New Tuberculosis Test Could Improve TB Care Globally by Increasing Access to Testing in Low- and Middle-Income Countries

Findings Published in ADLM's Clinical Chemistry Journal

WASHINGTON, March 14, 2024 /PRNewswire/ -- A new tuberculosis (TB) test disclosed in the Association for Diagnostics & Laboratory Medicine's (formerly AACC's) Clinical Chemistry journal would allow testing for TB treatment monitoring to occur outside of a biosafety level 3 (BSL-3) laboratory. This could help reduce worldwide mortality from TB by enabling low- and middle-income countries that lack BSL-3 facilities to treat TB more efficiently.

View the full study here: https://doi.org/10.1093/clinchem/hvae013

TB is the second leading infectious killer worldwide after COVID-19, and monitoring how the infection responds to treatment over time is a critical step in reducing mortality. However, because TB is highly infectious, patient samples can currently only be tested in BSL-3 laboratories, which contain resource-intensive features like directional air flow and incinerators that minimize the risk of contamination. This is a major hurdle to combatting TB globally, because approximately 80% of TB cases occur in low- and middle-income countries, many of which lack a BSL-3 laboratory.

A team of researchers designed this test — called rapid enumeration and diagnostic for tuberculosis (READ-TB) — specifically to address lack of access to labs that meet BSL-3 requirements. This novel test determines how patients are responding to TB treatment. With READ-TB, sputum — thick mucus coughed up from the lungs — is treated with acetic acid, a chemical that kills bacteria but leaves bacterial RNA intact. A laboratory professional can then safely feed the RNA into a machine that measures RNA concentration, which is an indicator for how much Mycobacterium tuberculosis a patient is carrying and how the infection is responding to treatment.

Compared to guanidium salts, the class of chemicals currently considered the gold standard for preserving RNA, acetic acid was more effective at killing sputum bacteria, doing so in just 30 minutes, which eliminates the need for a BSL-3 laboratory. Acetic acid was also just as effective as guanidium salts in preserving bacterial RNA. Notably, the researchers found that RNA was preserved in acetic acid for 14 days when kept at 25°C, and for at least 1 year when kept at –20°C. This is an important advantage for laboratories that lack –70°C freezers, which require a much greater amount of energy. Additionally, guanidium salts are toxic, while the concentration of acetic acid used for READ-TB is much safer to work with.

Clinical trials for anti-TB drugs also stand to benefit from READ-TB. By providing a safe and efficient way to measure the concentration of TB RNA, it could enable researchers to compare the antibacterial strength and properties of drugs or combinations of drugs against one another.

"We wanted to improve the assay for integration into diagnostic microbiology laboratories, for use in clinical trials, and to make it tenable in low- and middle-income countries, e.g., where no BSL-3 laboratory exists," the authors of the study write, referring to their earlier test. "READ-TB allows measurement of the molecular bacterial load to now be adopted by routine clinical microbiology laboratories for measuring M. tuberculosis bacterial load in sputum."

About the Association for Diagnostics & Laboratory Medicine (ADLM)

Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.

Clinical Chemistry (clinchem.org) is the leading international journal of laboratory medicine, featuring nearly 400 peer-reviewed studies every year that help patients get accurate diagnoses and essential care. This vital research is advancing areas of healthcare ranging from genetic testing and drug monitoring to pediatrics and appropriate test utilization.

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SOURCE Association for Diagnostics & Laboratory Medicine (ADLM)