Dried blood spots are a valid alternative to venipuncture for COVID-19 antibody testing.

BACKGROUND: Serologic analysis is an important tool towards assessing the humoral response to COVID-19 infection and vaccination. Numerous serologic tests and platforms are currently available to support this line of testing. Two broad antibody testing categories are point-of-care lateral flow immunoassays and semi-quantitative immunoassays performed in clinical laboratories, which typically require blood collected from a finger-stick and a standard venipuncture blood draw, respectively. This study evaluated the use of dried blood spot (DBS) collections as a sample source for COVID-19 antibody testing using an automated clinical laboratory test system. METHODS: Two hundred and ninety-four participants in the BLAST COVID-19 seroprevalence study (NCT04349202) were recruited at the time of a scheduled blood draw to have an additional sample taken via finger stick as a DBS collection. Using the EUROIMMUN assay to assess SARS-CoV-2 anti-spike IgG status, DBS specimens were tested on 7, 14, 21, and 28 days post- collection and compared to the reference serum sample obtained from a blood draw for the BLAST COVID-19 study. RESULTS: SARS-CoV-2 anti-spike IgG status from DBS collections demonstrated high concordance with serum across all time points (7-28 days). However, the semi-quantitative value from DBS collections was lower on average than that from serum, resulting in increased uncertainty around the equivocal-to-positive analytical decision point. CONCLUSIONS: DBS collections can be substituted for venipuncture when assaying for COVID-19 IgG antibody, with samples being stable for at least 28 days at room temperature. Finger-stick sampling can therefore be advantageous for testing large populations for SARS-CoV-2 antibodies without the need for phlebotomists or immediate processing of samples. We have high confidence in serostaus determination from DBS collections, although the reduced semi-quantitative value may cause some low-level positives to fall into the equivocal or even negative range.

A Potassium-Based Quality-of-Service Metric Reduces Phlebotomy Errors, Resulting in Improved Patient Safety and Decreased Cost.

OBJECTIVES: Poor phlebotomy technique can introduce pseudohyperkalemia without hemolysis, requiring additional workup and placing a significant burden on patients, clinical teams, and laboratories. Such preanalytical biases can be detected through systematic evaluation of potassium concentrations on a per-phlebotomist basis. We report our long-term experience with a potassium-based quality-of-service phlebotomy metric and its effects on resource utilization. METHODS: Potassium monitoring and retraining of 26 full-time phlebotomists were piloted as a quality-of-service intervention. Changes in potassium concentrations and impact on resource utilization were assessed. An algorithm for data monitoring and phlebotomist feedback was developed, followed by institution-wide implementation. RESULTS: Systematic intervention and retraining normalized K+ concentrations and lowered the percentage of venipunctures with K+ above 5.2 mmol/L, leading to a marked increase in phlebotomist compliance. This change resulted in resources savings of 13% to 100% for individual phlebotomists, reducing the total extra laboratory time required for repeat phlebotomies to determine hyperkalemia, mostly in the high-volume phlebotomist group. CONCLUSIONS: A quality-of-service algorithm that involved monitoring potassium concentrations on a per-phlebotomist basis with feedback and retraining contributed to a concrete, data-based quality improvement plan. The institution-wide implementation of this metric allowed for significant cost savings and a reduction in critical value alerts, directly affecting the quality of patient care.

The impact of COVID-19 on medical students' practical skills and hygiene behavior regarding venipuncture: a case control study.

