Blood Collection Devices Research Articles

B-242 Improved Patient Satisfaction With Novel Capillary Blood Collection Devices as an Alternative to Venipuncture for Applications in Clinical Proteomic Assays

Abstract Background Two new clinical diagnostic tests are available that aid in the identification of lung nodules as likely malignant or likely benign. One test is an ELISA that measures the levels of seven autoantibodies to tumor-associated antigens that aids in the identification of patients with likely malignant lung nodules who may benefit from timely intervention. The other is an LC-MS/MS-based (MRM) test that measures the ratio of two proteins (LG3BP and C163A) combined with several clinical and radiological factors to aid in the identification of patients with likely benign lung nodules who may benefit from additional CT surveillance. Since commercialization, we have found that test access may be improved by providing alternatives to traditional venipuncture. Therefore, we conducted evaluation studies with two novel non-fingerstick capillary blood collection devices. These devices puncture the skin by utilizing either microneedles (Device A) or a lancet (Device B) for capillary blood collection. Methods Blood specimens were collected from consented donors using one of the two capillary blood collection devices and by venipuncture into K2EDTA blood collection tubes. Feedback was also solicited from the healthcare professionals and donors via a standard questionnaire. The whole blood specimens were shipped to the testing laboratory where the samples were processed according to the respective clinical assay workflows. Feasibility testing for the ELISA-based assay was conducted with both devices using normal healthy donor specimens (105 donors for Device A and 43 for Device B). Clinical evaluation was executed utilizing only Device B (77 donors with lung cancer and 13 with an indeterminate lung nodule). Feasibility testing for the LC-MS/MS-based assay was conducted with both devices using healthy donor specimens (103 donors for Device A and 41 for Device B), while clinical evaluation utilized only Device B (80 donors with lung cancer and 30 with an indeterminate lung nodule). Results Both capillary blood collection devices revealed good correlations to venous blood draws for the ELISA-based test during feasibility. The two devices also showed good correlations for the LC-MS/MS-based test, with the results from Device A requiring a correction factor. Due to technical and operational challenges throughout feasibility, Device B became the preferred device to be evaluated for the clinical study. Good correlations for both diagnostic tests were observed from the clinical study. During clinical evaluation, healthcare professionals and donors were asked to rate the ease-of-use, pain, and speed of collection when using Device B. Most healthcare professionals (108/126) rated the device as easy to use. Ninety-five percent of the donors reported minimal pain while the remainder reported moderate pain. Ninety-one percent of the donors felt that the time required to collect blood using Device B was acceptable. Sixty percent of the donors preferred the capillary collection device (Device B), 17% preferred venipuncture, while 23% reported no preference for blood collection. Conclusions The novel capillary blood collection devices demonstrated high correlations for two clinical diagnostic tests. Feedback collected from healthcare professionals and donors revealed that the majority preferred the capillary blood collection device as compared to traditional venipuncture for blood collection.

Consistency analysis of two fingertip capillary blood sampling methods for complete blood count

This study was performed to analyze fingertip capillary blood sampling in pediatric patients using microcapillary blood collection tubes and microhematocrit tubes and to compare the blood cell analysis results obtained via these two blood collection methods. Finger capillary blood was collected from 110 outpatients using microcapillary blood collection tubes and microhematocrit tubes and complete blood count analysis was performed with a Sysmex XS-900i hematology analyzer and manual microscopy for blood cell morphology. Paired data was evaluated for agreement and bias using the microhematocrit samples as the reference group and the samples from the microcapillary blood collection tubes as the observation group. The two blood collection methods demonstrated good agreement for measuring red blood cell (RBC) parameters (i.e., RBC, Hb, Hct, MCV, MCH and MCHC), wherein the relative bias was > allowable total error (TEa) in 0.91%, 1.82%, 11.82%, 1.82%, 0.91% and 8.18% of the parameter measures, respectively. According to industry requirements, the proportion of samples meeting the acceptable bias level should be > 80%. Additionally, the estimated biases at each medical decision level were within clinically acceptable levels for RBC, Hb, Hct, and MCV. However, the proportion of WBC and PLT counts with relative bias > TEa was 25.45% and 35.45%, respectively. Furthermore, the relative bias of the WBC count at the medical decision level of 0.5 × 109/L and that of the PLT counts at the medical decision levels of 10 × 109/L and 50 × 109/L were clinically significant. Bland–Altman analysis further showed a mean bias of 0.66 × 109/L (95% LoA, − 0.79 to 2.11) for the WBC count and 39 × 109/L (95% LoA, − 46 to 124) for the PLT count from the blood samples collected in the microcapillary blood collection tubes compared with the counts of those collected in the microhematocrit tubes. Neutrophil, monocyte, lymphocyte, eosinophil, and PLT counts increased significantly in the microcapillary blood collection tubes compared with those in the microhematocrit tubes, along with an elevated number of instrument false alarms (P < 0.05). The two capillary blood collection devices exhibit performance differences. Therefore, clinicians should pay attention to the variation in results caused by different blood collection methods.

