01 December, 2025
The Importance of Diagnostic Testing on World AIDS Day
Each year on 1 December, World AIDS Day calls global attention to the HIV/AIDS pandemic: its ongoing impact, the progress made, and the work still required. One of the most critical pillars in the fight against HIV/AIDS is diagnostic testing - without knowing who is infected, timely treatment, prevention of transmission, and effective public health planning all falter.
Diagnosing HIV infection early and accurately is central to achieving the goals of ending AIDS as a public health threat. In what follows, I discuss why diagnostic testing matters, challenges and opportunities in HIV diagnostics, and how diagnostic innovators such as Fortress Diagnostics play a role in enabling better HIV care and control.
Why Diagnostic Testing Matters in HIV/AIDS
- Early detection enables earlier care
HIV can remain asymptomatic for years. Many individuals may not know they are infected until their immune system is damaged or opportunistic infections appear. Diagnostic testing allows for early identification of infection so that antiretroviral therapy (ART) can begin sooner, improving health outcomes and reducing morbidity.
- Reduces onward transmission
People who know their status can take steps to prevent transmission (e.g. safer sex practices, use of PrEP for negative partners, or treatment as prevention). Importantly, those on effective ART who maintain viral suppression effectively eliminate the risk of sexual transmission (i.e. “undetectable = untransmittable,” or U=U). Without testing, these benefits are lost.
- Informs public health planning and surveillance
Accurate testing data helps health authorities understand epidemic trends—where new infections are concentrated, which populations are underserved, and how resources should be allocated. Surveillance based on reliable diagnostics is key to targeted interventions.
- Testing is the gateway to the HIV care cascade
The “care cascade” (or “treatment cascade”) maps the steps from diagnosis, linkage to care, initiation of ART, retention in treatment, and achieving viral suppression. Without robust testing as the first step, the cascade collapses.
- Equity and reach in low-resource settings
To reach underserved or remote communities, diagnostics must be affordable, robust, easy to use, and adaptable to minimal infrastructure. Rapid tests, point-of-care assays, and reliable immunoassays help bridge disparities in access.
Diagnostic Technologies & Advances in HIV Testing
HIV diagnostics have advanced over the decades, with multiple modalities now in use:
- Antibody detection (ELISA, rapid tests, immunoassays)
These tests detect antibodies produced in response to HIV infection. For many years, this was the mainstay of HIV screening.
- Fourth-generation antigen/antibody (Ag/Ab) assays
These newer assays detect both the p24 antigen (a viral protein) and host antibodies, allowing earlier detection after infection.
- Rapid diagnostic tests (RDTs, point-of-care tests)
Designed for use outside advanced laboratories, often giving results in minutes. These are especially valuable where laboratory infrastructure is limited.
- Molecular tests / nucleic acid testing (NAT, PCR)
These detect viral RNA or DNA directly, useful for early detection (before antibodies appear), for confirming uncertain cases, and monitoring viral load (i.e. amount of HIV in blood) to assess treatment efficacy.
Each type has roles, advantages, and limitations (e.g. sensitivity in acute infection, cost, complexity).
The Role of Fortress Diagnostics in HIV Diagnostics
Fortress Diagnostics is a company that operates in the in vitro diagnostics (IVD) space, producing a wide portfolio of clinical tests to support immunology, serology, and infectious disease diagnostics.
Here are some ways Fortress contributes to HIV diagnostics:
- HIV ELISA kits
Fortress provides HIV ELISA kits for the qualitative detection of antibodies to HIV‑1 and HIV‑2 in serum or plasma. These kits can be used for screening in laboratory settings, such as hospitals or blood banks.
- Fourth-generation Ag/Ab assays
They also offer HIV antigen/antibody (Ag/Ab) assays, which enable earlier detection of HIV infections by detecting both viral antigen (p24) and host antibodies.
- Rapid HIV diagnostic tests
For settings lacking full laboratory infrastructure, Fortress offers rapid HIV 1/2 cassette devices and strips for the detection of antibodies in whole blood, plasma or serum. In addition, they produce a combo rapid test that simultaneously screens for HIV, HCV, HBV (HbsAg), and syphilis — useful in integrated screening approaches.
- Controls & calibrators
To ensure laboratory assays are reliable, Fortress provides control panels (e.g. antibody and antigen control panels) used in quality control and calibration of HIV testing systems.
- Quality standards and innovation
Fortress operates an ISO-accredited facility, underscoring its commitment to quality and regulatory compliance. The company reinvests heavily in research and development to improve existing tests, develop new diagnostics, and maintain technological relevance. In 2024, Fortress was awarded “IVD Product Manufacturer of the Year – UK,” reflecting its leadership in diagnostics.
By offering both laboratory-based and rapid testing options and supporting quality assurance, a company like Fortress helps bridge the gap between ideal diagnostic coverage and real-world resource constraints.
Challenges and Considerations in HIV Diagnostics
While diagnostic testing is vital, achieving broad, effective HIV diagnostics faces several challenges:
- Window period and early detection
Even advanced assays have “blind spots” immediately after infection, before antigen or antibodies reach detectable levels. Molecular testing helps, but at a higher cost and complexity.
- False positives / false negatives
No test is perfect. Rapid tests may occasionally produce false results; positive screens must be confirmed via more specific assays.
- Access and infrastructure
In many low- and middle-income regions, laboratory infrastructure, electricity, cold chain, skilled personnel, and supply chains are limited. Diagnostics must be robust and easy to deploy.
- Stigma and barriers to testing
Social barriers may discourage people from getting tested. Confidentiality, counseling, and community support are essential complements to diagnostics.
- Sustainability and funding
Procuring tests, maintaining supplies, and quality assurance require consistent funding and supply chains. Interruptions could jeopardize gains.
- Regulation and quality control
Diagnostic tests must be approved and regularly quality-controlled to ensure reliability. Strategic Imperatives for World AIDS Day Messaging
On World AIDS Day, diagnostic testing deserves emphasis in campaigns and policies. Here are strategic messaging and actions:
- “Know Your Status” campaigns
Encourage everyone, especially high-risk populations, to get tested regularly. Promote accessible rapid and laboratory based testing options.
- Promote integration of multi‑disease screening
Tests that screen for multiple infections simultaneously help streamline screening, reduce barriers, and improve overall sexual health coverage.
- Scale point-of-care diagnostics
Where laboratory reach is limited, rapid tests (with high accuracy) are critical. Investments in point-of-care HIV diagnostics must continue.
- Strengthen laboratory capacity and quality systems
Ensuring laboratories can run ELISA and molecular testing with good quality control (e.g. via calibrators and control panels) is key.
- Support research, innovation, and local manufacturing
To reduce dependence on imports and respond to local needs, investment in diagnostic R&D and manufacturing is crucial.
- Address stigma and barriers
Offering anonymous, community-based, self-testing options (where permitted) can increase uptake.
Conclusion
On this World AIDS Day, diagnostic testing stands as a cornerstone of the global HIV response. Without robust, accessible, and accurate testing, the goals of early treatment, prevention, and ultimately ending the epidemic remain out of reach. Through innovation and quality, companies like Fortress Diagnostics provide essential tools that help save lives and bring hope. Together, by expanding testing coverage and strengthening diagnostic infrastructure, we move closer to a world where AIDS is no longer a public health threat.
