A scoping review of sociology of voluntary blood donation.

BACKGROUND AND OBJECTIVES: Maintaining stable blood supplies presents an increasing challenge for blood collection agencies (BCAs). Novel and multidisciplinary approaches and research have been called for to understand the mechanisms underlying the trends. The current body of sociological research on blood donation is a potentially valuable resource, but it is dispersed over different publications and theoretical frameworks. MATERIALS AND METHODS: We conducted a scoping review of sociological research on voluntary, non-remunerated blood donation to identify insights and practical applications for researchers and BCAs. RESULTS: Four organizing themes were identified: donated blood, blood donors, organizations and blood service systems. Key challenges associated with the organization of voluntary blood donation exist at the institutional and systems levels, and they may not be readily resolved by interventions focussed solely on the individual donor level. We identified opportunities for organizations to build trust with donors and the public through communications and working with communities to promote inclusion in blood donation. CONCLUSION: The results support a multidisciplinary approach and research for BCAs to move forward and find novel ways to ensure safe, resilient blood service systems.

Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems.

Venous blood collection systems (VBCSs) are combinations of in-vitro diagnostics and medical devices, usually available as integrated set. However, purchasing and using a combination of devices from different sets is considered by clinical laboratories as an option to achieve specific sampling tasks or reduce costs. This systematic review aimed to retrieve available evidence regarding safety, efficacy, and economic aspects of VBCSs, focusing on differences between integrated and combined systems. The literature review was carried out in PubMed. Cited documents and resources made available by scientific organisations were also screened. Extracted evidence was clustered according to Quality/Efficacy/Performance, Safety, and Costs/Procurement domains and discussed in the current European regulatory framework. Twenty documents published between 2010 and 2021 were included. There was no evidence to suggest equivalence between combined and integrated VBCSs in terms of safety and efficacy. Scientific society's consensus documents and product standards report that combined VBCS can impact operators' and patients' safety. Analytical performances and overall efficacy of combined VBCSs are not guaranteed without whole system validation and verification. EU regulatory framework clearly allocates responsibilities for the validation and verification of an integrated VBCS, but not for combined VBCSs, lacking information about the management of product nonconformities and post-market surveillance. Laboratory validation of combined VBCS demands risk-benefit and cost-benefit analyses, a non-negligible organisational and economic burden, and investment in knowledge acquisition. Implications in terms of laboratory responsibility and legal liability should be part of a comprehensive assessment of safety, efficacy, and cost carried out during device procurement.

Equity in blood transfusion precision services.

BACKGROUND: Blood collection agencies are integrating precision medicine techniques to improve and individualise blood donor and recipient outcomes. These organisations have a role to play in ensuring equitable application of precision medicine technologies for both donors and transfusion recipients. BODY: Precision medicine techniques, including molecular genetic testing and next generation sequencing, have been integrated in transfusion services to improve blood typing and matching with the aim to reduce a variety of known transfusion complications. Internationally, priorities in transfusion research have aimed to optimise services through the use of precision medicine technologies and consider alternative uses of genomic information to personalise transfusion experiences for both recipients and donors. This has included focusing on the use of genomics when matching blood products for transfusion recipients, to personalise a blood donor's donation type or frequency, and longitudinal donor research utilising blood donor biobanks. CONCLUSION: Equity in precision services and research must be of highest importance for blood collection agencies to maintain public trust, especially when these organisations rely on volunteer donors to provide transfusion services. The investment in implementing equitable precision medicine services, including development of blood donor biobanks, has the potential to optimise and personalise services for both blood donors and transfusion recipients.

Blood transfusion in the Caribbean: Historical perspective in the context of Trinidad and Tobago.

