Questions Submitted from the CDC Broadcast "Update on Rapid Testing for HIV" April 24, 2003

Broome Developmental Center

Is the Rapid Test like the ELISA test, in that it is testing for HIV antibodies?

Yes, the rapid test detects the presence of antibodies for HIV.

If this test is preliminary positive can an Orasure be done for confirmation?

Yes, preliminary positive rapid test results may be confirmed with standard blood or oral fluid testing (Orasure).

If the test is preliminary positive, will the laboratory that conducts confirmatory testing still perform an EIA or just a Western Blot on blood work?

Laboratories will perform an EIA on all specimens submitted and will follow-up with Western Blot on all EIA reactives. If the laboratory receives information that this is a rapid preliminary positive, the laboratory will perform both the EIA and Western Blot.

What are the specific responsibilities of the Limited Test Sites surrounding confirmatory testing of preliminary positive results?

In requesting approval to offer HIV counseling and testing, Limited Testing Sites are making a commitment to fulfill the complete HIV counseling and testing process, including provisions for consent, confidentiality, pre- and post-test counseling and confirmatory testing, and reporting of confirmed positive results. Limited Testing Sites using the rapid test must have mechanisms in place to fulfill all of the necessary steps for both negative and preliminary positive rapid test results.

The rapid test provides reliable negative test results. In the case of a negative result, no further confirmatory testing is required. The negative test result can be shared with the client in the context of post-test counseling. The Limited Testing Site must document the negative result, consistent with internal policies and procedures and NYSDOH requirements.

In the case of a preliminary positive result via the rapid test, the Limited Testing Site is required to collect another specimen (blood or oral fluid) to be sent for confirmatory testing and to provide the client with post-test counseling appropriate to the outcome of the confirmatory testing. It is not appropriate to simply refer a client for whom a preliminary positive result is obtained to another provider. The Limited Testing Site, not the client, is responsible for steps necessary to complete the testing process. Limited Test Sites are also responsible for reasonable follow-up with clients who fail to return for the confirmatory result and post-test counseling and for linking clients to on-going prevention services and/or HIV primary care, as appropriate.

What will the cost be?

The cost of the rapid test is determined by the manufacturer.

Does the lab director have to be a doctor?

No. A limited laboratory must have a director who holds an appropriate certificate of qualification (CQ) for the testing performed. Physicians, dentists or mid-level practitioners (e.g., physician assistants and nurse practitioners, as defined by CLIA) with experience in laboratory testing performed at that facility, may serve as lab director. For more information see http://www.wadsworth.org/labcert/clep/faq/faq.htm

What type of other antibodies can cause a false positive?

There are some unrelated medical conditions that may cause a false-reactive (positive) rapid test result as with all HIV antibody tests. The package insert of the OraQuick Rapid HIV-1 Antibody Test includes the study analysis detailing the medical conditions tested and which ones may interfere. To view the OraQuick Package Insert see http://www.orasure.com/uploaded/331.pdf

Will we be able to use a finger stick for a filter paper test for the Western Blot instead of phlebotomy?

A Western Blot test is available that utilizes a dried whole-blood sample; the trade name is Genetic Systems HIV-1 Western Blot manufactured by Bio-Rad Laboratories Blood Virus Division. Check with your laboratory to find out if this test is offered. For more information, go to http://www.fda.gov/cber/products/testkits.htm

St. Peter’s Hospital

Are there any reference serum materials that exhibit low-level reactivity that can be used for initial training and competency testing of staff?

There are many companies that sell reference materials for HIV. Suggestions include: Blackhawk, Boston Biomedica, NABI, Serologics (further information can be found on the internet).

How lengthy is the process for application processing for a limited lab permit?

Limited service laboratories, which are sites that perform only simple tests that have been designated as waived tests by the federal government, must register with the Department and pay a $100 fee at the time of application. The application is available on the web site: http://www.wadsworth.org/labcert/clep/clep.html. Department review of a complete application that includes the name of the person who will act as director of the site, typically takes no more than two weeks. A notice of registration is sent out immediately upon a determination that the site qualifies as a limited service laboratory.

What is the CPT code for a Rapid HIV test?

CPT codes are used when billing Medicaid for services to Medicaid-eligible persons. CPT codes are found in the ICD9-CM Code Book. The general code for HIV Counseling is V-65.44. No specific code is now available for rapid testing. Providers currently enrolled in the HIV Primary Care Medicaid Program should have received a mailing about rapid testing in early May that included billing instructions. If the facility has not received this mailing, contact John Schnurr at 518-473-3786. Providers who are not currently enrolled in the HIV Primary Care Medicaid Program who are interested in doing so, should contact John Schnurr. Other facilities should direct specific billing questions to Medicaid Provider Relations at 1-800-522-1892.

Is Directorship of a limited site different if HIV Testing is performed there?

