Innovation in Advanced HIV Disease Management
Image Source: Providing care to people with advanced HIV disease who are seriously ill: policy brief. Geneva: World Health Organization; 2023. Licence: CC BY-NC-SA 3.0 IGO. Image was not altered.
In much of the world today, HIV gets few (if any) headlines, and hence many people mistakenly believe there’s little need to be concerned.
Nothing could be further from the truth.
More than 40 years after HIV first appeared, there are still an estimated 38.5 million cases worldwide, and most individuals affected by HIV live in low- and middle-income (LMIC) countries. Nearly 70% of HIV+ patients can be found in Sub-Saharan Africa, followed by Southeast Asia, Eastern Europe, and Latin America. There are 120,000 new HIV infections every year.1
It's heartbreaking to report that globally, 630,000 people living with HIV die annually from advanced HIV disease. HIV diagnosis for newborns has decreased by 100,000 between 2022 and 2023. Tragically, an estimated 12% of all HIV deaths are children aged 0-14 years. There are 1.4 million children living with HIV, with a little more than half receiving treatment. Women living with HIV comprise the lowest rate of viral suppression at 22%, and they make up 52% of all people living with HIV.2
Across the globe, people living with HIV (PLHIV) still need support and assistance. And we want to help.
A legacy of serving humanity
As the data above indicates, the worldwide need for effective HIV assessment and treatment is more urgent than ever, and Beckman Coulter Life Sciences has been, is, and will continue to be part of the solution.
Many patients with advanced HIV disease may look healthy, so accurate and early diagnosis are key to ensuring they receive an advanced care plan that can prevent potentially fatal outcomes.
In the 1980s, we helped pioneer the use of flow cytometry to confront the emerging threat of HIV. For labs that lacked access to flow cytometry, we introduced the manual CD4 counting test, which can be used with only a microscope. Manual CD4 count was also deployed in Haiti to fight an HIV outbreak in the Caribbean.
We were also the first company to provide a no-wash, 4-color T-cell analysis system, which comprises TetraCHROME multicolor reagents, the EPICS XL flow cytometer, and TetraONE software.
Today, we continue to apply more than 80 years of experience in laboratory innovation to the ongoing global challenges posed by HIV and AIDS. With us on this journey are numerous partners. One innovation we are especially excited about, which was recently developed by a leading South African research institute, is PanLeucoGating (PLG) for CD4 monitoring.
The PLG CD4 test story
Monitoring CD4 lymphocyte counts is essential for providing critical information that impacts HIV patient care. CD4 monitoring helps caregivers know when the disease transforms and stages its progression so they can implement the most appropriate intervention.3
We’ve been providing cost-effective solutions to monitor CD4 status in resource-limited countries for several decades. The mounting HIV problem in these regions of the world has led to innovative solutions with a mission to deliver effective patient care.
One example of innovative solutions driven by need is the breakthrough PanLeucoGating (PLG) story from South Africa. Developed by the University of the Witwatersrand, a leading South African research institute, PLG CD4 was adopted in response to the urgent need for simple, rapid, accurate, and low-cost CD4 results primarily in centralized labs that monitor large numbers of HIV patients.
PLG CD4 addresses this urgent need, and provides busy laboratories with an affordable, high-performance monitoring solution that also offers standardization and simplicity. Its efficient operation is taking CD4 testing to new places.
According to the South African National Health Laboratory Service (NHLS), large-scale use of PLG CD4 can potentially reduce the cost of HIV monitoring. PLG CD4 was subsequently licensed to Beckman Coulter Life Sciences for manufacturing and worldwide distribution — with a provision that the technology be priced affordably for resource-limited countries.
The PLG “Africa Gate” identifies lymphocytes, monocytes and granulocytes based on CD45 express and cell complexity (side scatter). This is a sample plot from the peripheral blood of a normal donor, depicting all white blood cells (CD45+), as well as a region to identify the lymphocyte (Lymphs) subpopulation for further analysis of CD4 cells. The name “Africa Gate” stems from the form of the region used to identify all white blood cells.
ADVANTAGES OF PLG CD4
- 2-color, pre-optimized reagent for PanLeucoGating (CD45/CD4)
- Provides both CD4% and absolute counts
- Accommodates sample age of up to 72 hours
Today, we remain a proud partner with the NHLS.
“We’re proud of our ongoing commitment to patient care for those affected by HIV/AIDS, and we will continue to seek partnerships with NGOs in areas where the challenge is most acute,” says Pietro Lopriore, Vice President of the Flow Cytometry division of Beckman Coulter Life Sciences.
“Our effort in supporting the development of the FlowCARE PLG CD4 solution in South Africa is a good example of our collaboration with healthcare leaders to develop breakthrough CD4 monitoring solutions that contribute directly to the healing process. It also reflects our broader purpose to advance healthcare for every person.”
Our work continues…
Through automation and innovation, we are dedicated to providing essential testing resources to critical regions worldwide, helping to bring us closer to a future without HIV/AIDS.
We provide testing for immunological assessment of patients having or suspected of having immune deficiency using the AQUIOS CL flow cytometry platform.
This state-of-the-art platform can help deliver accurate results while also reducing costs. AQUIOS CL and Tetra assays are the only high-throughput HIV immunophenotyping solutions prequalified under the World Health Organization Pre-Qualification Program for in vitro diagnostics.