To compare the historical development of blood transfusion in Britain and a former British West Indian colony. International transfusion bodies recommend national coordination and exclusively voluntary non-remunerated donation as essential pre-requisites for blood safety. These ideals have been achieved in high-income countries including Great Britain, the United States of America and Canada. However, most West Indian countries have fragmented, hospital-based blood services that rely on family replacement and remunerated donors. Comparative historical analysis of blood transfusion service development in Great Britain and Trinidad and Tobago was undertaken to provide insight into their dichotomous development and inform policy decisions to bridge the gap between the two types of transfusion service. The British National Blood Transfusion service was based on voluntary non-remunerated blood donation from its inception but achieved national coordination over 50 years that included a period of regional control during which incoordination contributed to a tainted blood scandal. Failure to establish community voluntary non-remunerated donation in Trinidad and Tobago during the colonial period, before independence in 1962, allowed regionally-controlled family replacement and remunerated blood donation to become entrenched then perpetuated by path dependence. A university-led programme has recently used historically-proven methods, drawing on the experiences of the British National Blood Transfusion Service, to establish a model for developing a voluntary non-remunerated programme. The programme aims to avoid historical pitfalls during its national extension. Historical analysis provided information for introducing voluntary non-remunerated blood donation and planning a nationally-coordinated blood transfusion service.

End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6.

Tube manufacturers use different composition of gels and blood clot activator formulations in serum tube production. Our aim was to investigate the within-tube (repeatability) and between-tube variation, concordance between comparison results of BD and VacuSEL tubes. Blood samples were collected from control subjects (n = 20) and patients (n = 30) in accordance with the CLSI GP41-A6 and CLSI GP34-A guidelines. Twenty-three clinical chemistry parameters were analysed via Roche Cobas C702 Chemistry Analyzer on T0 (0 hour) and T24 (24 hour). Mean differences % were compared with Wilcoxon matched pair test. Clinical significance was evaluated based on desirable bias according to total allowable error (TEa). VacuSEL tubes demonstrated acceptable performance for the results of 20 parameters with regards to desirable bias % limits. Lactate dehydrogenase (LD) [mean difference % (%95 confidence intervals (CI) values of BD and VacuSEL tubes at T0 [6.41% (4.80-8.01%)]; sodium (Na) and total protein (TP) at T24 [-0.27% (-0.46 to -0.07%) and -1.39% (-1.87 to -0.91), respectively] were over the desirable bias limits (LD: 4.3%, Na: 0.23% and TP: 1.36%, respectively) but not exceeding total biological variation CV % [Na: 0.5 (0.0-1.0) % and TP: 2.6 (2.3-2.7) %). %95 confidence intervals (CI) of T0 LD values overlap with within-subject biological variation % (CI) limits (LD: 5.2 (4.9-5.4) %). The differences between two tubes were not medically significant and necessarily conclusive. VacuSEL serum tubes presented comparable performance with BD serum tubes.

Effects of Blood Collection Tubes on the Quantification of Catecholamines and Their O-Methylated Metabolites by Liquid Chromatography Coupled With Tandem Mass Spectrometry.

BACKGROUND: Catecholamines (epinephrine; norepinephrine; and dopamine) and their O-methylated metabolites (metanephrine; normetanephrine; and 3-methoxytyramine) are biomarkers for pheochromocytoma and paraganglioma. Liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was recommended by Endocrine Society for detecting these compounds. The influence of blood collection tubes on the analysis of the six analytes by LC-MS/MS was not thoroughly investigated, which we want to clarify in our study. METHODS: Blood samples of healthy individuals were collected into serum, lithium heparin, and K2EDTA plasma tubes separately. Samples were subjected to solid phase extraction and then analyzed by LC-MS/MS. The retention behavior and assay performance of the six analytes were assessed for samples from different collection containers. The impacts of potassium and sodium as the counter ions of EDTA on the retention time and matrix effect were also studied. RESULTS: Compared with O-methylated metabolites, the results for catecholamines were more affected by the collection tubes, especially for norepinephrine, which displayed severely suppressed signal and very low extraction efficiency in K2EDTA plasma. Changing the counter ion of EDTA from potassium to sodium dramatically changed the retention behavior and matrix effect of norepinephrine. CONCLUSIONS: It is necessary to evaluate blood collection tubes for catecholamines and their O-methylated metabolites analyzed by LC-MS/MS. In addition, attention should also be paid when the anticoagulant counter ion was changed.

Impact of a Modified Protocol for Blood Collection on Hemolysis Rates and Nurses' Perceptions About Improving Their Practice Environment.

