Browsing by Author "Hanson, Kimberly E"

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    Blastomyces helicus, a New Dimorphic Fungus Causing Fatal Pulmonary and Systemic Disease in Humans and Animals in Western Canada and the United States.
    (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019-01) Schwartz, Ilan S; Wiederhold, Nathan P; Hanson, Kimberly E; Patterson, Thomas F; Sigler, Lynne

    Background

    Blastomyces helicus (formerly Emmonsia helica) is a dimorphic fungus first isolated from a man with fungal encephalitis in Alberta, Canada. The geographic range, epidemiology, and clinical features of disease are unknown.

    Methods

    We reviewed human and veterinary isolates of B. helicus identified among Blastomyces and Emmonsia isolates at the University of Alberta Microfungus Collection and Herbarium, University of Texas Health San Antonio's Fungus Testing Laboratory, and Associated Regional and University Pathologists Laboratories. Isolates were selected based on low Blastomyces dermatitidis DNA probe values and/or atypical morphology. Species identification was confirmed for most isolates by DNA sequence analysis of the internal transcribed spacer with or without D1/D2 ribosomal RNA regions. Epidemiological and clinical data were analyzed.

    Results

    We identified isolates from 10 human and 5 veterinary cases of B. helicus infection; all were referred from western regions of Canada and the United States. Isolates remained sterile in culture, producing neither conidia nor sexual spores in the mycelial phase, but often producing coiled hyphae. Isolates were most frequently cultured from blood and bronchoalveolar lavage in humans and lungs in animals. Most infected persons were immunocompromised. Histopathological findings included pleomorphic, small or variably sized yeast-like cells, with single or multiple budding, sometimes proliferating to form short, branching, hyphal-like elements. Disease carried a high case-fatality rate.

