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Stethoscope hygiene is rarely done despite guideline recommendations. We wanted to determine whether demonstrating what is growing on the stethoscopes of providers via culture or bioluminescence technology alters perceptions and improves compliance.Providers were given the opportunity to (1) culture their stethoscopes before and after disinfection with alcohol pads, alcohol-based hand rub, or hydrogen peroxide disinfectant wipes and (2) swab stethoscopes for bioluminescence-based adenosine triphosphate testing before and after disinfection. Outcomes were observed for hand and stethoscope hygiene rates and before and after intervention survey responses. The bacteria that were isolated, colony-forming units (CFU), and bioluminescence scores were tracked.A total of 1,245 observed hand hygiene opportunities showed that compliance improved from 72.5%-82.3% (P.001). In addition, 590 observed patient-provider encounters revealed no significant change in stethoscope hygiene rates of 10% initially and 5% afterward (P = .08), although self-reported rates trended from 56%- 67% postintervention (P = .06). Perceptions regarding stethoscope hygiene importance improved (8.5/10 to 9.3/10; P = .04). Disinfection with alcohol pads, alcohol-based hand rub, and hydrogen peroxide disinfectant wipes were equivalent in CFU reduction (P = .21).Showing providers what is growing on their stethoscopes via cultures and bioluminescence technology before and after disinfection improved "buy in" regarding stethoscope hygiene importance. Both methods were rated as having an equal impact, however, objective observations failed to show improvement.

BACKGROUND Laboratory medicine, like other areas of medicine, is obliged to adhere to high ethical standards. There are particular ethical issues that are unique to laboratory medicine and other areas in which ethical issues uniquely impact laboratory practice. Despite this, there is variability in ethics education within the profession. This review provides a foundation for the study of ethics within laboratory medicine. CONTENT The Belmont Report identifies 3 core principles in biomedical ethics: respect for persons (including autonomy), beneficence (and its corollary nonmalfeasance), and justice. These core principles must be adhered to in laboratory medicine. Informed consent is vital to maintain patient autonomy. However, balancing patient autonomy with the desire for beneficence can sometimes be difficult when patients refuse testing or treatment. The use of leftover or banked samples is fundamental to the ability to do research, create reference intervals, and develop new tests, but it creates problems with consent. Advances in genetic testing have created unique ethical issues regarding privacy, incidental findings, and informed consent. As in other professions, the emergence of highly contagious and deadly infectious diseases poses a difficult ethical dilemma of helping patients while protecting healthcare workers. CONCLUSIONS Although many clinical laboratorians do not see or treat patients, they must be held accountable to the highest ethical and professional behavior. Recognition and understanding of ethical issues are essential to ethical practice of laboratory medicine.

Patient care and public health require timely, reliable laboratory testing. However, clinical laboratory professionals rarely know whether patient specimens contain infectious agents, making ensuring biosafety while performing testing procedures challenging. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola outbreak, where concerns about biosafety resulted in delayed diagnoses and contributed to patient deaths. This review is a collaboration between subject matter experts from large and small laboratories and the federal government to evaluate the capability of clinical laboratories to manage biosafety risks and safely test patient specimens. We discuss the complexity of clinical laboratories, including anatomic pathology, and describe how applying current biosafety guidance may be difficult as these guidelines, largely based on practices in research laboratories, do not always correspond to the unique clinical laboratory environments and their specialized equipment and processes. We retrospectively describe the biosafety gaps and opportunities for improvement in the areas of risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; equipment and instrumentation safety; disinfection practices; personal protective equipment; waste management; laboratory personnel training and competency assessment; accreditation processes; and ethical guidance. Also addressed are the unique biosafety challenges successfully handled by a Texas community hospital clinical laboratory that performed testing for patients with Ebola without a formal biocontainment unit. The gaps in knowledge and practices identified in previous and ongoing outbreaks demonstrate the need for collaborative, comprehensive solutions to improve clinical laboratory biosafety and to better combat future emerging infectious disease outbreaks.

The SARS-CoV-2 virus has emerged and rapidly evolved into a current global pandemic. Although bacterial and fungal coinfections have been associated with COVID-19, little is known about parasitic infection. We report a case of a COVID-19 patient who developed disseminated strongyloidiasis following treatment with high-dose corticosteroids and tocilizumab. Screening for Strongyloides infection should be pursued in individuals with COVID-19 who originate from endemic regions before initiating immunosuppressive therapy.

We discuss the current practice of point-of-care diagnostics in infectious diseases as methods transition from antigen-based to molecular, and beyond simple molecular to the next generations of point-of-care testing methods. We evaluate the role of point-of-care at different sites of care and describe and evaluate trends likely to be driven by advances in molecular methodology, emerging biomarkers, and informatics. We describe strengths, weaknesses, opportunities, and threats to the development of point-of-care diagnostics in the near (1-10 years) and more distant (10-20 years) future.

