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Article ; Online: Designing Studies Acceptable for Abstraction and Inclusion in Evidence-Based Laboratory Practice Guidelines.

Saubolle, Michael A / Weissfeld, Alice S / Kraft, Colleen S

2019 Volume 57, Issue 3

Abstract: Expansion of technologies, changing infrastructure, and dwindling resources have produced the need for health care reform and changes in clinical laboratories. The health care model will have to shift increasingly from a fee-for-service model to a value- ... ...

Abstract	Expansion of technologies, changing infrastructure, and dwindling resources have produced the need for health care reform and changes in clinical laboratories. The health care model will have to shift increasingly from a fee-for-service model to a value-based model. Laboratories will have to focus more on evidence-based outcome studies evaluating the effects of their preanalytical and postanalytical practices on real patient outcomes. Although well-designed clinical trials and multicenter studies are needed to determine the effects of laboratory processes on outcomes, there has been concern that too few well-designed studies have been published. To help improve the quality of study design and to facilitate reporting transparency, several method statements have been developed. The Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative was recently updated, listing 30 items deemed crucial for transparent reporting of studies, thereby allowing the creation of a robust database for clinical practice guidelines. Three methods describing the assessment of the quality of data on which to base recommendations for such guidelines are also available. Close attention must be given to study design so that parameters ensuring study quality are met, thereby allowing inclusion of the study data in the formulation of evidence-based laboratory best practices guidelines.
MeSH term(s)	Clinical Studies as Topic ; Evidence-Based Practice/standards ; Evidence-Based Practice/statistics & numerical data ; Guidelines as Topic ; Humans ; Laboratories/standards ; Laboratories/statistics & numerical data ; Quality Control ; Research Design/standards ; Research Report/standards
Language	English
Publishing date	2019-02-27
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.00842-18
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Article: Laboratory aspects in the diagnosis of coccidioidomycosis.

Saubolle, Michael A

Annals of the New York Academy of Sciences

2007 Volume 1111, Page(s) 301–314

Abstract: Coccidioides immitis and Coccidioides posadasii, the two recognized causes of coccidioidomycosis, may be detected by direct microscopy, culture, and serologic documentation. Two useful stains include the Grocott methenamine silver (GMS) and the ... ...

Abstract	Coccidioides immitis and Coccidioides posadasii, the two recognized causes of coccidioidomycosis, may be detected by direct microscopy, culture, and serologic documentation. Two useful stains include the Grocott methenamine silver (GMS) and the calcofluor white (CFW). Other useful stains used in histopathologic studies include hematoxylin-eosin (H&E) and periodic acid Schiff (PAS). Nucleic acid amplification tests (NAATs) have been introduced for detection of Coccidioides spp. in specimens, but are not yet commercially available. Isolation of Coccidioides spp. by culture is not difficult as many fungal as well as routine bacteriologic media are available. For the safe isolation of Coccidioides spp., the laboratory should maintain a biological safety level 2 or 3. Identification of Coccidioides spp. uses the organisms' phenotypic or genotypic characteristics. Phenotypic identification to genus level may be achieved by visualization of spherules in specimens and/or by the presence of arthroconidia in culture. Isolates may be confirmed as Coccidioides spp. by molecular probes. Separation of species into C. immitis and C. posadasii is best achieved by specialized molecular techniques which are not normally available in routine clinical laboratories. Humoral antibodies can be used for the diagnosis and prognosis of coccidioidomycosis. Although positive serologic results may be helpful in the diagnosis of coccidioidomycosis, negative serologic results cannot be used to rule out the disease. Enzyme immunoassays (EIA) and immunodiffusion methods are commonly used for detection of both IgM and IgG antibody groups. Sequential complement fixation (CF) studies for IgG class of antibody are useful for the prognosis of coccidioidomycosis.
MeSH term(s)	Benzenesulfonates/chemistry ; Chemistry, Clinical/methods ; Coccidioidomycosis/diagnosis ; Eosine Yellowish-(YS)/chemistry ; Hematoxylin/chemistry ; Humans ; Immune System/microbiology ; Immunoglobulin G/chemistry ; Inflammation ; Methenamine/chemistry ; Microbiological Techniques ; Mycological Typing Techniques ; Periodic Acid-Schiff Reaction
Chemical Substances	Benzenesulfonates ; Immunoglobulin G ; C.I. Fluorescent Brightening Agent 28 (7S9P0Y4313) ; Methenamine (J50OIX95QV) ; Eosine Yellowish-(YS) (TDQ283MPCW) ; Hematoxylin (YKM8PY2Z55)
Language	English
Publishing date	2007-09
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	211003-9
ISSN	1749-6632 ; 0077-8923
ISSN (online)	1749-6632
ISSN	0077-8923
DOI	10.1196/annals.1406.049
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Article ; Online: Aerobic Actinomycetes of Clinical Significance.