    Conclusions

    Blastomyces helicus causes fatal pulmonary and systemic disease in humans and companion animals. It differs from B. dermatitidis in morphological presentation in culture and in histopathology, by primarily affecting immunocompromised persons, and in a geographic range that includes western regions of North America.
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    Envisioning Future UTI Diagnostics.
    (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021-08-31) Patel, Robin; Polage, Christopher R; Dien Bard, Jennifer; May, Larissa; Lee, Francesca M; Fabre, Valeria; Hayden, Mary K; Doernberg, Sarah DB; Haake, David A; Trautner, Barbara W; Grigoryan, Larissa; Tsalik, Ephraim L; Hanson, Kimberly E
    Urinary tract infections (UTIs) are among the most common bacterial infections in the United States and are a major driver of antibiotic use - both appropriate and inappropriate - across healthcare settings. UTI treatment has become complex due to antibacterial resistance; one quarter of urinary tract isolates of Escherichia coli in the United States in 2017 were resistant to fluoroquinolones and one third to trimethoprimsulfamethoxazole (1), agents with historically predictable activity against E. coli. As a result, more broad-spectrum antibiotics are being used to treat UTIs, contributing to selection of further antibiotic resistance.
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    Performance of the Euroimmun Aspergillus Antigen ELISA for the Diagnosis of Invasive Pulmonary Aspergillosis in Bronchoalveolar Lavage Fluid.
    (Journal of clinical microbiology, 2022-04) Egger, Matthias; Penziner, Samuel; Dichtl, Karl; Gornicec, Max; Kriegl, Lisa; Krause, Robert; Khong, Ethan; Mehta, Sanjay; Vargas, Milenka; Gianella, Sara; Porrachia, Magali; Jenks, Jeffrey D; Venkataraman, Iswariya; Hoenigl, Martin
    Invasive pulmonary aspergillosis (IPA) is a life-threatening disease that affects mainly immunocompromised hosts. Galactomannan testing from serum and bronchoalveolar lavage fluid (BALF) represents a cornerstone in diagnosing the disease. Here, we evaluated the diagnostic performance of the novel Aspergillus-specific galactomannoprotein (GP) enzyme-linked immunosorbent assay (ELISA; Euroimmun Medizinische Labordiagnostika) compared with the established Platelia Aspergillus GM ELISA (GM; Bio-Rad Laboratories) for the detection of Aspergillus antigen in BALF. Using the GP ELISA, we retrospectively tested 115 BALF samples from 115 patients with clinical suspicion of IPA and GM analysis ordered in clinical routine. Spearman's correlation statistics and receiver operating characteristics (ROC) curve analysis were performed. Optimal cutoff values were determined using Youden's index. Of 115 patients, 1 patient fulfilled criteria for proven IPA, 42 for probable IPA, 15 for putative IPA, 10 for possible IPA, and 47 did not meet criteria for IPA. Sensitivities and specificities for differentiating proven/probable/putative versus no IPA (possible excluded) were 74% and 96% for BALF GP and 90% and 96% for BALF GM at the manufacturer-recommended cutoffs. Using the calculated optimal cutoff value of 12 pg/mL, sensitivity and specificity of the BALF GP were 90% and 96%, respectively. ROC curve analysis showed an area under the curve (AUC) of 0.959 (95% confidence interval [CI] of 0.923 to 0.995) for the GP ELISA and an AUC of 0.960 (95% CI of 0.921 to 0.999) for the GM ELISA for differentiating proven/probable/putative IPA versus no IPA. Spearman's correlation analysis showed a strong correlation between the ELISAs (rho = 0.809, P < 0.0001). The GP ELISA demonstrated strong correlation and test performance similar to that of the GM ELISA and could serve as an alternative test for BALF from patients at risk for IPA.
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    The Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Molecular Diagnostic Testing.
    (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023-12) Hayden, Mary K; Hanson, Kimberly E; Englund, Janet A; Lee, Mark J; Loeb, Mark; Lee, Francesca; Morgan, Daniel J; Patel, Robin; El Mikati, Ibrahim K; Iqneibi, Shahad; Alabed, Farouk; Amarin, Justin Z; Mansour, Razan; Patel, Payal; Falck-Ytter, Yngve; Morgan, Rebecca L; Murad, M Hassan; Sultan, Shahnaz; Bhimraj, Adarsh; Mustafa, Reem A
    Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19) and for identifying asymptomatic carriage of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The number of available SARS-CoV-2 nucleic acid detection tests continues to increase as does the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) developed an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients, and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss nuances of test result interpretation in a variety of practice settings, and highlight important unmet research needs related to COVID-19 diagnostic testing. IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel agreed on 12 diagnostic recommendations. Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention, and the public health response to COVID-19 infection. Information on the clinical performance of available tests continues to grow, but the quality of evidence of the current literature to support this updated molecular diagnostic guideline remains moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is suggested for asymptomatic individuals with known or suspected contact with a COVID-19 case when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions. Evidence in support of rapid testing and testing of upper respiratory specimens other than nasopharyngeal swabs, which offer logistical advantages, is sufficient to warrant conditional recommendations in favor of these approaches.
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    The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing.
    (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021-01-22) Hanson, Kimberly E; Caliendo, Angela M; Arias, Cesar A; Hayden, Mary K; Englund, Janet A; Lee, Mark J; Loeb, Mark; Patel, Robin; El Alayli, Abdallah; Altayar, Osama; Patel, Payal; Falck-Ytter, Yngve; Lavergne, Valery; Morgan, Rebecca L; Murad, M Hassan; Sultan, Shahnaz; Bhimraj, Adarsh; Mustafa, Reem A

    Background

    Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance.

    Objective

    The IDSA's goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space.

    Methods

    IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations.

    Results

    The panel agreed on 17 diagnostic recommendations.

