FINDRISK questionnaire combined with HbA1c testing as a potential screening strategy for undiagnosed diabetes in a healthy population.

Despite the efforts to control the epidemic of diabetes the total number of people living with diabetes is still steadily rising. In order to detect people at risk, cost-effective, convenient, and sensitive screening tools to assess the diabetes risk and to detect undiagnosed type 2 diabetes need to be developed and implemented in the primary care setting. To evaluate the combination of the well established FINDRISK questionnaire and HbA1c testing as a potential screening strategy the data obtained from 671 blood donors were analyzed for a potential correlation with the results of an oral glucose tolerance test. Based on the oral glucose tolerance test, 65 blood donors (9.7%) were newly diagnosed with diabetes, 336 (50.1%) with prediabetes, and 270 (40.2%) had a normal test result. Of the 401 blood donors diagnosed with prediabetes or diabetes 322 (80.3%) had a HbA1c between 5.7% and 6.4% and 27 (6.7%) with a HbA1c of 6.5% or greater. The majority of the blood donors newly diagnosed with diabetes or prediabetes (n=327) had a FINDRISK result of 12 points or higher. ROC analyses confirmed that the optimal cut off levels were for FINDRISK ≥ 12 points and for HbA1c ≥ 5.9%. Thus, a 3-step screening strategy applying the FINDRISK questionnaire followed by HbA1c testing and performing an oral glucose tolerance test on selected individuals could be a cost-saving approach for screening large populations and identifying people at risk for diabetes or undiagnosed diabetes.

[The BSD Health Study: a pilot study to examine the comparability of Bavarian blood donors with the Bavarian general population by a comparison with KORA S4]. / Die BSD Gesundheitsstudie: eine Pilotstudie zur Untersuchung der Vergleichbarkeit bayerischer Blutspender mit der Allgemein-bevölkerung Bayerns durch einen Vergleich mit KORA S4.

AIM: The aim of this pilot study was to compare the health status of Bavarian blood donors to the general population in Bavaria (Southern Germany). METHODS: Blood donors in Bavaria were evaluated with respect to socio-demographic characteristics, smoking status and selected diseases. The subset of blood donors from rural areas and aged 35-74 years (n=1 187), was compared to participants in the population-based survey KORA S4 living in rural areas near Augsburg (n=1 870). The comparison was based on logistic regression models adjusted for age and sex. RESULTS: Bavarian blood donors lived significantly more often in communities with less than 20 000 inhabitants (OR=4.73, KI: 3.69-6.13). They were more often born in Germany (OR=2.71, KI: 2.12-3.50) and had less university degrees (OR=0.60, KI: 0.44-0.81). Never smoking is more common in blood donors (OR=1.53, 95% KI: (1.30; 1.80)). The prevalence of asthma, myocardial infarction (HI) and cancer (men only) is significantly lower in blood donors compared to the general population both living in rural areas (OR (Asthma)=0.32, 95% KI: (0.20; 0.52); OR (HI)=0.17, 95% KI: (0.08; 0.34)). The initially significantly lower number of cancer cases in male blood donors disappeared after adjustment for smoking status and community size. No difference was detected for type 2 diabetes. CONCLUSION: With the exception of type 2 dia-betes, the prevalence of the investigated diseases was lower in blood donors than in the general population. Differences can probably be explained by lifestyle factors as there might be a selection of healthier and more health-conscious blood donors. In the literature, a reduced risk of MI is discussed to be related to the frequency of blood donation. However, these questions need further research.

[Diabetes study in Bavaria: known risk factors correlate with an increased level of HbA1c]. / Diabetes Studie Bayern: Bekannte Risikoparameter korrelieren mit erhöhten HbA1c-Werten.

