk of HIV 1,2,3
  • Overall about half (46%) of nonelderly adults in the United States (U.S.) have ever been tested for HIV, including 8% in the last year. The Centers for Disease Control and Prevention (CDC) recommends routine HIV screening in health-care settings for all adults, aged 13-64, and repeat screening for those at higher risk.
  • Early knowledge of HIV status is critical for linkage to medical care and treatment that can reduce morbidity and mortality and improve quality of life.4 Treatment guidelines recommend starting antiretroviral treatment as soon as one is diagnosed with HIV.5 Individuals with HIV who have an undetectable viral load, typically as a result of effective antiretroviral therapy, cannot sexually transmit HIV to others.6
  • Most people with health insurance – both public and private – have access to HIV testing, often at no cost. And, for those without insurance, HIV testing can often be obtained at little or no cost in community settings.
Key Dates in the History of HIV Testing7
1981: First AIDS case reported
1984: Human immunodeficiency Virus (HIV) identified
1985: First test for HIV licensed (ELISA)
1987: First Western Blot blood test kit
1992: First rapid test
1994: First oral fluid test
1996: First home and urine tests
2002: First rapid test using finger prick
2003: Rapid finger prick test granted CLIA (Clinical Laboratory Improvement Amendments) waiver
2004: First rapid oral fluid test (also granted CLIA waiver)
2006: CDC recommends routine HIV screening in U.S. health care settings8
2007: CDC launches Expanded HIV Testing Initiative in U.S.
2007: WHO/UNAIDS global guidelines recommend routine HIV screening in health care settings9
2010: First test approved that detects both antigen and antibodies10
2012: First rapid oral fluid home test11
2013: USPSTF gives routine HIV screening an “A” rating12
2013: First rapid test approved that detects both antigen and antibodies, and distinguishes between acute and established HIV-1 infection13
2015: Centers for Medicare and Medicaid Services announces Medicare coverage of annual HIV screening for all beneficiaries 15-65, and for those older and younger beneficiaries at “increased risk” for HIV14
2019: USPSTF reaffirms its “A” rating for HIV screening

Testing Statistics

  • Among the more than 1.1 million people with HIV in the U.S., an estimated 15% do not know they are infected and this share accounts for nearly 40% of new transmissions.15,16 Studies show that those who learn they are HIV positive modify their behavior to reduce the risk of HIV transmission.17
  • Through earlier detection, raising awareness of HIV status, and linkage to care and treatment, testing could play an important role in addressing the U.S. epidemic.
  • According to the CDC’s Behavioral Risk Factor Surveillance System (BRFSS) about half (46%) of U.S. adults, aged 18-64, reported ever having been tested for HIV, including 8% who reported being tested in the last year (see Figure 1).
  • HIV testing varies by state, age, race/ethnicity, and other factors.18,19,20,21,22 For example, Blacks and Latinos are more likely to report recent testing and having ever been tested for HIV than whites (e.g. 68% and 49% vs 46%, respectively have ever been tested).23 (See Figure 1.)
  • According to a 2014 survey of gay and bisexual men in the U.S., relatively few report being tested as regularly as is often advised. Seven in 10 say they have been tested at some point in their lives, 1 in 5 say they were tested within past six months, and 3 in 10 say they’ve never been tested for HIV, a share that rises to 44 percent among those under age 35.24
  • Findings from a recent CDC analysis of a decade of testing data suggests that some people at risk for HIV are not getting tested as frequently as recommended.25

Figure 1: Percent of Nonelderly Adults who Reported Being Tested for HIV, by Race/Ethnicity, 2017

Testing Recommendations and Requirements

The U.S. Centers for Disease Control and Prevention (CDC) recommends routine HIV screening in health-care settings for all adults, aged 13-64, and repeat screening at least annually for those at higher risk.26,27 Per the CDC individuals who may benefit from at least annual screening include:28

  • sexually active gay or bisexual men (some of whom may benefit from more frequent testing, such as every 3 to 6 months)
  • individuals who have had sex with an HIV-positive partner
  • individuals who have had more than one partner since their last HIV test
  • those who have shared needles or works to inject drugs
  • people who have exchanged sex for drugs or money
  • individuals who have another sexually transmitted disease, hepatitis, or tuberculosis
  • those who have had sex with someone who has participated in any of the above activities or with someone with an unknown sexual history

Certain factors are known to reduce the risk of HIV transmission including condom use, antiretroviral treatment leading to durable viral load suppression among those with HIV, which prevents further transmission, and the use of pre-exposure prophylaxis (PrEP) among those at increased risk for HIV.29

Additionally, HIV testing is recommended for all pregnant women and for any newborn whose mother’s HIV status is unknown.30 Treatment provided to pregnant HIV-positive women and to their infants for 4-6 weeks after delivery can reduce the risk of transmitting HIV to 1% or less.31 HIV testing is also recommended for anyone who has been sexually assaulted.

