Rapid HIV Testing FAQ
Overview of Rapid HIV Testing
Q: What is a rapid HIV test?
A:
A rapid HIV test is a screening test that produces very quick results, in approximately 20 minutes. Rapid tests use blood from a vein or from a finger stick, or oral fluid, to look for the presence of antibodies to HIV. A standard HIV test may take several days to obtain a result.
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Q: Why is rapid HIV testing important?
A:
Tremendous strides have been made in the care of pregnant women living with HIV. Because of this progress the risk of vertical transmission (when HIV is transmitted from a mother to her baby) can be as low as 1-2%. Maximum reduction in transmission occurs when a woman knows her HIV status early in pregnancy and receives treatment in the prenatal period and during labor and her infant receives treatment once he or she is born. Some women present to labor and delivery without a documented HIV test or may require repeat HIV testing in the third trimester. In these cases a rapid HIV test on labor and delivery is necessary. It is critical that a woman’s HIV status is known because appropriate medical decisions can be made at the time of delivery that have the potential to reduce the risk of HIV transmission by almost half. The sooner a doctor or nurse knows that a woman is HIV positive, the sooner treatment can be started, and the greater the chance her baby will be born HIV negative.
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Q: What are the advantages of a rapid test in labor and delivery?
A:
A rapid test in the labor and delivery setting offers several advantages. Firstly, rapid testing identifies a woman as preliminarily HIV positive before she leaves labor and delivery. This allows for confirmatory testing and for her to be linked with care assuring appropriate follow up. Furthermore, the sooner an HIV infection is identified and a woman is linked to care the greater the chance she will have an undetectable viral load at delivery increasing the chance her baby will be HIV negative.
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Q: Where can I get additional information about rapid HIV Testing?
A:
For additional information about rapid HIV testing, click here.
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Who Needs a Rapid Test
Q: Who should be offered rapid HIV testing?
A:
- Any woman who presents to labor and delivery without a documented HIV test during the current pregnancy
- Any woman with a negative HIV test result early in pregnancy who is at increased risk of acquiring HIV during pregnancy should be offered repeat testing in the third trimester. This includes women who:
- have a history of sexually transmitted infections
- participate in the exchange of sex for money or drugs
- have had multiple sex partners during the current pregnancy
- use illicit drugs
- have a sex partner[s] known to be HIV positive or at high risk for an HIV infection
- have signs and symptoms of seroconversion
If a patient presents to labor and delivery without documented third trimester testing and warrants repeat testing a rapid HIV test can be offered.
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Q: Is it necessary to offer a rapid test to a pregnant woman on labor and delivery who is NOT in labor or at risk of delivery?
A:
Yes. Illinois law requires that all pregnant women on labor and delivery who do not have a documented HIV test for the current pregnancy in their record, be counseled and recommended a rapid HIV test.
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HIV Counseling and Testing for Pregnant Women and Newborns in Illinois
Q: Who is required to offer HIV counseling and testing?
A:
Every healthcare professional involved in providing prenatal care, labor and delivery services, or care for newborns—including licensed physicians, physician’s assistants, and registered nurses—must counsel pregnant women about HIV and, unless they decline, provide HIV testing. For delivering women and newborns, that HIV test must be a rapid test.
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Q: What counseling and testing services must providers offer to pregnant women?
A:
- Prenatal care: Health care professionals must counsel every pregnant woman about HIV and provide HIV testing unless they decline or there is documentation that they were previously tested during the current pregnancy. Providers must explain that women may decline HIV testing, but that if they decline testing, HIV testing will be mandatory for the newborn.
- Third trimester repeat HIV testing: Because Illinois has a high incidence of women with HIV, the CDC recommends that all pregnant women in Illinois be tested a second time for HIV during the third trimester to ensure that they have not been infected with HIV during the pregnancy. This is not required by Illinois law but is the CDC-recommended standard of care. The testing is not recommended to be a risk-based screening, but universal, voluntary, repeat testing in the third trimester for ALL pregnant women.
- Labor and delivery: When pregnant women present to deliver, women who lack a documented HIV test result during the current pregnancy must be counseled and provided rapid testing for HIV unless they decline. Providers must explain that women may decline HIV testing, but that if they decline testing, HIV testing will be mandatory for their newborn.
- After delivery: If a woman’s HIV status is still unknown after she delivers, as soon as possible within medical standards, providers must counsel the mother about HIV testing and conduct a rapid HIV test for the newborn. The mother’s or guardian’s consent is not required to test the newborn.
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Q: What must HIV counseling include?
A:
All HIV counseling for pregnant women must be in accordance with the AIDS Confidentiality Act and include:
- The voluntary nature of testing for pregnant women.
