Key result
The automated Thrombomate XRA device provided reproducible light transmission aggregometry results with a mean coefficient of variation of 2.8%, comparable to the 3.3% observed with an established manual method.
Why the study?
Light transmission aggregometry is the gold standard for evaluating platelet function but is labor-intensive and involves numerous manual steps, which automation may help standardize.
Does automated light transmission aggregometry using Thrombomate XRA provide comparable maximum aggregation values to manual methods?
Observational (n=147)
No
Does automated light transmission aggregometry using Thrombomate XRA provide comparable maximum aggregation values to manual methods?
Absolute Event Rate: 2.8% vs 3.3%
The automated Thrombomate XRA provides reproducible light transmission aggregometry results comparable to manual methods, simplifying the process by eliminating the need for autologous platelet-poor plasma.
Automated LTA shows high reproducibility; extends technical validation but leaves open clinical adoption.
Background Light transmission aggregometry (LTA) is considered the gold standard for the evaluation of platelet function but is labor-intensive and involves numerous manual steps. Automation may contribute to standardization. Here, we evaluate the performance characteristics of a new automated instrument, Thrombomate XRA (TXRA), and compare it against a manual instrument (PAP-8). Materials and Methods Leftover blood samples from blood donors or patients were tested in parallel with identical reagents and in identical concentrations both manually using PAP-8 and automated on the TXRA. In addition to precision and method comparison, an additional evaluation was performed on the TXRA against “virtual” platelet-poor plasma (VPPP) based on artificial intelligence. The main focus was on comparing the maximum aggregation (MA%) values. Results Precision for MA% ranged from 1.4 to 4.6% on TXRA for all reagents. Normal ranges for 100 healthy blood donors on both instruments were in a similar range for all reagents, with a tendency to slightly higher values with TXRA. Most agonists resulted in normally distributed MA%. Comparing 47 patient samples on both devices showed a good correlation for both slope and MA% with some differences in individual samples with epinephrine and TRAP. Correlation between the TXRA measurement against PPP and “virtual” PPP demonstrated excellent correlation. Reaction signatures of both devices were very similar. Conclusion TXRA provides reproducible LTA results that correlate with an established manual method when tested against PPP or VPPP. Its ability to perform LTA only from platelet-rich plasma without requiring autologous PPP simplifies LTA. TXRA is an important step not only for further standardizing LTA but also for a more widespread use of this important method.
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Sachs et al. (2023) conducted an observational in Suspected hemostatic disorders or healthy blood donors (n=147). Thrombomate XRA (TXRA) automated light transmission aggregometry vs. PAP-8 manual light transmission aggregometry was evaluated on Mean coefficient of variation (CV) for maximum aggregation across all reagents. The automated Thrombomate XRA device provided reproducible light transmission aggregometry results with a mean coefficient of variation of 2.8%, comparable to the 3.3% observed with an established manual method.
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