Interest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitations and reporting considerations for laboratories. Assessments concerning single-antibody and multiantibody isotype detection assays, which may provide either differentiated or nondifferentiated (i.e., total antibody) antibody class results, are addressed. Additional considerations prior to assay implementation are also discussed, including biosafety, quality control, and proficiency testing strategies. As the landscape of SARS-CoV-2 serologic testing is rapidly changing, this document provides updated guidance for laboratorians on application of these assays.

The need for accurate antibody testing in patients following symptomatic or asymptomatic infections with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is well documented. How we best utilize the data obtained from these antibody studies is still a haunting question ([1][1]). There are

We present a case of a 20-year-old male who had ambiguous HIV test results after entering new provider care and whose status was later complicated by undetectable viral RNA off antiretroviral therapy (ART). Verifying HIV infection status may occasionally require sensitive DNA testing that might need to be considered in diagnostic guidelines to resolve diagnosis and ensure appropriate ART management.

BackgroundThe global pandemic of Severe Acute Respiratory Syndrome-Related Coronavirus 2 (SARS-CoV2) has resulted in unprecedented challenges for healthcare systems. One barrier to widespread testing has been a paucity of traditional respiratory viral swab collection kits relative to the demand. Whether other sample collection kits, such as widely available MRSA nasal swabs can be used to detect SARS-CoV-2 is unknown.MethodsWe compared simultaneous nasal MRSA swabs (COPAN ESwabs ® 480C flocked nasal swab in 1mL of liquid Amies medium) and virals wabs (BD H192(07) flexible mini-tip flocked nasopharyngeal swabs in 3mL Universal Transport Medium) for SARS-CoV-2 PCR testing using Simplexa COVID-19 Direct assay on patients over a 4-day period. When the results were discordant, the viral swab sample was run again on the Cepheid Xpert Xpress ® SARS-CoV-2 assay.ResultsOf the 81 included samples, there were 19 positives and 62 negatives in viral media and 18 positives and 63 negative in the MRSA swabs. Amongst all included samples, there was concordance between the COPAN ESwabs ® 480C and the viral swabs in 78 (96.3%).ConclusionWe found a high rate of concordance in test results between COPAN ESwabs ® 480C in Amies solution and BD H192(07) nasopharyngeal swabs in in 3 mL of Universal Viral Transport medium viral media. Clinicians and laboratories should feel better informed and assured using COPAN ESwabs ® 480C to help in the diagnosis of COVID-19.

Background and objectives Opioid overdose-related deaths increased from approximately 18 000 deaths in 2007 to 46 802 deaths in 2018. Fentanyl is primarily responsible for the increase in opioid overdose deaths from 2011 through 2017. The primary aim of this study is to determine the rates of fentanyl in the urine drug screens of all patients who presented to the psychiatric emergency room at VA Connecticut, over 7 months in 2018. Methods Data were collected for all patient presentations between June 2018 and December 2018. There were 746 total patient presentations, with 497 being unique. Collected data included basic demographic information, psychiatric diagnosis, and urine drug screen for various illicit substances, including fentanyl. Results Over 15% of patients screened positive for fentanyl. Patients who tested positive for fentanyl were further classified based on positive urine drug screening results for other opioids, cocaine, or both. Twenty percent of patients who screened positive for fentanyl and cocaine tested negative for other opioids. This category suggests that some veterans might be consuming fentanyl with cocaine. Discussion and conclusions Fentanyl was found at a high rate, even in the absence of other opioids, which suggests that some veterans might be consuming fentanyl with cocaine. Consequently, harm reduction strategies should be broadened to include all patients at risk of fentanyl overdose, including patients who use substances (eg, cocaine) that are potentially adulterated with fentanyl. Scientific significance This study is the first one of its kind that looked at rates of fentanyl use in all presentations to a psychiatric emergency room. While it is well-known that fentanyl is highly prevalent, these findings extend the current state of knowledge by replication in a psychiatric emergency population. (Am J Addict 2021;30:92-95).