PURPOSE: In 2019, approximately 5% of blood draws in the postanesthesia care unit (PACU) were hemolyzed compared to 1.1% across other hospital units. A preliminary review showed almost 60% of patients sampled blood employing arterial lines in the unit. The purpose of this quality improvement study was to improve blood drawing practices and reduce the occurrence of hemolysis. A secondary aim was for PACU nurses to lead this unit-based initiative. DESIGN: Team members led by PACU nurses used the Deming model of quality improvement as a framework to better the process of specimen collection. METHODS: The team employed the Plan-Do-Check-Act procedure to organize their improvement efforts. Specimen collection protocol was modified to include manual aspiration from arterial lines and hemolysis data was retrieved from laboratory generated reports and electronic medical records. FINDINGS: By changing blood drawing practices, the hemolysis rate was significantly reduced from 5.2% to 3.6%. Two years postimplementation, rates continue to decline with the current rate at 1.97%. CONCLUSION: This nurse-led interdisciplinary improvement initiative identified and trialed evidence-based solutions to reduce blood specimen hemolysis.

[Effects of tetramethylpyrazine on pharmacokinetics in plasma and brain dialysate and neuropathic pain in rat model of spared sciatic nerve injury].

This study aims to explore the effects of tetramethylpyrazine(TMP) on pharmacokinetics in plasma and brain dialysate and neuropathic pain in the rat model of partial sciatic nerve injury(SNI), and to investigate the correlation between the analgesic effect of TMP and its concentrations in the plasma and brain dialysate. Male SD rats were randomized into Sham, SNI, and SNI+TMP groups. Mechanical stimulation with von frey filaments and cold spray method were employed to evaluate the mechanical sensitivity and cold sensitivity of rats. Another two groups, Sham+TMP and SNI+TMP, were used to intubate the common jugular vein and implant microdialysis probes into the anterior cingulate gyrus(ACC), respectively.After intraperitoneal injection of TMP at a dose of 80 mg·kg~(-1), automatic blood collection and intracerebral microdialysis(perfusion rate of 1 µL·min~(-1)) systems were used to collect the blood and brain dialysate for 24 h. HSS T3 C_(18) reversed-phase chromatographic column(2.1 mm×50 mm, 2.5 µm) was used for liquid chromatographic separation. Gradient elution was carried out with the mobile phase of methanol-water(containing 0.005% formic acid) at a flow rate of 0.25 mL·min~(-1). Electrospray ion source was used for mass spectrometry, and the scanning mode was multi-reaction monitoring under the positive ion mode. The ion pairs for quantitative analysis were TMP m/z 137/122 and aspirin m/z 179/137, respectively. DAS 2.11 was used to calculate the pharmacokinetic parameters. The optimal time of TMP to exert the analgesia effect and inhibit cold pain sensitivity was 60 min after treatment. The TMP in the plasma and brain dialysate of SNI rats showed the T_(max) of 15 min and 30 min, the C_(max) of(2 866.43±135.39) and(1 462.14±197.38) µg·L~(-1), the AUC_(0-t) of(241 463.30±28 070.31) and(213 115.62±32 570.07) µg·min·L~(-1), the MRT_(0-t) of(353.13±47.73) and(172.16±12.72) min, and the CL_Z of 0.73 and 0.36 L·min·kg~(-1), respectively. The analgesic effect of TMP had a significant correlation with the blood drug concentration in the ACC, which indicated that this method was suitable for the detection of TMP in rat plasma and brain dialysate. The method is accurate, reliable, and sensitive and can realize the important value of the application of correlation analysis theory of "automatic blood collection-microdialysis/PK-PD" in the research on neuropathic pain.

Impact of donor ferritin testing on iron deficiency prevention and blood availability in France: A cohort simulation study.

BACKGROUND AND OBJECTIVES: Implementing a ferritin testing policy for whole blood (WB) donors may prevent iron deficiency (ID, ferritin <26 ng/mL) and anaemia, but may induce donation losses. As part of a national prevention plan in France, we aimed to estimate its impact on ID, anaemias and WB donations among donors at high risk of ID. MATERIALS AND METHODS: A micro-simulation model was developed to evaluate different scenarios compared to the current situation without ferritin testing as a reference scenario. The following scenarios were simulated: a minimum scenario with a 6-month deferral for donors with absent iron store (AIS, ferritinemia <15 ng/ml), a main scenario with additional delayed invitations for donors with ferritinemia 15-25 ng/ml and a supplementation scenario with additional iron supplementation for 50% of the donors with AIS. RESULTS: In the main scenario, 52,699 WB donations per year were estimated to be lost after 1 year (-8%), falling to 27,687 (-4.7%) after 5 years. IDs and anaemias were reduced by 13.6% and 29.3%, respectively, after 1 year. The supplementation scenario increased the number of prevented IDs and anaemias to 24.1% and 35.4%, respectively, after 1 year, and halved the number of anaemias at 5 years. The latter scenario also had the least impact on the number of donations (-3.2% after 5 years). CONCLUSION: A ferritin testing policy resulting in delayed donations for ID donors is effective in reducing IDs and anaemias, but significantly impacts the number of donations, thereby posing a self-sufficiency challenge.