- The requirement that opt-out testing of the mother be performed, unless she declines, and how to decline.
- The benefits of HIV testing for pregnant women, including the opportunity to prevent HIV transmission to the newborn.
- The benefit of HIV testing for the infant, including interventions to prevent transmission, and the side effects of those interventions.
- The confidentiality provisions that relate to HIV and AIDS.
- The requirement that if the mother’s HIV status is unknown, the newborn must be tested for HIV.
- An explanation of the test, including its purpose, limitation, and the meaning of its results.
- An explanation of the procedures followed.
- The availability of additional or confirmatory testing, if appropriate.
- Counseling may be provided in writing, verbally, by video, electronic or other means. The woman must be offered an opportunity to ask questions about testing and to decline testing for herself.
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Q: How must the HIV test be administered?
A:
- All testing of pregnant women must be voluntary. Only newborns whose mother’s HIV status is unknown may be tested without consent.
- Opt-out HIV testing must be conducted for all pregnant women. They must be provided with counseling prior to HIV testing. Providers must explain that women may decline HIV testing, advise that they will be tested for HIV unless they decline, and informed how to decline testing. They must be counseled on the benefits of HIV testing, and providers must inform women that their newborn will be tested if they are not tested.
- Any testing and test results must be documented in accordance with the AIDS Confidentiality Act (410 ILCS 305/). All counseling and acceptance or refusal of testing must be recorded in the woman’s medical records.
- The law requires that the mother’s HIV test results be recorded in her newborn’s chart. The provider must note if the test results are not available because the mother declined testing or was not tested.
- Testing of women in labor and newborns must be performed by a rapid HIV test.
- Providers may be fined for violations of the AIDS Confidentiality Act, including failing to provide adequate pre-test counseling.
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Interpretation of Rapid Test Results
Q: What does a positive rapid HIV test mean?
A:
A positive rapid HIV test is interpreted as a preliminary positive. Because no test can be both 100% sensitive (no false-negative results) and 100% specific (no false-positive results), a given test is typically designed to primarily possess one of these characteristics at the expense of the other. A rapid HIV test is a screening test meaning that it is a sensitive test but not specific. Practically, this translates to more false-positive test results. This is why all positive rapid HIV test results require a confirmation with a more specific test such as a Western blot. In certain situations, such as labor, it may be necessary to initiate treatment prior to obtaining a confirmatory result. Other times treatment can be delayed until a confirmatory test result is obtained. The Illinois Perinatal HIV Hotline is available to help you make these treatment decisions.
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Q: What does a negative rapid HIV test mean?
A:
A negative rapid HIV test is interpreted as negative. No confirmatory testing is required. If a woman was exposed to the virus within the last 3 months, repeat testing is recommended as the rapid test may not detect a recent infection.
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How to Handle a Positive Rapid HIV Test Result
Q: What should we do if a patient has a positive rapid HIV test result?
A:
It is critical that when a patient has a positive rapid test result a confirmatory Western blot test is sent immediately. A positive result should promptly trigger a call to the Illinois Perinatal HIV Hotline as required by Illinois law. As a team you and the hotline staff will determine the most appropriate clinical and social course to assure the risk of HIV transmission from the patient to her infant is optimally reduced.
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Q: How should preliminary positive test results be communicated to the patient?
A:
During this time it is important to note that a patient’s decision to accept an HIV test and the results of that test are to be kept confidential. Labor and delivery staff need to be vigilant of this at all times. The discussion of test results should occur in an environment where the patient feels comfortable and safe. The patient may not want to disclose information regarding her choice to be tested or the results of the test to her family members, partner, or friends. Ask the patient prior to obtaining the rapid HIV test who she wants present when she receives the results. Only the individuals identified should be in the room when the results are relayed. If English is not the patient’s primary language, interpretation services should be utilized. Staff should not use family members or friends to discuss test results or provide information surrounding the results.
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Q: What should the patient be told about the preliminary positive result?
A:
Patients should be counseled that positive test results are only preliminary and that additional testing is necessary to confirm the diagnosis. If she is at risk for delivery she should be informed that the second test will likely not be back prior to delivery of her baby. She should be counseled that antiretroviral medication is recommended to reduce the risk of transmission of the virus to her baby. Additionally, she should be counseled to avoid breastfeeding until confirmatory test results are available.
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Q: If the rapid test is preliminary positive, should we repeat it?
A:
No. Rapid tests cannot be confirmed with another rapid test. It is important to act quickly and obtain a confirmatory test, report the result, and depending on the scenario initiate treatment.