BACKGROUND: Despite their importance to current and future patient care, medical students' hygiene behaviors and acquisition of practical skills have rarely been studied in previous observational study. Thus, the aim of this study was to investigate the potential impact of the COVID-19 pandemic on medical student's hygiene and practical skills. METHODS: This case-control study assessed the effect of the COVID-19 pandemic on hygiene behavior by contrasting the practical skills and hygiene adherence of 371 medical students post the pandemic associated lockdown in March 2020 with that of 355 medical students prior to the SARS-CoV-2 outbreak. Students' skills were assessed using an objective structured clinical examination (OSCE). Their skills were then compared based on their results in hygienic venipuncture and the total OSCE score. RESULTS: During the SARS-CoV-2 pandemic, medical students demonstrated an increased level of compliance regarding hand hygiene before (prior COVID-19: 83.7%; during COVID-19: 94.9%; p < 0.001) and after patient contact (prior COVID-19: 19.4%; during COVID-19: 57.2%; p = 0.000) as well as disinfecting the puncture site correctly (prior COVID-19: 83.4%; during COVID-19: 92.7%; p < 0.001). Prior to the pandemic, students were more proficient in practical skills, such as initial venipuncture (prior COVID-19: 47.6%; during COVID-19: 38%; p < 0.041), patient communication (prior COVID-19: 85.9%; during COVID-19: 74.1%; p < 0.001) and structuring their work process (prior COVID-19: 74.4%; during COVID-19: 67.4%; p < 0.024). CONCLUSION: Overall, the COVID-19 pandemic sensitized medical students' attention and adherence to hygiene requirements, while simultaneously reducing the amount of practice opportunities, thus negatively affecting their practical skills. The latter development may have to be addressed by providing additional practice opportunities for students as soon as the pandemic situation allows.

Comparison of Dried Blood Spots and Venous Blood for the Detection of SARS-CoV-2 Antibodies in a Population of Nursing Home Residents.

In the current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, testing for SARS-CoV-2-specific antibodies is paramount for monitoring immune responses in postauthorization vaccination and seroepidemiological studies. However, large-scale and iterative serological testing by venipuncture in older persons can be challenging. Capillary blood sampling using a finger prick and collection on protein saver cards, i.e., dried blood spots (DBSs), has already proven to be a promising alternative. However, elderly persons have reduced cutaneous microvasculature, which may affect DBS-based antibody testing. Therefore, we aimed to evaluate the performance of DBS tests for the detection of SARS-CoV-2 antibodies among nursing homes residents. We collected paired venous blood and DBS samples on two types of protein saver cards (Whatman and EUROIMMUN) from nursing home residents, as well as from staff members as a reference population. Venous blood samples were analyzed for the presence of SARS-CoV-2 IgG antibodies using the Abbott chemiluminescent microparticle immunoassay (CMIA). DBS samples were analyzed by the EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for SARS-CoV-2 IgG antibodies. We performed a statistical assessment to optimize the ELISA cutoff value for the DBS testing using Youden's J index. A total of 273 paired DBS-serum samples were analyzed, of which 129 were positive, as assessed by the reference test. The sensitivities and specificities of DBS testing ranged from 95.0% to 97.1% and from 97.1% to 98.8%, respectively, depending on the population (residents or staff members) and the DBS card type. Therefore, we found that DBS sampling is a valid alternative to venipuncture for the detection of SARS-CoV-2 antibodies among elderly subjects. IMPORTANCE Since the implementation of newly developed SARS-CoV-2 vaccines in the general population, serological tests are of increasing importance. Because DBS samples can be obtained with a finger prick and can be shipped and stored at room temperature, they are optimal for use in large-scale SARS-CoV-2 serosurveillance or postauthorization vaccination studies, even in an elderly study population.

Optimal serum ferritin level range: iron status measure and inflammatory biomarker.

This report provides perspectives concerning dual roles of serum ferritin as a measure of both iron status and inflammation. We suggest benefits of a lower range of serum ferritin as has occurred for total serum cholesterol and fasting blood glucose levels. Observations during a prospective randomized study using phlebotomy in patients with peripheral arterial disease offered unique insights into dual roles of serum ferritin both as an iron status marker and acute phase reactant. Robust positive associations between serum ferritin, interleukin 6 [IL-6], tissue necrosis factor-alpha, and high sensitivity C-reactive protein were discovered. Elevated serum ferritin and IL-6 levels associated with increased mortality and with reduced mortality at ferritin levels <100 ng mL-1. Epidemiologic studies demonstrate similar outcomes. Extremely elevated ferritin and IL-6 levels also occur in individuals with high mortality due to SARS-CoV-2 infection. Disordered iron metabolism reflected by a high range of serum ferritin level signals disease severity and outcomes. Based upon experimental and epidemiologic data, we suggest testing the hypotheses that optimal ferritin levels for cardiovascular mortality reduction range from 20 to 100 ng mL-1 with % transferrin levels from 20 to 50%, to ensure adequate iron status and that ferritin levels above 194 ng mL-1 associate with all-cause mortality in population cohorts.