Context.— A novel electronic consult (e-consult) system for a pathology and laboratory medicine service (PLMS) was implemented in 2015 at a high-complexity Veterans Administration health care facility. Consults were previously made through direct provider communication without documentation in the medical record. Objective.— To evaluate the utilization trends of the laboratory e-consult system at the Department of Veterans Affairs Connecticut facility during the first 2 years since inception. Design.— E-consultation involves pathology and laboratory medicine resident review followed by attending pathologist review and cosignature. E-consults to the pathology and laboratory medicine service from 2015 to 2017 were reviewed to record type of consult, requesting department, patient location, and turnaround time. Results.— The pathology and laboratory medicine service received 351 e-consults from 2015 to 2017. The volume varied by subsection: hematology and coagulation (215 of 351; 61%), chemistry (109 of 351; 31%), blood bank (19 of 351; 6%), and microbiology/virology (8 of 351; 2%). Hematology and coagulation consults were entirely for peripheral blood smear review (215 of 215; 100%). Chemistry consults were placed for toxicology/drugs of abuse (81 of 109; 74%), test utilization (17 of 109; 16%), or nontoxicology (11 of 109; 10%). Three services placed the majority of consults: primary care (279 of 351; 80%), hematology/oncology (39 of 351; 11%), and psychiatry (27 of 351; 8%). The median turnaround time for completion of e-consults was 1.2 days. Since e-consult implementation, the mean number of consults increased from 8.6/mo in 2015 to 18.1/mo in 2017, peaking in the last quarter of analysis in 2017 with a mean of 25.3 consults/mo. Conclusions.— This novel e-consult system improved accessibility to and documentation of answers to laboratory questions and increased the visibility of the pathology and laboratory medicine service. Future goals include development of outcomes-based measures to better assess the clinical impact of e-consults.

On August 24, 2020, the Centers for Disease Control and Prevention (CDC) updated its website to highlight that asymptomatic individuals, even those with exposure to a COVID-19 positive contact, do not necessarily need to be tested unless they have medical conditions associated with increased risk of severe illness from COVID-19. The CDC subsequently updated its guidance on September 19, 2020 to support testing of asymptomatic persons, including close contacts of persons with documented SARS-CoV-2 infection. In this editorial, the American Society for Microbiology Clinical and Public Health Microbiology Committee's Subcommittee on Laboratory Practices comments on testing of asymptomatic individuals relative to current medical knowledge of the virus and mitigation measures. Specific points are provided concerning such testing when undertaking contact tracing and routine surveillance. Limitations to consider when testing asymptomatic persons are covered, including the need to prioritize testing of contacts of positive COVID-19 cases. We urge the CDC to consult with primary stakeholders of COVID-19 testing when making such impactful changes in testing guidance.

A previously undescribed, rapidly growing, scotochromogenic species of the genus Mycobacterium (represented by strains PB739T and GK) was isolated from two clinical sources – the sputum of a 76-year-old patient with severe chronic obstructive pulmonary disease, history of tuberculosis exposure and Mycobacterium avium complex isolated years prior; and the blood of a 15-year-old male with B-cell acute lymphoblastic leukaemia status post bone marrow transplant. The isolates grew as dark orange colonies at 25–37 °C after 5 days, sharing features in common with other closely related species. Analysis of the complete 16S rRNA gene sequence (1492 bp) of strain PB739T demonstrated that the isolate shared 98.8 % relatedness with Mycobacterium wolinskyi . Partial 429 bp hsp65 and 744 bp rpoB region V sequence analyses revealed that the sequences of the novel isolate shared 94.8 and 92.1 % similarity with those of Mycobacterium neoaurum and Mycobacterium aurum , respectively. Biochemical profiling, antimicrobial susceptibility testing, HPLC/gas-liquid chromatography analyses and multilocus sequence typing support the taxonomic status of these isolates (PB739T and GK) as representatives of a novel species. Both isolates were susceptible to the Clinical and Laboratory Standards Institute recommended antimicrobials for susceptibility testing of rapidly growing mycobacteria including amikacin, ciprofloxacin, moxifloxacin, doxycycline/minocycline, imipenem, linezolid, clarithromycin and trimethropin/sulfamethoxazole. Both isolates PB739T and GK showed intermediate susceptibility to cefoxitin. We propose the name Mycobacterium grossiae sp. nov. for this novel species and have deposited the type strain in the DSMZ and CIP culture collections. The type strain is PB739T (=DSM 104744T=CIP 111318T).

Logical Observation Identifiers Names and Codes (LOINC) is the most widely used controlled vocabulary to identify laboratory tests. A given laboratory test can often be reported in more than 1 unit of measure (eg, grams or moles), and LOINC defines unique codes for each unit. Consequently, an identical laboratory test performed by 2 different clinical laboratories may have different LOINC codes. The absence of unit conversions between compatible LOINC codes impedes data aggregation and analysis of laboratory results. To develop such conversions, a computational process was developed to review the LOINC standard for potential conversions, and multiple expert reviewers oversaw and finalized the conversion list. In all, 285 bidirectional conversions were identified, including conversions for routine clinical tests such as sodium, magnesium, and human immunodeficiency virus (HIV). Unit conversions were applied to the aggregation of laboratory test results to demonstrate their usefulness. Diverse informatics projects may benefit from the ability to interconvert compatible results.