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Q: If the mother’s test is preliminary positive, should we also test the baby?
A:
No. There should be only one rapid HIV test on the mother/baby pair. The best chance for prevention is diagnosis of HIV infection in a pregnant woman. The rapid test detects maternal antibodies to HIV and does not diagnose HIV infection in infants. A different test, a DNA PCR (polymerase chain reaction) test is used to begin the process of determining if the infant is infected. If the mother declines HIV testing, or is missed for HIV testing when pregnant and/or delivering, the baby must be tested (by law in Illinois). If the baby’s test is preliminary positive, it means that maternal antibodies to HIV may have been detected in the baby’s blood. Therefore, it is not necessary to rapid test the mother postpartum after the baby has been tested. A sample may be drawn from the mother for confirmatory Western blot testing.
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Management of Pregnant Women with a Preliminary Positive Rapid HIV Test
Q: How should staff manage a pregnant patient with a preliminary positive rapid HIV test in labor and delivery?
A:
Women with a preliminary positive rapid HIV test who are in active labor should be counseled on the test result, the risk of vertical transmission and the potential benefit of a cesarean delivery in reducing that risk. The mother should be treated as positive until confirmatory tests prove otherwise. The Department of Health and Human Services Perinatal Guidelines indicate that intravenous AZT should be initiated immediately and that blood be sent for a Western blot test to confirm the positive rapid HIV result. The neonate should also be managed as though the mother is positive until confirmatory tests prove otherwise. Click here for the IL Perinatal HIV Hotline’s best practices for labor and delivery care for patients with a positive rapid HIV test.
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Q: How should staff manage a pregnant patient with a positive rapid HIV test who is not in active labor?
A:
If the woman is not in labor, and delivery is not imminent, confirmatory testing should be conducted and the patient managed accordingly.
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Q: If the patient’s rapid test is preliminary positive and a confirmatory result is urgently needed, how can we obtain an expedited Western blot?
A:
The Illinois Perinatal HIV Hotline offers expedited tests for HIV-1 Western blot for calls to the Hotline in which an urgent confirmatory HIV test result is needed for obstetrical decision making. The specimens are processed for HIV 1 & 2 EIA and HIV-1 Western blot at Northwestern Memorial Hospital’s Immunology Laboratory in Chicago, IL. Please call the Illinois Perinatal HIV Hotline for information regarding how to prepare and ship the specimen and click here for further instructions.
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Reporting of Positive Rapid HIV Tests in Illinois
Q: When is it required to report a preliminary positive rapid test?
A:
In the state of Illinois, all rapid HIV tests performed on labor and delivery, whether or not delivering women, must be reported. Reporting consists of calling the Illinois Perinatal HIV Hotline at 1-800-439-4079 and completing the Preliminary Positive Case Reporting Form.
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Q: How soon should we call the Illinois Perinatal HIV Hotline to report a preliminary positive rapid HIV test?
A:
Ideally, the call should be made to the Hotline as soon as possible. By Illinois law, the call must be placed within 24 hours of birth
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Q: Why is it important to call the Illinois Perinatal HIV Hotline as soon as the preliminary positive result is obtained?
A:
Twenty-four hours a day, 7 days a week expert, up-to-date, real-time consultation on each individual case is available to assure that all clinical and social issues are addressed for each patient with a preliminary positive result. The intent of the legislation requiring the call is to ensure that experienced case management helps the woman and her family with this information in the very vulnerable time between receipt of the rapid result and receipt of the confirmatory Western blot result. Oftentimes, case management can also provide a home visit and help ensure the return visit to the hospital or clinic to receive the confirmatory results. Hotline staff work with hospitals and providers as a team to make clinical decisions, connect patients with case management, and assure appropriate follow up.
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Indeterminate Western Blot Test Results
Q: What does an indeterminate Western blot result mean?
A:
For a Western blot to be considered positive it has to meet certain criteria. If the results only meet some of the criteria it is considered indeterminate. It is important to understand that an indeterminate result does not denote a positive or negative HIV status.
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Q: What can cause an indeterminate Western blot result?
A:
- An acute HIV infection
- Advanced HIV infection with decreased titers of p24 antibodies
- HIV-2 infection
- Recent vaccination with:
- Influenza vaccine
- Experimental HIV vaccine
- Cross-reacting alloantibodies from pregnancy
- Blood transfusions
- Organ transplantation
- Autoantibodies (collagen-vascular diseases, autoimmune diseases, and malignancy)
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Q: How should indeterminate Western blot results be managed in pregnant patients?