Minimally Invasive Blood Collection for an Mpox Serosurvey among People Experiencing Homelessness.

People experiencing homelessness (PEH) are underrepresented in public health and clinical research. Study methods that can improve participation by this group are needed. In late 2022, the Centers for Disease Control and Prevention conducted an mpox serological survey using venipuncture among PEH in San Francisco, California. Blood collection by a minimally invasive device was offered if venipuncture was not possible or preferred. Participants who had a successful blood draw using the device were asked about device acceptability. Of the 209 successful blood collections, 137 (66%) were among participants who underwent venipuncture and 72 (34%) were among participants who used the device. Use of the device increased overall blood collection participation by 53%. Participants reported high acceptability and preference for the device over venipuncture. Minimally invasive blood collection devices may increase participation and representation of PEH in serosurveys.

Effect of using smaller blood volume tubes and closed blood collection devices on total blood loss in patients undergoing major cardiac and vascular surgery.

Diagnostic laboratory tests are an integral part of managing hospitalized patients. In particular, patients in the intensive care units (ICUs) can experience a concerning amount of blood loss due to diagnostic testing, which can increase the risk developing iatrogenic anemia. Several interventions exist to curtail avoidable blood loss, for example computerized decision support, smaller phlebotomy tubes, and other blood conservation devices. Nevertheless, use of these interventions is not standardized. Therefore, the objective of our study was to quantify the daily phlebotomy volume taken from patients who had undergone major cardiac or vascular surgery. We estimated the number of blood analyses and volumes of drawn blood of 400 consecutive patients (≥18 yr) undergoing major cardiac or vascular surgery. The amount of blood saved using small-volume tubes and in combination with blood conservation device rather than standard-volume tubes was estimated for serum chemistry (serum), ethylenediaminetetraacetic acid (EDTA) tubes, sodium citrate coagulation (SCC) tubes, and arterial blood gas (ABG) analysis. The mean total blood loss due to phlebotomy drawing using standard-volume tubes during hospitalization was 167.9mL (95% confidence interval [CI], 158.0 to 177.8), 255.6mL (95% CI, 226.5 to 284.6), and 695.3mL (95% CI, 544.1 to 846.4) for patients undergoing cardiac surgery with a hospital length of stay (LOS) of 0-10, 11-20, and ≥ 21 days, respectively. The mean total blood loss due to phlebotomy during hospitalization was 80.5mL (95% CI, 70.5 to 90.6), 225.0mL (95% CI, 135.1 to 314.8mL) and 470.3mL (95% CI, 333.5 to 607.1) for vascular surgery patients with LOS 0-10, 11-20, and ≥ 21 days, respectively. Patients with at least a two-day stay at the ICU had a mean blood loss of 146.6mL (95% CI, 134.6 to 158.6mL) and those with ≥ 11 days incurred a loss of 1,428mL (95% CI, 1,117.8 to 1,739.2). The use of closed blood collection device and small-volume tubes (serum, EDTA, SCC, and ABG) reduced blood loss by 82.8mL for patients with an ICU stay of 2 days and up to 824.0mL for patients with a ICU stay of ≥ 11 days. Diagnostic laboratory tests are associated with significant patient blood loss, but are a modifiable risk factor. The use of small-volume tubes and closed blood collection devices decreases the volume of patient blood drawn for analysis and prevents blood waste.

