In Vitro Quantitative HIV Nucleic Acid Test (HIV NAT-1) for screening and diagnosis of HIV type 1 infection in HIV-exposed infants and children
General Track - Cycle 3 | Clinical Equipment and DevicesHTA Council Recommendation (as of 18 June 2025)
The HTA Council positively recommends the government financing of In Vitro Quantitative HIV Nucleic Acid Test (HIV NAT-1) for screening and diagnosis of HIV type 1 infection in HIV-exposed infants and children.
The HTA Council strongly recommends that implementation of HIV health technologies should follow the WHO testing strategy for HIV diagnosis (i.e., serial assay testing) to ensure that HIV cases are detected within the HIV diagnosis window period. Additionally, it should be coupled with information dissemination and awareness campaigns, with clear messaging pointing out the advantages and disadvantages of the test. Information on the specific use cases of these tests, especially among other populations for whom the test may be made accessible (e.g., individuals with tuberculosis but without HIV, or pregnant women without HIV) must be made clear to prevent misinterpretation, reduce stigma, and specifically for HIV self test kit, encourage reporting of results. Further, the HTA Council highlights the importance of informed consent for the implementation of these tests.
In addition to this, the HTA Council recommends that the Department of Health refer to existing and future WHO target product profiles (TPPs) when selecting tests for procurement. In the absence of target product profiles, WHO prequalification may be used as a requirement to ensure the quality of the test to be procured.
(See below for more details)
Relevant Information
- Status: With Final HTA Council Recommendation
- Topic Assignment: Internal Assessment
- Policy Question: Should In Vitro Quantitative HIV Nucleic Acid Test (HIV NAT-1) for screening and diagnosis of HIV type 1 infection in HIV-exposed infants and children be funded by the government?
- Secretary of Health Decision: Approved for government financing
Evidence and Relevant Documents