Recommendations for in vitro evaluation of blood components collected, prepared and stored in non-DEHP medical devices.

BACKGROUND AND OBJECTIVES: DEHP, di(2-ethylhexyl) phthalate, is the most common member of the class of ortho-phthalates, which are used as plasticizers. The Medical Device Regulation has restricted the use of phthalates in medical devices. Also DEHP has been added to the Annex XIV of REACH, "Registration, Evaluation, Authorisation and Restriction of Chemicals" due to its endocrine disrupting properties to the environment. As such, the sunset date for commercialisation of DEHP-containing blood bags is May 27th 2025. There are major concerns in meeting this deadline as these systems have not yet been fully validated and/or CE-marked. Also, since DEHP is known to affect red cell quality during storage, it is imperative to transit to non-DEHP without affecting blood product quality. Here, EBA members aim to establish common grounds on the evaluation and assessment of blood components collected, prepared and stored in non-DEHP devices. MATERIALS AND METHODS: Based on data as well as the input of relevant stakeholders a rationale for the validation of each component was composed. RESULTS: The red cell components will require the most extensive validation as their quality is directly affected by the absence of DEHP, as opposed to platelet and plasma components. CONCLUSION: Studies in the scope of evaluating the quality of blood products obtained with non-DEHP devices, under the condition that they are carried out according to these recommendations, could be used by all members of the EBA to serve as scientific support in the authorization process specific to their jurisdiction or for their internal validation use.

Self-sampling of blood using a topper and pediatric tubes; a prospective feasibility study for PSA analysis using 120 prostate cancer patients.

OBJECTIVES: Self-collection of blood for diagnostic purposes by blood collection assist devices (BCAD) has gained a lot of momentum. Nonetheless, there are a lack of studies demonstrating the feasibility and reliability of self-collecting capillary blood for routine (immuno)chemistry testing. In this study we describe the topper technology together with pediatric tubes to enable self-collection of blood and investigated its feasibility for PSA testing by prostate cancer patients. METHODS: A total of 120 prostate cancer patients for which a routine follow-up PSA test was requested, were included in this study. Patients received instruction materials and the blood-collection device consisting of a topper, pediatric tube and base-part, and performed the blood collection procedure themselves. Afterwards a questionnaire was filled-in. Finally, PSA was measured on a Roche Cobas Pro. RESULTS: The overall self-sampling success rate was 86.7 %. Furthermore, when specified per age category, a 94.7 % success rate for patients under 70 years and a 25 % success rate for patients of 80 years and older was observed. Venous and self-collected PSA were highly comparable when analyzed by Passing-Bablok regression with a slope of 0.99 and intercept of 0.00011, Spearmans correlation coefficient (0.998) and average self-collected PSA recovery of 99.8 %. CONCLUSIONS: Evidence is presented that self-collected capillary blood by topper and pediatric tube from the finger is feasible, particularly for patients under 70 years. Furthermore, capillary blood self-sampling did not compromise any of the PSA test results. Future validation in a real-world setting, without supervision and including sample stability and logistics, is required.

The effect of regional massage performed before blood collection on pain and vital signs in newborns.