AQUIOS CL Flow Cytometer
On the front lines of the fight
By focusing on innovative yet affordable solutions for CD4 enumeration for patients suspected to have HIV, we’re committed to supporting the UNAIDS 2030 Targets4 to ensure that, by the year 2030:
- 95% of people living with HIV would know their HIV status
- 95% of people with diagnosed HIV infection will have received sustained antiretroviral therapy (ART)
- 95% of all people receiving ART will have achieved viral suppression
- 95% coverage of services for eliminating vertical transmission
- 95% of women access HIV and sexual and reproductive health services.
In the meantime, our testing portfolio also supports the UN Sustainable Development Goal #3 for Wellness by providing improved diagnostics that support better health for people living with HIV, opportunistic infections, and hematological malignancies.
As we look ahead, hopefully to an end to the AIDS epidemic once and for all, our focus is increasingly on the importance of tiered laboratory networks.
Tiered laboratory networks
Laboratories are the backbone of the entire public health system, and standardization is the key to successful communication and collaboration among those labs.
Within a tiered public healthcare system, near-patient testing, in many cases, still means high-throughput testing, combined with centralized data collection and storage requirements.
While basic peripheral testing sites usually need to rely on point-of-care testing using rapid test diagnostics due to infrastructural challenges, all other laboratory categories require state-of-the-art solutions that meet flexible workload requirements and automated, integrated approaches.
Regarding people infected with HIV, the 2013 WHO guidelines—and the 2016 revision thereof—call for earlier treatment with antiretroviral therapy (ART). Further, these guidelines identify CD4 count and viral load analysis as the two main technologies to monitor ART treatment initiation and follow-up.
This requires countries to build capacity for the analysis of immune system integrity for Advanced HIV Disease (AHD), and especially for CD4 analysis platforms for laboratory testing in district-level health facilities and above. It is critical that patients with advanced HIV disease be identified through CD4 testing, aiding clinical risk assessment for deadly opportunistic infections.
| Health care delivery level3 | Laboratory service |
| National reference laboratory |
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| Regional or provincial reference laboratory |
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| District-level laboratory |
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| Primary care setting |
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| Community based and community outreach |
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Supporting Implementation Sciences in Africa
Uganda’s strategy to improve laboratory services involved setting up more than 1,500 clinical laboratories of different sizes. This was to ensure that 90% of the country would be served either by larger clinical laboratories in major hospitals and health center IVs or by smaller health centers.
In 2011, 100 regional hubs were created in major hospitals and health center IVs to support the transport system, each serving 25 to 30 lower-tier health facilities, resulting in 90% coverage. Laboratory capacity at the hubs was meant to support lower-tier sites and refer only high-complexity tests to the Uganda National Health Laboratory Service (UNHLS), formerly known as Central Public Health Laboratories (CPHL). However, many of these regional labs were either not functioning at all or were operating at maximum capacity, leaving no available resources to support lower-tier sites.
The current system was suffering from several operational and governance challenges, such as frequent shortages of supplies, poor equipment maintenance, lengthy instrument downtime, poor patient specimen quality, and slow turnaround times.
With UNHLS support, a bold experiment was initiated that made a fundamental change to the way the regional laboratory service was managed.
This change focused on moving away from a centralized approach by transferring responsibility for laboratory sample coordination to the regional level. Integral to this was the need to address flaws in the transport management of samples from rural catchment areas.
The West Nile’s Arua central referral laboratory was chosen as the test case because of the challenges it presented in terms of distance, existing health facilities and its high refugee population. The UNHLS funded the placement of an experienced lab scientist to take responsibility for sample coordination for 12 months, including mentoring the hub laboratory team and engaging with stakeholders.
Baseline performance and workflow data were collected prior to the start of the trial and then tracked on a quarterly basis throughout. Before the intervention, hubs in the area were sending an average of 38,534 viral load (VL) samples per quarter. After the intervention, this increased by an incredible 350% to 130,346 VL samples per quarter.
Also, before the intervention, lower-tier sites under the hubs were sending 1,517 VL samples each quarter. This increased by well over 800% to 13,958 samples.
The pilot showed how delegating coordination to health facilities within the hub system, where patient demand is created, resulted in more samples being transported and processed in a timely fashion, with bottlenecks reduced and overall workflow improved.
This clearly demonstrates how establishing a coordination resource at a regional hub level, and empowering and mentoring local laboratory professionals in workflow management, has transformed the routine laboratory service in Arua.
BENEFITS OF THE TIERED LAB NETWORK
- Created a reliable, efficient sample transportation system
- Reduced lab turnaround time for all tests
- Improved overall laboratory inventory management
- Developed an ethos of collaboration, improved communication & better reporting among stakeholders at all levels of the lab hub system
- Increased timely patient access to diagnostics for HIV & opportunistic infections
- Illustrated the cost implications for implementing changes throughout the country
The magnitude of the success of this approach sets down a clear and practical roadmap for delivering greater efficiencies that strengthen the laboratory system and improve overall laboratory services if funding can be made available to other regional hubs.
Learn More
Our team continues to partner with the scientific community to expand critical resources through our Global Health Access Initiative. If you’d like more information, including collaboration opportunities, please contact us.
1 CHAI HIV Market Report (2024), “The state of HIV treatment, testing, and prevention in low- and middle-income countries”, Issue 15, December 2024.
2 The urgency of now: AIDS at a crossroads. Geneva: Joint United Nations Programme on HIV/AIDS; 2024. Licence: CC BY-NC-SA 3.0 IGO.
3 Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. eneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.
4 Global HIV Target Setting for 2030 — Global Task Team on 2030 Targets Recommendations. UNAIDS 2025.