BACKGROUND AND OBJECTIVE: Approximately six million Germans have been diagnosed with diabetes mellitus. A continuously increasing number of people with diabetes is expected within the next few years. Genetic disposition, age and especially lifestyle play an important role in the development of the disease. Diabetes normally develops during a long preclinical phase. During this preclinical phase an impaired glucose tolerance can easily be detected. Since an impaired glucose tolerance is often reversible the onset of diabetes can be prevented effectively by a change of lifestyle during this phase. The Bavarian Red Cross Blood Transfusion Service therefore determined the diabetes risk among its blood donors during two one-week study periods. PATIENTS AND METHODS: The diabetes risk of the participating donors was assessed by using the FindRisk diabetes test published by the German Diabetes Foundation and the HbA1c test. RESULTS: Approximately 12 percent of the participants (8187 persons aged 18-68 years) showed a moderate, high or even very high risk of developing diabetes within the next 10 years. The probability of developing the disease ranged from 17% (moderate risk) to 50% (very high risk). This corresponds to 3% of persons with unknown diabetes among the total population. An elevated HbA1c was found in approximately 5% of the donors in the first study week and in approximately 19% in the second study week. The analysis of the questionnaire and the HbA1c results indicated that elevated HbA1c values correlate with known diabetes risk factors. Persons with a body mass index greater than 25, an increased score in the FindRisk questionnaire and aged over 50 years more frequently showed an elevated HbA1c value. CONCLUSIONS: The combination of a diabetes risk questionnaire and HbA1c testing could be used successfully for diabetes screening in an identified risk group.

Comparison of three bacterial detection methods under routine conditions.

BACKGROUND AND OBJECTIVES: Since 2004, bacterial screening of platelets has been required in the USA and is also done on a voluntary basis in many European countries. The German Red Cross blood donor services conducted a prospective multicentre study in order to investigate the prevalence of bacterially contaminated pool platelet concentrates and apheresis platelet concentrates. This substudy compares three different bacterial detection systems. STUDY DESIGN AND METHODS: Platelet concentrates were tested in parallel with BacT/ALERT, Scansystem and Pall eBDS (n = 6307) in pool platelets. Apheresis platelets were tested in parallel with BacT/ALERT and Pall eBDS (n = 4730). All initially positive results were evaluated by a standardized procedure including evaluation by a microbiology reference laboratory. RESULTS: One in 6307 pool platelets were confirmed positive by BacT/ALERT, whereas Pall eBDS and Scansystem failed to detect these samples. Only three samples were initially reactive with Pall eBDS without proof of any bacteria strains. The rate of false-positive results was substantially higher for BacT/ALERT (0.25%, 28 in 11,037 tested samples) than for eBDS (0.03%, 3 in 11 037 tested samples) or Scansystem (0.0%, 0 in 6307 tested samples). Three of 4730 apheresis platelets were confirmed positive by BacT/ALERT. These were negative with Pall eBDS. CONCLUSION: Sensitivity was best for BacT/ALERT, whereas specificity was enhanced for Pall eBDS and Scansystem. Scansystem required specially trained staff, whereas BacT/ALERT and Pall eBDS were easy, quick, user-friendly and objective methods.

Analysis and cryopreservation of hematopoietic stem and progenitor cells from umbilical cord blood.

BACKGROUND: Umbilical cord blood (UCB) is an important source of hematopoietic stem and progenitor cells (HSC/HPC) for the reconstitution of the hematopoietic system after clinical transplantation. Cryopreservation of these cells is critical for UCB banking and transplantation as well as for research applications by providing readily available specimens. The objective of this study was to optimize cryopreservation conditions for CD34+ HSC/HPC from UCB. METHODS: Cryopreservation of CD34+ HSC/HPC from UCB after mononuclear cell (MNC) preparation was tested in a research-scale setup. Experimental variations were concentration of the cryoprotectant, the protein additive and cell concentration. In addition, protocols involving slow, serial addition and removal of DMSO were compared with standard protocols (fast addition and removal of DMSO) in order to avoid osmotic stress for the cryopreserved cells. Viability and recoveries of MNC, CD34+ cells and total colony-forming units (CFU) were calculated as read-outs. In addition, sterility testing of the collected UCB units before further processing was performed. RESULTS: The optimal conditions for cryopreservation of CD34+ HPC in MNC preparations were 10% DMSO and 2% human albumin at high cell concentrations (5 x 10(7) MNC/mL) with fast addition and removal of DMSO. After cryopreservation using a computer-controlled freezer, high viabilities (89%) and recoveries for CD34+ cells (89%) as well as for CFU (88%) were observed. Microbial contamination of the collected UCB samples was reduced to a rate of 6.4%. DISCUSSION: Optimized cryopreservation conditions were developed for UCB MNC in respect of the composition of the cryosolution. In addition, our results showed that fast addition of DMSO is essential for improved cryopreservation and post-thaw quality assessment results, whereas the speed of DMSO removal after thawing has little influence on the recoveries of CD34+ cells and CFU.

Filter Buffy Coats (FBC): a source of peripheral blood leukocytes recovered from leukocyte depletion filters.

