Quality Control Testing
Platelets are used in a wide variety of treatments; however the desired clinical outcomes are not always achieved. The quality of platelet concentrates has been shown to have an effect on clinical outcomes1,2. In addition, there is a constant threat of insufficient supply and continuing concerns over transfusion-borne diseases which has led to the introduction of pathogen inactivation technologies. It is critical to determine the impact of these new innovations on the function and composition of platelet products to ensure consistent product production quality, however, the options available for evaluating platelet products are limited, and due to cost, complexity and accessibility. As a result, these options cannot be used routinely.
What does ThromboLUX do?
ThromboLUX® can characterize platelet samples based on platelet size distribution, microparticles and microaggregate content and provide producers of platelet concentrates with a means to monitor their processes and assess the impact of changes to their processes.
Why use ThromboLUX?
Evidence from testing normal volunteer blood donors has shown that:
- Platelet composition and function is highly variable between individual donors
- Preparation methods impact the composition and function of Platelets
- Donors can have high levels of microparticles, microaggregates and immobilized platelets
- Platelet count is highly variable within a normal range
Therefore ThromboLUX may be beneficial for optimizing platelet product compositions, processes monitoring and process development in order to provide optimal platelet product.
When can ThromboLUX be used?
ThromboLUX can be used:
- At any stage of platelet production
- At any stage of process development
- For process validation
- For process monitoring
- For any type of platelet product. (ie Plasma, PAS, frozen, artificial)
- To conduct research for optimizing platelet product composition
The test requires 100 µL of sample to perform the quick 20 minute analysis. The user is provided with a histogram and ThromboLUX Score. Offline analysis software can be used to provide additional details.
ThromboLUX performs measurements at 37°C, then 20°C, then again at 37°C; and calculates a size distribution for each temperature. ThromboLUX then uses a proprietary algorithm to analyze the size distribution at the three test temperatures. The data that is gathered during the test is used to output the following parameters: photon rate, mean particle size, gated microparticle size and intensity, gated platelet size and intensity, MP factor and the ThromboLUX Score.
The gated parameters are calculations of the size and percent intensity within two windows that represent platelets and microparticles. The window from 50nm to 550nm is used for Gated MP parameters, and the window from 550nm to infinity is used for Gated PLT parameters.
The MP Factor parameter is an estimate of the relative concentration of microparticles to platelets based on the gated parameters. If a platelet count of the sample is available, then the product of MP Factor and Platelet count gives an approximate microparticle count.
- Goodrich RP, Li JZ, Pieters H et al. Correlation of in vitro platelet quality measurements with in vivo platelet viability in human subjects. Vox Sang. 2006 May;90(4):279-85.
- Arnold DM, Heddle N et al. In vivo recover and survival of apheresis and whole blood- derived platelets: a paired comparison in healthy volunteers. Transfusion. 2006; 46;257-64