Assessing quality of blood components derived from whole blood treated with riboflavin and ultraviolet light and separated with a fully automated device

Abstract

Background: Combining pathogen reduction and automated separation of whole blood (WB), together with the use of improved additive solutions, may increase reproducibility and extend shelf-life of blood components.

Materials and methods: Forty WB units were collected from volunteer donors and randomised 1:1 into two groups: 1) pathogen reduction with riboflavin and ultraviolet light (PRT); or 2) no treatment (Control). After two hours (h) at room temperature, all units underwent fully automated separation into red blood cell concentrate (RBCC), plasma and leukopack components. RBCCs were leukoreduced and stored in phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) solution while plasma units were shock frozen within 8 h of collection and stored at ≤ -25°C. RBCCs were sampled on day 1 and weekly thereafter until day 42, while plasma was sampled on days 1 and 30. The main study objective was to assess the in vitro quality of separated RBCCs using biochemical and haematological parameters. Plasma protein content after one cycle of freeze-thaw was also analysed.

Results: The quality of RBCCs was largely comparable between the PRT and Control groups, except for a significantly higher degree of haemolysis and extracellular potassium levels in the PRT group after 35 days of storage. While potassium concentration was significantly higher in the PRT group at all timepoints, the degree of haemolysis exceeded the accepted European threshold (i.e., <0.8% of red cell mass in ≥ 90.0% of tested units) after day 35. Most plasma protein levels were significantly lower in the PRT than the Control group at both day 1 and day 30.

Discussion: Pathogen reduction with riboflavin and ultraviolet light treatment of WB can be combined with fully automated separation to obtain RBCCs that may be stored for up to 35 days in PAGGSM solution with acceptable quality, comparable to that of RBCCs from untreated blood. The relative differences between factor concentrations in plasma from the PRT and the Control groups were similar during the 30-day storage.

Figure 1

Study design D1, D7, D14, D21, D28, D30, D35, and D42: sampling points after indicated days of storage; n: number of whole blood units processed in each group; PAGGSM: phosphate-adenine-glucose-guanosine-saline-mannitol; PRT: pathogen reduction technology; RBCC: red blood cell concentrate; RF: riboflavin; SAGM: saline-adenine-glucose-mannitol; UV: ultraviolet light.

Figure 2

Characteristics* of red blood cell concentrates (RBCC) obtained from pathogen-reduced (PRT) or untreated (Control) whole blood units subjected to fully automated separation *Dashed lines represent thresholds as defined by European (EDQM) or Polish guidelines for acceptable quality of red blood cell concentrates. The threshold values are either upper (haemolysis) or lower (haemoglobin) cut-off values or range (haematocrit). **Threshold for haemoglobin (15.4g/dL) was manually calculated as a ratio of the EDQM-required concentration (40g/unit) and the average RBCC unit volume for the PRT group (259.4 mL or 2.6 dL). Error bars represent standard deviations from the mean; 2,3-DPG: 2,3-diphosphoglycerate concentration; fL: femtolitre; K+: potassium ion concentration; MCV: mean corpuscular volume; PRT: pathogen reduction technology.