Two Postpartum Blood Collection Devices: The Brass-V Drape and MaternaWell Tray-As Experienced by Birth Attendants and Birthing Women-A Questionnaire-Based Randomised Study.

Postpartum haemorrhage is the leading cause of preventable maternal mortality worldwide. Early identification and prompt management of postpartum haemorrhage improve outcomes. Objective assessment of postpartum blood loss is an important step in identifying postpartum haemorrhage. The Brass-V drape and MaternaWell tray have been designed for routine measurement of postpartum blood loss. The perceived utility and acceptability of these devices to the parturients and birth attendants still begged exploring. To assess the perceived usefulness and ease of use of a Brass-V drape versus a MaternaWell tray for the collection of postpartum blood loss. We conducted a prospective parallel randomised trial, employing a questionnaire to assess the experiences of birth attendants and birthing women who used these devices. The study was conducted at site B midwife obstetric unit in Khayelitsha Cape Town. Pregnant women presenting in early labour were approached for voluntary participation. After informed consent was obtained, participants were randomly assigned to the Brass-V drape or the MaternaWell tray, which the birth attendant placed after the birth of the baby. There were 63 participants, of which 33 were assigned to the MaternaWell tray and 30 to the Brass-V drape. Birth attendants indicated a desire to use the MaternaWell tray (30 (90%)) or Brass-V drape (26 (87%)) in future deliveries. The parturients were also in favour of the future use of MaternaWell tray (33 (100%)) and Brass-V drape (28 (93%)). Ease of measurement favoured the Brass V-drape, and ease of placement favoured the MaternaWell tray. Five (8%) participants experienced postpartum haemorrhage, two with the MaternaWell tray and three with the Brass-V drape. One parturient required hospital transfer. The responses of the birth attendants and parturients were positive. The MaternaWell tray has the benefit of reuse and lower cost and is an acceptable alternative to the Brass-V drape. Both devices aid in the early recognition of postpartum haemorrhage.

Investigation of the relationship between phenylalanine in venous plasma and capillary blood using volumetric blood collection devices.

Measurement of plasma and dried blood spot (DBS) phenylalanine (Phe) is key to monitoring patients with phenylketonuria (PKU). The relationship between plasma and capillary DBS Phe concentrations has been investigated previously, however, differences in methodology, calibration approach and assumptions about the volume of blood in a DBS sub-punch has complicated this. Volumetric blood collection devices (VBCDs) provide an opportunity to re-evaluate this relationship. Paired venous and capillary samples were collected from patients with PKU (n = 51). Capillary blood was collected onto both conventional newborn screening (NBS) cards and VBCDs. Specimens were analysed by liquid-chromatography tandem mass-spectrometry (LC-MS/MS) using a common calibrator. Use of VBCDs was evaluated qualitatively by patients. Mean bias between plasma and volumetrically collected capillary DBS Phe was -13%. Mean recovery (SD) of Phe from DBS was 89.4% (4.6). VBCDs confirmed that the volume of blood typically assumed to be present in a 3.2 mm sub-punch is over-estimated by 9.7%. Determination of the relationship between plasma and capillary DBS Phe, using a single analytical method, common calibration and VBCDs, demonstrated that once the under-recovery of Phe from DBS has been taken into account, there is no significant difference in the concentration of Phe in plasma and capillary blood. Conversely, comparison of plasma Phe with capillary DBS Phe collected on a NBS card highlighted the limitations of this approach. Introducing VBCDs for the routine monitoring of patients with PKU would provide a simple, acceptable specimen collection technique that ensures consistent sample quality and produces accurate and precise blood Phe results which are interchangeable with plasma Phe.