AIM: This randomised-controlled trial aims to examine the effect of regional massage performed before blood collection on pain and vital signs in term newborns. METHODS: The study sample consisted of a total of 96 term newborns, 49 in the experimental group and 47 in the control group, in the neonatal intensive care unit (NICU). Before the blood collection process, those in the experimental group received two (2) minutes of massage on their blood collection region, and their pain levels and vital signs were observed. Data were collected using a newborn information form, an intervention follow-up form, and the Neonatal Infant Pain Scale (NIPS). Statistical analyses of the collected data included descriptive statistics, Chi-squared test, independent-samples t test, paired-samples t test and Cohen's kappa statistic. A value of P < 0.05 was considered statistically significant. RESULTS: While 51% (n = 49) of the newborns were included in the experimental group, 38.5% (n = 37) were born at the 38th gestational week. Their mean post-natal age was 4.82 ± 4.04 days. The newborns in the experimental and control groups had similar demographic characteristics and blood collection experiences, and there was no statistically significant difference between them (P > 0.05). The mean crying time in the control group (56.9 ± 25.4 s) was significantly longer than that in the experimental group (30.6 ± 29.3 s) (P < 0.05). The newborns in the experimental group had shorter crying times, lower pain levels and heart rate, and higher oxygen saturation than those in the control group. CONCLUSION: The regional massage intervention reduced pain in term newborns. Therefore, neonatal nurses can be trained to use massage as an alternative infant care practice.

The effect of lighted toy on reducing pain and fear during blood collection in children between 3 and 6 years: A randomized control trial.

BACKGROUND: This study was carried out as an experimental research to determine the effect of the light toy on reducing pain and fear during blood collection in children. METHODS: The data were obtained 116 children. The "Interview and Observation Form Children's Fear Scale, Wong-Baker Faces, Luminous Toy and Stopwatch" was used for data collection. The data were evaluated using percentage, mean, standard deviation, chi-square, t-test, correlation analysis and Krusskal Wallis test in SPSS 21.0 package program. FINDINGS: The fear score average of the children in the lighted toy group was 0.95 ± 0.80, while it was 3.00 ± 0.74 in the control group. The difference between the groups in terms of the fear score average of the children was found statistically significant (p < 0.05). When the difference between groups in terms of pain status of children is examined, the pain level of children in the lighted toy group (2.83 ± 2.82,) was found to be significantly lower than the pain level of the children in the control group (5.86 ± 2.72) (p < 0.05). DISCUSSION: As a result of the study, it was found that the lighted toy given to the children during blood collection reduces their fear and pain levels. In the light of these findings, it is recommended to increase the use of lighted toys in blood collection. APPLICATION TO PRACTICE: The use of lighted toys as a distraction method during blood collection in children is an effective, easy-to-access and low-cost method. This method demonstrates that there is no need for expensive methods of distraction.

The effect of buzzy®, DistrACTION® cards on reducing pediatric pain and fear during blood collection in the rheumatology polyclinic: A randomized controlled trial.

PURPOSE: The aim of this study was to compare the effectiveness of Buzzy® and DistrACTION® Cards in reducing children's pain and fear while taking venous blood samples. METHODS: This research was designed as a randomized controlled experimental study. The study population consisted of children aged 6-12 years admitted to the Pediatric Rheumatology Diseases Polyclinic in a Faculty of Medicine in Germany. The sample of the study consisted of 96 children (Buzzy® = 32, DistrACTION® Cards = 32, control = 32) who met the patient selection criteria and agreed to participate in the study. The data were obtained using a Child and Family Information Form, the Children Fear Scale (CFS), and the Faces Pain Scale-Revised (FPS-R). The data were evaluated using the Pearson chi-square test, Kruskal-Wallis test, One-way ANOVA test with Bonferroni correction, and Fisher-Freeman-Halton. FINDINGS: In the study, the average age of the children was 9.21 ± 2.15 years. The Buzzy® group had the lowest pain and procedural fear scores (self-report = 0.88 ± 1.13, 0.31 ± 0.47; parent report = 0.75 ± 0.98, 0.34 ± 0.48, and researcher report = 0.81 ± 1.00, 0.31 ± 0.54, respectively) than the DC, and control groups. CONCLUSIONS: The Buzzy® method was effective in reducing venipuncture pain and fear in children. PRACTICE IMPLICATIONS: Nurses can use the Buzzy® methods to help reduce venipuncture pain and fear in children. The clinical trial registration number is NCT05560074. (https://clinicaltrials.gov/ct2/show/study/NCT05560074).

The effect of a hand puppet-based therapeutic play for preschool children on the fear and pain associated with blood collection procedure.