    Conclusions

    Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.
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    Universal digital high-resolution melting for the detection of pulmonary mold infections
    (Journal of Clinical Microbiology) Goshia, Tyler; Aralar, April; Wiederhold, Nathan; Jenks, Jeffrey D; Mehta, Sanjay R; Karmakar, Aprajita; E S, Monish; Sharma, Ankit; Sun, Haoxiang; Kebadireng, Refilwe; White, P Lewis; Sinha, Mridu; Hoenigl, Martin; Fraley, Stephanie I
    ABSTRACT Invasive mold infections (IMIs) are associated with high morbidity, particularly in immunocompromised patients, with mortality rates between 40% and 80%. Early initiation of appropriate antifungal therapy can substantially improve outcomes, yet early diagnosis remains difficult to establish and often requires multidisciplinary teams evaluating clinical and radiological findings plus supportive mycological findings. Universal digital high-resolution melting (U-dHRM) analysis may enable rapid and robust diagnoses of IMI. A universal fungal assay was developed for U-dHRM and used to generate a database of melt curve signatures for 19 clinically relevant fungal pathogens. A machine learning algorithm (ML) was trained to automatically classify these pathogen curves and detect novel melt curves. Performance was assessed on 73 clinical bronchoalveolar lavage samples from patients suspected of IMI. Novel curves were identified by micropipetting U-dHRM reactions and Sanger sequencing amplicons. U-dHRM achieved 97% overall fungal organism identification accuracy and a turnaround time of ~4 hrs. U-dHRM detected pathogenic molds ( Aspergillus , Mucorales , Lomentospora , and Fusarium ) in 73% of 30 samples classified as IMI, including mixed infections. Specificity was optimized by requiring the number of pathogenic mold curves detected in a sample to be > 8 and a sample volume to be 1 mL, which resulted in 100% specificity in 21 at-risk patients without IMI. U-dHRM showed promise as a separate or combination diagnostic approach to standard mycological tests. U-dHRM’s speed, ability to simultaneously identify and quantify clinically relevant mold pathogens in polymicrobial samples, and detect emerging opportunistic pathogens may aid treatment decisions, improving patient outcomes. IMPORTANCE Improvements in diagnostics for invasive mold infections are urgently needed. This work presents a new molecular detection approach that addresses technical and workflow challenges to provide fast pathogen detection, identification, and quantification that could inform treatment to improve patient outcomes.
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    β-D-glucan surveillance with preemptive anidulafungin for invasive candidiasis in intensive care unit patients: a randomized pilot study.
    (PloS one, 2012-01) Hanson, Kimberly E; Pfeiffer, Christopher D; Lease, Erika D; Balch, Alfred H; Zaas, Aimee K; Perfect, John R; Alexander, Barbara D

    Background

    Invasive candidiasis (IC) is a devastating disease. While prompt antifungal therapy improves outcomes, empiric treatment based on the presence of fever has little clinical impact. Β-D-Glucan (BDG) is a fungal cell wall component detectable in the serum of patients with early invasive fungal infection (IFI). We evaluated the utility of BDG surveillance as a guide for preemptive antifungal therapy in at-risk intensive care unit (ICU) patients.

    Methods

    Patients admitted to the ICU for ≥ 3 days and expected to require at least 2 additional days of intensive care were enrolled. Subjects were randomized in 3:1 fashion to receive twice weekly BDG surveillance with preemptive anidulafungin in response to a positive test or empiric antifungal treatment based on physician preference.

    Results

    Sixty-four subjects were enrolled, with 1 proven and 5 probable cases of IC identified over a 2.5 year period. BDG levels were higher in subjects with proven/probable IC as compared to those without an IFI (117 pg/ml vs. 28 pg/ml; p<0.001). Optimal assay performance required 2 sequential BDG determinations of ≥ 80 pg/ml to define a positive test (sensitivity 100%, specificity 75%, positive predictive value 30%, negative predictive value 100%). In all, 21 preemptive and 5 empiric subjects received systemic antifungal therapy. Receipt of preemptive antifungal treatment had a significant effect on BDG concentrations (p< 0.001). Preemptive anidulafungin was safe and generally well tolerated with excellent outcome.

    Conclusions

    BDG monitoring may be useful for identifying ICU patients at highest risk to develop an IFI as well as for monitoring treatment response. Preemptive strategies based on fungal biomarkers warrant further study.

    Trial registration

    Clinical Trials.gov NCT00672841.