Mochon, A Brian / Sussland, Den / Saubolle, Michael A

Microbiology spectrum

2016 Volume 4, Issue 4

Abstract: The group of Gram-positive bacillary organisms broadly known as "aerobic actinomycetes" consists of heterogeneous and taxonomically divergent genera. They are found in a wide variety of natural and man-made environments but are rarely considered a part ... ...

Abstract	The group of Gram-positive bacillary organisms broadly known as "aerobic actinomycetes" consists of heterogeneous and taxonomically divergent genera. They are found in a wide variety of natural and man-made environments but are rarely considered a part of the normal human flora, with infections normally originating from exogenous sources. An extensive number of genera have been described, but only a minority of these has been associated with human or veterinary health. The association with human disease is usually of an opportunistic nature, either through accidental means of inoculation or through involvement with immunocompromising conditions in the host. They cause a wide spectrum of diseases in humans, which may differ greatly between the genera and even between species, but which also may have a great amount of overlap. The occurrence of such infections is probably greater than appreciated, since many may go unrecognized. Etiologic prevalence of specific genera and species varies geographically within the United States and worldwide. Traditional phenotypic identification methods for separation of the many genera and species of aerobic actinomycetes have found great difficulties. Recent use of chemotaxonomic analyses and emerging technologies such as molecular analysis of nucleic acids, and more recently proteomics for identification to the genus/species level, has provided a far more robust technique to understand the organisms' relatedness, distribution, epidemiology, and pathogenicity in humans.
MeSH term(s)	Actinobacteria/classification ; Actinobacteria/isolation & purification ; Bacteriological Techniques/methods ; Disease Susceptibility ; Global Health ; Gram-Positive Bacterial Infections/diagnosis ; Gram-Positive Bacterial Infections/drug therapy ; Gram-Positive Bacterial Infections/epidemiology ; Gram-Positive Bacterial Infections/pathology ; Humans ; Immunocompromised Host ; Opportunistic Infections/diagnosis ; Opportunistic Infections/drug therapy ; Opportunistic Infections/epidemiology ; Opportunistic Infections/pathology
Language	English
Publishing date	2016-10-10
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2165-0497
ISSN (online)	2165-0497
DOI	10.1128/microbiolspec.DMIH2-0021-2015
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Article: Antimicrobial resistance: current status and future direction.

Saubolle, Michael A

American journal of rhinology

2006 Volume 20, Issue 6, Page(s) 667–671

Abstract: Background: Antimicrobial resistance is initiated through mutations in bacterial genes, culminating in end products that help circumvent the action of specific antimicrobial agents. Resistant mutants can proliferate under a number of circumstances but ... ...

Abstract	Background: Antimicrobial resistance is initiated through mutations in bacterial genes, culminating in end products that help circumvent the action of specific antimicrobial agents. Resistant mutants can proliferate under a number of circumstances but primarily through the action of selective pressure from the overuse of antimicrobial agents. Methods: The results of surveillance studies over approximately the last ten years were evaluated. Conclusion: Resistance rates in the group of microorganisms associated with respiratory tract infections had been increasing rapidly over the past 10 years, but, recently, many seem to have reached a plateau. However, newer, more invasive clones of methicillin resistant Staphylococcus aureus (MRSA), differing from health care-associated MRSA (HA-MRSA), and typically associated with community-acquisition (CA-MRSA), recently have begun to proliferate. Burgeoning use of fluoroquinolones has impacted the Gram-negative bacilli (e.g., Pseudomonas aeruginosa, Escherichia coli, and Salmonella), causing their resistance rates to approach the critical point. A better understanding of the epidemiology of resistance and responsible use of antimicrobial agents are mandatory if the continuing rates of increasing resistance are to be abrogated.
MeSH term(s)	Anti-Bacterial Agents/pharmacology ; Bacteria/drug effects ; Bacteria/growth & development ; Bacterial Infections/drug therapy ; Bacterial Infections/microbiology ; Drug Resistance, Bacterial ; Humans ; Sinusitis/drug therapy ; Sinusitis/microbiology
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2006-12-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	645175-5
ISSN	1050-6586 ; 1945-8924
ISSN	1050-6586 ; 1945-8924
DOI	10.2500/ajr.2006.20.2953
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Article ; Online: Transmission of coccidioidomycosis to a human via a cat bite.

Gaidici, Adriana / Saubolle, Michael A

Journal of clinical microbiology

2008 Volume 47, Issue 2, Page(s) 505–506

Abstract: We report an unusual case of coccidioidomycosis in the arm of a veterinary assistant without pulmonary symptoms. The patient had been bitten on the hand by a cat which was later diagnosed with disseminated disease. The patient responded to fluconazole ... ...