The absence of markers of inflammation in the cerebrospinal fluid (CSF) commonly predicts the absence of herpes simplex virus (HSV) central nervous system (CNS) infection. Consequently, multiple authors have proposed and validated criteria for deferring HSV PCR testing of CSF in immunocompetent hosts with normal CSF white blood cell and protein levels (≤5 cells/mm 3 and ≤50 mg/dl, respectively). Hosts are considered immunocompetent if they are ≥2 years old and have not had HIV or an organ transplant. Adoption of the criteria may erroneously exclude HSV-infected persons from a necessary diagnostic test or, alternatively, reduce the costs associated with HSV tests with minimal to no effect on patient care. Little is known about the cost-effectiveness of this approach. A decision analysis model was developed to evaluate the adoption of criteria for screening HSV tests of CSF. Estimates of input parameter values combined available literature with a multiyear multisite review at two of the largest health care systems in the United States. Adoption of criteria to screen for HSV test need proved cost-effective when less than 1 in 200 patients deferred from testing truly had an HSV CNS infection. Similar to prior studies, none of the deferred cases had HSV encephalitis ( n = 3120). Adoption of these criteria in the United States would save an estimated $127 million ($95 million to $158 million [±25%]) annually. The model calculations remained robust to variation in test cost, prevalence of HSV infection, and random variation to study assumptions. The adoption of criteria to screen HSV PCR tests in CSF represents a cost-effective approach.

Multiplex tests for respiratory tract infections include up to 20 targets for common pathogens, predominantly viruses. A specific therapeutic intervention is available for individuals testing positive for influenza viruses (oseltamivir), and it is potentially beneficial to identify non-influenza viruses to avoid unnecessary antibiotic use. We evaluated antimicrobial prescriptions following respiratory pathogen testing among outpatients at a large Veterans Administration (VA) medical center. Results of the FilmArray respiratory panel (BioFire, Salt Lake City, UT) from 15 December 2014 to 15 April 2015 were evaluated among 408 outpatients, and patient medical records were reviewed. Differences in antibiotic and oseltamivir prescription rates were analyzed. Among 408 patients tested in outpatient centers (emergency departments, urgent care clinics, and outpatient clinics), 295 (72.3%) were managed as outpatients. Among these 295 outpatients, 105 (35.6%) tested positive for influenza virus, 109 (36.9%) tested positive for a non-influenza virus pathogen, and 81 (27.5%) had no respiratory pathogen detected. Rates of oseltamivir and antibiotic prescriptions were significantly different among the three test groups (chi-squared values of 167.6 [ P < 0.0001] and 10.48 [ P = 0.005], respectively), but there was no significant difference in antibiotic prescription rates between the non-influenza virus pathogen group and those who tested negative (chi-square value, 0; P = 1.0). Among adult outpatients, testing positive for influenza virus was associated with receiving fewer antibiotic prescriptions, but no such effect was seen for those who tested positive for a non-influenza virus. These data suggest that testing for influenza viruses alone may be sufficient and more cost-effective than multiplex pathogen testing for outpatients.

We discuss the current practice of point-of-care diagnostics in infectious diseases as methods transition from antigen-based to molecular, and beyond simple molecular to the next generations of point-of-care testing methods. We evaluate the role of point-of-care at different sites of care and describe and evaluate trends likely to be driven by advances in molecular methodology, emerging biomarkers, and informatics. We describe strengths, weaknesses, opportunities, and threats to the development of point-of-care diagnostics in the near (1-10 years) and more distant (10-20 years) future.

Emerging pathogens have affected, and will continue to affect, the health care system in diverse ways. Clinical laboratories face ethical challenges in responding to emerging pathogens. We use the 2014-2015 outbreak of Ebola virus disease as a model to explore some of the ethical issues in laboratory medicine related to emerging infectious disease.To describe the major ethical concerns raised in the clinical laboratory environment by emerging infections.We assessed current guidelines and practices in the Ebola outbreak in developed-world clinical laboratories, reviewed risk assessment practices and the role of the clinical laboratory in providing care for patients with potential or confirmed Ebola, and reviewed the relevant literature on duty to provide care in the laboratory context.Clinical laboratories in developed countries have to rely more on expert guidelines and theoretical risk assessments than on practice in less-developed areas. Risk minimization for clinical laboratory workers is essential but may conflict with the laboratory's duty to provide standard of care. Patients can be put at risk not only from loss of laboratory services from restriction of testing but also from impairment of laboratory services in cases of spills or accidents. Significant discrepancies in guidelines from professional and governmental sources exacerbate the difficulty and confusion inherent in dealing with a dynamic, emerging infectious disease crisis. The duty to provide care for laboratory workers is ill-defined. Balancing risks to patients and laboratory workers and benefits to patients presents challenges to laboratory professionals at all levels.

