The Latest Developments in HIV Diagnostic Testing

HIV remains a deadly disease, but fortunately, in vitro diagnostic solutions abound for its detection and progress-tracking of treatments.  In this article, we chronicle the developments in HIV IVD – more information can be found in our Worldwide Market for In Vitro Diagnostics Tests, 11th Edition:

Many of the 35.3 million people infected with HIV worldwide are unaware of their condition, as symptoms may not always be apparent.  A few weeks occur between contamination and the appearance of the first anti-HIV serum antibodies. This makes early detection of seroconversions a focus for healthcare providers and the IVD vendors that serve them.  Fortunately, there are an array of in vitro diagnostic solutions to the detection, identification and prognosis assessment of HIV:

New Small-Hospital Analyzer HIV Test: Ortho Clinical Diagnostics announced that its VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) received approval from the U.S. Food and Drug Administration for use on Ortho’s VITROS® ECi/ECiQ Immunodiagnostic Systems. The product is aimed at the small hospital market and is sold in and outside the U.S. The VITROS® HIV Combo test was previously approved for use on Ortho’s VITROS® 5600 Integrated System and Ortho’s VITROS® 3600 Immunodiagnostic System. VITROS® HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag), enabling detection of acute HIV-1 infection earlier than third-generation tests, according to the company.

Roche’s Plasma Separation Card: In January 2018, Roche announced the launch of its cobas Plasma Separation Card, a simple and stable device for the collection of plasma for HIV viral load testing, with Roche’s cobas AmpliPrep, cobas TaqMan, and cobas 6800/8800 HIV tests. The device requires only a small volume of blood taken the patient’s fingertip, and can be transported with the need for cold storage, making the Plasma Separation Card ideal for use in remote areas and those of extreme temperature and humidity.

Recent Use: In August 2018, Roche installed the system at the Kenya Medical Research Institute (Kemri). for testing in remote areas months after it launched its Cobas Plasma Separation Card. The easy-to-use sample collection device will make it possible to transport plasma for testing in far-flung regions without the use of refrigeration. The machine can handle up to 960 samples within an eight-hour shift compared to the one-month span it traditionally took patients to get results. The Cobas 8800 instrument installed at the Kemri has a capacity to test more than 300,000 Kenyans living with HIV annually.

Using Dentists for HIV Screening: Dental clinics may provide expanded opportunities for oral HIV rapid testing and conversations about HIV prevention in high HIV prevalence communities. A recent study assessed HIV testing in dental clinics in South Florida, an urban area with the highest rates of HIV diagnoses in the United States in 2015. During 2014 and 2015, dentists and hygienists at two federally qualified health center (FQHC) dental clinics who serve racial/ethnic minority patient populations in South Florida were trained to administer oral HIV rapid tests as a part of a routine dental visit.   Expanding HIV screening for populations at risk necessitates testing in nontraditional settings. Patients presenting for dental services were offered a rapid HIV test and brief survey regarding their demographics, HIV testing history and behaviors. Most (85%) accepted oral HIV rapid testing (none tested HIV-positive); 14% had never been tested for HIV.

Latent HIV Quantification: A latent HIV reservoir is a group of immune cells in the body that are infected with HIV but are not actively producing new HIV. Latent HIV reservoirs can hide cells for years, and they can “wake up” and start making more HIV. If someone with HIV is not taking HIV medicines when this happens, the level of HIV in their body (called the viral load) will start to increase. The University of North Carolina at Chapel Hill (UNC) HIV Cure Center and Cell Microsystems, a provider of instruments for the sorting and isolation of single cells, have received an approximately $283,000, 12-month Phase I Small Business Innovation and Research contract from the National Institutes of Health to develop an automated platform to quantify the latent HIV reservoir. As researchers develop therapies to reverse HIV latency—a step toward clearing the virus from the body—an accompanying diagnostic test is also needed to accurately measure the viral reservoir and judge the efficacy of these new latency reversal agents. The collaboration between UNC and Cell Microsystems aims to fill this need by using Cell Microsystems automated images analysis tools, the CytoSort Array and CellRaft AIR system, to screen and isolate thousands of patient-derived cells to detect emergence of HIV after exposure to potential therapeutics.