COVID-19 serological survey using micro blood sampling.

During August 2020, we carried out a serological survey among students and employees at the Okinawa Institute of Science and Technology Graduate University (OIST), Japan, testing for the presence of antibodies against SARS-CoV-2, the causative agent of COVID-19. We used a FDA-authorized 2-step ELISA protocol in combination with at-home self-collection of blood samples using a custom low-cost finger prick-based capillary blood collection kit. Although our survey did not find any COVID-19 seropositive individuals among the OIST cohort, it reliably detected all positive control samples obtained from a local hospital and excluded all negatives controls. We found that high serum antibody titers can persist for more than 9 months post infection. Among our controls, we found strong cross-reactivity of antibodies in samples from a serum pool from two MERS patients in the anti-SARS-CoV-2-S ELISA. Here we show that a centralized ELISA in combination with patient-based capillary blood collection using as little as one drop of blood can reliably assess the seroprevalence among communities. Anonymous sample tracking and an integrated website created a stream-lined procedure. Major parts of the workflow were automated on a liquid handler, demonstrating scalability. We anticipate this concept to serve as a prototype for reliable serological testing among larger populations.

Feasibility of a Pilot Home Phlebotomy Program for Pediatric Hematology/Oncology Patients During the COVID-19 Pandemic.

Medical care during the Coronavirus 2019 global pandemic required significant shifts in health care delivery systems. Telehealth was widely deployed but was of limited utility for patient populations who rely heavily on laboratory monitoring. This includes pediatric hematology and oncology patients. We report on the feasibility and successful implementation of a home phlebotomy program that has minimized disruption in care for this high-risk patient population. During the initial months of the COVID-19 outbreak, we completed 189 home phlebotomy visits for pediatric hematology and oncology patients. Patient and staff satisfaction with the program were high, and potential exposures to COVID were avoided.

The use of whole blood capillary samples to measure 15 analytes for a home-collect biochemistry service during the SARS-CoV-2 pandemic: A proposed model from North West London Pathology.

BACKGROUND: The COVID-19 pandemic has drastically changed the delivery of secondary care services. Self-collection of capillary blood at home can facilitate the monitoring of patients with chronic disease to support virtual clinics while mitigating the risk of SARS-CoV-2 infection and transmission. OBJECTIVE: To investigate the comparability of whole blood capillary and plasma venous samples for 15 routinely used biochemical analytes and to develop and pilot a user-friendly home-collection kit to support virtual outpatient clinical services. METHODS: To investigate the comparability of whole blood capillary and plasma venous samples for 15 routinely requested biochemical analytes, simultaneous samples of venous and capillary blood were collected in EDTA and lithium-heparin plasma separation tubes that were of 4-6 mL and 400-600 µL draw volume, respectively. Venous samples were analysed within 4 h of collection while capillary samples were kept at ambient temperature for three days until centrifugation and analysis. Analyte results that were comparable between the matrices were then piloted in a feasibility study in three outpatient clinical services. RESULTS: HbA1c, lipid profile and liver function tests were considered comparable and piloted in the patient feasibility study. The home-collect kit demonstrated good patient usability. CONCLUSION: Home collection of capillary blood could be a clinically-useful tool to deliver virtual care to patients with chronic disease.

Research initiatives of blood services worldwide in response to the covid-19 pandemic.

