Download Article PDF/SlidesWhen it comes to HIV infection, the need for improved diagnostic care couldn’t be more evident. According to the U.S. Centers for Disease Control (CDC), 29% of HIV-infected persons in this country are unaware of their HIV status. CDC surveillance data also indicate that 37% of persons who test positive for HIV develop AIDS within a year after their diagnosis, meaning that many individuals likely remain unaware of their infection for several years, potentially putting their own health—and the health of others—in jeopardy. New York City Department of Health and Mental Hygiene (NYC DOHMH) statistics mirror those of the CDC: approximately 25% of HIV-positive New Yorkers learn that they are infected with HIV at the time of an AIDS diagnosis.
Another central concern is the fact that between 27,000 and 30,000 of blood tests conducted annually at publicly funded testing sites are positive for HIV antibodies. However, approximately 31% of those who test positive do not return to anonymous testing sites to receive their results.
In light of these statistics, public health officials, clinic directors, and individual clinicians have been involved in initiatives to make confidential HIV testing a routine part of medical care with the use of new diagnostic technologies, including rapid HIV assays. These assays have been developed to make point-of-care (POC) HIV testing feasible and to greatly reduce the number of persons who do not learn their HIV status by providing immediate results. “When it comes to these assays,” Dr. Kevin Armington said in his introductory remarks, “we live in an instant gratification society. If people can get a negative or preliminary positive result in twenty minutes, that’s the test most people are going to want. The numbers suggest that a lot of people change their mind about learning their results during the older one- to two-week waiting period. This is something we can improve with same-day testing.”
| About Rapid HIV Testing | Top of page |
There are four rapid HIV tests approved by the U.S. Food and Drug Administration. Two of these assays are designed to be POC tests, in both medical and non-medical settings. They can also be performed in separate laboratories after a specimen has been obtained.
Figure 1. Performing an OraQuick Rapid Advance Antibody Test
A sample OraQuick Rapid Advance antibody test is shown here (image 1). To collect a specimen for the test, either touch the collection loop to a fingerstick blood droplet (image 2) or use standard phlebotomy collection procedures for whole blood with the following test tubes: EDTA, Sodium Heparin, Sodium Citrate, or ACD Solution and dip the collection loop into the test tube (image 3). Five microliters of whole blood should adhere to and fill a single collection loop (image 4). Insert the loop and stir the specimen in the vial of developer solution (image 5). The OraQuick device is inserted into the developer vial where it remains until the results are read (image 6). Test results must be read no sooner than 20 minutes but no later than 40 minutes after the device is added to the developer solution (image 7).
Source: Orasure, Inc.; U.S. Centers for Disease Control and Prevention
The first assay—which Dr. Armington referenced often in his March 2005 PRN lecture—is Orasure’s OraQuick Advance, which can be used to detect antibodies to HIV-1 and HIV-2 in whole blood, oral fluid, and plasma. Results are available in 20 minutes. OraQuick Advance is the only FDA-approved rapid assay that can be used with oral fluid. An earlier (and still available) version of the OraQuick assay, the Oraquick Rapid HIV-1 Antibody test, can only be used on whole blood or plasma samples collected via finger stick or venipuncture, and only to look for antibodies to HIV-1.
There also is Trinity Biotech’s Uni-Gold Recombigen, useful for the detection of HIV-1 antibodies in serum and plasma. Results using Uni-Gold Recombigen are available in ten minutes. MedMira Labs, a Canadian company, has FDA approval for Reveal G2, for detection of antibodies to HIV-1 in serum and plasma. Results are available in five minutes using this assay. Finally there is Bio-Rad Laboratories’ Multispot assay, approved for the detection of both HIV-1 and HIV-2 antibodies in serum and plasma. The Multispot assay differentiates HIV-1 from HIV-2 antibodies, and produces accurate results after 15 minutes.
Any medical office, clinic, or organization that performs a rapid HIV test to provide results to patients is considered to be a laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). As a result, all laboratories must comply with the regulations of the CLIA Program and with any applicable state requirements.
Sale of rapid HIV tests is restricted to clinical laboratories that have an adequate quality assurance program where persons who use the test will receive and use the instructional materials provided with the tests. The FDA also requires that persons tested with rapid assays receive the "Subject Information" pamphlet provided with the test. Details about other restrictions that apply to the rapid HIV tests are outlined in the package inserts provided with the test kits.