A:
Clinicians should interview the patient to assess risk of HIV infection and counsel about safer sex practices until the results of further testing clarify the patient’s status. Clinicians should interview the patient about signs and symptoms of acute retroviral syndrome (including fevers, sore throat, headache, rash, lymphadenopathy). If the risk of HIV infection appears high or if the patient has had recent illness consistent with acute retroviral syndrome, we urge that health care workers contact the Illinois Perinatal HIV Hotline at 1-800-439-4079 or another infectious disease specialist.
If an indeterminate Western blot test result is identified during the first trimester, the test should be repeated in 4-6 weeks to ensure that the woman is not in the process of seroconversion (the process of developing HIV antibodies). An HIV PCR (polymerase chain reaction) viral load test is also sent. If follow-up tests are read as negative, the woman is usually considered HIV negative. If repeated test results are read as indeterminate, you should consider having the sample run in a different laboratory that utilizes a different assay in order to discern whether there is a problem with cross reactivity with a specific antigen or if the woman is in fact HIV positive. If test results are found to be indeterminate at or around the time of delivery, protocols for HIV positive patients should be followed until a true determination can be made. Please feel free to call the Illinois Perinatal HIV Hotline at 1-800-439-4079 with specific questions or concerns.
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Implementation of Rapid HIV Testing in Illinois Hospitals
Q: Who can help me implement rapid HIV testing?
A:
The Perinatal Rapid Testing Implementation Initiative in Illinois (PRTII2) can assist you. It was created to help support hospital implementation of rapid HIV testing as mandated by the Perinatal HIV Prevention Act. The Illinois Department of Public Health funds this effort. Leadership is provided by Dr. Mardge Cohen, MD (Cook County Bureau of Health Services), Dr. Pat Garcia, MD, MPH (Northwestern Memorial Hospital), Yolanda Olszewski, MSc, MPH (Cook County Bureau of Health Services) and Anne Statton (PACPI). Regional coordinators are assigned to individual hospitals to help with implementation of rapid testing, troubleshooting and as a resource for information on best practices. Click here for resources for Illinois hospitals currently conducting rapid testing or if you are interested in implementing rapid testing in your hospital. You may also contact PRTII2 at info@hivpregnancyhotline.org for specific questions about rapid HIV testing.
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Q: What is the role of the PRTII2 Regional Coordinator?
A:
The regional coordinator is responsible for overseeing the implementation of rapid testing at hospitals, provides education and training to site administrators and staff, and provides consultation/technical assistance as needed.
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The Law: Illinois Perinatal HIV Prevention Act
Q: What is the law in Illinois regarding perinatal HIV prevention?
A:
The Illinois Perinatal HIV Prevention Act (410 ILCS 335/) aims to eliminate HIV transmission from mothers to newborns. The U.S. Centers for Disease Control and Prevention (CDC) recommended in 2006 that providers conduct opt-out HIV testing of pregnant women. According to CDC, before testing, providers should counsel pregnant women about the benefits of HIV testing, inform them that they will be tested unless they decline, explain how to decline, advise that HIV testing is voluntary, and test the women for HIV unless they decline. Illinois Public Law 95-702, effective June 1, 2008, implements these guidelines, mandates the counseling before the offer of testing and permits opt-out HIV testing. For additional information about the law, click here
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Q: What is the benefit of the Illinois Perinatal HIV Prevention Act?
A:
According to the CDC, without treatment, there is a one in four chance that a woman will pass HIV along to her newborn. With treatment, that risk can be reduced to less than 1 in 50. The Illinois law ensures that pregnant women are strongly encouraged to accept HIV testing and offered treatment if they are HIV positive.
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Q: Where can I get more information about the Perinatal HIV Prevention Act and other legal topics?
A:
For information about the Act, click here. For information on the Illinois AIDS Confidentiality Act and other legal topics, you can download a legal guide at www.aidslegal.com or contact the AIDS Legal Council of Chicago at 312-427-8990. To view the Illinois Perinatal Prevention Act, 2007 amendments, and other resources, click here.
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Sections of this fact sheet highlighting Illinois law regarding HIV counseling and testing for pregnant women and newborns were prepared by the AIDS Foundation of Chicago, AIDS Legal Council and the Pediatric AIDS Chicago Prevention Initiative.
1 U.S Centers for Disease Control and Prevention, "Revised Recommendations for HIV Testing of
Adults, Adolescents, and Pregnant Women in Health-Care Settings," September 22, 2006,
http://www.cdc.gov/mmwr/pdf/rr/rr5514.pdf, accessed November 29, 2007.
2 U.S Centers for Disease Control and Prevention, "Pregnancy and Childbirth",
http://www.cdc.gov/hiv/topics/perinatal/index.htm, accessed November 29, 2007.