A-178 Reduced Hemolysis with a Novel Capillary Collection System as Compared With Conventional Capillary Collection Devices

Abstract Background Capillary blood collection is often cumbersome and lacks consistency in the applied pressure during squeezing of the finger. This may result in poor sample quality (i.e., hemolysis and dilution of the sample with interstitial fluid). Standardizing the capillary collection process and thereby making it less technique dependent can enable diagnostic blood testing to be performed in non-traditional settings (e.g., retail pharmacy). A novel capillary blood collection system has been developed to help standardize the process and may enable blood sampling by non-traditional healthcare workers (e.g., pharmacists, pharmacy technicians). Multiple studies were performed to evaluate the performance of this capillary blood collection system on sample quality in comparison with currently marketed capillary and venous blood collection devices. Sample quality was assessed by visual observation of hemolysis and by quantitative assessment of Plasma Free Hemoglobin (PFH). Methods Participants were enrolled at three sites representative of the intended use environment (i.e., retail pharmacy site or patient service center). Phlebotomists performed venipuncture using a currently marketed venous comparator and conventional capillary collection using a capillary comparator. Capillary collection was also performed using the novel capillary device in the same subjects by targeted trained healthcare workers (e.g., retail pharmacists, pharmacy technicians). Blood was collected using each method (venous and two capillary–conventional and novel capillary devices) into serum separator tubes from the same subject within the same timeframe. Data from the studies were pooled in a meta-analysis to assess device performance across multiple studies. Visual assessment of hemolysis was performed post centrifugation using a rating scale (0 = None, 1 = Trace, 2 = Moderate, 3 = Gross). For PFH measurement, a cut-off of &amp;gt;50 mg/dL was selected, as hemolysis interference may be observed at these levels in highly sensitive analytes. Results When compared with the venous comparator, the incidences of hemolysis, as assessed by visual hemolysis and PFH measurements, were higher with capillary collections. However, the incidences were significantly lower with the novel capillary collection system than with the capillary comparator. The overall incidence of visual hemolysis was significantly lower for the new capillary device when compared to the capillary comparator (“None” rating of 94% vs 64.5%). The frequency of trace, moderate and gross hemolysis was also less in the new capillary device when compared to the capillary comparator (4.4% vs 23.2%, 1.2% vs 9.8%, 0.4% vs 2.5%, respectively). For the quantitative measurement of PFH as an indicator of hemolysis, a similar trend was observed. The mean PFH value in the new capillary device was significantly lower than in the capillary comparator (29.87 vs 55.18), and the frequency of PFH &amp;gt;50 mg/dL was also significantly lower in the new capillary device than in the capillary comparator (11.7% vs 42.0%). Conclusions Improved sample quality was demonstrated with a novel capillary blood collection system, as the incidences of hemolysis, as measured visually and quantitatively as PFH measurement, were significantly lower than in conventional capillary blood collection devices. Consequently, this may result in fewer rejected samples in the lab than conventional capillary methods and help meet the demands for more convenient, patient-centric healthcare services.

Effect of Blood Collection Devices on Quality Blood Transmission: A Review

Effect of Blood Collection Devices on Quality Blood Transmission: A Review

Concordance in COVID-19 serology, bone mineralization, and inflammatory analytes between venous and self-collected capillary blood samples exposed to various pre-analytical conditions.

The COVID-19 has led to a significant increase in demand for remote blood sampling in clinical trials. This study aims to ascertain the concordance between venous versus capillary samples, processed immediately or exposed to various pre-analytical conditions. Participants (≥12years old) provided a venous blood sample (processed immediately) and capillary samples allocated to one of the following conditions: processed immediately or exposed to 12-, 24-, or 36-h delays at room temperature or 36-h delays with a freeze-thaw cycle. The analytes of interest included SARS-CoV-2 IgG, 25-hydroxy vitamin D (25(OH)D), alkaline phosphate (ALP), calcium (Ca), phosphate (Ph), and c-reactive protein (CRP). Paired samples were considered interchangeable if they met three criteria: minimal within-subject mean difference, 95% of values within desirable total errors, and inter-class correlation (ICC) > 0.90. 90 participants (44.1% male) were enrolled. When comparing rapidly processed venous with capillary samples, 25(OH)D, ALP, and CRP met all three criteria; SARS-CoV-2 IgG met two criteria (mean difference and ICC); and Ca and Ph met one criterion (mean difference). When considering all three criteria, concentrations of 25(OH)D, CRP, and ALP remained unchanged after delays of up to 36h; SARS-CoV-2 IgG met two criteria (mean difference and ICC); Ca and Ph met one criterion (mean difference). These findings suggest that remote blood collection devices can be used to measure anti-SARS-CoV-2 IgG, 25(OH)D, CRP, and ALP. Further analysis is required to evaluate the interchangeability between venous and capillary testing in Ca and Ph levels, which are more sensitive to pre-analytical conditions.

