Frequently Asked Questions (FAQs) Concerning Rapid Testing for HIV

Resources for seeking additional information from other sources are noted within the section(s) to which they pertain.

General Questions

What are the benefits of rapid testing for HIV?

Rapid tests offer great promise to help fight the HIV/AIDS epidemic. They can:

  • increase the number of individuals who seek testing and who actually receive their test results;
  • facilitate early identification of infection and help reduce the number of persons who are tested late in the course of their HIV disease;
  • prevent new infections by ensuring that those at highest risk for infection learn their status and receive information that can help them protect their partners;
  • help individuals maintain negative status by providing immediate test results along with HIV risk reduction information and counseling;
  • help eliminate perinatal transmission; and
  • make the most efficient use of resources.

Are there any disadvantages of offering a rapid test?

Yes, a rapid test does not offer a rapid confirmed positive result. This means that individuals who receive a preliminary positive test must wait to receive a confirmed positive result. For some individuals, this additional time may be unexpected. These persons may need extra support and counseling. It is important for them to return for their "final" test result. For some persons, this additional step to return for the results of the confirmatory test may be a challenge. Effective strategies to make certain that individuals receive their "final" test results are vitally important.

What are the limitations of rapid tests?

No test is perfect - there may be a very small proportion of people who are not infected with HIV who will have a reactive result on this test (false positive), and a similar small proportion of people who are infected with HIV who will have a non-reactive result (false negative). Also, this test will not detect HIV infection in people who are tested within about 3 months of exposure to the virus (3 months is the time it takes for detectable antibodies to appear in the blood in response to the HIV infection). These limitations are true for all currently approved HIV antibody tests. For these reasons, it is essential that all individuals who are tested with this rapid test be appropriately counseled both before being tested and after receiving their test results. For those individuals with reactive test results, follow-up testing using another technique is necessary to confirm that the result is positive for HIV antibodies.

What is meant by"confirmatory test" and how can the confirmatory test be obtained?

The standard HIV testing algorithm in the U.S. consists of a screening test, such as an enzyme immunoassay (EIA), followed by confirmatory testing (e.g., a western blot) of all samples determined to be reactive or preliminary positive or presumptive positive by the screening assay. Confirmatory testing must be accomplished by collection of an oral fluid, venous blood specimen, or dried blood spot that is submitted by the Limited Testing Site to a laboratory holding a NYS permit to conduct confirmatory testing. A list of laboratories qualified to perform HIV confirmatory tests may be obtained from the licensing program at (518) 485-5378.

What else is required in terms of any necessary agency policies and procedures?

Agency policies and procedures for implementation of rapid testing must address confidentiality, informed consent, pre-test counseling, a system for return appointments, arrangements for confirmatory testing, post-test counseling (including provision for referral to the NYS Partner Services Program and/or the NYC Contact Notification Assistance Program, known as CNAP), screening for risk of domestic violence, crisis counseling, referral to HIV primary care and case management, record keeping, reporting of results, and referrals (i.e., for ongoing HIV prevention services, substance abuse treatment and other services).

Test performed by a Limited Testing Site must be ordered by a physician or other health care provider, such as a nurse practitioner or physician assistant, who is legally authorized (by NYS professional practice law) to use the results of clinical laboratory tests in the practice of his or her profession. A nurse (RN or LPN) or a MSW counselor may not authorize testing.

Since some rapid tests involve collection of blood specimens, safety precautions and staff training consistent with the federal OSHA (Occupational Safety and Health Administration) requirements for occupational exposure to blood borne pathogens and arrangements for safe and proper disposal of regulated medical waste are required. Information about OSHA's requirements can be found on their website.

NYS requirements for regulated medical waste are set forth in Part 6 of the Environmental Conservation Law.

What training is available to prepare test counselors to offer rapid testing?

In offering rapid tests, HIV test counselors would benefit greatly from attending certain courses prior to initiating testing.. Courses are available at no charge through the AIDS Institute's Statewide Calendar of HIV/AIDS Training. The courses that constitute the basic core to prepare staff to offer HIV counseling and testing are: HIV/AIDS Confidentiality Law, HIV Testing Procedures and Practicing the NYS Domestic Violence Screening Protocol.

Specific questions may be directed to the training center at which you/your staff wish to attend training. In addition, manufacturers' themselves offer a variety of training tools.

Can rapid tests be used in mobile outreach settings?

There are some practical issues to consider when planning where and how rapid tests will be used. Test devices and controls must be stored and used within prescribed temperature ranges. Once the test device is placed in the developer solution vial, it must be kept on a flat, level surface and should not be moved. The manufacturer specifies a number of circumstances under which controls need to be run before the rapid test device can be used. One such circumstance is a change in the condition of testing (new location, lighting, temperature, etc.). Rapid test package inserts contain more specific information about each of these issues.

How does reporting of HIV/AIDS take place in NYS when a rapid test is involved?

All confirmed reactive test results must be reported to the NYSDOH by the laboratory conducting the confirmatory test and by the authorizing physician or other health care practitioner, pursuant to Article 21 of the NYS Public Health law and Section 63.4 of Part 63 of 10NYCRR.

