HIV/AIDS Surveillance: Changes You Should Know About
This information sheet will help answer your questions about the three basic changes to the disease reporting rules related to HIV in Minnesota.
On this page:
What are the changes?
What are “clinical materials?”
Do clinical materials include positive results from rapid test and non-confirmatory tests conducted in a clinic or small laboratory?
Why is the MDH collecting clinical materials for HIV/AIDS?
Does MDH require clinical materials from every HIV+ person that health care providers see?
Are health care providers or laboratories required to submit clinical materials?
How do health care providers submit clinical materials?
What if health care providers send the materials to an out-of-state laboratory?
Do patients’ physicians have access to the HIV drug resistance and subtype test results?
Why is pregnancy in a person chronically infected with HIV now reportable?
Many health providers have educated their patients on how to prevent the spread of HIV/AIDS, what is different with the new rule?
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Surveillance: Recent Changes You Should Know About (PDF: 57KB/2 pages) August 2005
What are the changes?
There are three basic changes to the disease reporting rules related to HIV. They are:
- Laboratories that conduct confirmatory HIV testing must now submit to MDH leftover clinical materials from specimens that test positive;
- Pregnancy in a chronically infected case-patient with HIV, hepatitis B or other reportable perinatally-transmissible disease is reportable to MDH; and
- Health care providers who provide care to HIV/AIDS patients must provide education to these patients on how to prevent disease spread.
What are “clinical materials?”
“Clinical materials” means “clinical isolate containing the infectious agent for which submission of material is required; or if an isolate is not available, material containing the infectious agent for which submission of material is required, in the following order of preference: (1) a patient specimen; (2) nucleic acid; or (3) other laboratory material.”
Do clinical materials
include positive results from rapid test and non-confirmatory tests conducted
in a clinic or small laboratory?
No. Although health care providers and clinics have the authority to submit all HIV specimens, MDH is only seeking clinical materials from Western blot positive or other confirmatory tests; as a result only laboratories conducting Western blot tests will be solicited to submit clinical materials from positive specimens for HIV/AIDS.
Why is the MDH collecting
clinical materials for HIV/AIDS?
Tracking the relative prevalence and variety of HIV strains in Minnesota, and elsewhere, is important for HIV diagnostic testing, clinical treatment, and vaccine development to keep pace with the genetic diversity of HIV.
In the past, with few exceptions, only one strain of HIV (subtype B)
was present in the United States. However, more recently different strains
of HIV, including drug-resistant strains, have been seen in the United
States, including Minnesota. Monitoring the level of drug resistance among
persons newly diagnosed with HIV will inform treatment recommendations.
require clinical materials from every HIV+ person that health care providers
No. MDH’s new program is only monitoring HIV subtypes and drug resistance among newly diagnosed individuals. Only specimens from patients meeting the following criteria will be tested:
- Diagnosed with HIV infection within the past 12 months
- No prior exposure to antiretroviral drugs
- Minnesota resident
- Not previously tested through this MDH program
Are health care providers or
laboratories required to submit clinical materials?
If the diagnostic laboratory facility you use for confirmatory HIV testing already sends the clinical material to MDH, you do not have to send in any material. However, if the diagnostic laboratory you use does not send MDH the clinical material, then you are responsible for sending it to MDH.
How do health care providers submit
Information about submitting clinical materials can be found at: Clinical Materials: Infectious Disease Reporting.
What if health care providers
send the materials to an out-of-state laboratory?
The law now requires that a medical laboratory, physician, or other healthcare facility that sends clinical materials out-of-state for testing ensure that the results are reported and clinical materials are submitted to MDH.
Do patients’ physicians
have access to the HIV drug resistance and subtype test results?
Yes. A health care provider may request a copy of a patient’s HIV drug resistance and subtype test results if it is for the patient’s medical care. See the HIV/AIDS Surveillance Program Web site listed at the end of this fact sheet for more information.
Why is pregnancy in a person
chronically infected with HIV now reportable?
MDH has, for a number of years, collected pregnancy status of newly reported cases of HIV infection to monitor and facilitate the implementation of the U.S. Public Health Service guidelines to prevent mother-to-child HIV transmission.
However, problems in reporting arose when women, whose HIV infection
was previously reported, later became pregnant, potentially multiple times.
Often, subsequent pregnancies did not trigger a report to MDH. As a result,
the pregnancy did not come to MDH’s attention, and MDH could not
ensure the mother had access to appropriate medical care to prevent perinatal
transmission of the disease, or do adequate surveillance for perinatally
Many health providers have educated
their patients on how to prevent the spread of HIV/AIDS, what is different
with the new rule?
Even though most providers already did this, the rules did not require it. It is now a legal requirement and is consistent with existing requirements for chlamydia, syphilis, and gonorrhea.
Copies of the revised rules and a summary of the rule revision process are available at the MDH web site.
You can get a copy of the complete
Communicable Disease Rule, Minn. Rules Chapter 4605.
A summary of the recent changes and reasons for all the changes can be found at Rulemaking Process for Revisions to the Communicable Disease Reporting Rule.
For more information about HIV/AIDS surveillance, visit the Minnesota Department of Health’s HIV/AIDS Surveillance web site.
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