CDC recommends that all HIV screening be voluntary, and opt-out (patient is notified that the test will be performed and consent is inferred unless the patient declines) vs. opt-in (test is offered to the patient who must explicitly consent to an HIV test, often in writing).32

HIV testing is mandatory in the U.S. in certain cases, including for: blood and organ donors;33 military applicants and active duty personnel;34 federal and state prison inmates under certain circumstances;35,36 and newborns in some states.37 As of January 2010, HIV testing is no longer mandatory for those wishing to emigrate to the United States or for refugees.38

Insurance Coverage of HIV Testing

Most insurers now broadly cover HIV testing, many without cost-sharing, in part due to a decision made by the United States Preventive Services Task Force (USPSTF), an independent panel that assess the net benefit of preventive services and assigns a subsequent letter grade (A-D). Under the ACA, any “A” or “B” graded preventive services must be provided by most insurers without cost-sharing; in addition, traditional Medicaid programs, while not required to provide USPSTF top graded services are incentivized to do so. In 2013, the USPSTF gave HIV screening an “A” rating for all adolescents and adults, ages 15 to 65.39  It  also gave an “A” grade to HIV screening for pregnant women. Both of these recommendations were reaffirmed in 2019.40 The current insurance coverage landscape of HIV testing is as follows:

  • Private Insurance: Most private plans cover HIV testing without cost-sharing. All plans created after the ACA was signed in 2010 must cover.41,42
  • Medicaid: All Medicaid programs cover “medically necessary” HIV testing and most cover routine HIV screening.
    • Traditional Medicaid Programs: While all Medicaid programs must cover “medically necessary” HIV testing,43 coverage of “routine” HIV screening is an optional benefit in traditional (non-expansion) Medicaid programs. Still, most states (42 states and DC) do cover routine HIV screening; only eight cover just “medically necessary” testing (AL, FL, GA, ME, MS, NE, SD, and VA).44 Among the 43 states that cover routine HIV screening, 15 (CA, CO, DE, HI, KY, LA, MT, NH, NJ, NV, NY, OH, OR, WA and WI) cover all USPTSF “A” and “B” graded services and have sought an additional 1% increase in their federal matching rate (FMAP) for these services under Sec. 4106 of the ACA. 45
    • Medicaid Expansion Programs: In addition to covering medically necessary testing, Medicaid programs expanded under the ACA are required to cover preventive services rated “A” or “B” by the USPSTF, including HIV screening, without cost-sharing. To date 37 states and DC have expanded their Medicaid programs.46
  • Medicare: In April 2015, following the 2013 USPSTF recommendation and a subsequent National Coverage Determination, CMS expanded Medicare coverage to include annual HIV testing for beneficiaries ages 15-65 regardless of risk, and those outside this age range at increased risk without cost-sharing.47Additionally, Medicare will cover up to three tests for pregnant beneficiaries.48
  • Uninsured: For those without insurance coverage (or wishing not to use their insurance), HIV testing can be obtained at little or no cost in some community based settings (e.g., stand-alone HIV testing sites, community health centers, mobile testing clinics).

Testing Sites and Policies

HIV testing is offered at CDC-funded testing sites (accounting for more than 3 million tests) and in other public and private settings, including free-standing HIV counseling and testing centers, health departments, hospitals, private doctor offices, STD clinics, and mobile testing units.49 The overall positivity rate at CDC funded test sites was 0.9% in 2017, including testing among those newly and previously diagnosed. The positivity rate for new diagnoses was 0.4% but was substantially higher for certain sub-populations (e.g. 3.2% for black men who have sex with men).50 Among CDC-funded testing sites, non-health care facilities have a higher rate of clients testing HIV-positive than do health care and correctional facilities.51

All states/territories have moved to HIV name reporting (in addition to reporting AIDS cases) where a person’s name is reported to the state if they test HIV positive. The state then reports the number of unique positive HIV tests to CDC (no names or other personally identifying information are reported to CDC; only clinical and basic demographic information are forwarded). This is considered confidential HIV testing. There is also anonymous HIV testing offered at some testing sites where identifying information is not collected.