A limited laboratory must have a director who holds an appropriate certificate of qualification (CQ) for the testing performed. A lab director may also be a physician, dentist or mid-level practitioner (e.g., physician assistant and nurse practitioner as defined by CLIA) with experience in laboratory testing performed at that facility.

Kingsboro Psychiatric Center

Is there a time frame for the decision re: Medicaid reimbursement for rapid HIV testing-combining a rate for pre-test and post test on the same day?

Yes, effective May 1, 2003, health facilities enrolled in the HIV Primary Care Medicaid Program may bill an HIV pre-test counseling visit on the same day as an HIV post-test counseling visit when rapid testing technology is used.

What level of staff is able to provide the rapid HIV test or do agencies assess and evaluate the individual labs?

To perform waived rapid testing the laboratory director is responsible for the overall management and direction of the lab and the testing personnel. Testing personnel are responsible for specimen processing, test performance and reporting of test results. The minimum requirement for staff conducting a waived rapid HIV test is training for the testing performed. To ensure high quality counseling and testing a routine quality management system should be in place. This system would include training, evaluation of the counseling and testing process, the ability to identify and correct problems or errors and conduct remedial actions, review of documentation, confidential record maintenance and a standard operating procedure manual for both counseling and testing. An important resource for developing a comprehensive quality assurance program is the CDC document titled “Quality Assurance Guidelines for Testing Using the OraQuick Rapid HIV-1 Antibody Test”.

If a rapid test is negative after a post-exposure (source client), can that be used as a way to offer/start or not to initiate (HAART) regimens?

Yes, rapid testing will aid decisions regarding administration of post-exposure prophylaxis (PEP) following significant occupational exposure to blood or body fluids. New York State 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

Can the rapid test be used as a preliminary testing in the care of post exposure?

Yes.

Suffolk County Department of Health

If the rapid test is that simple and accurate, why can't this test be made available "over the counter" as the pregnancy tests are? I appreciate the counseling aspect but think we could still reach our goals better if an individual could privately know what his/her status is immediately (20 minutes) by doing this as a self-test.

In the case of the OraQuick Rapid HIV-1 Antibody Test, the test was not submitted by the manufacturer to the FDA for approval as an "over the counter" product for home use. It is also important to remember that, in the case of a preliminary positive result, the OraQuick test alone does not provide a complete, confirmed test result. The U.S. Food and Drug Administration (FDA) is responsible for approving diagnostic devices, including "over the counter" or home-use tests. Home Access is one HIV test that is currently approved for use at home but it is not a rapid test. No manufacturer has submitted a rapid HIV test to the FDA for approval as an “over the counter” or home test. If submitted for approval, the FDA review and approval process seeks to assure that the user will get acceptable results from the test compared to the results obtained when a professional performs the test; the user will be able to interpret test results correctly; and the benefits of the test outweigh its risks. To access information from the FDA about home use tests, go to the FDA’s web site at: http://www.fda.gov/cdrh/oivd/consumer-homeuse.html .

If your rapid test is (+) and your patient refuses to have the Western Blot what is your recourse? Do we still have to report the (+) rapid test result? Or does this fall through the cracks?

The process of obtaining consent for conducting a rapid test includes explaining that if the rapid test result is preliminary positive, follow-up standard testing is needed to determine the person’s HIV infection status. The pre-test counseling session also involves an assessment by the test counselor that the individual is prepared to receive a same day result. When a client consents for an HIV test using rapid testing, he/she is consenting for the entire testing process, including confirmatory testing. However, under Article 27-F a person can withdraw consent for an HIV test at any time. If a person who tests preliminary positive does not want to have the follow-up testing performed (this is not likely to occur frequently), the provider should work closely to assess the patient’s concerns and try to address them. Concerns might include patient safety, fear of domestic violence, etc. It would be important for the provider to establish a follow-up plan with the patient to provide on-going support and re-assess the patient’s readiness for follow-up testing. Only a confirmed positive test result is reported to the Department of Health. Preliminary positive results obtained using the rapid test are not confirmed positive test results and are not reported.

Mount Sinai Medical Center

What percent of preliminary positives on the rapid test are verified positive on the Western Blot?

According to the manufacturer’s study (included in the OraQuick package insert) 100% of the OraQuick preliminary positives were verified positive with the Western Blot.

Is there any confirmatory back up with a negative result?

A non-reactive or negative OraQuick rapid test is considered a final test result. However, as with standard blood or oral fluid testing, there is a three-month “window period”. Re-testing should be performed if the person was tested during the window period. In order to definitively rule out HIV infection, an HIV test should be performed three months after the last possible exposure.

Other than relative prevalence are there any reasons technical or otherwise why HIV-2 rapid testing has not been developed?