Background The global pandemic of Severe Acute Respiratory Syndrome-Related Coronavirus 2 (SARS-CoV2) has resulted in unprecedented challenges for healthcare systems. One barrier to widespread testing has been a paucity of traditional respiratory viral swab collection kits relative to the demand. Whether other sample collection kits, such as widely available MRSA nasal swabs can be used to detect SARS-CoV-2 is unknown. Methods We compared simultaneous nasal MRSA swabs (COPAN ESwabs ® 480C flocked nasal swab in 1mL of liquid Amies medium) and virals wabs (BD H192(07) flexible mini-tip flocked nasopharyngeal swabs in 3mL Universal Transport Medium) for SARS-CoV-2 PCR testing using Simplexa COVID-19 Direct assay on patients over a 4-day period. When the results were discordant, the viral swab sample was run again on the Cepheid Xpert Xpress ® SARS-CoV-2 assay. Results Of the 81 included samples, there were 19 positives and 62 negatives in viral media and 18 positives and 63 negative in the MRSA swabs. Amongst all included samples, there was concordance between the COPAN ESwabs ® 480C and the viral swabs in 78 (96.3%). Conclusion We found a high rate of concordance in test results between COPAN ESwabs ® 480C in Amies solution and BD H192(07) nasopharyngeal swabs in in 3 mL of Universal Viral Transport medium viral media. Clinicians and laboratories should feel better informed and assured using COPAN ESwabs ® 480C to help in the diagnosis of COVID-19.

The critical nature of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician/advanced practice provider and the microbiologists who provide enormous value to the healthcare team. This document, developed by experts in laboratory and adult and pediatric clinical medicine, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. This document presents a system-based approach rather than specimen-based approach, and includes bloodstream and cardiovascular system infections, central nervous system infections, ocular infections, soft tissue infections of the head and neck, upper and lower respiratory infections, infections of the gastrointestinal tract, intra-abdominal infections, bone and joint infections, urinary tract infections, genital infections, and other skin and soft tissue infections; or into etiologic agent groups, including arthropod-borne infections, viral syndromes, and blood and tissue parasite infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. In addition, the pediatric needs of specimen management are also emphasized. There is intentional redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a guidance for physicians in choosing tests that will aid them to quickly and accurately diagnose infectious diseases in their patients.

The mammalian immune system deploys complex mechanisms to identify and defeat infections. Innate immunity recognizes molecular patterns associated both with entire classes of pathogens and with cell damage and distress. Adaptive immunity develops target-specific recognition and attack molecules aimed at specific and unique molecular elements of pathogens. A panoply of effector mechanisms directed by the innate and adaptive immune systems delay, damage, expel, contain, or destroy invading microbes. Unfortunately, most pathogenic microbes multiply hundreds of times as rapidly as we; so for every complex and elegant mechanism of immunity, microbes have found ways to subvert or evade. This chapter provides an outline of the components of mammalian immunity and, using five model organisms, explore a few of the astonishing array of mechanisms pathogenic microbes use to maintain themselves and proliferate inside the human body. Additionally, we attempt to describe the regulatory subtlety and discretion of both the immune system and the pathogen; the former to avoid overreaction and self-damage, the latter to utilize the resources of the host for efficient maintenance and transmission. Human infections are the outcome of these intricate, edged molecular conversations between host and pathogen.

The Andromeda Galaxy is the closest spiral galaxy to us and has been the subject of numerous studies. It harbors a massive dark matter (DM) halo which may span up to ~600 kpc across and comprises ~90% of the galaxy's total mass. This halo size translates into a large diameter of 42 degrees on the sky for an M31-Milky Way (MW) distance of 785 kpc, but its presumably low surface brightness makes it challenging to detect with gamma-ray telescopes. Using 7.6 years of Fermi Large Area Telescope (Fermi-LAT) observations, we make a detailed study of the gamma-ray emission between 1-100 GeV towards M31's outer halo, with a total field radius of 60 degrees centered at M31, and perform an in-depth analysis of the systematic uncertainties related to the observations. We use the cosmic ray (CR) propagation code GALPROP to construct specialized interstellar emission models (IEMs) to characterize the foreground gamma-ray emission from the MW, including a self-consistent determination of the isotropic component. We find evidence for an extended excess that appears to be distinct from the conventional MW foreground, having a total radial extension upwards of ~120-200 kpc from the center of M31. We discuss plausible interpretations of the excess emission but emphasize that uncertainties in the MW foreground, and in particular, modeling of the H I-related components, have not been fully explored and may impact the results. This study was first presented in a poster at the 8th International Fermi Symposium. The article describing the full analysis is under preparation and will be published elsewhere., Comment: Presented at the 8th International Fermi Symposium, Oct. 14-19, 2018, Baltimore, MD