Has the CDC conducted any studies that are specifically about rapid tests for HIV?

Yes, there have been CDC studies about rapid tests for HIV. Several abstracts have been developed that summarize the results of these studies. They may be located using the internet as follows:

Questions About Specific Rapid Tests

How can I obtain additional information about available rapid tests?

The Centers for Disease Control and Prevention (CDC) offers several documents that are accessible via the Internet.

Where can I go for an overview of rapid tests for HIV that are available for use in the United States?

The Centers for Disease Control and Prevention (CDC) offers several documents that are accessible via the Internet. "General and Laboratory Consideration: Rapid HIV Tests Currently Available in the United States" can be found at on the CDC's website. Rapid test technology updates and information regarding new product approval can be found on the FDA website.

Non-Clinical Providers' Use of Rapid Tests for HIV

Can non-clinical providers [i.e., community-based organizations (CBOs)] offer rapid tests ?

Yes, under certain circumstances, described below, non-clinical providers can offer rapid testing. Any non-clinical provider that receives funding from the AIDS Institute and would like to consider offering rapid testing should discuss this possibility with their AIDS Institute contract manager.

What do non-clinical providers have to do to offer the rapid tests?

Non-clinical providers must register their testing site(s) with the NYS Department of Health (NYSDOH) Wadsworth Center as a Limited Testing Site to offer rapid testing. This registration requires completion of an application form and submission of the application with a fee. The NYSDOH requires designation of a licensed health care practitioner who will function as director and provide technical and clinical oversight of testing. Please be aware that only individuals currently certified by NYS as laboratory directors, or individuals authorized by law to order and use laboratory tests in their practice, are eligible to be designated as directors of a Limited Testing Site. A nurse (RN or LPN) or a MSW counselor may not direct testing at a Limited Testing Site. The Limited Testing Site Registration Application and Instructions may be obtained online or by calling (518) 485-5378.

Tests performed by a Limited Testing Site must be ordered by a physician or other health care provider, such as a nurse practitioner or physician assistant, who is legally authorized (by NYS professional practice law) to use the results of clinical laboratory tests in the practice of his or her profession. A nurse (RN or LPN) or a MSW counselor may not authorize testing.

How can non-clinical providers assure that they fulfill the requirements for HIV counseling and testing, informed consent and confidentiality?

The authorizing physician responsible for HIV testing is responsible for overseeing ordering the test and arrangements for confirmatory testing. Second, the individual designated as the director of the Limited Testing Site provides technical and clinical oversight of testing. Third, trained HIV test counselors play vitally important roles in offering HIV tests and in assuring that all existing requirements are met.

What other specific resource needs accompany rapid testing?

In addition to staff required (i.e., an authorizing physician, a director of the Limited Testing Site, trained staff to serve as HIV test counselors) and the rapid test devices, supplies needed to perform the test include a timer(s), thermometer(s), antiseptic wipes, band aids, sterile lancets, sterile gauze pads, disposable gloves and biohazard sharps containers.

My agency already offers HIV testing. What do I need to do to get started?

Non-clinical providers that already offer HIV C& T using resources provided by a contract with the AIDS Institute that wish to offer rapid testing should contact their contract managers to determine how best to integrate rapid tests financially and programmatically into their services. As appropriate, the AIDS Institute will approve the redirection of existing resources to support the adoption of rapid tests.

My agency has not offered HIV testing in the past but we are interested in offering rapid testing. What should we do?

Non-clinical providers not currently offering HIV C & T that wish to offer rapid testing should contact their AIDS Institute contract managers to discuss their interest in rapid testing and to be briefed on the full range of issues involved.

Clinical Providers' User of Rapid Tests for HIV

What is the New York State Department of Health's policy regarding rapid testing in outpatient health settings?

The Department supports and encourages the use of rapid HIV testing in health care settings, provided that facilities adhere to Centers for Disease Control and Prevention (CDC) guidelines and to State regulations. These regulations set forth requirements for performing HIV tests, providing HIV counseling, obtaining informed consent for HIV testing, protecting the confidentiality of HIV-related information, reporting cases of HIV/AIDS, and providing partner notification assistance services. In particular, rapid testing is consistent with the Department's goal to integrate HIV counseling and testing into general primary care services delivered in a variety of health settings.

New York State regulations require that women in prenatal care, regardless of specific risk factors, receive HIV counseling with testing presented as a clinical recommendation. Consistent with CDC guidelines, the Department also recommends that HIV testing be routinely recommended for clients in health settings located in high seroprevalence areas. In low seroprevalence areas, health facilities should provide HIV counseling with testing recommended for all clients at increased risk if HIV.

What is the State Department of Health's policy regarding rapid testing in the labor and delivery setting?

The Department is notifying every New York State birth facility that the rapid HIV tests have been approved and encourage them to perform the test at point of care in labor and delivery when the mother's HIV status is unknown. In most cases, rapid testing will allow obstetricians to have preliminary HIV test results before the mother delivers, when the initiation of antiretroviral therapy can be of significant benefit. The rates of perinatal HIV transmission in New York State have decreased from 10.9% in 1997 to 2.8% in 2004. Rapid testing at a point of care in labor and delivery will be of critical importance in further reducing the number of infants who are infected with HIV through perinatal transmission.