Abstract	We report an unusual case of coccidioidomycosis in the arm of a veterinary assistant without pulmonary symptoms. The patient had been bitten on the hand by a cat which was later diagnosed with disseminated disease. The patient responded to fluconazole therapy and remained asymptomatic at 2 months after cessation of therapy.
MeSH term(s)	Adult ; Animals ; Antifungal Agents/therapeutic use ; Bites and Stings ; Cat Diseases/microbiology ; Cat Diseases/transmission ; Cats ; Coccidioidomycosis/drug therapy ; Coccidioidomycosis/transmission ; Coccidioidomycosis/veterinary ; Female ; Fluconazole/therapeutic use ; Humans
Chemical Substances	Antifungal Agents ; Fluconazole (8VZV102JFY)
Language	English
Publishing date	2008-12-03
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.01860-08
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Article ; Online: Multicenter Clinical Validation of a Cartridge-Based Real-Time PCR System for Detection of Coccidioides spp. in Lower Respiratory Specimens.

Saubolle, Michael A / Wojack, Bette R / Wertheimer, Anne M / Fuayagem, Atehkeng Z / Young, Stephen / Koeneman, Brian A

Journal of clinical microbiology

2018 Volume 56, Issue 2

Abstract: Available methods for the diagnosis of coccidioidomycosis have significant shortcomings relative to accuracy and timeliness. We retrospectively and prospectively evaluated the diagnostic performance and reproducibility of a new cartridge-based real-time ... ...

Abstract	Available methods for the diagnosis of coccidioidomycosis have significant shortcomings relative to accuracy and timeliness. We retrospectively and prospectively evaluated the diagnostic performance and reproducibility of a new cartridge-based real-time PCR assay for
MeSH term(s)	Bronchoalveolar Lavage Fluid/microbiology ; Coccidioides/genetics ; Coccidioides/isolation & purification ; Coccidioidomycosis/diagnosis ; Coccidioidomycosis/microbiology ; DNA, Fungal/genetics ; Humans ; Limit of Detection ; Molecular Diagnostic Techniques/methods ; Prospective Studies ; Real-Time Polymerase Chain Reaction/standards ; Reproducibility of Results ; Retrospective Studies ; Sensitivity and Specificity ; Southwestern United States ; Time Factors
Chemical Substances	DNA, Fungal
Language	English
Publishing date	2018-01-24
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't ; Validation Studies
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.01277-17
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Article ; Online: Comparison of a Novel Rapid Lateral Flow Assay to Enzyme Immunoassay Results for Early Diagnosis of Coccidioidomycosis.

Donovan, Fariba M / Ramadan, Ferris A / Khan, Sher A / Bhaskara, Apoorva / Lainhart, William D / Narang, Aneesh T / Mosier, Jarrod M / Ellingson, Katherine D / Bedrick, Edward J / Saubolle, Michael A / Galgiani, John N

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2020 Volume 73, Issue 9, Page(s) e2746–e2753

Abstract: Background: Coccidioidomycosis (CM) is a common cause of community-acquired pneumonia where CM is endemic. Manifestations include self-limited pulmonary infection, chronic fibrocavitary pulmonary disease, and disseminated coccidioidomycosis. Most ... ...

Abstract	Background: Coccidioidomycosis (CM) is a common cause of community-acquired pneumonia where CM is endemic. Manifestations include self-limited pulmonary infection, chronic fibrocavitary pulmonary disease, and disseminated coccidioidomycosis. Most infections are identified by serological assays including enzyme-linked immunoassay (EIA), complement fixation, and immunodiffusion. These are time-consuming and take days to result, impeding early diagnosis. A new lateral flow assay (LFA; Sōna; IMMY, Norman, OK) improves time-to-result to 1 hour. Methods: We prospectively enrolled 392 patients with suspected CM, compared the LFA with standard EIA and included procalcitonin evaluation. Results: Compared with standard EIA, LFA demonstrates 31% sensitivity (95% confidence interval [CI], 20-44%) and 92% specificity (95% CI, 88-95%). Acute pulmonary disease (74%) was the most common clinical syndrome. Hospitalized patients constituted 75% of subjects, and compared with outpatients, they more frequently had ≥3 previous healthcare facility visits (P = .05), received antibacterials (P < .01), and had >3 antibacterial courses (P < .01). Procalcitonin (PCT) was <0.25 ng/mL in 52 (83%) EIA-positive patients, suggesting infection was not bacterial. Conclusions: When CM is a possible diagnosis, LFA identified nearly one-third of EIA-positive infections. Combined with PCT <0.25 ng/mL, LFA could reduce unnecessary antibacterial use by 77%.
MeSH term(s)	Coccidioidomycosis/diagnosis ; Early Diagnosis ; Humans ; Immunoassay ; Immunoenzyme Techniques ; Sensitivity and Specificity
Language	English
Publishing date	2020-08-17
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciaa1205
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Article: Nocardiosis: review of clinical and laboratory experience.

