policy

New Analysis Identifies Feasible TB Diagnostic Instrument Prices for Healthcare Systems in Low-Resource Countries 

A new study found that offering decentralized tuberculosis testing in local clinics could be cost-effective in low- and middle-income countries if the diagnostic instruments used to run those tests were priced roughly between $400 and $800.

Tuberculosis (TB) is the deadliest infectious disease worldwide, but timely and accurate diagnoses remain challenging in low- and middle-income (LMIC) countries where access to accurate, timely, and affordable testing is limited. Within the current, centralized testing model that high-burdened countries have adopted, TB molecular testing is only offered at designated hospitals and requires specimens to be transported to testing facilities, resulting in operational limitations: of the 10.8 million people estimated to have TB in 2023, only 3.9 million were diagnosed with molecular testing.

Decentralized testing, in which same-day testing is available at local clinics, could increase access to timely and cost-effective testing, but there is a lack of data on optimal pricing for TB tests, as well as how this model could be implemented on a global scale.

A new study led by researchers at the School of Public Health and the University of Amsterdam filled this gap by building a mathematical model that examined whether decentralized TB testing is actually worth the cost and, if so, at what instrument price point it becomes worthwhile. Unlike centralized testing, where one instrument (the diagnostic tool used to detect TB) serves many people across clinics, decentralized testing means placing an instrument in each local clinic. That makes the price of each instrument a make-or-break factor for whether this approach is affordable for countries with high TB burden. 

Published in eClinical Medicine, the study found that decentralized molecular testing could diagnose up to 23 percent more people. But at current pricing for the molecular instrument itself—which can range between $17,530–$90,854—fully decentralized TB testing is not cost-effective in most scenarios. Partial decentralization among medium- and high-volume healthcare clinics could be more feasible for same-day testing at current prices, as long as common testing malfunctioning issues were minimized. 

In order for fully decentralized TB testing to become cost-effective, the analysis revealed that the threshold would have to fall to $400-$800 per instrument, including warranty.

While prior studies have assessed the cost-effectiveness of decentralized TB testing in trials or for individual countries, this study is the first to examine this approach across the healthcare system and identify specific price thresholds for policymakers and test manufacturers to target for real-world feasibility. 

“The cost-effectiveness of decentralized testing is overwhelmingly driven by how much the instrument costs and how heavily it gets used,” says study senior and corresponding author Brooke Nichols, associate professor of global health. The molecular TB tests most commonly used today, including the Cepheid GeneXpert systems, are too expensive to justify placing one in every clinic, especially in areas where patient volumes are low, she says, and the cost per test balloons when an expensive instrument sits mostly idle.

“An expensive instrument sitting at a low-volume clinic is a poor investment regardless of how good the test is, and yet instrument pricing and utilization rarely feature prominently in rollout decisions,” Nichols says. “We wanted to give policymakers and manufacturers concrete price targets, rather than just a ‘yes/no’ answer on whether decentralization is worthwhile.”

This pricing information is particularly valuable, as international funding for TB prevention and treatment has plummeted since the Trump administration dismantled the U.S. Agency for International Development. The theme of the upcoming World Tuberculosis Day, held each year on March 24 to commemorate the discovery of the bacterium that causes TB, emphasizes country leadership and the practical steps that policymakers and other stakeholders can take to advance prevention, testing, and treatment.

For the study, Nichols, lead author Tom Ockhuisen of the Amsterdam Institute for Global Health and Development at the University of Amsterdam, and colleagues conducted a series of threshold analyses to identify the instrument and warranty price point at which fully decentralized testing would be considered cost-effective, using a threshold of $500 per disability-adjusted life years (DALY) averted, a standard metric used in global health to assess if a health intervention is a worthwhile investment of resources.

For decentralized testing to meet a $500/DALY averted benchmark, the team found that the cost of an instrument needed to decrease substantially to $410–$824 for low-volume instruments and $616–$1,238 for medium-volume instruments in low-density settings. The cost-effective price for these instruments could be 4–5 times and 14–16 times higher in medium- and high-density settings, respectively. 

One recurring issue is that the molecular TB testing often encounters technical problems and can break down about 30 days per year, Nichols says. For clinics that only have a single testing tool, that means they lose all testing capacity when this interruption occurs. On the other hand, providing multiple tests in low-resourced areas also creates a burden for the workforce. The estimates in this study take these issues into consideration and provide optimal price points for TB testing based on high- and low-volume settings.

Policymakers, test manufacturers, and international donors can all utilize these findings to determine the pricing range that is most feasible for their country based on facility density and expected testing volumes. 

“Policymakers now have a concrete decision-making framework for evaluating the new generation of low-cost molecular instruments entering the market,” says Nichols. “Rather than making procurement decisions based on sensitivity data or price alone, they can use the threshold prices from this analysis to ask a specific question: does the instrument being offered actually clear the cost-effectiveness bar? This turns what is often an opaque negotiation into an evidence-based one, and gives health ministries and procurement agencies real leverage when engaging with manufacturers.”

Similarly, test manufacturers who target their pricing for the $400-$800 range can ensure that their tests are feasible for most countries for a decentralized testing approach. Donors can use these findings to match their funding for tests to each country’s healthcare system structure, Dr. Nichols says.

“Funding the wrong instrument for the wrong context, however well-intentioned, is unlikely to be cost-effective,” she says. “Donors should also invest in the infrastructure that keeps instruments running: power, maintenance, and rapid-response repair in remote settings—or investing in instruments that are inexpensive enough to have back-up testing ready for use instead of waiting for repair.”