In light of this change in technology, the Department is considering a proposal to change 10NYCRR 69-1.3(2), which applies in cases where a woman presents for delivery with no documentation of her HIV status. The amended regulation would require the birth facility to arrange an immediate HIV screening test of the mother with her consent or of her newborn without consent with results available as soon as possible, but in no event longer than 12 hours. The maximum 12-hour turnaround time would apply from the time the mother consents to testing or from the time of the infant's birth. Current regulations allow a 48-hour turnaround time, for expedited HIV screening. The requirement for confirmatory testing within four days of a preliminary positive result would remain in effect.

Should employee health services have the capacity to provide rapid HIV testing?

Yes. Rapid testing will aid decisions regarding administration of post-exposure prophylaxis (PEP) following significant occupational exposure to blood or body fluids. New York Department of Health guidelines for implementing PEP recommend immediate HIV testing, with informed consent, of the source patient with the result of the test available as soon as possible after the exposure. The guidelines further recommend that PEP be initiated immediately when indicated, ideally within two hours post-exposure. More information on New York State guidelines for HIV prophylaxis following occupational exposure is available at: www.hivguidelines.org.

What are New York State application procedures and requirements for health facilities and physicians seeking to perform rapid HIV antibody testing?

The federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) require all facilities performing laboratory tests to obtain a federal CLIA number. CLIA is administered in New York State through the Department of Health, and all facilities, with the exception of privately owned and operated physician office laboratories, must obtain a CLIA number through enrollment with the Clinical Laboratory Evaluation Program (CLEP). For information on requirements and application procedures, facilities may contact CLEP at (518) 485-5378 or visit the website and click on the "Application Materials" link.

Physicians in private practice should contact the Department's Physician Office Laboratory Evaluation Program (POLEP) at (518) 485-5352 for information on application procedures and requirements.

What are the program requirements for user of rapid testing under the HIV Primary Care Medicaid Program?

Facilities must train all users of the test, develop or revise HIV counseling and testing protocols (using AIDS Institute guidelines), and have in place a quality improvement plan that includes rapid testing. It is recommended all non-clinical staff providing HIV counseling must complete an HIV test counselor training program approved by the Department of Health.

How will providers enrolled in the HIV Primary Care Medicaid Program be reimbursed for HIV counseling and testing when a rapid HIV test is used?

Health facilities enrolled in the HIV Primary Care Medicaid Program will bill the HIV testing visit for their eligible patients. When the test is preliminary positive, they may bill an HIV post-test positive visit on the same day when rapid testing technology is used. No reimbursement will be available to Article 28 facilities to cover the costs of the rapid HIV test kit or test kit controls. Complete program visit and documentation standards are detailed in AI DOHM 06-01.

Reimbursement will be available to physicians enrolled in the HIV Enhanced Fees for Physicians Program (HIV EFP) to cover the costs of the rapid HIV test kit. To be eligible for this reimbursement, the HIV-EFP physician must have submitted an application to the DOH Physician Office Laboratory Evaluation Program (POLEP). Contact POLEP at (518) 485-5352 for further information. Contact John Schnurr at (518) 426-1383 for information on enrollment in HIV EFP.

Birth facilities currently receive a Medicaid payment of $96 for every expedited HIV test conducted in the labor and delivery setting when the mother's HIV status is unknown or undocumented at the time she presents for delivery. This payment covers the cost of counseling the mother ($44) and conducting the HIV test ($52). The payment amount will not change with the introduction of rapid testing in the labor and delivery setting.

Can facilities receive Medicaid reimbursement for HIV counseling and testing offered at part-time and satellite clinics?

Yes. As noted above, the facility must have a CLIA number and register the site with the DOH Clinical Laboratory Evaluation Program (CLEP).

Facilities seeking to add HIV counseling and testing at existing part-time and satellite clinics should send a request in writing, on the facility's letterhead, to the following address:

New York State Department of Health
AIDS Institute
Bureau of Program Review and System Development
Empire State Plaza
Corning Tower, Room 372
Albany, NY 12237

Telephone: (518) 426-1383
Fax: (518) 473-8905
Email: HIV Primary Care Medicaid Program or HIV Enhanced Fees for Physicians Program

For information on satellite or part-time clinics, contact the New York State Department of Health, Bureau of Health Facility Planning at (518) 402-0911.

Resources for Additional Information

What can I do if I have additional questions about using rapid tests for HIV in New York State?

You may submit questions by email to: hivct@health.state.ny.us

If my interest in rapid tests for HIV is more general, where can I access basic information?

The Centers for Disease Control and Prevention (CDC) offers several documents about rapid testing for HIV that are accessible via the Internet. These pages include descriptions of the rapid HIV tests approved by the FDA, how the tests can be implemented in different settings, and research on the effectiveness and possible uses of the tests.