PrimeStore® MTM Shows Strong Validation for Global TB Testing
Longhorn Vaccines & Diagnostics (“Longhorn”), a One Health-focused biotechnology company advancing innovative diagnostics and antibody platforms to address global public health threats and zoonotic disease challenges, today announced new clinical data demonstrating the effectiveness of PrimeStore® Molecular Transport Medium (MTM) in enabling reliable tuberculosis (TB) detection from multiple non-invasive swab types. These new findings highlight the potential of PrimeStore MTM to significantly improve TB diagnostic workflows in both pediatric clinical environments and in high-volume community screening programs across resource-limited regions.
The results were presented at The Union World Conference on Lung Health 2025 and delivered in two scientific sessions by Sharon L. Olifant, a specialist in infectious disease research and current PhD candidate in Medical Microbiology at the University of Pretoria, South Africa. Her presentations explored how alternative sample collection methods—including tongue and rectal swabs—combined with PrimeStore MTM processing enable simplified, more acceptable, and scalable approaches to TB diagnosis, especially in populations where obtaining high-quality sputum samples remains difficult or impractical.
Tuberculosis remains one of the world’s most persistent infectious diseases, disproportionately affecting low-resource nations and vulnerable groups such as young children, immunocompromised adults, and individuals living in overcrowded environments. Traditional sputum-based diagnostics are often unsuitable for pediatric cases and can present logistical hurdles in community-wide screening. Longhorn’s research underscores how stabilizing genetic material at the point of sample collection—without the need for cold-chain transport—could reshape how testing is performed globally.
“In pediatric patients who are often among the most difficult to test for tuberculosis, tongue and rectal swabs processed in PrimeStore MTM provide a non-invasive, stable, and highly informative sample type for detecting TB in such vulnerable populations,” said Jeff Fischer, President of Longhorn Vaccines & Diagnostics. “When Longhorn examining testing needs from a global health perspective, the findings also show that batch-processed tongue swabs represent a highly scalable, cost-efficient approach to large-population TB screening. Taken together, the new data show real potential to reduce logistically complex diagnostic procedures and make TB case finding more accessible, equitable, and effective worldwide.”
Study One: Community-Based Screening Using Batch-Processed Tongue Swabs
The first study, titled “qPCR batch-processed tongue swabs as a screening tool for large-scale community-based case-finding of TB,” evaluated how tongue swab samples collected in PrimeStore MTM performed when batch-processed using quantitative PCR (qPCR) at a centralized laboratory. Researchers collected samples from 914 household contacts of confirmed TB cases in Buffalo City, South Africa. All swabs were transported without refrigeration to Pretoria for testing—demonstrating the stability benefits of PrimeStore MTM in decentralized environments.
Key findings from the study included:
- 98% of participants accepted tongue swab collection, demonstrating a high level of comfort and ease compared to sputum collection.
- TB was detected in 4.9% of processed samples.
- In paired sample comparisons, swab-based qPCR showed:
- 56.5% sensitivity
- 96.7% specificity
- 83% concordance with sputum-based Xpert Ultra testing for medium/high bacterial load cases
- Notably, 3.4% of individuals who were unable to provide sputum samples tested positive using swabs, suggesting value for screening individuals who would otherwise remain untested or undiagnosed.
These results support the potential use of tongue swabs as a scalable specimen type for active surveillance and screening programs, Longhorn especially in rural locations or field environments where conventional diagnostic workflows cannot be deployed.
Study Two: Improving Diagnosis in Children Using Tongue and Rectal Swabs
The second study, titled “Tongue and rectal swab samples processed by manual qPCR enhance clinical decision-making in paediatric patients with presumptive tuberculosis,” investigated how swab-based sampling could address the urgent need for more child-friendly diagnostic pathways. The research involved 45 children under the age of five who exhibited symptoms Longhorn consistent with TB. Standard-of-care (SOC) methods—including gastric aspirate and sputum collection—were also performed to compare diagnostic outcomes.
Samples placed in PrimeStore MTM were manually processed using qPCR to evaluate sensitivity and clinical relevance.
Major findings included:
- 35.6% of participants tested positive using qPCR, despite all gastric aspirate and sputum samples returning negative results under SOC protocols.
- Treatment decisions were significantly misaligned: only 2 of the 16 qPCR-positive children were started on therapy based on SOC findings alone.
These results suggest that swab-based diagnostics could prevent overlooked or delayed diagnoses in young children, improving early treatment decisions and potentially reducing disease progression and transmission.
Broader Impact and Future Potential
Collectively, these studies provide evidence that non-invasive swab sampling Longhorn preserved in PrimeStore MTM may represent a major advancement in TB diagnostics. The research supports three key global health advantages:
- Improved Sample Accessibility: Swab collection is faster, simpler, and more acceptable to patients, particularly children and community screening participants who struggle to produce sputum.
- Elimination of Cold Chain Requirements: PrimeStore MTM stabilizes genetic material at room temperature, enabling long-distance or batch transport to centralized laboratories without degradation.
- Enhanced Case Identification: The ability to detect TB missed by standard diagnostic workflows demonstrates clear potential for earlier and more accurate intervention.
As global TB organizations continue working toward early detection initiatives and elimination goals set by the World Health Organization (WHO), innovations like PrimeStore MTM may provide new tools capable of reaching underserved populations at scale.
The Union World Conference on Lung Health 2025, where the data were presented, was held in Copenhagen, Denmark, from November 18–21, 2025, bringing together policymakers, clinicians, researchers, and Longhorn global health advocates working to address lung disease and infectious threat challenges. For additional details on Longhorn Vaccines & Diagnostics and PrimeStore MTM, visit the company’s website at www.LHNVD.com.
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