DrCatherine Kibirige

My principal scientific contribution is HIVQuant, an ambient-temperature, platform-agnostic HIV-1 viral load assay developed for decentralised testing in settings without cold chain or centralised laboratory capacity. It targets a conserved region of the HIV-1 long terminal repeat and combines TaqMan minor-groove-binding chemistry with inosine and wobble bases at polymorphic sites, achieving broad subtype coverage from a single primer and probe set: over 99% detection across the 127-member EQAPOL diversity panel, a dynamic range exceeding seven log10, and a limit of detection of 88 copies per millilitre at 95% detection.

In 2023 and 2024 I designed and led a feasibility study at Zomba Central Hospital, Malawi, in 116 participants, conducted deliberately before full analytical validation in order to establish which parts of the workflow fail in the field rather than which parts perform in a laboratory. Three failures were identified, all in reagent formulation and sample preparation: lyophilised reagents did not survive transit, the crude lysis buffer degraded, and only plasma magnetic-bead extraction yielded usable nucleic acid. Those findings, rather than the assay's analytical performance, define the work that follows.

The intellectual property position is deliberate. The international patent application covering the assay was published in 2023 with its full sequence listing and then not taken into national phase, ceasing in 2024. No patent is in force in any jurisdiction and none can now be obtained over the disclosed subject matter, which places the design permanently in the public domain and removes licensing barriers to manufacture in low- and middle-income countries. The HIVQuant name is separately protected as a trade mark, so that a quality standard can be maintained without restricting who may produce the assay. Holding a post in intellectual property strategy is continuous with this rather than a departure from it: how a technology reaches the people it was designed for is the same question, approached from the institutional side.

Alongside the assay work my interests include ultra-sensitive cell-associated nucleic acid quantification for HIV cure-related research and vaccine-candidate screening, HIV-1 integration-site profiling, and the regulatory and market pathways that determine whether a validated diagnostic is ever manufactured and deployed in low- and middle-income countries.

My current work develops the assay toward a dual-target format with improved specificity and an ambient-stable formulation suitable for deployment, alongside implementation scoping with partners in Malawi, Tanzania, Uganda and India. The wider aim is viral load testing that reaches the people who need it, supplied where possible by manufacturers in the countries that need it, to a standard everyone can verify.