The HIV-2 genome is patent protected and can not be included/acknowledged unless royalties are paid to the patent holder. Most rapid tests are manufactured to detect HIV-1 and HIV-2 but the patent issues preclude them from claiming HIV-2 sensitivity in the product insert. (OraQuick is an HIV 1/2 assay but the company can only claim sensitivity to HIV-1).

How long does it take for HIV antibodies to develop in someone who has been exposed to HIV? If there is a gap in time how does the rapid test address this?

It can take up to 3 months for HIV antibodies to develop in someone who is infected with HIV. This time frame is referred to as the “window period”. As with standard blood or oral fluid testing, in order to rule out HIV infection, an HIV rapid test should be performed three months after the last possible exposure.

Will homeless youth that test HIV positive on mobile medical units be guaranteed housing? Will more money be approved for housing?

It is the hope of the CDC and the NYSDOH that rapid HIV testing will play an important role in promoting early identification of HIV infection, including early identification among adolescents. Homeless adolescents, particularly those who test HIV positive, should be referred to health care, case management and other support services to ensure that the young person’s health and social services needs are met.

Is there a list of MIRIAD participating health care facilities available?

The Mother-Infant Rapid Intervention at Delivery (MIRIAD) study examines the use of rapid testing in the labor and delivery setting. This national study has important implications for the reduction of perinatal transmission. Information about MIRIAD may be found at:
http://www.cdc.gov/hiv/pubs/rt-women.htm#miriad

How do we charge for pre and posttest sessions at the same time? Would programs be losing money or would the fee for service change to reflect the new way of testing?

Effective May 1, 2003, health facilities enrolled in the HIV Primary Care Medicaid Program may bill an HIV pre-test counseling visit on the same day as an HIV post-test counseling visit when rapid testing technology is used. No separate reimbursement will be available to Article 28 facilities to cover the costs of the rapid HIV test kit or test kit controls.

Buffalo General Hospital

When will the rapid test be reimbursable through HMOs or other private insurance?

Each HMO and private insurance company will determine whether they will extend benefits for rapid HIV testing and for whom. Patients who are interested in rapid testing should discuss the issue of coverage with their primary care provider.

What is the current sensitivity and specificity of the EIA/Western Blot testing algorithm? In NYS? (as compared to the rapid test)

The current testing algorithm with EIA is 99.99% sensitive and WB is 98% specific. Data on rapid tests are still preliminary but sensitivity is quoted at 99.6% and specificity 100%. Further studies are needed to better evaluate the rapid test in Point of Care settings as the data for the rapid test is based on testing in controlled laboratory testing settings.

Can the rapid test be used on an infant in lieu of the SUDS test?

OraQuick is the first of a new generation of rapid tests, which have the following advantages when a mother's HIV status is unknown at presentation for delivery and expedited testing is indicated:

  • the tests can be performed at point of care
  • preliminary test results are available in 20-30 minutes, and
  • in the event of a preliminary positive test result, antiretroviral therapy (ART) can be delivered when most effective , i.e., initiated in the intrapartum period, or to the newborn immediately after birth.
    In light of the advantages offered by rapid tests, the Department of Health has issued an emergency regulation, effective November 1, 2003, requiring birth facilities to provide expedited testing, when indicated, with the result available as soon as possible but in no case later than 12 hours after the mother consents to testing or after the birth of the child. The current regulation requires the result to be available as soon as possible but in no event later than 48 hours.

Should a delivering woman without prior HIV testing, refuse the test in the labor and delivery setting?

New York State Department of Health regulations require birth facilities to provide expedited testing in labor and delivery only when the mother’s HIV status is undocumented at presentation for delivery. In New York State, approximately 94% of women presenting for delivery have been tested for HIV during pregnancy. Expedited testing of the mother can only be done with her consent; expedited testing of the newborn may be done without consent. When expedited testing is indicated, HIV counseling should strongly emphasize the benefits of the mother knowing her HIV status as soon as possible so that, if she is positive, she can take advantage of treatment to prevent transmission to her baby.

New York City Department of Health and Mental Hygiene

In a low prevalence community, is there more of a risk of false negatives with rapid testing than with the traditional ELISA testing?

Clinical studies have demonstrated that the sensitivity and specificity of rapid HIV tests are comparable to those of EIAs often used by clinical labs for screening. The probability that the screening test result predicts the true infection status of the person tested (negative predictive value), is high at the HIV prevalence observed in U.S. testing sites (CDC 1989). Therefore a client with a negative rapid HIV test result can be told he or she is not infected. However, because antibodies take time to develop, retesting should be recommended to persons with a possible HIV exposure within the three previous months.

If a pregnant woman is asked to give informed consent to rapid testing just as she is about to give birth, can she really be considered to be giving informed consent?

NYS hospitals have experience providing HIV counseling and testing in the maternity setting and should take every effort to tailor the counseling to the patient’s unique situation.