Reducing the financial impact of pathogen inactivation technology for platelet components: our experience.

BACKGROUND: Pathogen inactivation (PI) technology for blood components enhances blood safety by inactivating viruses, bacteria, parasites, and white blood cells. Additionally, PI for platelet (PLT) components has the potential to extend PLT storage time from 5 to 7 days. STUDY DESIGN AND METHODS: A retrospective analysis was conducted into the percentage of outdated PLT components during the 3 years before and after the adoption of PLT PI technology in our institution. The PLT transfusion dose for both pre-PI and post-PI periods was similar. A retrospective analysis to study clinical safety and component utilization was also performed in the Balearic Islands University Hospital. RESULTS: As a result of PI implementation in our institution, the PLT production cost increased by 85.5%. However, due to the extension of PLT storage time, the percentage of outdated PLT units substantially decreased (-83.9%) and, consequently, the cost associated with outdated units (-69.8%). This decrease represented a 13.7% reduction of the initial cost increase which, together with the saving in blood transportation (0.1%), led to a saving of 13.8% over the initial cost. Therefore, the initial 85.5% increase in the cost of PLT production was markedly reduced to 71.7%. The mean number of PLT concentrates per patient was similar during both periods. CONCLUSIONS: The extension of PLT storage time can substantially contribute to reducing the financial impact of PI by decreasing the percentage of outdated PLTs while improving blood safety. Since the adoption of PI, there have been no documented cases of PLT transfusion-related sepsis in our region.

Asymptomatic infection by Leishmania infantum in blood donors from the Balearic Islands (Spain).

BACKGROUND: Visceral leishmaniasis (VL) caused by Leishmania infantum is a zoonotic disease endemic throughout the Mediterranean basin. The existence of asymptomatic human infection entails the risk of transmission by blood transfusion. STUDY DESIGN AND METHODS: The prevalence of Leishmania infection was studied in 1437 blood donors from the Balearic Islands (Majorca, Formentera, and Minorca) using immunologic (Western blot [WB] and delayed-type hypersensitivity [DTH]), parasitologic (culture), and molecular (nested polymerase chain reaction [PCR]) methods. In addition, the efficiency of leukoreduction by filtration to remove the parasite was tested by nested PCR in the red blood cell (RBC) units. RESULTS: Leishmania antibodies were detected in 44 of the 1437 blood donors tested (3.1%). A sample of 304 donors from Majorca was selected at random. L. infantum DNA was amplified in peripheral blood mononuclear cells (PBMNCs) in 18 of the 304 (5.9%), and cultures were positive in 2 of the 304 (0.6%). DTH was performed on 73 of the 304 donors and was positive for 8 of them (11%). Of the 18 donors with positive L. infantum nested PCR, only 2 were seropositive. All the RBC samples tested (13 of 18) from donors with a positive PBMNC nested PCR yielded negative nested PCR results after leukodepletion. CONCLUSIONS: Cryptic Leishmania infection is highly prevalent in blood donors from the Balearic Islands. DTH and L. infantum nested PCR appear to be more sensitive to detect asymptomatic infection than the serology. The use of leukodepletion filters appears to remove parasites from RBC units efficiently.

HCV screening in blood donations using RT-PCR in mini-pool: the experience in Spain after routine use for 2 years.

BACKGROUND: The aim of this study is to evaluate the feasibility of implementing a commercial HCV RNA RT-PCR screening method and provide data on the prevalence and incidence rates of hepatitis C in Spain. STUDY DESIGN AND METHODS: Five transfusion centers participated in the study, covering 34.1 percent of the country's total number of donations. All the centers evaluated the sensitivity and characteristics of a commercial RT-PCR reagent kit designed for pool testing (Cobas AmpliScreen HCV v2.0), for which serial dilutions of HCV WHO International Standard 96/790 and preseroconversion samples were used. The data obtained from this technique, employed routinely from May 1999 to June 2001 in 22- to 48-unit mini-pools, are presented in this study. RESULTS: An overall 95-percent detection limit was obtained either at 69 IU per mL when 0.2 mL volume of plasma was extracted (used to analyze individual units), or at 20 IU per mL, when viral particles were pelleted from 1 mL plasma (as used for screening in mini-pool) Three HCV-RNA-positive anti-HCV-negative donations were identified out of 1,015,482 screened donations. One of these had an initially undisclosed risk of HCV sexual transmission and carried a low viral load of 104.2 IU per mL HCV RNA. The analysis of first-time (FT) donations during the period of study (21.3% of the total) indicated an average prevalence rate of 2.05 per 103 FT donors (of which 1.55/103 FT donors were RNA positive); the residual risk calculated on repeat (RPT) donors was 3.91 per 106 donations (serology) or 0.59 per 106 donations (serology + NAT), and the predicted NAT yield estimate was 4.2 per 106 FT + RPT donations. CONCLUSIONS: The commercial RT-PCR reagent kit complies with the current European and FDA recommendations on sensitivity and can be easily implemented on a routine basis. The results obtained by the five transfusion centers on the predicted NAT yield (1/302,000 RPT donations or 1/237,000 FT + RPT donations) are very close to the published estimates corresponding to a larger area of our country (1/237,000 RPT donations) and are somewhat higher than, though in line with, the observed NAT yield (1/338,000 FT + RPT donations).