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The top five most read articles of 2019 in The Journal of Applied Laboratory Medicine (JALM) touched on a broad range of topics, including the growing importance of procalcitonin (PCT) as a sepsis marker, a novel approach for detecting bloodborne pathogens, and challenges that phlebotomists face in performing blood draws in children. New developments in assays and analyzers rounded out the top five most read papers.

JALM publishes translational and pragmatic research: well-done science that can be applied in laboratory medicine, immediately or eventually, over a 7-year period. The top five articles that received the most views in 2019 include:

  1. The Use of Procalcitonin as a Sepsis Marker in a Community Hospital;
  2. XW-100: First FDA CLIA-Waived CBC Analyzer Designed for Physician Office Use;
  3. It’s Not Just a Needlestick: Exploring Phlebotomists’ Knowledge, Training, and Use of Comfort Measures in Pediatric Care to Improve the Patient Experience;
  4. Rapid Rule Out of Culture-Negative Bloodstream Infections by Use of a Novel Approach to Universal Detection of Bacteria and Fungi; and
  5. Reproducibility and Variability of Protein Analytes Measured Using a Multiplexed Modified Aptamer Assay.

JALM’s most-read article examined the capabilities of PCT as a sepsis predictor in a community hospital setting. Researchers compared this marker against lactic acid in patients with or without blood cultures, looking at variables such as length of stay and direct costs. Among 165 sepsis cases with positive cultures, PCT’s overall sensitivity was 89.7%, notably higher than that of lactic acid (64.9%). The investigators also noted a drop in hospitalization costs after implementing PCT testing although no changes were noted in length of stay. “We will have to further investigate how the savings were realized and how to better impact length of stay,” they summarized. According to JALM's editor-in-chief Robert Christenson, PhD, DBACC,"Procalcitonin and lactic acid measurements were compared in patients with or without blood cultures for direct cost and length of stay. The authors concluded that procalcitonin was a better tool than lactic acid for identifying patients ultimately diagnosed with sepsis. These data resulted in increased acceptance and utilization by the local emergency department and hospital units."

Several top JALM articles examined up-and-coming technologies. One study leveraged a multiplexed, modified aptamer-based assay to quantify 3,693 plasma protein analytes. Investigators collected plasma samples using well-defined protocols from 42 Atherosclerosis Risk in Communities (ARIC) study participants. In a comparison across assay methods, six of nine proteins had good correlation between the aptamer-based assay and immunoassay methods, and three had moderate correlation. “Our cross-platform comparison revealed that the established and the modified aptamer methods may differ meaningfully for estimating disease risk for some proteins,” co-authors Adrienne Tin, PhD, MS, assistant scientist at Johns Hopkins Bloomberg School of Public Health’s Department of Epidemiology, and Bing Yu, PhD, associate professor of epidemiology, human genetics and environmental sciences at UTHealth, told CLN Stat. The large numbers of proteins aptamer-based assays quantify might help to identify disease biomarkers and therapeutic targets for clinical practice. 

Christenson added about this research, "Proteomic approaches can have productive use in epidemiological studies and analytic performance of the basic assays is of critical importance. This study assessed a mutiplexed strategy for over 3500 protein analytes that employed multiple aptamers, i.e. oligonucleotide or peptide molecules that each bind to a specific target, for reproducibility and short- and long-term analytic variation. This study provides evidence that modified aptamer techniques can have the characteristics required for large-scale longitudinal studies of the plasma proteome."

In a step toward reducing antibiotics overuse, a diagnostic test using enzymatic template generation and amplification (ETGA) technology was able to measure blood culture negativity in just a day’s time with high negative predictive value. Quicker results mean stopping or de-escalating antimicrobial therapy earlier in patients with negative cultures, limiting the chances of a patient developing multidrug-resistant pathogen infections. "The practice of widely prescribing antibiotics in patient populations suspected of having bacterial infections has been a target of many hospital stewardship efforts," Christenson noted. "Earlier de-escalation or cessation of antibiotics in culture-negative patients should limit adverse effects of inappropriate treatment of patients with antibiotic-related or multidrug resistant pathogens. This publication describes a method for determining negative blood culture results in <24 hours with high negative predictive value that is 1–4 days faster compared to current standards of care."

