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COVER STORY / ADVERTISING FEATURE


The R Biopharm IP-10 platform is intentionally designed to be intuitive: three stimulation tubes and one of two possible detection methods. This concept addresses two very different laboratory realities.


basis for comparing the diagnostic potential of new technologies. Across a multicentre study involving


sites in Germany and South Africa, the IP- 10 ELISA (RIDASCREEN TB) demonstrated a sensitivity of 85.2% in active TB patients, while the rapid lateral flow assay (RIDA QUICK TB) reached 80%. In contrast, the established interferon gamma–based method used for comparison showed a lower sensitivity of 71.7% in the same cohort. These findings were supported by additional international datasets, including a high incidence cohort from South Africa showing sensitivities of 91.43% for RIDASCREEN TB and 85.29% for RIDA QUICK TB, in comparison with 74.29% for the comparator method (QuantiFERON TB Gold Plus). Likewise, results from Romania demonstrated sensitivities of 92% (RIDASCREEN TB) and 86% (RIDA QUICK TB) for the IP-10 based assays in active pulmonary TB, outperforming the comparator, which reached 71.4% (QuantiFERON TB Gold Plus). While sensitivity is best evaluated in


active TB, agreement with existing testing strategies in non-active cases remains important for practical implementation. In these cohorts, the IP-10 assays showed very high concordance with the established method. Specific data originating from India


focusing more on immunocompromised patients yielded a higher proportion of positive results with the RIDASCREEN TB compared with the comparator method. In addition, the rate of indeterminate results was reduced by 30.3% (eight versus 28 cases), indicating improved robustness in clinically challenging samples. Taken together, these findings


illustrate that IP-10 represents not merely an incremental improvement, but a diagnostic approach with consistently stronger performance, especially where conventional assays face their greatest limitations.


Call for courage and curiosity Whenever a new technology enters a field that has relied on the same tools for many years, there is a moment of hesitation. Sometimes we cling to established workflows simply because they are familiar, not because they are the best available. With the IP-10 based TB diagnostic, we


now have an opportunity to move beyond the limitations of older systems. The data are strong, the workflow is practical, and the need, particularly for vulnerable patients, is undeniable. This may be an appropriate moment to


explore new diagnostic technologies that have the potential to genuinely improve patient care. Not simply because they are new, but because they address limitations we have long considered unavoidable, and offer solutions that could move TB diagnostics forward.


Efficient workflow The system starts with the RIDA TB Tubes, sterile vacuum blood collection tubes that allow direct venous sampling. They include: NEG tube for background IP-10 levels TEST tube coated with ESAT 6 and CFP 10 antigens POS tube coated with a mitogen for non-specific immune activation.


Incubation takes 16–24 hours at 37°C, after which the plasma can be analysed. The use of well characterised antigens provides a defined and specific immune activation, and laboratories appreciate that the workflow is straightforward and compatible with their current IGRA processes. After stimulation, users choose


between:


1. RIDASCREEN TB (ELISA) for medium to high throughput Up to 28 samples per plate per run Works with manual or automated ELISA systems


All reagents provided in a single kit, reducing operational complexity.


This option fits well into central laboratories or hospital diagnostic units that want standardised plate-based processing.


2. RIDA QUICK TB (lateral flow) for low complexity setings One cassete per patient, results in 15 minutes Robust gold particle technology, not requiring fluorescence Can be read visually or via the RIDAQ3 reader.


This is ideal for decentralised clinics, smaller laboratories or remote areas where equipment is limited. Together, the system achieves


something important: a biomarker with high sensitivity delivered in workflows for both advanced laboratories and low- resource setings. And yes, the tests are already included on the Global Fund Procurement List, underlining their suitability for implementation in the Global Health Market. IP-10 will not replace every method, nor will it solve TB on its own. However, it offers something rare in diagnostics: a combination of scientific validity, operational flexibility, and real-world performance. Surely that deserves our atention and willingness to try something beter.


PPi


Raani Lekh UK Product Manager TB


07764 967 539 raani@r-biopharmrhone.com htps://clinical.r-biopharm.com/ diagnostics/tuberculosis


April 2026 WWW.PATHOLOGYINPRACTICE.COM 7


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