Testing Techniques

HIV tests aim to detect the virus by looking for evidence of the body’s immune response (antibodies), proteins on the surface of the virus (antigens), or genetic material from the virus (RNA). Detectable antibodies usually develop within 3-8 weeks after infection, but may take longer; the period after initial infection with HIV before detectable antibodies develop is the “window period.”52 In 2010, the FDA approved the first HIV diagnostic test that detects both antibodies and antigen, a component of the virus that triggers the production of antibodies.53 In 2013, the FDA approved the first rapid antigen-antibody test, the first test also to distinguish between acute and established HIV-1 infection.54 Tests for antigen allow for earlier detection of HIV because they can detect the virus before the body has mounted a response, although there will still be a window period of approximately two weeks after initial infection during which no test can detect the virus. RNA, or nucleic acid tests, which detect the virus itself in the blood, are also available, but not routinely used for screening. The test may be used in cases where there has been a high-risk exposure to HIV and as a follow-up test to a positive antibody test.55

The currently HIV diagnostics in the U.S differ based on type of specimen tested (whole blood, serum, or plasma; oral fluid; urine); how the specimen is collected (blood draw/venipuncture; finger prick; oral swab; via urination); where the test is done (laboratory; point-of-care site; at home); and how quickly results are available (conventional or rapid).56,57 The main types of tests are:

  • Conventional Blood Test: Blood sample drawn by health care provider; tested at lab. Results: less than an hour to several days.
  • Conventional Oral Fluid Test: Oral fluid sample collected by health care provider, who swabs inside of mouth; tested at lab. Results: a few days to two weeks.
  • Rapid Tests:58 Whole blood finger prick or venipuncture; plasma; oral fluid sample collected depending on complexity of rapid test and individual administering test. Results: approximately 10 minutes. If test is negative, no further testing is needed. If positive, test must be confirmed with a more specific test through conventional method. Some rapid tests have been granted CLIA waivers which allow them to be used outside traditional laboratories.
  • Home Tests: There are two approved home tests, one of which is performed with a finger prick finger with a lancet, placing drops of blood on treated card, and mailed to lab for testing. An identification number on the card is used when phoning for results; counseling and referral available by phone. Results: in approximately three days. The other is a rapid oral fluid test for home use. Results: approximately 20 minutes.  Both home tests may be purchased from drug stores and online.59
  • Urine Test: Urine sample collected by health care provider; tested at lab. Results: a few days to two weeks.

After an HIV Test

Following an HIV test, individuals who test positive can expect a confirmatory test and linkage to HIV care and treatment. It is considered a best practice to initiate antiretroviral treatment as soon as possible after diagnosis.60 Doing so facilitates the best possible clinical outcomes for the HIV positive individual and is also a prevention opportunity, as once that individual has an undetectable viral load they cannot transmit HIV to others.61  Individuals who test HIV negative but who are at high risk for the infection, may be referred to additional prevention services such as PrEP which can reduce the risk of HIV acquisition through sex by more than 90%.62

Endnotes
  1. Li, Z., et al. CDC, Vital Signs: HIV Transmission Along the Continuum of Care — United States, 2016

    Weekly / March 22, 2019 / 68(11);267–272.

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  2. CDC, MMWR 55(RR14); September 2006.

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  3. CDC, MMWR 52(15); April 2003.

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  4. CDC, MMWR 55(RR14); September 2006; CDC, MMWR 52(15); April 2003.

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  5. U.S. Department of Health and Human Services, Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV; updated October 2018.

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  6. CDC, HIV Basics: Prevention; updated January 2019.

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  7. KFF, Global HIV/AIDS Timeline.

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  8. CDC, MMWR 55(RR14); September 2006.

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  9. WHO/UNAIDS Press Release, “WHO and UNAIDS issue new guidance on HIV testing and counselling in health facilities;” May 2007.

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  10. FDA Consumer Information, “Fourth Generation HIV Diagnostic Test Approved, permitting earlier detection of infection;” June 2010.

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  11. FDA Approval Letter, July 3, 2012 Approval Letter, OraQuick In-Home HIV Test.

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  12. U.S. Preventive Services Task Force, “Human Immunodeficiency Virus (HIV): Screening;” April 2013.

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  13. FDA Consumer Information, “First rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies approved.”

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  14. Centers for Medicare & Medicaid Services, “Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R);” April 2015.

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  15. CDC. Li, Z. et al. Vital Signs: HIV Transmission Along the Continuum of Care — United States, 2016 68(11);267–272

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  16. CDC. Li, Z. et al. Vital Signs: HIV Transmission Along the Continuum of Care — United States, 2016 68(11);267–

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  17. CDC, MMWR 55(RR14); September 2006.

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  18. KFF analysis of 2017 Behavioral Risk Factor Surveillance System (BRFSS).

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  19. CDC, Behavior Risk Factor Surveillance System.

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  20. CDC, National Health Interview Surveys.