BACKGROUND AND OBJECTIVES: While coronavirus (COVID-19) is not transfusion-transmitted, the impact of the global pandemic on blood services worldwide is complex. Convalescent plasma may offer treatment, but efficacy and safety are not established. Measuring seroprevalence in donors would inform public health policy. Here, we survey blood services around the world to assess the different research programmes related to COVID-19 planned or in progress. MATERIALS AND METHODS: Blood collection services were surveyed in June 2020 to determine whether they were participating in serosurveys or convalescent plasma collection and clinical trials. RESULTS: A total of 48 countries (77% of those contacted) responded. Seroprevalence studies are planned or in progress in 73% of countries surveyed and in all continents, including low- and middle-income countries. Most aimed to inform public health policy. Convalescent plasma programmes have been initiated around the globe (79% of surveyed), about three quarters as clinical trials in high-, middle- and low-income countries. CONCLUSION: Blood services around the world have drawn upon their operational capacity to provide much-needed seroprevalence data to inform public health. They have rapidly implemented preparation of potential treatment when few treatments are available and mostly as clinical trials. At the same time, they must continue to provide blood products for recipients despite challenges of working in a state of emergency. It is important to track and coordinate research efforts across jurisdictions to gain a composite evidence-based view that will influence future practice and preparative strategies.

Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation.

Importance: Before the widespread implementation of robotic systems to provide patient care during the COVID-19 pandemic occurs, it is important to understand the acceptability of these systems among patients and the economic consequences associated with the adoption of robotics in health care settings. Objective: To assess the acceptability and feasibility of using a mobile robotic system to facilitate health care tasks. Design, Setting, and Participants: This study included 2 components: a national survey to examine the acceptability of using robotic systems to perform health care tasks in a hospital setting and a single-site cohort study of patient experiences and satisfaction with the use of a mobile robotic system to facilitate triage and telehealth tasks in the emergency department (ED). The national survey comprised individuals living in the US who participated in a sampling-based survey via an online analytic platform. Participants completed the national survey between August 18 and August 21, 2020. The single-site cohort study included patients living in the US who presented to the ED of a large urban academic hospital providing quaternary care in Boston, Massachusetts between April and August 2020. All data were analyzed from August to October 2020. Exposures: Participants in the national survey completed an online survey to measure the acceptability of using a mobile robotic system to perform health care tasks (facilitating telehealth interviews, acquiring vital signs, obtaining nasal or oral swabs, placing an intravenous catheter, performing phlebotomy, and turning a patient in bed) in a hospital setting in the contexts of general interaction and interaction during the COVID-19 pandemic. Patients in the cohort study were exposed to a mobile robotic system, which was controlled by an ED clinician and used to facilitate a triage interview. After exposure, patients completed an assessment to measure their satisfaction with the robotic system. Main Outcomes and Measures: Acceptability of the use of a mobile robotic system to facilitate health care tasks in a hospital setting (national survey) and feasibility and patient satisfaction regarding the use of a mobile robotic system in the ED (cohort study). Results: For the national survey, 1154 participants completed all acceptability questions, representing a participation rate of 35%. After sample matching, a nationally representative sample of 1000 participants (mean [SD] age, 48.7 [17.0] years; 535 women [53.5%]) was included in the analysis. With regard to the usefulness of a robotic system to perform specific health care tasks, the response of "somewhat useful" was selected by 373 participants (37.3%) for facilitating telehealth interviews, 350 participants (35.0%) for acquiring vital signs, 307 participants (30.7%) for obtaining nasal or oral swabs, 228 participants (22.8%) for placing an intravenous catheter, 249 participants (24.9%) for performing phlebotomy, and 371 participants (37.1%) for turning a patient in bed. The response of "extremely useful" was selected by 287 participants (28.7%) for facilitating telehealth interviews, 413 participants (41.3%) for acquiring vital signs, 192 participants (19.2%) for obtaining nasal or oral swabs, 159 participants (15.9%) for placing an intravenous catheter, 167 participants (16.7%) for performing phlebotomy, and 371 participants (37.1%) for turning a patient in bed. In the context of the COVID-19 pandemic, the median number of individuals who perceived the application of robotic systems to be acceptable for completing telehealth interviews, obtaining nasal and oral swabs, placing an intravenous catheter, and performing phlebotomy increased. For the ED cohort study, 51 individuals were invited to participate, and 41 participants (80.4%) enrolled. One participant was unable to complete the study procedures because of a signaling malfunction in the robotic system. Forty patients (mean [SD] age, 45.8 [2.7] years; 29 women [72.5%]) completed the mobile robotic system-facilitated triage interview, and 37 patients (92.5%) reported that the interaction was satisfactory. A total of 33 participants (82.5%) reported that their experience of receiving an interview facilitated by a mobile robotic system was as satisfactory as receiving an in-person interview from a clinician. Conclusions and Relevance: In this study, a mobile robotic system was perceived to be acceptable for use in a broad set of health care tasks among survey respondents across the US. The use of a mobile robotic system enabled the facilitation of contactless triage interviews of patients in the ED and was considered acceptable among participants. Most patients in the ED rated the quality of mobile robotic system-facilitated interaction to be equivalent to in-person interaction with a clinician.

