256 results on '"Procop GW"'
Search Results
2. Erratum: Persistence of Plasmodium falciparum in the Placenta After Apparently Effective Quinidine/Clindamycin Therapy
- Author
-
Procop, GW, Jessen, R, Hyde, SR, and Scheck, DN
- Published
- 2001
- Full Text
- View/download PDF
3. PIN34 COST MINIMIZATION ANALYSIS OF THREE CANDIDA IDENTIFICATION TESTS WITH PREDICTION MODELS BASED ON REAL-WORLD DATA
- Author
-
Yen, JY, primary, Sims, SV, additional, Sekeres, JK, additional, Neuner, EA, additional, Shrestha, NK, additional, Hall, GS, additional, and Procop, GW, additional
- Published
- 2010
- Full Text
- View/download PDF
4. Lack of association of sarcoidosis and intestinal lymphoma with T. Whippelii infection
- Author
-
Abdelmalek, MF, primary, Procop, GW, additional, Mitchell, PS, additional, and Persing, DH, additional
- Published
- 1998
- Full Text
- View/download PDF
5. Fatal parasitic meningoencephalomyelitis caused by Halicephalobus deletrix: a case report and review of the literature.
- Author
-
Ondrejka SL, Procop GW, Lai KK, and Prayson RA
- Published
- 2010
- Full Text
- View/download PDF
6. Improved detection of biofilm-formative bacteria by vortexing and sonication: a pilot study.
- Author
-
Kobayashi H, Oethinger M, Tuohy MJ, Procop GW, and Bauer TW
- Published
- 2009
- Full Text
- View/download PDF
7. Molecular identification of bacteria from aseptically loose implants.
- Author
-
Kobayashi N, Procop GW, Krebs V, Kobayashi H, Bauer TW, Kobayashi, Naomi, Procop, Gary W, Krebs, Viktor, Kobayashi, Hideo, and Bauer, Thomas W
- Abstract
Unlabelled: Polymerase chain reaction (PCR) assays have been used to detect bacteria adherent to failed orthopaedic implants, but some PCR assays have had problems with probable false-positive results. We used a combination of a Staphylococcus species-specific PCR and a universal PCR followed by DNA sequencing to identify bacteria on implants retrieved from 52 patients (92 implants) at revision arthroplasty. We addressed two questions in this study: (1) Is this method able to show the existence of bacterial DNA on presumed aseptic loosed implants?; and (2) What proportion of presumed aseptic or culture-negative implants was positive for bacterial DNA by PCR? Fourteen implants (15%) were believed infected, whereas 74 implants (85%) were believed aseptic. Each implant was sonicated and the resulting solution was submitted for dual real-time PCR assay and culture. All implants believed aseptically loose were culture-negative, but nine of the 74 (12%) had bacterial DNA by PCR; two (2.7%) were PCR-positive and also showed histologic findings suggestive of infection. Uniquely developed PCR and bacterial sequencing assays showed bacterial DNA on 12% of implants removed for presumed aseptic loosening. Additional studies are needed to determine the clinical importance of bacterial DNA detected by PCR but not by conventional culture.Level Of Evidence: Level III, diagnostic study. [ABSTRACT FROM AUTHOR]- Published
- 2008
- Full Text
- View/download PDF
8. Brief ultrasonication improves detection of biofilm-formative bacteria around a metal implant.
- Author
-
Kobayashi N, Bauer TW, Tuohy MJ, Fujishiro T, and Procop GW
- Published
- 2007
- Full Text
- View/download PDF
9. Gonorrhea in the HIV era: a reversal in trends among men who have sex with men.
- Author
-
Fox KK, del Rio C, Holmes KK, Hook EW III, Judson FN, Knapp JS, Procop GW, Wang SA, Whittington WLH, and Levine WC
- Abstract
OBJECTIVES: Gonorrhea cases among men who have sex with men (MSM) declined in the early years of the HIV epidemic. We evaluated more recent trends in gonorrhea among MSM through the Centers for Disease Control and Prevention's Gonococcal Isolate Surveillance Project. METHODS: Isolates and case information were collected from 29 US sexually transmitted disease (STD) clinics. Gonococcal urethritis cases among MSM were compared with those among heterosexual men, and cases among MSM in 1995 to 1999 were compared with earlier MSM cases. RESULTS: Of 34,942 cases, the proportion represented by MSM increased from 4.5% in 1992 to 13.2% in 1999 (P < .001). Compared with heterosexuals, MSM were older, more often White, and more often had had gonorrhea previously, although fewer had had gonorrhea in the past year. MSM with gonorrhea in 1995 to 1999 were slightly older than those with gonorrhea in 1992 to 1994, and a higher proportion had had gonorrhea in the past year. CONCLUSIONS: MSM account for an increasing proportion of gonococcal urethritis cases in STD clinics. Given recent evidence that gonorrhea may facilitate HIV transmission, these trends demand increased attention to safe sexual behaviors and reducing STDs among MSM. [ABSTRACT FROM AUTHOR]