PURPOSE: The aim of this study was to determine the effects of a therapeutic play involving a hand puppet on the fear and pain associated with blood collection procedure in preschool children. DESIGN AND METHODS: The research was conducted as a randomised controlled experiment. The sample included children aged 3-6 years who attended the blood collection unit between July and October 2022 and met the study's inclusion criteria. The research was completed with a total of 120 children, divided evenly into one of two groups. The nursing intervention of the research was a therapeutic play applied with a hand puppet. Data were collected through face-to-face interviews using a Questionnaire Form, the Child Fear Scale and the Wong-Baker Faces Pain Rating Scale. Ethical principles were followed in the research. RESULTS: Differences between mean fear and pain level scores between the groups were statistically significant (p < 0.05). CONCLUSIONS: The therapeutic play applied with a hand puppet reduced the level of fear and pain associated with the blood collection process. PRACTICE IMPLICATIONS: Health professionals working in units related to paediatrics can use hand puppets, which are easy to use, inexpensive and practical, to reduce the fear and pain associated with blood collection from pre-school children.

Preanalytical Quality Evaluation of Citrate Evacuated Blood Collection Tubes-Ultraviolet Molecular Absorption Spectrometry Confronted with Ion Chromatography.

We previously enabled a direct insight into the quality of citrate anticoagulant tubes before their intended use for specimen collection by introducing an easy-to-perform UV spectrometric method for citrate determination on a purified water model. The results revealed differences between the tubes of three producers, Greiner BIO-ONE (A), LT Burnik (B), and BD (C). It became apparent that tubes C contain an additive, which absorbs light in the ultraviolet range and prevents reliable evaluation of citrate anticoagulant concentration with the suggested method. In this research, we re-evaluate the quality of citrate-evacuated blood collection tubes by complementing UV spectrometry with ion chromatography. (1) Comparable results were obtained for tubes B at 220 nm. (2) Citrate concentrations determined with ion chromatography were lower for tubes A and C. Chromatograms reveal additional peaks for both. (3) Influences of heparin on absorption spectra and chromatograms of citrate were studied. Some similarities with the shape of the anticoagulant spectra of tubes A and C were observed, and the lithium heparin peak in chromatograms is close to them, but a confident judgment was not possible. (4) Contamination of anticoagulant solution with potassium, magnesium, and calcium was confirmed for all the brands, and contamination with lithium for B and C.

Accuracy of Citrate Anticoagulant Amount, Volume, and Concentration in Evacuated Blood Collection Tubes Evaluated with UV Molecular Absorption Spectrometry on a Purified Water Model.

Citrate anticoagulant concentration affects the results of coagulation tests. Until now, the end user had no direct insight into the quality of evacuated blood collection tubes. By introducing an easy-to-perform UV spectrometric method for citrate determination on a purified water model, we enabled the evaluation of (1) the accuracy of the anticoagulant amount added into the tubes by a producer, (2) the accuracy of the volume of anticoagulant solution in the tube at the instant of examination, (3) the anticoagulant concentrations at a draw volume. We examined the Vacuette®, Greiner BIO-ONE, Vacutube, LT Burnik d.o.o., and BD Vacutainer® tubes. The anticoagulant amount added into the tubes during production had a relative bias between 3.2 and 23.0%. The anticoagulant volume deficiency at the instant of examination expressed as a relative bias ranged between -11.6 and -91.1%. The anticoagulant concentration relative bias after the addition of purified water in a volume that equalled a nominal draw volume extended from 9.3 to 25.7%. Draw-volume was mostly compliant during shelf life. Only Vacutube lost water over time. Contamination with potassium, magnesium, or both was observed in all the tubes but did not exceed a 0.21 mmol/L level. This study enables medical laboratories to gain insight into the characteristics of the citrate blood collection tubes as one of the preanalytical variables. In situations that require anticoagulant adjustment for accurate results, this can help make the right decisions. The methodology gives producers additional means of controlling the quality of their production process.

Evaluation of at-home serum anti-Müllerian hormone testing: a head-to-head comparison study.