Delineation of the Arm Blood Vessels Utilizing Hyperspectral Imaging to Assist with Phlebotomy for Exploiting the Cutaneous Tissue Oxygen Concentration.

SIGNIFICANCE: The estimation of tissue oxygenation is vital in the diagnosis and therapeutic evaluation of a huge assortment of diseases. The hyperspectral (HS) imaging system is a rising innovation that can be utilized to build a highly sensitive, non-invasive, and tissue hemoglobin immersion map. OBJECTIVE: As a result of the urgent need to design and implement early detection devices and applications for the COVID-19 pandemic, we propose building a non-invasive custom optical imaging system to assist with phlebotomy and vascular approach to survey the reliability of blood oxygen saturation (SpO2) levels recovered from spectral images. MATERIALS AND METHODS: HS images were gathered from 15 healthy subjects without previous medical history complications and with an average age range of 20 to 38 years, who were undergoing phlebotomy. The forearm was vigorously illuminated utilizing an HS camera with polychromatic source light of spectrum range (400∼980 nm). Spectroscopic reflectance images were caught by a focal plane exhibit for the region of interest (ROI). Then the custom algorithm comprising normalization and moving average filtering for noise removal was applied, followed by K-mean clustering for image segmentation to visualize and highlight the arteries and the veins in the investigated forearm. RESULTS: The investigations show that after normalization of the recorded signal from the HS camera of the participating subjects it was noticed that at wavelength of 460 nm the oxygenated arteries had a stronger signal than the de-oxygenated veins, and at a wavelength of 750 nm the de-oxygenated veins had a stronger signal than the oxygenated arteries. Thus, the ideal wavelength to reveal the oxygenated arteries was 460 nm, and the ideal wavelength to reveal the de-oxygenated veins was 750 nm. CONCLUSIONS: HSI is a prospective technique to assist with phlebotomy and non-contact oxygen saturation approach. Additionally, it may permit future surgical or pharmacological intercessions that titrate or limit ischemic injury continuously.

Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis.

Aim: Evaluation of a novel microsampling device for its use in clinical sample collection and biomarker analysis. Methodology: Matching samples were collected from 16 healthy donors (ten females, six males; age 42 ± 20) via K2EDTA touch activated phlebotomy (TAP) device and phlebotomy. The protein profile differences between sampling groups was evaluated using aptamer-based proteomic assay SomaScan and selected ELISA. Conclusion: Somascan signal concordance between phlebotomy- and TAP-generated samples was studied and comparability of protein abundances between these blood sample collection methods was demonstrated. Statistically significant correlation in selected ELISA assays also confirmed the TAP device applicability to the quantitative analysis of protein biomarkers in clinical trials.