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CSTE Position Statement Number: n/a,
any of the following HIV virologic (i.e., non-antibody) tests†:* Rapid tests are EIAs that do not have to be repeated but require a confirmatory test if reactive. Most conventional EIAs require a repeatedly reactive EIA that is confirmed by a positive result with a supplemental test for HIV antibody. Standard laboratory testing procedures should always be followed.
† For HIV screening, HIV virologic (non-antibody) tests should not be used in lieu of approved HIV antibody screening tests. A negative result (i.e., undetectable or nonreactive) from an HIV virologic test (e.g., viral RNA nucleic acid test) does not rule out the diagnosis of HIV infection.
Confirmed: meets the laboratory criteria for diagnosis of HIV infection and one of the four HIV infection stages (stage 1, stage 2, stage 3, or stage unknown)
HIV Infection, Stage 1AIDS-Defining Conditions
* Only among children aged <13 years1
† Condition that might be diagnosed presumptively.
§ Only among adults and adolescents aged >13 years2
Source: MMWR3
HIV infection diagnosed by a physician or qualified medical-care provider§ based on the laboratory criteria and documented in a medical record.
Oral reports of prior laboratory test results are not acceptable.
An original or copy of the laboratory report is preferred; however, in the rare instance the laboratory report is not available, a description of the laboratory report results by a physician or qualified medical-care provider documented in the medical record is acceptable for surveillance purposes. Every effort should be made to obtain a copy of the laboratory report for documentation in the medical record.
The 2008 HIV infection case definition for adults and adolescents (aged >13 years) replaces the HIV infection and AIDS case definitions and the HIV infection classification system (2, 4--6). The case definition is intended for public health surveillance only and not as a guide for clinical diagnosis. The definition applies to all HIV variants (e.g., HIV-1 or HIV-2) and excludes confirmation of HIV infection through diagnosis of AIDS-defining conditions alone. For surveillance purposes, a reportable case of HIV infection among adults and adolescents aged >13 years is categorized by increasing severity as stage 1, stage 2, or stage 3 (AIDS) or as stage unknown
HIV infected
Confirmed: One of laboratory criteria or other criteria listed below is met:
AIDS
Confirmed: Criteria for HIV infection are met and at least one of the AIDS-defining conditions has been documented (see clinical description).
*** For HIV screening among children aged 18 months to <13 years infected through exposure other than perinatal exposure, HIV virologic (non-antibody) tests should not be used in lieu of approved HIV antibody screening tests. A negative result (i.e., undetectable or nonreactive) by an HIV virologic test (e.g., viral RNA nucleic acid test) does not rule out the diagnosis of HIV infection.
No changes have been made to the existing classification system for HIV infection among children aged 18 months to <13 years (7). To classify HIV-infected children in this age group, refer to the 1994 revised classification system for HIV infection among children aged <13 years (7).
HIV infection
Presumptive: Positive results on one specimen (not including cord blood) from the listed HIV virologic tests (HIV nucleic acid detection test; HIV p24 antigen test, including neutralization assay, for a child aged >1 month; or HIV isolation [viral culture] for definitively HIV infected) and no subsequent negative results from HIV virologic or HIV antibody tests.