Immunoassays for the detection of the antigens of microorganisms remain important tools for the diagnosis and management of infectious diseases. Antigen tests have long been used to detect infectious agents and are particularly useful for those agents that are difficult, slow, or hazardous to culture. While antigen tests are being superseded in many cases by simple and rapid molecular amplification methods, the combination of speed, economy, simplicity, and lack of expensive equipment allows antigen tests to retain a role in rapid testing, point-of-care testing, testing in low- to mid-resource areas, and global health testing. In this chapter, the principles of antigen detection techniques are reviewed, along with their current applications in diagnostic microbiology and clinical practice, including in global health testing.

Many of you reading this feature spend roughly half your waking hours in some form of professional activity. Why did you choose that particular activity? For the money? Because your parents or a teacher made you? Many of you might answer “because it's important.” However, that answer is not very particular. We live in a complex world in which a capable person can pursue any number of career paths. Why pursue the particular path that you do? Why, among the vast array of potential occupations, are you interested in microbiology?

The absence of markers of inflammation in the cerebrospinal fluid (CSF) commonly predicts the absence of herpes simplex virus (HSV) central nervous system (CNS) infection. Consequently, multiple authors have proposed and validated criteria for deferring HSV PCR testing of CSF in immunocompetent hosts with normal CSF white blood cell and protein levels (≤5 cells/mm

We present an analysis of the radial angular profile of the galacto-isotropic (GI) $\gamma$-ray flux--the statistically uniform flux in circular annuli about the Galactic center. Two different approaches are used to measure the GI flux profile in 85 months of Fermi-LAT data: the BDS statistic method which identifies spatial correlations, and a new Poisson ordered-pixel method which identifies non-Poisson contributions. Both methods produce similar GI flux profiles. The GI flux profile is well-described by an existing model of bremsstrahlung, $\pi^0$ production, inverse Compton scattering, and the isotropic background. Discrepancies with data in our full-sky model are not present in the GI component, and are therefore due to mis-modeling of the non-GI emission. Dark matter annihilation constraints based solely on the observed GI profile are close to the thermal WIMP cross section below 100 GeV, for fixed models of the dark matter density profile and astrophysical $\gamma$-ray foregrounds. Refined measurements of the GI profile are expected to improve these constraints by a factor of a few., Comment: 20 pages, 15 figures, references added

AccuProbe (Hologic, Marlborough, MA) is an FDA-approved commercial test used for the identification of Mycobacterium tuberculosis complex, Mycobacterium avium, Mycobacterium intracellulare, Mycobacterium avium complex (MAC), Mycobacterium gordonae, and Mycobacterium kansasii from growth in solid or

The West African Ebola virus epidemic of 2013–2016 was the most widespread epidemic of this disease in history; it is estimated that this occurrence contributed to more than 11000 deaths. During the epidemic, healthcare workers (HCW)8 (including laboratorians) were mobilized to care for individuals with suspected or confirmed Ebola virus disease (EVD). However, at the height of the epidemic, guidance on appropriate safety measures for laboratory workers manipulating specimens from EVD patients was sparse. This highlighted the need for data and guidelines for laboratories testing specimens not only for patients with EVD, but for any emerging infectious disease. During the Ebola epidemic, questions were raised about the roles and responsibilities of laboratories in responding to highly infectious diseases, and the burden of ongoing readiness for rare events. As the outbreak decelerates, laboratorians must regroup, gather data, and prepare for future outbreaks. We have asked 4 experts in this field to share their thoughts on contemporary challenges in laboratory preparedness for emerging infectious diseases. During the recent Ebola epidemic, what laboratory testing did your hospital offer for patients with suspected EVD? Who performed this testing and where was the testing performed? Did you have dedicated equipment for laboratory testing or did you utilize existing core laboratory equipment? Eileen Burd: Patients with clinical symptoms and appropriate epidemiologic risk factors for EVD were stratified as high, intermediate, or low risk by the provider seeing the patient. If evaluation revealed low risk or no identifiable risk, standard tests were generally ordered that included tests for diagnoses other than EVD including complete blood count (CBC) with differential, complete metabolic profile (CMP), and malaria testing. Other tests that were ordered as indicated by the patient's symptoms included blood cultures, respiratory virus testing, urinalysis, urine culture, and molecular gastrointestinal panels. Blood and other specimens were collected …

