Search Results (3)

Background/Objectives: Conventional blood collection can be challenging in a non-clinical or home-based setting. In response, vacuum-assisted lancing devices for capillary blood collection (typically from the upper arm) have gained popularity to broaden access to diagnostic testing. However, these devices are often costly relative to the reimbursement rate for common laboratory testing panels. This study describes the design and evaluation of Comfort Draw™, a simplified and economical vacuum-assisted capillary blood collection device. Methods: Comfort Draw™ was evaluated by 12 participants in a preliminary study and by 42 participants in a follow-up study. Metrics assessed included the following: vacuum pressure of the device, skin temperature generated by the Comfort Draw prep warmer, blood collection volume, and analytical accuracy (for 19 common serum-based analytes). Results: Acceptable blood volume (>400 µL) and serum volume (>100 µL) were collected by Comfort Draw in 85.5% and 95.1% of cases, respectively. Seventeen of the nineteen analytes examined were within CLIA acceptance limits compared to matched venous samples. Self-reported pain scores associated with Comfort Draw collection averaged 0.39 on a scale from 0 to 10. Conclusions: In this preliminary clinical study, Comfort Draw was found to be a valid and relatively painless method for collecting capillary blood specimens. The device’s simple design and lower cost could enable broader applications compared to more complex alternative capillary blood collection devices. Full article

Background: The COVID-19 pandemic has significantly impacted the status of clinical trials in the United States, requiring researchers to reconsider their approach to research studies. In light of this, we discuss the changes we made to the protocol of the Home Air Filtration for Traffic-Related Air Pollution (HAFTRAP) study, a randomized crossover trial of air filtration in homes next to a major highway. The senior authors designed the trial prior to the pandemic and included in-person data collection in participants’ homes. Because of the pandemic, we delayed the start of our trial in order to revise our study protocol to ensure the health and well-being of participants and staff during home visits. To our knowledge, there have been few reports of attempts to continue in-home research during the pandemic. Methods: When pandemic-related protective measures were imposed in March 2020, we were close to launching our trial. Instead, we postponed recruitment, set a new goal of starting in September 2020, and spent the summer of 2020 revising our protocol by developing increased safety precautions. We reviewed alternative approaches to installing portable air filtration units in study participants’ homes, in order to reduce or eliminate entry into homes. We also developed a COVID-19 safety plan that covered precautionary measures taken to protect both field team staff and study participants. Results: Our primary approach was to minimize contact with participants when collecting the following measures in their homes: (1) placing portable air filtration units; (2) conducting indoor air quality monitoring; (3) obtaining blood samples and blood pressure measurements; and (4) administering screening, consent, and follow-up questionnaires that coincided with collection of biological measures. Adapting our public health trial resulted in delays, but also helped ensure ethical and safe research practices. Perceived risk of COVID-19 infection appeared to have been the primary factor for an individual in deciding whether or not to participate in our trial, particularly at the beginning of the pandemic, when less was known about COVID-19. Conclusions: We needed to be flexible, creative, and calm when collaborating with community members, the IRB, and the universities, while repeatedly adjusting to changing guidelines as we determined what worked and what did not for in-home data collection. We learned that high-quality air monitoring data could be collected with minimal in-person contact and without compromising the integrity of the trial. Furthermore, we were able to collect blood pressure and phlebotomy data with minimal risk to the participant. Full article

Dried blood spots (DBS) are commonly used for serologic testing for viruses and provide an alternative collection method when phlebotomy and/or conventional laboratory testing are not readily available. DBS collection could be used to facilitate widespread testing for SARS-CoV-2 antibodies to document past infection, vaccination, and potentially immunity. We investigated the characteristics of Roche’s Anti-SARS-CoV-2 (S) assay, a quantitative commercial assay for antibodies against the spike glycoprotein. Antibody levels were reduced relative to plasma following elution from DBS. Quantitative results from DBS samples were highly correlated with values from plasma (r² = 0.98), allowing for extrapolation using DBS results to accurately estimate plasma antibody levels. High concordance between plasma and fingerpick DBS was observed in PCR-confirmed COVID-19 patients tested 90 days or more after the diagnosis (45/46 matched; 1/46 mismatched plasma vs. DBS). The assessment of antibody responses to SARS-CoV-2 using DBS may be feasible using a quantitative anti-S assay, although false negatives may rarely occur in those with very low antibody levels. Full article