Mass Spectrometry Analysis of Globotriaosylsphingosine and Its Analogues in Dried Blood Spots

Fabry disease (FD) is an X-linked lysosomal storage disorder where impaired α-galactosidase A enzyme activity leads to the intracellular accumulation of undegraded glycosphingolipids, including globotriaosylsphingosine (lyso-Gb3) and related analogues. Lyso-Gb3 and related analogues are useful biomarkers for screening and should be routinely monitored for longitudinal patient evaluation. In recent years, a growing interest has emerged in the analysis of FD biomarkers in dried blood spots (DBSs), considering the several advantages compared to venipuncture as a technique for collecting whole-blood specimens. The focus of this study was to devise and validate a UHPLC-MS/MS method for the analysis of lyso-Gb3 and related analogues in DBSs to facilitate sample collection and shipment to reference laboratories. The assay was devised in conventional DBS collection cards and in Capitainer®B blood collection devices using both capillary and venous blood specimens from 12 healthy controls and 20 patients affected with FD. The measured biomarker concentrations were similar in capillary and venous blood specimens. The hematocrit (Hct) did not affect the correlation between plasma and DBS measurements in our cohort (Hct range: 34.3-52.2%). This UHPLC-MS/MS method using DBS would facilitate high-risk screening and the follow-up and monitoring of patients affected with FD.

Standard Venipuncture vs a Capillary Blood Collection Device for the Prospective Determination of Abnormal Liver Chemistry.

Abnormal liver function is a common manifestation of human disease and may also occur in approved and investigational medications as drug-induced liver injury (DILI). Capillary blood collection devices may allow for more frequent and convenient measurement outside of the clinic. Validation of such approaches is lacking. This prospective, biospecimens collection study evaluated the Tasso+ in patients with abnormal liver tests (NCT05259618). The primary objective was to define the concordance of alanine aminotransferase (ALT) obtained via Tasso+ compared to standard venipuncture. Secondary objectives included measurement of 14 other analytes and patient surveys. At the time of venipuncture, 2 Tasso+ samples were collected: one was centrifuged and shipped, and the other was refrigerated and shipped as whole blood. Thirty-six patients with elevated ALT values were enrolled. In total, 100 venipuncture, 50 Tasso+ centrifuged, and 48 Tasso+ whole blood samples were obtained. Tasso+ centrifuged samples demonstrated concordance correlation coefficients (CCC) of >0.99 for ALT, alkaline phosphatase (ALP), aspartate aminotransferase (AST), and total bilirubin and CCC >0.95 for albumin, chloride, enzymatic creatinine, serum glucose, magnesium, and phosphorus. Tasso+ whole blood showed CCC of >0.99 for AST, bilirubin total, and enzymatic creatinine and CCC >0.95 for ALT, ALP, albumin, magnesium, and phosphorus. Hemolysis was comparable across the 3 sample types, but its impact was reflected in the Tasso+ potassium data. Patient feedback indicated a very favorable patient experience. The capillary blood collection device, Tasso+, showed substantial to almost perfect concordance to standard venipuncture for measurement of abnormal liver function. Studies are ongoing to validate longitudinal sampling outside of the clinic. Clinicaltrials.gov Registration Number: NCT05259618.

Prevention from Sharp Injuries in the Hospital Sector: An Italian National Observatory on the Implementation of the Council Directive 2010/32/EU before and during the COVID-19 Pandemic.