Objectives Patient care and public health in the United States depend on timely and reliable clinical laboratory testing. A third of the roughly 500 million yearly patient visits to health care providers involve at least one laboratory test, and approximately 70% of medical decisions are based upon test results. However, the performance of clinical laboratory testing could be compromised by patient specimens potentially contaminated with highly infectious materials. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola crisis, where fears about safety resulted in some institutions refusing or delaying tests on patient specimens, which resulted in delayed diagnoses and contributed to patient deaths. Methods In collaboration with subject matter experts from academia, medical centers, and federal institutions, the Centers for Disease Control and Prevention has reviewed the capability of clinical laboratories to safely test patient specimens potentially contaminated with highly infectious materials, like Ebola. Current biosafety guidance for clinical laboratories has been largely based on biosafety practices in research laboratories, so the guidelines do not always correspond to clinical laboratories and may be incomplete or occasionally inconsistent. While essential to patient care, clinical laboratories are also unique environments with specialized equipment, processes, and therefore distinct challenges. Here we discuss the complexity of clinical laboratories and describe how applying current biosafety guidance to clinical laboratories may be difficult and confusing at best or inappropriate and harmful at worst. We describe biosafety gaps and opportunities for improvement in the areas of ethics; risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; waste management; laboratory personnel training and competency assessment; and accreditation processes. Conclusion These identified gaps in knowledge and practice could inform future research and education in clinical laboratory biosafety.

Lower respiratory tract infections (LRTIs) produce between 5 and 10% of all deaths reported to the CDC via the 122 Cities Mortality Reporting System ([5][1]). The clinical laboratory plays a vital role in the diagnosis of these infections but faces numerous challenges due to the complexity of LRTIs

Tuberculosis is a serious global health threat for which new treatments are urgently needed. This study examined the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of the oxazolidinone PNU-100480 in healthy volunteers, using biomarkers for safety and efficacy. Subjects were randomly assigned to PNU-100480 or placebo (4:1) at schedules of 100, 300, or 600 mg twice daily or 1,200 mg daily for 14 days or a schedule of 600 mg twice daily for 28 days to which pyrazinamide was added on days 27 and 28. A sixth cohort was given linezolid at 300 mg daily for 4 days. Signs, symptoms, and routine safety tests were monitored. Bactericidal activity against Mycobacterium tuberculosis was measured in ex vivo whole-blood culture. Plasma drug and metabolite concentrations were compared to the levels required for inhibition of M. tuberculosis growth and 50% inhibition of mitochondrial protein synthesis. All doses were safe and well tolerated. There were no hematologic or other safety signals during 28 days of dosing at 600 mg twice daily. Plasma concentrations of PNU-100480 and metabolites at this dose remained below those required for 50% inhibition of mitochondrial protein synthesis. Cumulative whole-blood bactericidal activity of PNU-100480 at this dose (−0.316 ± 0.04 log) was superior to the activities of all other doses tested ( P < 0.001) and was significantly augmented by pyrazinamide (−0.420 ± 0.06 log) ( P = 0.002). In conclusion, PNU-100480 was safe and well tolerated at all tested doses. Further studies in patients with tuberculosis are warranted. Biomarkers can accelerate early development of new tuberculosis treatments.

Virological, epidemiologic, and operational barriers have slowed the progress toward effective management and eradication of HIV infection, despite significant advances in diagnosis since the early 1980s. Because early diagnosis profoundly affects the health care and survival of infected/high-risk individuals, and because the time required for conventional testing remains a barrier in many settings, rapid HIV testing has been developed for use both in the clinical laboratory and at the point of care. Recent studies have identified applications, advantages, and limitations of these assays, which may influence the development of new and more effective public health testing and screening protocols. In the United States, the Food and Drug Administration has approved the use of six rapid HIV tests. This review summarizes these modern rapid point-of-care HIV tests and their role in preventing the spread of HIV and in detecting, managing, and treating patients affected by the HIV pandemic.

We present raytracing computations for light emitted from the surface of a rapidly-rotating neutron star in order to construct light curves for X-ray pulsars and bursters. These calculations are for realistic models of rapidly-rotating neutron stars which take into account both the correct exterior metric and the oblate shape of the star. We find that the most important effect arising from rotation comes from the oblate shape of the rotating star. We find that approximating a rotating neutron star as a sphere introduces serious errors in fitted values of the star's radius and mass if the rotation rate is very large. However, in most cases acceptable fits to the ratio M/R can be obtained with the spherical approximation., Comment: Accepted by the Astrophysical Journal. 13 pages & 7 figures

Nocardia thailandica is a rare pathogen related to Nocardia asteroides , Nocardia neocaledoniensis , and Nocardia caishijiensis that, since its original description in 2004, has only been reported to cause wound and ocular infections in humans. We report a case of pulmonary nocardiosis caused by Nocardia thailandica in a 66-year-old solid organ transplant patient from Connecticut, which was identified at the molecular taxonomic level by secA1 analysis, 16S rRNA gene sequencing, and matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS). To our knowledge, this is the first reported case of N. thailandica in the United States and the first report of pulmonary infection by this pathogen in the literature.