- Published
- 2001
- Full Text
- View/download PDF
10. An unusual source of Vibrio alginolyticus-associated otitis: prolonged colonization or freshwater exposure?
- Author
-
Mukherji A, Schroeder S, Deyling C, and Procop GW
- Published
- 2000
- Full Text
- View/download PDF
11. The use of real-time polymerase chain reaction for rapid diagnosis of skeletal tuberculosis.
- Author
-
Kobayashi N, Fraser TG, Bauer TW, Joyce MJ, Hall GS, Tuohy MJ, and Procop GW
- Published
- 2006
- Full Text
- View/download PDF
12. Low board pass rates in Blood Banking/Transfusion Medicine.
- Author
-
Procop GW, Sandersfeld T, and Fung MK
- Subjects
- Humans, Blood Banking methods, Transfusion Medicine, Blood Banks
- Published
- 2024
- Full Text
- View/download PDF
13. Reply to Kidd et al., "Inconsistencies within the proposed framework for stabilizing fungal nomenclature risk further confusion".
- Author
-
de Hoog S, Walsh TJ, Ahmed SA, Alastruey-Izquierdo A, Alexander BD, Arendrup MC, Babady E, Bai F-Y, Balada-Llasat J-M, Borman A, Chowdhary A, Clark A, Colgrove RC, Cornely OA, Dingle TC, Dufresne PJ, Fuller J, Gangneux J-P, Gibas C, Glasgow H, Graser Y, Guillot J, Groll AH, Haase G, Hanson K, Harrington A, Hawksworth DL, Hayden RT, Hoenigl M, Hubka V, Johnson K, Kus JV, Li R, Meis JF, Lackner M, Lanternier F, Leal SM Jr, Lee F, Lockhart SR, Luethy P, Martin I, Kwon-Chung KJ, Meyer W, Nguyen MH, Ostrosky-Zeichner L, Palavecino E, Pancholi P, Pappas PG, Procop GW, Redhead SA, Rhoads DD, Riedel S, Stevens B, Sullivan KO, Vergidis P, Roilides E, Seyedmousavi A, Tao L, Vicente VA, Vitale RG, Wang Q-M, Wengenack NL, Westblade L, Wiederhold N, White L, Wojewoda CM, and Zhang SX
- Abstract
Competing Interests: The authors declare no conflict of interest.
- Published
- 2024
- Full Text
- View/download PDF
14. Reply to "Fellowship Board Pass Rates Rising: Analysis of Pathology Subspecialty Examination Performance".
- Author
-
Procop GW and Nayar R
- Subjects
- Humans, Specialty Boards, Fellowships and Scholarships, Certification
- Abstract
Competing Interests: Procop is the chief executive officer for the American Board of Pathology (ABPath), and Nayar is the immediate past president of ABPath. The authors have no relevant financial interest in the products or companies described in this article.
- Published
- 2024
- Full Text
- View/download PDF
15. Detection of Clostridioides difficile infection by assessment of exhaled breath volatile organic compounds.
- Author
-
John TM, Shrestha NK, Hasan L, Pappan K, Birch O, Grove D, Boyle B, Allsworth M, Shrestha P, Procop GW, and Dweik RA
- Subjects
- Humans, Breath Tests methods, Gas Chromatography-Mass Spectrometry, ROC Curve, Diarrhea, Volatile Organic Compounds analysis
- Abstract
Clostridioides difficile infection (CDI) is the leading cause of hospital-acquired infective diarrhea. Current methods for diagnosing CDI have limitations; enzyme immunoassays for toxin have low sensitivity and Clostridioides difficile polymerase chain reaction cannot differentiate infection from colonization. An ideal diagnostic test that incorporates microbial factors, host factors, and host-microbe interaction might characterize true infection. Assessing volatile organic compounds (VOCs) in exhaled breath may be a useful test for identifying CDI. To identify a wide selection of VOCs in exhaled breath, we used thermal desorption-gas chromatography-mass spectrometry to study breath samples from 17 patients with CDI. Age- and sex-matched patients with diarrhea and negative C.difficile testing (no CDI) were used as controls. Of the 65 VOCs tested, 9 were used to build a quadratic discriminant model that showed a final cross-validated accuracy of 74%, a sensitivity of 71%, a specificity of 76%, and a receiver operating characteristic area under the curve of 0.72. If these findings are proven by larger studies, breath VOC analysis may be a helpful adjunctive diagnostic test for CDI., (© 2024 IOP Publishing Ltd.)