In compliance with federal regulations, blood banks routinely use leukocyte depletion filters to eliminate contaminating leukocytes from blood products such as red blood cell and platelet concentrates. We developed and optimized conditions to elute leukocytes adsorbed to these filters; resulting in leukocyte suspensions which we termed Filter Buffy Coats (FBCs). These Filter Buffy Coats can replace standard buffy coats for various research applications. After optimizing both the filter elution medium as well as elution protocols, we compared commonly used leukocyte depletion filters from four different manufacturers. Relative fractions as well as total recoveries of leukocyte subsets, such as lymphocytes, monocytes and granulocytes, found in Filter Buffy Coats were identified and compared among the filters as well as to standard buffy coats and whole blood. Flow cytometric analysis of Filter Buffy Coats confirmed the presence of T- and B-lymphocytes, NK cells and monocytes. Furthermore, a significant quantity of CD34(+) hematopoietic stem or progenitor cells (HSC/HPC) was detected in Filter Buffy Coats prepared from different filters, thus making FBCs a valuable source for research on HSC/HPC. Colony assays revealed that most of these CD34(+) cells are functional. Using immunomagnetic cell sorting (MACS), we isolated a variety of leukocyte populations from FBC mononuclear cells (Filter-PBMCs) including T lymphocytes (CD4(+), CD8(+), CD3(+)), B lymphocytes (CD19(+)), NK cells (CD56(+)), HSC/HPC (CD34(+), CD133(+)) or dendritic cells (BDCA-4(+)). Functional properties of Filter-PBMCs, as well as of some of these isolated leukocyte populations, were confirmed using standard assays. In summary, Filter Buffy Coats are a valuable and convenient source of different peripheral leukocyte populations and can replace standard buffy coat preparations for research applications.

[Assessment of the tetanus immune status in plasma donors of the Blood Donor Service of the Bavarian Red Cross]. / Evaluierung des Tetanus-Immunstatus bei Plasmaspendern des Blutspendedienstes des Bayerischen Roten Kreuz.

BACKGROUND AND OBJECTIVE: Tetanus is nowadays largely under control, as a result of the preventive immunization programme. This prophylactic measure is important also because there is no specific treatment. In Germany tetanus occurs almost exclusively in elderly, not adequately immunized persons. This study determined the existing immune status of plasma donors in the region of Ingolstadt, Bavaria. SUBJECTS AND METHODS: Tetanus IgG antibody concentrations were measured with the ELISA test in serum of 1742 plasma donors (891 women, 851 men, age range 18-64 years). RESULTS: An adequately protective immunity against tetanus was found in 98.7% of men and 94.1% of women, while 5 women and 3 men had no protection. Demographic data indicated that the immunization protected males longer than females, regardless of age, especially in those over 50 years of age (85% of females, 99% of males). CONCLUSION: Adequate tetanus protection was achieved in the overwhelming majority of test subjects. This demonstrates that the prevalence of protection is lower in females than in males, a difference most marked in those over 50 years of age. It is important that this age group in particular should, as part of health care, be informed by their medical practitioner of the dangers of tetanus and the advantages of immunization.

A combination of the effects of rare genotypes at the XK and KEL blood group loci results in absence of Kell system antigens from the red blood cells.

The 22 antigens of the Kell blood group system are located on a red blood cell (RBC) membrane glycoprotein that shows sequence homology with a family of metalloendopeptidases. Expression of the Kell system antigens is partially governed by XK, an X-linked gene that encodes the Kx protein; absence of Kx results in reduced Kell antigen expression. Almost total absence of Kell antigens from the RBCs of a German man with no symptoms of neuroacanthocytosis could not be due to the Kell-null phenotype, Ko, because his RBCs had very weak expression of Kx antigen and his three children were Kp(a + b+). Kell antigens were normal on the RBCs of his son but weak on those of his two daughters. An Nla III restriction fragment-length polymorphism within the KEL gene showed the Kpa/Kpa genotype in the propositus. Sequencing of his XK gene showed a single base change within the donor splice consensus sequence of intron 2. A BsaAl restriction fragment-length polymorphism showed the mutation in both of his daughters but not in his son. The extreme depression of the Kell antigens of the propositus must be due to a combination of effects, ie, homozygosity for Kpa and deficiency of Kx protein, each of which is capable of causing some degree of weakening of Kell antigens.