Point-of-care testing (POCT) has become a popular means of delivering faster test results for timely medical decision-making. So, it’s not surprising that a story about the Sysmex XW-100 made the top 5. According to James Nichols, PhD, DABCC, FADLM, the article’s editor, this was the first analytical evaluation of a CLIA-waived complete blood count (CBC) analyzer. “Up to this time, hematology testing was only available in CLIA-moderate complexity laboratories and facilities,” said Nichols, a professor of pathology, microbiology, and immunology at Vanderbilt University in Nashville, Tennessee. The Sysmex XW-100, which provides cell counts with a three-part white cell differential, demonstrated a precision of <6% for all tests with no carryover.

“Correlation was highly concordant with the predicate analyzer and samples with interfering substances were appropriately flagged and results suppressed by the analyzer,” Nichols summarized. The results show promise for expanding POCT technology into physician’s offices and clinics. Patients want to get their lab results during their office visit to the doctor, Nichols emphasized. “Providing hematology tests in the primary care practice enhances patient satisfaction, avoids separate travel to a lab for phlebotomy and eliminates follow-up visits to discuss test results.” 

Christenson observed, "Availability of a waived point-of-care hematology analyzer would facilitate greater access to testing, particularly in outpatient populations. A multicenter study that included over 550 subjects demonstrated that performance of a commercially available device providing a three-part white cell differential was substantially equivalent to a moderately complex analyzer, and was cleared for CLIA-Waived use by the Food and Drug Administration."

Addressing another topic on patient preferences and needs, institutions are always on the lookout for improving the blood draw process in children. “Pediatric patients often don't understand what is happening, and it is scary for them,” said Deborah French, PhD, DABCC, FADLM, who edited the article on pediatric phlebotomy. Such specialists are often taught to focus on the clinical technique rather than patient comfort.

The study sought to identify phlebotomists’ techniques that improve the experience of these young patients, explained French, an assistant director of chemistry and director of mass spectrometry at the University of California San Francisco Clinical Laboratories. Investigators conducted a survey of phlebotomists at their institution to determine what training they received, if they were aware of comfort measures, and which ones they commonly used. Eighty-six percent said they had a moderate to high level of knowledge regarding providing comfort measures to pediatric patients during blood draws. This is a positive finding, especially if training programs do not currently provide education on these measures, French said.

Frequent techniques included words of explanation or comfort (70%) followed by positioning options (67%) and distractions (including bubbles, small toys, iPads; 43%). Some phlebotomists reported calling for child life specialists (18%). Others offered a pain-minimizing, electronic numbing device or topical anesthetic or sucrose for children < 2 years of age. For the most part, phlebotomists used what was directly available, such as talking to and/or repositioning the patient to provide comfort rather than employing other comfort measures that would require extra steps. According to French, this may reflect time constraints or prior success with the more simple techniques.

Overall, phlebotomists seemed well-versed in comfort measures. Nevertheless, “phlebotomy training should include child development and comfort techniques for blood draws to help ensure a more comfortable and less stressful experience for the child, parent and phlebotomist,” French said. While a majority reported having no high stress levels during draws, patient/parent anxiety did have an effect on their own anxiety. "Reduced anxiety during phlebotomy will improve the healthcare experience, particularly for pediatric patients. To this end, this study assessed phlebotomists' self-reported knowledge, experience, training and use of comfort techniques during pediatric blood draws," Christenson summarized. "This study found that a multifaceted approach that provides patients and families with at least 1 pain reducing option and varying distractions reduces phlebotomy discomfort.

These popular stories and more are available online. 2020 promises even more exciting research and insights into clinical laboratory medicine.