Sharp injuries, determining the risk of bloodborne infections and psychological distress in healthcare workers, may be prevented by a set of strategies, legally enforced in Europe through the Directive 2010/32/EU. To assess its level of implementation in Italy, a national survey was conducted in 2017 and again in 2021, evaluating the progress and possible drawbacks of the COVID-19 pandemic. Altogether, 285 safety managers and 330 nurses from a representative sample of 97 and 117 public hospitals were interviewed using a standardized questionnaire. Knowledge of the Directive requirements decreased significantly, with <60% of participants answering correctly in 2021, and nurses’ attendance in specific courses dropped to 25% in 2021 compared to 54% in 2017. Over 75% of hospitals introduced multiple safety-engineered devices (SED), though total replacement occurred in <50% of cases; routine SED availability increased for blood collection (89%) and venous access devices (83%). Incorrect behaviors in handling sharps decreased significantly over time. Nurses’ HBV vaccination coverage was high (89% in both surveys); in the last year, 97% were vaccinated against COVID, and 47% against influenza. Average annual injuries per hospital did not increase significantly (32 in 2021 vs. 26 in 2017). In 2017, nurses’ perceived safety barriers were working in emergency situations (49%) and lack of resources (40%); in 2021, understaffing (73%), physical fatigue (62%), and handling difficulties while wearing full protective equipment (59%). Safety measures were implemented in Italian hospitals, and although the average injuries per hospital did not show a decrease, these measures could have helped protect healthcare workers during the pandemic, mitigating its potential impact on the increase in situations at risk of injury.

Evaluation of volumetric blood collection devices for the measurement of phenylalanine and tyrosine to monitor patients with phenylketonuria

BackgroundMeasurement of dried blood spot (DBS) phenylalanine (Phe) is central to the monitoring of patients with phenylketonuria. However, the volume and hematocrit (Hct) of the blood applied to conventional DBS cards significantly affects analytical results. Volumetric blood collection devices are reported to be more accurate, precise and less prone to Hct effects. MethodsAccuracy, imprecision, effect of blood volume and Hct were evaluated for measurement of Phe and tyrosine using three volumetric devices and compared with the conventional PerkinElmer-226 filter-paper collection devices. i.e. conventional DBS cards. Applicability for use in a clinical laboratory was assessed qualitatively. ResultsBlood volume did not impact on the performance of the volumetric devices; however, significant biases were observed with the conventional DBS card. A higher Hct introduced unacceptable bias for Neoteryx-Mitra and conventional DBS card. All devices had a mean relative standard deviation (RSD) ≤ 4.1 %, except for the Neoteryx-Mitra (≤ 6.2 %). Relative to liquid blood, the mean biases of Phe for the various devices were −5.1 (HemaXis-DB10), −7.8 (Capitainer-qDBS), −12.0 (Neoteryx-Mitra) and −32.6 % (conventional DBS card). ConclusionsIntroducing volumetric collection devices will overcome the significant pre-analytical issues associated with conventional DBS collection and improve the biochemical monitoring of patients with PKU.

Paper-based molecularly imprinted-interpenetrating polymer network for on-spot collection and microextraction of dried blood spots for capillary electrophoresis determination of carbamazepine.

Carbamazepine is an antiepileptic drug with a narrow therapeutic index, which requires an efficient method for blood level monitoring. Finger-prick dried blood spot (DBS) collection is an alternative microsampling technique, which is less invasive than conventional venipuncture. Paper-based molecularly imprinted-interpenetrating polymer networks (MI-IPN) were developed as blood collection devices, which allowed for selective on-spot microextraction of carbamazepine from DBS. A hybrid of homogeneous polystyrene and silica gel polymer was synthesized and coated on a Whatman® Grade 1 filter paper. Proteins and other interferences in the blood samples were eliminated by using the MI-IPN collection devices, and the resulting DBS extracts were suitable for direct injection into the capillary electrophoretic instrument. The lower limit of quantitation of 4μg/mL in capillary blood was achieved by the sweeping-micellar electrokinetic chromatography method using a KCl-containing matrix, which was sufficient for the therapeutic drug monitoring purposes. Method accuracies were in the range of 88.4 ± 4.5% to 94.5 ± 2.7% with RSD values ≤ 5.1%. The developed paper-based MI-IPN provided superior extraction efficiencies (92.2 ± 2.5%) in comparison with commercially available DBS collection cards, i.e., Whatman® 903 protein saver card (59.8 ± 2.8%) and GenCollect™ 2.0 card (47.2 ± 1.4%). The paper-based MI-IPN devices for DBS collection and on-spot extraction were characterized by simple fabrication, low costs, disposability, and reduction in sample preparation steps, and their further developments might open new perspectives in clinical applications, such as in therapeutic drug monitoring. Graphical abstract.