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  21. CDC, MMWR 65(6); June 2016.

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  22. CDC, MMWR 67(24); June 2018.

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  23. KFF analysis of 2017 Behavioral Risk Factor Surveillance System (BRFSS).

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  24. KFF, HIV/AIDS In The Lives Of Gay And Bisexual Men In The United States; September 2014.

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  25. CDC, MMWR 67(24); June 2018.

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  26. CDC, MMWR 55(RR14); September 2006.

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  27. CDC, MMWR 66(31); August 2017.

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  28. CDC. HIV Testing 101. February 2018.

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  29. CDC, HIV Basics: Prevention; updated February 27, 2018.

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  30. CDC, MMWR 55(RR14); September 2006.

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  31. CDC, HIV Among Pregnant Women, Infants, and Children; 2018.

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  32. CDC, MMWR 55(RR14); September 2006.

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  33. FDA, “Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood,” Publication No. FS 02-1; February 2002.

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  34. U.S. Department of Defense, Instruction Number 6485.01; October 2006.

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  35. U.S. Federal Bureau of Prisons, Legal Resource Guide to the Federal Bureau of Prisons; November 2008.

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  36. U.S. Department of Justice, Bureau of Justice Statistics, HIV in Prisons, 2007-2008; December 2009.

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  37. KFF/NASTAD, The National HIV Prevention Inventory; July 2009.

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  38. CDC, “Final Rule Removing HIV Infection from U.S. Immigration Screening.”

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  39. U.S. Preventive Services Task Force, “Human Immunodeficiency Virus (HIV): Screening;” April 2013.

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  40. U.S. Preventive Services Task Force, Human Immunodeficiency Virus (HIV) Infection: Screening” June 2019.

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  41. All non-grandfathered private plans, including those sold in both the individual and group markets are required to cover. Grandfathered plans, plans that were in place prior to the ACA and that have not undergone significant changes, are not required to cover preventive services without cost sharing. Per KFF’s Employer Health Benefit Survey, in 2018, 20% of firms offering health benefits offer at least one grandfathered health plan, and 16% of covered workers are enrolled in a grandfathered plan. The share of plans with grandfathered status is expected to decline over time.

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  42. KFF, Preventive Services Covered by Private Health Plans under the Affordable Care Act; June 2015.

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  43. Each state Medicaid program determines its own definition of medical necessity, although it generally refers to procedures recommended by a physician.  In the case of HIV, for example, HIV testing is clinically indicated based on a patient’s risk factors and/or signs of HIV infection.

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  44. KFF, State Medicaid Coverage of Routine HIV Screening; 2015.

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  45. Personal communications with HHS, June 2019.

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  46. KFF. Status of State Action on the Medicaid Expansion Decision, as of May 2019.  https://www.kff.org/health-reform/state-indicator/state-activity-around-expanding-medicaid-under-the-affordable-care-act/

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  47. Centers for Medicare & Medicaid Services, “Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R);” April 2015.

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  48. Centers for Medicare & Medicaid Services, “Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R);” April 2015.

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  49. CDC, CDC-Funded HIV Testing, United States, Puerto Rico, and the U.S. Virgin Islands, 2017; 2018.

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  50. CDC, CDC-Funded HIV Testing, United States, Puerto Rico, and the U.S. Virgin Islands, 2017; 2018.

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  51. CDC, CDC-Funded HIV Testing, United States, Puerto Rico, and the U.S. Virgin https://www.cdc.gov/hiv/pdf/library/reports/cdc-hiv-funded-hiv-testing-report-2017.pdfIslands, 2017; 2018..

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  52. CDC, HIV Basics: Testing; updated March 2018.

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  53. FDA Consumer Information, “Fourth Generation HIV Diagnostic Test Approved, permitting earlier detection of infection;” June 2010.

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  54. FDA Consumer Information, “First rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies approved.”

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  55. CDC, HIV Basics: Testing; updated March 2018.

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  56. Jeffrey L. Greenwald et al., “A Rapid Review of Rapid HIV Antibody Tests,” Clinical Infectious Diseases 8(2); March 2006.

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  57. FDA, Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays.

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  58. Jeffrey L. Greenwald et al., “A Rapid Review of Rapid HIV Antibody Tests,” Clinical Infectious Diseases 8(2); March 2006. FDA, Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays.

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  59. FDA Approval Letter, July 3, 2012 Approval Letter, OraQuick In-Home HIV Test.

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  60. U.S. Department of Health and Human Services, Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV; updated October 2018.

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  61. CDC, HIV Basics: Prevention; updated January 2019.

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  62. CDC. HIV Basics: PrEP; updated May 2019.

     

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