BACKGROUND: For optimal fertility testing, serum anti-Müllerian hormone levels are used in combination with other testing to provide reliable ovarian reserve evaluations. The use of the ADx 100 card is widely commercially available for at-home reproductive hormone testing, but data demonstrating that its results are reproducible outside of a clinical setting are limited, as well as comparisons of its performance with other newer blood collection techniques. This study aimed to evaluate the concordance of serum AMH levels found via standard venipuncture and self-administered blood collection using the TAP II device (TAP) and ADx card in women of reproductive age. METHODS: This was a prospective, head-to-head-to-head within-person crossover comparison trial that included 41 women of reproductive age (20-39 years). It was hypothesized that the TAP device would be superior to the ADx card both in terms of agreement with venipuncture reference standard and patient experience. Each subject had their blood drawn using the three modalities (TAP, ADx, and venipuncture). We evaluated the concordance of AMH assays from samples obtained via the TAP device and ADx card with the gold standard being venipuncture. Two-sided 95% CIs were generated for each method to compare relative performance across all three modes. Patient preference for the TAP device versus the ADx card was based on self-reported pain and Net Promoter Score (NPS). RESULTS: The TAP device was superior to the ADx card on all outcome measures. TAP R-squared with venipuncture was 0.99 (95% CI 0.99, > 0.99), significantly higher than the ADx card, which had an R-squared of 0.87 (95% CI 0.80, 0.94) under most favorable treatment. TAP sensitivity and specificity were both 100% (no clinical disagreement with venipuncture), versus 100 and 88%, respectively, for the ADx card. Average pain reported by users of the TAP device was significantly lower than the ADx card (0.75 versus 2.73, p < 0.01) and the NPS was significantly higher than the ADx card (+ 72 versus - 48, p < 0.01). CONCLUSIONS: The TAP was non-inferior to venipuncture and superior to the ADx card with respect to correlation and false positives. Moreover, the TAP was superior to both alternatives on patient experience. TRIAL REGISTRATION: NCT04784325 (Mar 5, 2021).

The new donor vigilance system in Denmark reveals regional differences in adverse reactions supposedly caused by variation in the registration.

BACKGROUND AND OBJECTIVES: In recent years, there has been an increased focus among blood bank professionals on the health and safety of blood donors. In 2019, the Danish Haemovigilance Committee designed a national donor vigilance system to improve the registration of adverse reactions (AR) in blood donors. The new donor vigilance system was implemented on 1 January 2020 and we here present the results from the first year of registration. MATERIALS AND METHODS: AR categories, severity level and imputability score were defined based on the definitions from the International Society of Blood Transfusion, AABB and the European Commission directive 2005/61/EC, respectively. RESULTS: Across all severity levels, AR in Danish blood donors were found to be rare (1498 per 100,000 donations). Only 0.2% of the registered reactions were classified as serious (2.7 per 100,000 donations). Large regional differences were seen in the registration of citrate reactions and haematomas. CONCLUSION: Significant differences across regions in what to categorize as an AR were persistent even when including a severity score in the reporting. The Danish Haemovigilance Committee will commence a national work to align the definitions but suggests that this matter is raised to an international level as part of the current work to agree upon definitions for assessment of donor AR.

Prediction and impact of personalized donation intervals.

BACKGROUND AND OBJECTIVES: Deferral of blood donors due to low haemoglobin (Hb) is demotivating to donors, can be a sign for developing anaemia and incurs costs for blood establishments. The prediction of Hb deferral has been shown to be feasible in a number of studies based on demographic, Hb measurement and donation history data. The aim of this paper is to evaluate how state-of-the-art computational prediction tools can facilitate nationwide personalized donation intervals. MATERIALS AND METHODS: Using donation history data from the last 20 years in Finland, FinDonor blood donor cohort data and blood service Biobank genotyping data, we built linear and non-linear predictors of Hb deferral. Based on financial data from the Finnish Red Cross Blood Service, we then estimated the economic impacts of deploying such predictors. RESULTS: We discovered that while linear predictors generally predict Hb relatively well, they have difficulties in predicting low Hb values. Overall, we found that non-linear or linear predictors with or without genetic data performed only slightly better than a simple cutoff based on previous Hb. However, if any of our deferral prediction methods are used to assign temporary prolongations of donation intervals for females, then our calculations indicate cost savings while maintaining the blood supply. CONCLUSION: We find that even though the prediction accuracy is not very high, the actual use of any of our predictors in blood collection is still likely to bring benefits to blood donors and blood establishments alike.