Development of Improved Devices for Handling and Restraining Experimental Laboratory Mice.

Most animal handling procedures are associated with injuries among veterinary staff and laboratory animal researchers. However, much of the currently available animal handling equipment is inadequate, limiting access to the treated animal or making workflow cumbersome. Moreover, restraining animals to perform procedures, such as blood collection or injection, elicits stress in both the animal and the worker. Herein, we present 4 home-built restraint and blood collection devices in extensive use in our institute. Animal laboratory workers and experienced veterinarians regularly using the devices (n = 14) were asked to complete a survey ranking the contribution of the devices to worker safety and procedural efficiency. The overwhelming majority of responders (≥75%) associated all 4 devices with substantial improvements in worker safety and procedural efficiency. There were no reports of impaired workflow or safety when using the devices. Infection and exposure control may be implemented on various levels, including use of safer procedures, such as injection and blood collection devices. The presented intuitive handling and restraint devices allow the animal worker/researcher to perform various procedures safely and efficiently while eliciting less animal and worker stress. The devices can be easily adjusted to accommodate animal size and disease status. The current devices will serve as prototypes for design of devices for larger laboratory animals.

The impact of automatic devices for capillary blood collection on efficiency and pain response in newborns: A randomized controlled trial

BackgroundThe heel stick is the method of choice in most neonatal units for capillary blood sampling, and it represents the most common event among all painful procedures performed on newborns. The type and design of heel stick device and the clinical procedure to collect a blood sample may have an impact on newborn pain response as well. ObjectiveTo compare the pain response and efficiency of different automated devices for capillary blood collection in newborns. DesignRandomized clinical trial. SettingPostnatal ward of a tertiary-care university hospital in Italy. ParticipantsNewborn infants at gestational age ≥34 weeks undergoing the metabolic screening test after the 49th hour of life. MethodsA total of 762 neonates were recruited and randomized into 6 groups (127 babies in each group) assigned to 6 different capillary blood collection devices (Ames Minilet™ Lancet; Cardinal Health Gentleheel®; Natus Medical NeatNick™; BD Quikheel™ Lancet; Vitrex Steriheel® Baby Lancet; Accriva Diagnostics Tenderfoot®). Main outcome measuresThe following data were collected and assessed for each of the 6 groups evaluated: a) number of heel sticks, b) pain score according to the Neonatal Infant Pain Scale (NIPS) and c) need to squeeze the heel. ResultsThe Ames Minilet™ Lancet device was found to perform by far the worst compared to the five device underexamination: it required the highest number of sticks (mean=3.91; 95% CI: 3.46–4.36), evoked the most intense pain (mean=3.98; 95% CI: 3.77–4.20), and most frequently necessitated squeezing the heel (92.9%; 95% CI: 86.9–96.3). The five devices under examination appeared to be similar in terms of the number of sticks required, but differed slightly in NIPS score and in need to squeeze the heel. ConclusionThe Accriva Diagnostics Tenderfoot® device demonstrated the greatest efficiency for blood sampling and evoked the least pain. With this device, the metabolic screening test could be performed with a single skin incision in the large majority of infants (98.4%), heel squeezing was limited to only 6.3% of infants, and the NIPS score turns out to be lower than other devices in our study (1.22; 95% CI 1.05–1.39).