Mobile HIV-1/2 Test: Arkansas-based start-up NOWDiagnostics is working on a handheld device for fingerstick blood tests called the Lateral Flow Reader that “can be adapted for almost any qualitative or quantitative rapid test.” The company’s ADEXUSDx hCG pregnancy test received 501(k) FDA clearance in 2015. The company’s HIV-1/2 Antibody Test has received CE mark in Europe. The test is an immunochromatographic assay used for the qualitative detection of antibodies against human immunodeficiency virus (HIV) in human whole blood, plasma or serum samples. Each cartridge takes a single drop of blood and returns a result in minutes. There are other tests that are used to measure the severity or monitor therapy of HIV infection such as CD4 count and the viral load test. HIV antibody detection based rapid test is the most appropriate test for routine diagnosis of HIV infection among adults.

Nanophone Technology: Investigators at Brigham and Women’s Hospital have designed a portable and affordable mobile diagnostic tool, utilizing a cellphone and nanotechnology, with the ability to detect HIV viruses and monitor its management in resource-limited regions. The novel platform was described in a paper published recently in Nature Communications. Utilizing nanotechnology, a microchip, a cellphone and a 3D-printed phone attachment, the researchers created a platform that can detect the RNA nucleic acids of the virus from a single drop of blood.

Rapids: Rapid (point-of-care) tests can be conducted away from laboratory facilities and give results in less than 30 minutes. A reactive results from a rapid should be followed up with a lab based test. Among marketed rapids:
• Alere Determine HIV–1/2 Ag/Ab Combo
• Chembio HIV 1/2 STAT-PAK® tests
• Uni-Gold™ Recombigen® HIV-1/2
• OraQuick® HIV Self-Test (HIVST)

Other HIV Testing Systems: There are scores of HIV IVD tests on the market. Besides the tests mentioned, other significant marketed tests include:
• Hologic Aptima HIV-1 RNA Qualitative Assay
• Abbott ARCHITECT HIV Ag/Ab Combo Assay
• Siemens ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay
• Roche Elecys HIV combi PT
• Bio-Rad GS HIV Combo Ag/Ab EIA
• bioMérieux VIDAS HIV DUO Ultra

Poor Trending with Youth Testing: Testing for HIV is at a crossroads as the youngest and most exposed population seems to be trending against getting tested for AIDs. According to a study published by the CDC in 2018, In the United States, 38.8% of women and 53.8% of men aged 15 to 44 reported they had never been tested for HIV outside of donating blood or blood products. Yet among those 15 to 24, the percentage who reported they had never been tested soared to 63.9% of women and 73.7% of men.
The most common reason reported by women and men for having never been tested was that they thought they were “unlikely to have been exposed to HIV,” or “never offered a test,” which indicates both This roughly matches a previous study, conducted by CDC researchers and published in the journal Pediatrics in 2016, found that the percentage of young adults aged 18 to 24 who reported they have never been tested for HIV remained steady among young men, and increased significantly among young women between 2011 and 2013. Specifically, among all young women, a significant decrease in the prevalence of HIV testing was detected overall, from 42.4% ever being tested in 2011 to 39.5% in 2013, according to that previous study, which was based on data from the national Youth Risk Behavior Survey and Behavioral Risk Factor Surveillance System.

Opt-Out HIV Testing and Other Solutions: The results have surprised experts given the amount of public education and the many HIV testing options available to the public, from at-home HIV testing kits to community health events that involve HIV testing. The decline of AIDs as a large scale national public health issue is a problem, or its status as an episodic event are possible factors. There are some calls for HIV testing to be added to common tests and conducted every year or every six months, at least for certain age groups. Other arrangements for opt-out type testing in certain areas. Opt-out HIV screening is performing an HIV test after notifying the patient that the test will be done; consent is inferred unless the patient declines. A study in San Francisco found that opt-out testing greatly increases test acceptance (

Kalorama’s market forecasts for multiple types of clinical testing, including HIV testing, can be found in its Worldwide Market for In Vitro Diagnostics Tests, 11th Edition: