Optimizing the data in direct access testing: information technology to support an emerging care model.

Direct access testing (DAT) is an emerging care model that provides on-demand laboratory services for certain preventative, diagnostic, and monitoring indications. Unlike conventional testing models where health care providers order tests and where sample collection is performed onsite at the clinic or laboratory, most interactions between DAT consumers and the laboratory are virtual. Tests are ordered and results delivered online, and specimens are frequently self-collected at home with virtual support. Thus, DAT depends on high-quality information technology (IT) tools and optimized data utilization to a greater degree than conventional laboratory testing. This review critically discusses the United States DAT landscape in relation to IT to highlight digital challenges and opportunities for consumers, health care systems, providers, and laboratories. DAT offers consumers increased autonomy over the testing experience, cost, and data sharing, but the current capacity to integrate DAT as a care option into the conventional patient-provider model is lacking and will require innovative approaches to accommodate. Likewise, both consumers and health care providers need transparent information about the quality of DAT laboratories and clinical decision support to optimize appropriate use of DAT as a part of comprehensive care. Interoperability barriers will require intentional approaches to integrating DAT-derived data into the electronic health records of health systems nationally. This includes ensuring the laboratory results are appropriately captured for downstream data analytic pipelines that are used to satisfy population health and research needs. Despite the data- and IT-related challenges for widespread incorporation of DAT into routine health care, DAT has the potential to improve health equity by providing versatile, discreet, and affordable testing options for patients who have been marginalized by the current limitations of health care delivery in the United States.

Colorectal cancer screening completion by patients due or overdue for screening after reminders: a retrospective study.

BACKGROUND: Patient and clinician reminders were implemented as part of an adherence improvement project at University of Florida (UF) Internal Medicine Clinics. We sought to assess colorectal cancer (CRC) screening completion rates among patients not up-to-date with screening following distribution of reminders and to identify characteristics correlated with screening outcomes. METHODS: Retrospective chart review was performed for patients not up-to-date with CRC screening for whom at least one reminder (patient and/or clinician) was issued in June 2018. The primary endpoint, the completion of a CRC screening test, is characterized as the ratio of completed screening tests to the number of patients not up-to-date with screening. All analyses were performed using R 4.0 software. RESULTS: Of the 926 patients included, 403 (44%; 95% CI, 0.40-0.47) completed a CRC screening test within 24 months following a reminder. Family history of CRC (relative risk (RR) 1.33; P = 0.007), flu immunization within two years of the reminder (RR 1.23; P = 0.019), and receiving a patient reminder either alone (RR 1.62; P < 0.001) or in combination with a clinician reminder (RR 1.55; P = 0.006) were positively associated with CRC screening completion. Reporting being divorced, separated, or widowed was negatively associated with screening completion (RR 0.70; P = 0.004). CONCLUSION: Reminders, in particular patient reminders, seem to be an effective method to enhance screening among patients not up-to-date with CRC screening. This study suggests that reminder efforts should be focused at the level of the patients and provides insight on target populations for practical interventions to further increase CRC screening adherence.

A Gastrointestinal PCR Panel Improves Clinical Management and Lowers Health Care Costs.

Conventional methods for the identification of gastrointestinal pathogens are time-consuming and expensive and have limited sensitivity. The aim of this study was to determine the clinical impact of a comprehensive molecular test, the BioFire FilmArray gastrointestinal (GI) panel, which tests for many of the most common agents of infectious diarrhea in approximately 1 h. Patients with stool cultures submitted were tested on the GI panel (n = 241) and were compared with control patients (n = 594) from the year prior. The most common organisms detected by the GI panel were enteropathogenic Escherichia coli (EPEC, n = 21), norovirus (n = 21), rotavirus (n = 15), sapovirus (n = 9), and Salmonella (n = 8). Patients tested on the GI panel had an average of 0.58 other infectious stool tests compared with 3.02 in the control group (P = 0.0001). The numbers of days on antibiotic(s) per patient were 1.73 in the cases and 2.12 in the controls (P = 0.06). Patients with the GI panel had 0.18 abdomen and/or pelvic imaging studies per patient compared with 0.39 (P = 0.0002) in the controls. The average length of time from stool culture collection to discharge was 3.4 days in the GI panel group versus 3.9 days in the controls (P = 0.04). The overall health care cost could have decreased by $293.61 per patient tested. The GI panel improved patient care by rapidly identifying a broad range of pathogens which may not have otherwise been detected, reducing the need for other diagnostic tests, reducing unnecessary use of antibiotics, and leading to a reduction in hospital length of stay.

Semi-quantitative Influenza A population averages from a multiplex respiratory viral panel (RVP): potential for reflecting target sequence changes affecting the assay.

BACKGROUND: Yearly influenza virus mutations potentially affect the performance of molecular assays, if nucleic acid changes involve the sequences in the assay. Because individual patient viral loads depend on variables such as duration of illness, specimen type, age, and immunosuppression, we examined seasonal population averages of positive tests to smooth inherent variability. METHODS: We studied the population seasonal averages of the semi-quantitative nAMPs for the influenza matrix and hemagglutinin genes in the GenMark (Carlsbad, CA) Respiratory Viral Panel assay between 3 institutions over 3 Influenza seasons. RESULTS: Population average nAMPs were strikingly consistent between separate institutions, but differed substantially between H3N2 and H1N1 seasons. In the 2012-2013 and 2014-2015 influenza seasons, matrix gene H3N2 nAMP averages were 50-70% less than those of the same assay in the 2013-2014 H1N1 season. Influenza strains representative of these seasons were grown in tissue culture and when the supernatant virus was adjusted to the same copy number using a TaqMan assay, the same relative differences were reproduced in the RVP assay. Because the sequences for the PCR and PCR product detection in the GenMark assay are proprietary, the manufacturer provided single stranded DNA matching the capture probe for the representative H3N2 (3 mismatches) and H1N1 strains (2 different mismatches). Equimolar concentrations of these synthetic DNA sequences gave average nAMP values that closely correlated with the average nAMPS of the representative strains and their respective seasonal averages. CONCLUSIONS: Seasonal averages of semi-quantitative data may provide a means to follow assay performance as a reflection of the effects of molecular drift.

Diagnostic Algorithm for the Diagnosis of Pediatric Parasitic Gastroenteritis.

BACKGROUND: Current practices for ordering stool studies in patients with abdominal and gastrointestinal symptoms are not standardized. We hypothesized that an algorithm involving first-line use of a Cryptosporidium/Giardia combination antigen test and stricter use of ova and parasite (O&P) examinations would be clinically and cost effective. METHODS: In this study, stool O&P test results for pediatric patients in Dallas, Texas, were reviewed. All results obtained between 2009 and 2012 were included. Patient charts were reviewed to determine test results, symptoms, treatment, travel, and past medical history. Using these data, a retrospective modeling study was done to evaluate the utility of a diagnostic algorithm that limits O&P testing to those patients who are immunocompromised or have travelled outside the United States. RESULTS: Over the 3-year period of this study, we found that the prevalence of gastrointestinal parasitic disease in children was 1.9%. Analysis of the diagnostic algorithm for the judicious use of stool O&P showed that as much as 65% of testing may be unnecessary and could be eliminated. CONCLUSIONS: Our findings show that the prevalence of pediatric gastrointestinal parasitic disease in Texas may be lower than expected. In addition, these data show that a diagnostic algorithm limiting O&P testing may be both clinically and cost effective in low-prevalence settings. However, such an algorithm would miss a significant number of infections due to Dientamoeba fragilis and Blastocystis hominis.

Evaluation of the nanosphere verigene gram-positive blood culture assay with the VersaTREK blood culture system and assessment of possible impact on selected patients.

The Verigene Gram-positive blood culture (BC-GP) assay (Nanosphere, Northbrook, IL) is a molecular method for the rapid identification of Gram-positive organisms and resistance markers directly from blood culture bottles. A total of 148 VersaTREK REDOX 1 40-ml aerobic bottles demonstrating Gram-positive bacteria were tested. Results were compared with those from conventional biochemical and matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identifications. We obtained isolates of methicillin-resistant Staphylococcus aureus (MRSA) (24), methicillin-susceptible Staphylococcus aureus (MSSA) (14), methicillin-resistant Staphylococcus epidermidis (MRSE) (17), methicillin-susceptible Staphylococcus epidermidis (MSSE) (9), other coagulase-negative staphylococci (19), Streptococcus salivarius (5), Streptococcus parasanguinis (2), Streptococcus sanguinis (1), Streptococcus cristatus (1), the Streptococcus bovis group (5), Streptococcus agalactiae (9), the Streptococcus anginosus group (1), Streptococcus pneumoniae (6), vancomycin-resistant Enterococcus faecium (VRE FCM) (16), vancomycin-susceptible Enterococcus faecalis (3), Aerococcus viridans (2), Bacillus (6), Corynebacterium (8), Lactobacillus (2), Micrococcus (2), Neisseria mucosa (1), Escherichia coli (3), Candida tropicalis (1), Propionibacterium (1), and Rothia (1). Overall agreement with the culture results was 95%. A total of 137 of 138 (99%) monomicrobial cultures were concordant. We tested 9 polymicrobial samples and found 33% agreement. A chart review of 31 patients with MRSA, MSSA, or VRE demonstrated that the Nanosphere BC-GP assay might have led to more appropriate antibiotic selection for these patients an average of 42 h earlier. Additionally, contact isolation could have been initiated an average of 37 h earlier for patients with MRSA or VRE. The BC-GP assay may have a positive impact on patient care, health care costs, and antibiotic stewardship.

Increasing medical student awareness of pathology through a virtual, asynchronous pathology elective.

Faculty from the University of Florida Department of Pathology, Immunology, and Laboratory Medicine developed an asynchronous, fully virtual pathology elective for medical students that emphasizes both foundational pathology concepts as well as the role of pathologists in the broader health system. The program includes ten core modules as well as several selective modules which allows students to tailor their coursework to better align with their desired specialty. After completing each module, students were required to concisely summarize the topic in the form of a 280-character tweet. Students were surveyed immediately after finishing the course and again one year after finishing the course to assess the effectiveness of the course in teaching students about pathology. Survey results showed significant improvement in student knowledge about the field of pathology and high levels of satisfaction with the course content and delivery. The tweet summaries required in the course provided a unique challenge for students. Although the course was initially developed in response to the COVID-19 pandemic, enrollment has continued steadily through 2023. Our study suggests that online pathology electives can be an effective way to increase medical student exposure to pathology and facilitate learning about the field of pathology, especially among students who may not ultimately pursue a career in pathology.

Diagnostic difficulties in non-tuberculous mycobacterial infection in lung transplant recipients.

Despite antimicrobial prophylaxis, 34% to 59% of lung transplant recipients experience severe life-threatening opportunistic infections, sometimes caused by Nontuberculous Mycobacteria (NTM) and Nocardia. Although differentiating these infections is of utmost importance for effective treatment, it can be challenging as they share morphological and growth characteristics. Therefore, culture remains the gold standard for laboratory confirmation. With the aid of novel molecular methods performed on the cultured organisms, diagnosis may be accomplished rapidly and precisely. We present a case of a lung transplant recipient with a pulmonary infection where long, thin, beaded, branching filamentous organisms were seen with Acid-Fast Bacilli (AFB) and Modified Gomori's Methenamine Silver (GMS) stains in bronchoalveolar lavage sample. Cytological characteristics led to the suspicion of a Nocardia species infection. However, culture and the PCR-restriction fragment length polymorphism analysis (PRA) identified M. fortuitum. Additionally, antibiotic resistance was detected, which aided in choosing the appropriate treatment. Therefore, to overcome such diagnostic difficulties to differentiate NTM and Nocardia, a multidisciplinary approach including culture, molecular methods, and cytology is needed to enhance clinical outcomes.

The Interaction between Hb A1C and Selected Genetic Factors in the African American Population in the USA.

BACKGROUND: The global prevalence of diabetes mellitus has been growing in recent decades and the complications of longstanding type 2 diabetes continue to place a burden on healthcare systems. The hemoglobin A1c (Hb A1c) content of the blood is used to assess an individual's degree of glycemic control averaged over 2 to 3 months. In the USA, diabetes is the seventh leading cause of death. Black, indigenous, people of color (BIPOC) are disproportionately affected by diabetes compared to non-Hispanic whites. There are many reports of interaction of Hb A1c and hematologic conditions that have a high prevalence in the Black population; some of these effects are contradictory and not easily explained. This review attempts to document and categorize these apparently disparate effects and to assess any clinical impact. METHODS: Hb A1C can be determined by a variety of techniques including cation-exchange chromatography, electrophoresis, immunoassays, and affinity chromatography. The amount of Hb A1c present in a patient specimen depends not only on blood glucose but is strongly influenced by erythrocyte survival and by structural variations in the globin chains. Sickling hemoglobinopathies are well-represented in the USA in African Americans and the effects of these hemoglobin disorders as well as G6PD deficiency is examined. CONCLUSION: Hb A1c measurement should always be performed with a cautious approach. The laboratory scientist should be aware of possible pitfalls in unquestioningly determining Hb A1c without a consideration of hematologic factors, both inherited and acquired. This presents a challenge as often times, the laboratory is not aware of the patient's race.

A Critical Review on the Use of Race in Understanding Racial Disparities in Preeclampsia.

BACKGROUND: Preeclampsia is a significant cause of maternal morbidity and mortality, affecting up to 8% of pregnancies globally. Although the precise etiology is still under study, the literature suggests that vascular changes reduce placental perfusion and affect the remodeling of spiral arteries to create the hallmark feature of preeclampsia: elevated blood pressure. Screening for preeclampsia is currently recommended for all pregnant women, particularly if risk factors exist. A noted risk factor codified in guidelines is "African-American race." CONTENT: We summarize the racial disparities in preeclampsia incidence, morbidity, and mortality. We consider the limitations of using race to understand disparities by also examining multiethnic, immigration, and international studies. We then critically evaluate laboratory analytes associated with racial disparities of preeclampsia and explore other mechanisms of action, such as socioeconomic status, stress, and access to care. SUMMARY: Black and African-American women are consistently at higher risk of preeclampsia incidence, morbidity, and mortality than their white counterparts. Asian women are consistently at lower risk of preeclampsia, whereas the association for Hispanic women remains unclear. When these broad racial categories are subdivided by geographic or cultural origin, preeclampsia disparities within racial groups are identified. The limited literature suggests that sub-Saharan African immigrants tend to have a higher risk of preeclampsia than US-born white populations but a lower risk than US-born Black women. Existing studies seeking to identify racial differences in analytes have limited research designs and tend to operationalize race as a proxy for biologically inherent (i.e., genetic) differences between races despite a plethora of other possible explanatory mechanisms.

Performance of a Semiquantitative Multiplex Bacterial and Viral PCR Panel Compared With Standard Microbiological Laboratory Results: 396 Patients Studied With the BioFire Pneumonia Panel.

BACKGROUND: Microbiologic results are critical to optimal management of patients with lower respiratory tract infection, but standard methods may take several days. The multiplex polymerase chain reaction BioFire Pneumonia (PN) panel detects 15 common bacterial species semiquantitatively as copy number/mL, 8 viral species, and 7 resistance genes in about an hour within the clinical laboratory. METHODS: We tested 396 unique endotracheal or bronchoalveolar lavage specimens with the BioFire Pneumonia panel and compared the bacterial detections to conventional gram stain and culture results. RESULTS: Of the 396 patients, 138 grew at least 1 bacterium that had a target on the PN panel, and 136/138 (98.6%) were detected by the panel. A total of 177 isolates were recovered in culture and the PN panel detected 174/177 (98.3%). A further 20% of patients had additional targets detected that were not found on standard culture (specificity 69%, positive predictive value 63%, and negative predictive value 98.9%). Copy number was strongly related to standard semiquantitative growth on plates reported by the laboratory (eg, 1+, 2+, 3+ growths) and was significantly higher in those specimens that grew a potential pathogen. Both higher copy number and bacterial detections found by the PN panel, but not found in culture, were strongly positively related to the level of white blood cells reported in the initial gram stain. CONCLUSIONS: Higher copy number and bacterial detections by the PN panel are related to the host respiratory tract inflammatory response. If laboratories can achieve a rapid turnaround time, the PN panel should have a significant impact both on patient management and on antibiotic stewardship.

A case report of primary amebic meningoencephalitis in North Florida.

Primary amebic meningoencephalitis is a rare, usually fatal disease, caused by Naegleria fowleri. This case highlights the challenging clinicopathologic diagnosis in a 13-year-old boy who swam in freshwater in northern Florida where a previous case had exposure to a body of water on the same property in 2009.

The Lines That Held Us: Assessing Racial and Socioeconomic Disparities in SARS-CoV-2 Testing.

BACKGROUND: Racial disparities in SARS-CoV-2 prevalence are apparent. Race is a sociocultural construct, necessitating investigation into how sociocultural factors contribute. METHODS: This cross-sectional study linked laboratory data of adult patients between February 29 and May 15, 2020 with socio-demographics variables from the 2018 American Community Survey (ACS). Medical sites included healthcare organizations in Michigan, New York, North Carolina, California, Florida, Pennsylvania, and Washington. Race was treated as a proxy for racism and not biological essentialism. Laboratory data included patient age, sex, race, ethnicity, test result, test location, and residential ZIP code. ACS data included economic and educational variables contributing to an SES Index, population density, proportion Medicaid, and racial composition for corresponding ZIP code. Associations between race/socioeconomic variables and test results were examined using odds ratios (OR). RESULTS: Of 126 452 patients [mean (SD) age 51.9 (18.4) years; 52 747 (41.7%) men; 68 856 (54.5%) White and 27 805 (22.0%) Black], 18 905 (15.0%) tested positive. Of positive tests, 5238 (SD 27.7%) were White and 7223 (SD 38.2%) were Black. Black race increased the odds of a positive test; this finding was consistent across sites [OR 2.11 (95% CI 1.95-2.29)]. When subset by race, higher SES increased the odds of a positive test for White patients [OR 1.10 (95% CI 1.05-1.16)] but decreased the odds for Black patients [OR 0.92 (95% CI 0.86-0.99)]. Black patients, but not White patients, who tested positive overwhelmingly resided in more densely populated areas. CONCLUSIONS: Black race was associated with SARS-CoV-2 positivity and the relationship between SES and test positivity differed by race, suggesting the impact of socioeconomic status on test positivity is race-specific.

Educational Case: Identification of Pulmonary Mycobacteria.

The following fictional case is intended as a learning tool within the Pathology Competencies for Medical Education (PCME), a set of national standards for teaching pathology. These are divided into three basic competencies: Disease Mechanisms and Processes, Organ System Pathology, and Diagnostic Medicine and Therapeutic Pathology. For additional information, and a full list of learning objectives for all three competencies, see http://journals.sagepub.com/doi/10.1177/2374289517715040.1.

Educational Case: Opportunistic Infections of the Central Nervous System.

The following fictional case is intended as a learning tool within the Pathology Competencies for Medical Education (PCME), a set of national standards for teaching pathology. These are divided into three basic competencies: Disease Mechanisms and Processes, Organ System Pathology, and Diagnostic Medicine and Therapeutic Pathology. For additional information, and a full list of learning objectives for all three competencies, see http://journals.sagepub.com/doi/10.1177/2374289517715040.1.