Saubolle, Michael A / Sussland, Den

Journal of clinical microbiology

2003 Volume 41, Issue 10, Page(s) 4497–4501

MeSH term(s)	Bacterial Typing Techniques ; Bacteriological Techniques ; Humans ; Nocardia/classification ; Nocardia/genetics ; Nocardia/pathogenicity ; Nocardia Infections/epidemiology ; Nocardia Infections/microbiology ; Nocardia Infections/physiopathology
Language	English
Publishing date	2003-08-20
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.41.10.4497-4501.2003
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Article ; Online: Interlaboratory agreement of coccidioidomycosis enzyme immunoassay from two different manufacturers.

Khan, Soofia / Saubolle, Michael A / Oubsuntia, Terry / Heidari, Arash / Barbian, Kelly / Goodin, Kate / Eguchi, Megan / McCotter, Orion Z / Komatsu, Kenneth / Park, Benjamin J / Geiger, Matthew Casey / Mohamed, Ahmed / Chiller, Tom / Sunenshine, Rebecca H

Medical mycology

2018 Volume 57, Issue 4, Page(s) 441–446

Abstract: Coccidioidomycosis, a fungal infection endemic to the Southwestern United States, is challenging to diagnose. The coccidioidomycosis enzyme immunoassay (EIA) test is the least expensive and simplest to perform to detect coccidioidomycosis antibodies in ... ...

Abstract	Coccidioidomycosis, a fungal infection endemic to the Southwestern United States, is challenging to diagnose. The coccidioidomycosis enzyme immunoassay (EIA) test is the least expensive and simplest to perform to detect coccidioidomycosis antibodies in the serum. Concerns regarding falsely positive immunoglobulin (Ig) M EIA test results have led to questions about the agreement of commercially available EIA test kits among laboratories. We sought to evaluate the laboratory agreement of the EIA test at three laboratories using both IMMY and Meridian EIA test kits. Sensitivity and specificity of EIA IgM and IgG were calculated as secondary outcomes. The percent agreement of the EIA IgM and IgG test results among all three laboratories was 90% and 89% for IMMY test kits, respectively, and 67% and 80.5% for Meridian test kits, respectively. Agreement between IgM and IgG combined test results was 85.5% and 70.5%, for IMMY and Meridian, respectively. Combined IgM and IgG assays demonstrated a sensitivity of 68% (62.7%-76%) and a specificity of 99.3% (98%-100%) [IMMY] and a sensitivity of 72.4% (57.3%-87.3%) and a specificity of 91.3% (74%-100%) [Meridian]. In summary, results from the IMMY EIA test kit agreed more often across laboratories than Meridian EIA results, especially for the IgM assay. Isolated positive IgM EIA results using the Meridian test kit should be interpreted with caution and consideration of clinical information and test methodology. Further study of the sensitivity and specificity of coccidioidomycosis EIA test kits is warranted.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Fungal/blood ; Child ; Child, Preschool ; Coccidioidomycosis/diagnosis ; Female ; Humans ; Immunoenzyme Techniques/methods ; Immunoglobulin G/blood ; Immunoglobulin M/blood ; Male ; Middle Aged ; Reagent Kits, Diagnostic ; Reproducibility of Results ; Sensitivity and Specificity ; Serologic Tests/methods ; United States ; Young Adult
Chemical Substances	Antibodies, Fungal ; Immunoglobulin G ; Immunoglobulin M ; Reagent Kits, Diagnostic
Language	English
Publishing date	2018-07-03
Publishing country	England
Document type	Evaluation Studies ; Journal Article
ZDB-ID	1421796-x
ISSN	1460-2709 ; 1369-3786
ISSN (online)	1460-2709
ISSN	1369-3786
DOI	10.1093/mmy/myy059
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Article: Epidemiologic, clinical, and diagnostic aspects of coccidioidomycosis.

Saubolle, Michael A / McKellar, Peter P / Sussland, Den

Journal of clinical microbiology

2007 Volume 45, Issue 1, Page(s) 26–30

MeSH term(s)	Adult ; Aged ; Coccidioides/isolation & purification ; Coccidioidomycosis/diagnosis ; Coccidioidomycosis/epidemiology ; Coccidioidomycosis/microbiology ; Coccidioidomycosis/physiopathology ; Humans ; Middle Aged
Language	English
Publishing date	2007-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.02230-06
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