d -Arabinitol (DA) is a useful diagnostic marker for candidiasis in patients with neutropenia and other high-risk groups, but its use in unselected patients with a broad range of underlying diseases and conditions has not been studied. We used an automated enzymatic fluorometric assay to measure serum DA/creatinine ratios (DA/cr's) in 30 healthy adults, 100 hospitalized controls without Candida fungemia, and 83 patients from a study of all Candida fungemias in Connecticut between October 1998 and September 1999. Sixty-three of 83 (76%) fungemic patients and 11 of 100 (11%) nonfungemic controls had serum DA/cr's ≥3.9 μM/mg/dl (mean + 3 standard deviations for 30 healthy adults). High serum DA/cr's were less frequent in patients with cancer or fungemia caused by the DA nonproducer Candida glabrata than in patients with cancer or fungemia caused by a DA producer, C. albicans , C. tropicalis , or C. parapsilosis . The serum DA/cr was first ≥3.9 μM/mg/dl before, on the same day as, or after the first positive blood culture was drawn for 30 (36%), 22 (27%), and 11 (13%) fungemia patients, respectively. Mortality did not differ significantly among the patients with high or normal initial or peak serum DA/cr's, but mortality was higher if any serum DA/cr value was ≥3.9 μM/mg/dl 3 or more days after the onset of fungemia (18/27 versus 4/24 patients, respectively; P < 0.001). We conclude that serum DA/cr's are useful both for the initial diagnosis of Candida fungemia and for prognostic purposes for unselected patients with a broad range of underlying diseases and conditions.

Eighty-one percent of U.S. laboratories operate under a certificate of waiver or a provider-performed microscopy certificate, which allow them to perform a strictly defined subset of tests essentially without oversight. Waived tests, under the Clinical Laboratory Improvement Amendments statute, are required to be “simple” and to have an “insignificant risk of an erroneous result.” The number of analytes and individual test systems available as waived methods is large and increasing. Infectious disease tests available in waived format include Helicobacter pylori antibody, HIV-1 and 2 antibody, Influenza A/B antigen, Lyme antibody screen, Monospot, respiratory syncytial virus (RSV) antigen, RSV antibody, and Streptococcus group A antigen. Waived tests represent a compromise between access and quality of care. Quality problems in waived testing settings, demonstrated by state and Centers for Medicare and Medical Services (CMS) surveys, suggest that laboratory professionals could improve care by supporting waived testing laboratories, if systems to facilitate such interactions can be developed.

Ten years have passed since the Graylyn Conference Report on Laboratory Medicine/Clinical Pathology training was issued. During that period, the Accreditation Council for Graduate Medical Education (ACGME) substantially revised the requirements for training programs, the American Board of Pathology (ABP) amended the requirements and the time needed for certification, and the discipline itself along with the broader discipline of pathology, evolved significantly. Recently, a curriculum proposal in anatomic pathology was published as a potential template to be used by training programs to help meet these new and evolving needs. Toward the same end, the Academy of Clinical Laboratory Physicians and Scientists has developed a template for a curriculum in clinical pathology (laboratory medicine), taking into account newly designated and revised areas of residency core competency, the alterations in training requirements promulgated by the ACGME and ABP, and the rapidly developing nature of the discipline itself The proposed clinical pathology curriculum defines goals and objectives for training, provides guidelines for instructional methods, and gives examples of how outcomes can be assessed. This curriculum is presented as a potentially helpful outline for use by pathology residency training programs.

Human immunodeficiency virus (HIV) is a major global public health problem. In the United States alone, 1 to 1.18 million people are affected, of whom approximately one quarter are unaware of their diagnosis. In the early stage of the epidemic, when effective therapy was not available, testing for HIV was done primarily to protect the nation’s blood supply. However, with the advent of highly active antiretroviral therapy, HIV is highly treatable, and those infected can live longer. Because more than one third of patients diagnosed with HIV are diagnosed with acquired immunodeficiency syndrome within 1 year after diagnosis, it is likely that many patients are infected for many years before diagnosis. Furthermore, beause approximately 20,000 new infections in the United tates are transmitted by people unaware of their HIV positive tatus, early detection of HIV has the potential to decrease ew infections and prevent complications from advanced disase and has been shown to be cost-effective. The Centers for Disease Control and Prevention recommends offering routine screening for HIV in health care settings for all patients aged 13 to 64 years, unless the prevalence of undiagnosed infection has been documented to be less than 0.1%.