Currently, two of the available rapid HIV tests are “waived” and two are categorized as “moderate complexity” under CLIA. CLIA requirements for laboratories—any medical office, clinic, or organization performing rapid HIV testing is considered to be a laboratory—differ depending on the category and complexity of the test.
The OraQuick Advance and Uni-Gold Recombigen assays are CLIA-waived tests when used with whole blood or oral fluid. For waived tests, there are no federal requirements for personnel, quality assessment, or proficiency testing, although the tests must comply with state and local regulations and laws. In turn, waived tests can easily be done in traditional laboratories or clinical settings, and also in settings such as doctors’ offices, HIV counseling and testing sites, mobile vans, and health fairs. To perform only waived tests, an organization must obtain a certificate of waiver from the CLIA program (or be included with a CLIA-certified laboratory under a multiple site exception) and follow the manufacturer’s instructions for the test procedure.
In New York State, this waiver must be obtained from the New York State Department of Health Wadsworth Center as a Limited Service Laboratory. For information on requirements and application procedures, clinicians may contact the Clinical Laboratory Evaluation Program (CLEP) at (518) 485-5378 or visit the website at: http://www.wadsworth.org.
The Reveal G2 and Multispot assays are both categorized as moderate complexity under CLIA. Because they must be performed on serum or plasma, the specimen must be centrifuged and these tests are best suited for a more traditional laboratory.
| Health Behavior Change: A Counseling Strategy for Clinicians | Top of page |
Many modern-day health risk behaviors result from voluntary behaviors such as unhealthy eating habits; the use of tobacco, alcohol, or other drugs; and, when it comes to HIV and STIs, the failure to utilize safety precautions that are, for the most part, readily available. Health risk behaviors, once considered the result of faulty decision-making, impulsive behavior, or characteristic of psychosocial development, are now recognized as dynamic conditions evolving across the lifespan. “These are very difficult topics for many patients and providers to discuss,” Dr. Armington noted, “but they really are topics that should be explored with patients’ clinicians.”
One method of applying health behavior change counseling is through motivational interviewing. This technique, which came about in the 1990s, was designed as a brief, non-confrontational way of helping patients make changes in their behavior. The goal of motivational interviewing is to create a safe and supportive rapport with a patient, in order to facilitate their thinking about their behavior and whether or how they might go about making changes. The technique acknowledges that the idea of change can have both positive and negative connotations and takes both of these aspects into account.
Strategies of motivational interviewing—and health behavior change counseling—include the following: 1) Asking for permission to discuss a subject, such as the patient’s sexual activity. 2) Asking open ended questions. Clinicians should avoid using questions that will elicit a literal answer that obscures pertinent information. For example, clinicians should ask what a patient likes to do sexually, instead of providing a list of activities. “Listen to the language they use,” Dr. Armington said. “Some patients may not know what anal intercourse means. And don’t be embarrassed to speak the language being used by patients.” 3) Engage in double-side reflective listening. Listen for the underlying meaning of what is being said and then reflect it back to the patient. An example provided by Dr. Armington: “So I hear you saying that you are spending $200 a month buying this miracle juice, which is supposed to be an immune enhancer, yet every weekend you’re going out and challenging your immune system with all of these drugs. There’s an inconsistency here.” 4) Provide non-judgmental feedback. “Clinicians need to create the sense that they are supportive,” he explained further. “Reinforce important statements with reflective listening and support, such as nods and an encouraging choice of words and tone.” 5) Bring attention to discrepancies between present behavior and a patient’s broader health goals. 6) Avoid arguing and pressuring a patient into action. 7) Negotiate goals that are realistic and attainable. “Somebody who is never using condoms is not going to start using condoms 100% of the time by their next office visit. Let the patient set a realistic goal for him or herself, such as using condoms one weekend a month, at least initially. It may sound silly, but these things really are meaningful. The emphasis here is on collaborative discussion and recognizes that incremental change—anything that helps a patient move along the spectrum of behaviors towards healthy activities—is better than no change at all. It is essential to find out what’s really going on, because this is what clinicians really want and need to know.”
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