Definitive: Positive results on two separate specimens (not including cord blood) from one or more of the following HIV virologic (non-antibody) tests:
-- HIV nucleic acid (DNA or RNA) detection**
-- HIV p24 antigen test, including neutralization assay, for a child aged >1 month
-- HIV isolation (viral culture)
HIV non-infection
Presumptive:
AND
Definitive:
AND
** HIV nucleic acid (DNA or RNA) detection tests are the virologic methods of choice for the diagnosis or exclusion of infection in children aged <18 months. Although HIV culture can be used, culture is less standardized and less sensitive than nucleic acid detection tests. The use of p24 antigen testing to exclude infection in children aged <18 months is not recommended because of poor sensitivity, especially in the presence of HIV antibody. Commercial tests for RNA and DNA detection have become widely available. Quantitative RNA tests have been approved by the Food and Drug Administration (FDA) for monitoring HIV infection, and qualitative RNA tests have been approved to aid diagnosis. The quantitative and qualitative RNA tests meet FDA standards for high analytic and clinical sensitivity and specificity (14--16). All available tests detect the subtypes of group M and strains of group O. HIV-2 can be diagnosed with HIV-2 DNA PCR. HIV RNA tests sometimes do not detect HIV-2 because the viral loads in some HIV-2--infected persons are below detectable levels. Because of the possibility of mutation or recombination involving the sequences detected by a particular test, occasionally, virus might not be detected in a specimen from an HIV-2 infected individual. If HIV-2 infection seems likely but results are negative, testing with a different assay might be advisable.
§§ If specimens for both negative RNA or DNA virologic tests are obtained at age >4 weeks, specimens should be obtained on separate days.
A child aged <18 months born to an HIV-infected mother
HIV Infection
Presumptive: Meets exposure criteria and presumptive laboratory criteria or at least one of the other criteria below
Definitive: Meets exposure criteria and definitive laboratory criteria or at least one of the other criteria below
Other Criteria (for Cases that Do Not Meet Laboratory Criteria for Definitive or Presumptive HIV Infection)
Uninfected with HIV
Presumptive: Meets exposure criteria, does not meet criteria for definitively uninfected with HIV, and meets one of the presumptive laboratory criteria for non-infection.
Definitive: Meets exposure criteria, does not meet criteria for presumptive or definitive HIV infection, and at least one of the laboratory criteria of non-infection, or other criteria below.
Other Criteria (for Cases that Do Not Meet Laboratory Criteria for Uninfected with HIV, Definitive or Presumptive)
AND
Indeterminate HIV infection
A child aged <18 months born to an HIV-infected mother is categorized as having perinatal exposure with an indeterminate HIV infection status if the criteria for infected with HIV and uninfected with HIV are not met.
AIDS Case Definition (<18 months)
AIDS-Defining Conditions
* Only among children aged <13 years1
† Condition that might be diagnosed presumptively.
§ Only among adults and adolescents aged >13 years2
Source: MMWR3
The 2008 definition takes into account new available testing technologies. Laboratory criteria for children aged <18 months at the time of diagnosis include revisions to one category: presumptively uninfected with HIV. No substantial changes have been made to the remaining three categories (definitively HIV infected, presumptively HIV infected, and definitively uninfected with HIV), and no changes have been made to the conditions listed under the AIDS criteria in the 1987 pediatric surveillance case definition for AIDS for children aged <18 months (4,5,8). Because diagnostic laboratory testing for HIV infection among children aged <18 months might be unreliable, children in this age group with perinatal HIV exposure whose illness meets the AIDS case definition on the basis of clinical criteria are considered presumptively HIV infected when the mother has laboratory-confirmed HIV infection. The definitive or presumptive exclusion of HIV infection for surveillance purposes does not mean that clinical HIV infection can be ruled out. For the purposes of calculating the exact timing of tests (e.g., when a specimen was obtained for laboratory testing) based on the surveillance case definition, 1 month corresponds to 30 days.
The exclusion of HIV infection (definitive or presumptive) for surveillance purposes does not mean that clinical HIV infection can be ruled out. These categories are used for surveillance classification purposes and should not be used to guide clinical practice. A child with perinatal HIV exposure should continue to be monitored clinically according to nationally accepted treatment and care guidelines (9--11) to 1) monitor for potential complications of exposure to antiretroviral medications during the perinatal period and 2) confirm the absence of HIV infection with repeat clinical and laboratory evaluations.
No changes have been made to the existing classification system for HIV infection among children aged <18 months (7). To classify HIV-infected children in this age group, use the 1994 revised classification system for HIV infection among children aged <13 years (7).
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