Evaluation of di‐potassium and tri‐potassium EDTA evacuated tubes for routine haematological testing

The influence of blood collection devices on laboratory tests is often overlooked. We have discussed here how blood collection materials and devices can alter haematological test results, with an emphasis on blood collection tube (BCT) additives. We have compared K2 & K3-EDTA vacuum tubes of same manufacturer IMPROVACUTER ® for CBC analysis. Blood was collected in both tubes simultaneously. Samples were analysed immediately after collection (<15minutes) and after 4hours by MEK-6318J/K Haematology Analyzer. Paired student's t-test was applied for statistical analysis. Significant differences among results and biases were compared with current quality specifications. Significant differences were found in Neutrophyls (GR) and mean platelets volume (MPV) when compared. K2-EDTA vs K3-EDTA(1st time) after< 15minutes of sample collection, for Monocytes counts (MO), MCV, MPV, and RDW when comparing K2-EDTA (first time) vs K2-EDTA(second time, after 4hours); and for Monocytes counts (MO), MCV, MPV, PCT, and RDW when comparing K3-EDTA(1st time) vs K3-EDTA(2nd time) in order to check the stability and reproducibility of vacutainers. This study assesses the use of K2& K3-EDTA vacuum tubes whether or not they represent a bias in haematological testing (CBC). The use of K2-EDTA and K3-EDTA vacuum tubes represent a clinically relevant source of variation for MCV, MPV, RDW, and PCT.

Detection of testosterone esters in blood.

Injections of synthetic esters of testosterone are among the most common forms of testosterone application. In doping control, the detection of an intact ester of testosterone in blood gives unequivocal proof of the administration of exogenous testosterone. The aim of the current project was to investigate the detection window for injected testosterone esters as a mixed substance preparation and as a single substance preparation in serum and plasma. Furthermore, the suitability of different types of blood collection devices was evaluated. Collection tubes with stabilizing additives, as well as non-stabilized serum separation tubes, were tested. A clinical study with six participants was carried out, comprising a single intramuscular injection of either 1000 mg testosterone undecanoate (Nebido(®)) or a mixture of 30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate, and 100 mg testosterone decanoate (Sustanon(®)). Blood was collected throughout a testing period of 60 days. The applied analytical method for blood analysis included liquid-liquid extraction and preparation of oxime derivatives, prior to TLX-sample clean-up and liquid chromatography-tandem mass spectrometry (LC-MS/MS) detection. All investigated testosterone esters could be detected in post-administration blood samples. The detection time depended on the type of ester administered. Furthermore, results from the study show that measured blood concentrations of especially short-chained testosterone esters are influenced by the type of blood collection device applied. The testosterone ester detection window, however, was comparable.

Low-Cost Fabrication of Hollow Microneedle Arrays Using CNC Machining and UV Lithography

In order to produce disposable microneedles for blood-collection devices in smart homecare monitoring systems, we have developed a simple low-cost scalable process for mass fabrication of sharp-tipped microneedle arrays. The key feature in this process is a design of computer numerical control-machined aluminum sample (CAS). The inclined sidewalls on the CAS enable microfabricated traditional-shaped microneedles (TMNs) to be produced in the desired shape. This process provides significant advantages over other methods that use inclined lithography or anisotropic wet etching. TMNs with a length of 1510 μm, a hollow diameter of 120 μm, and the tip radius of 16 μm were successfully fabricated. Theoretical study and practical measurements of fracture force verified the improved mechanical strength of TMNs for safe skin insertion. In addition, the penetration tests on cadaver pork skin demonstrated that the TMNs could pierce the pork skin without breaking, and create the transport conduits through microneedle lumens.

Interferences from blood collection tube components on clinical chemistry assays

Improper design or use of blood collection devices can adversely affect the accuracy of laboratory test results. Vascular access devices, such as catheters and needles, exert shear forces during blood flow, which creates a predisposition to cell lysis. Components from blood collection tubes, such as stoppers, lubricants, surfactants, and separator gels, can leach into specimens and/or adsorb analytes from a specimen; special tube additives may also alter analyte stability. Because of these interactions with blood specimens, blood collection devices are a potential source of pre-analytical error in laboratory testing. Accurate laboratory testing requires an understanding of the complex interactions between collection devices and blood specimens. Manufacturers, vendors, and clinical laboratorians must consider the pre-analytical challenges in laboratory testing. Although other authors have described the effects of endogenous substances on clinical assay results, the effects/impact of blood collection tube additives and components have not been well systematically described or explained. This review aims to identify and describe blood collection tube additives and their components and the strategies used to minimize their effects on clinical chemistry assays.