- Published
- 2024
- Full Text
- View/download PDF
16. When to take the primary certification examination: sooner or later?
- Author
-
Procop GW, Sandersfeld TJ, Levesque M, McCarthy T, Woodworth B, and Swerdlow SH
- Abstract
Most Pathology residents take the Anatomic Pathology and/or Clinical Pathology primary pathology certification examination(s) near the end of their final year of training (i.e., Spring), whereas some postpone the examination(s) to the Fall administration of that year or even later. We compared the Spring and Fall administration pass rates of initial primary certification candidates for those who graduated in the same year they took the examination. We also compared the pass rates of same-year graduates with individuals who postponed the examination for a year or more. We also surveyed the candidates regarding the reasons they chose the Spring or Fall administration. Candidates who chose the earlier (i.e., Spring) administration were more likely to pass compared with those who took the later Fall administration (p = 0.0026 for Anatomic Pathology; p = 0.0004 for Clinical Pathology). Delaying the certifying exams beyond the calendar year of residency graduation was associated with a higher failure rate (p < 0.0001 for both Anatomic and Clinical Pathology). The survey results suggest that residents often take their certification examinations earlier to not interfere with fellowship training, because it coincides with the completion of residency training, or it is expected by their program. Pathology residents are more likely to pass the primary certification examinations when they are taken closer to the end of training, rather than postponing it to a later administration. Pathology residency program directors should encourage residents, who are deemed ready, to take their certification examinations at the earliest possible administration., (© 2024 The Authors.)
- Published
- 2024
- Full Text
- View/download PDF
17. Leadership perspectives on osteopathic medical school applicants to pathology residency training.
- Author
-
George MR, Timmons CF, Johnson K, Barak S, Berg MP, Bryant B, Childs JM, Karp JK, Knollmann-Ritschel BEC, Lofgreen A, McCarthy T, Prieto VG, Procop GW, Sandersfeld T, White KL, and McCloskey CB
- Abstract
The number of graduating allopathic (MD) medical students matching into pathology has declined in recent years, while the number of osteopathic (DO) medical students has increased modestly, given the rapid expansion of osteopathic medical schools. Nonscholarly publications and materials on the internet often perpetuate negative perceptions of osteopathic physicians. Anecdotally, perspectives exist that some pathology residency programs are not DO-friendly; however, the reasons and how widespread an effect this might be are unclear. Our survey queried pathology chairs and residency program directors about their perceptions of osteopathic applicants and their knowledge of osteopathic medical school/training in general. This study utilized two similar, parallel surveys of pathology chairs and residency program directors with general questions structured around the perceptions and knowledge of both allopathic and osteopathic physicians, their medical training, and the consideration of osteopathic applicants to pathology residency. Pathology residency leaders acknowledge some negative perceptions of osteopathic physicians in the medical profession, the news, and social media. They also have some knowledge and perception gaps regarding osteopathic training and applicants, although experience with training osteopathic physicians as residents has been equivalent to that with allopathic physicians, and consideration appears to be fairly equal for osteopathic applicants. Even though negative perceptions of osteopathic physicians persist in news and social media, our surveys demonstrate that the leadership of pathology residency programs does not hold the same degree of bias and that DOs perform well in allopathic pathology residency programs without evidence of inferior outcomes., (© 2024 The Authors.)
- Published
- 2024
- Full Text
- View/download PDF
18. A conceptual framework for nomenclatural stability and validity of medically important fungi: a proposed global consensus guideline for fungal name changes supported by ABP, ASM, CLSI, ECMM, ESCMID-EFISG, EUCAST-AFST, FDLC, IDSA, ISHAM, MMSA, and MSGERC.
- Author
-
de Hoog S, Walsh TJ, Ahmed SA, Alastruey-Izquierdo A, Alexander BD, Arendrup MC, Babady E, Bai F-Y, Balada-Llasat J-M, Borman A, Chowdhary A, Clark A, Colgrove RC, Cornely OA, Dingle TC, Dufresne PJ, Fuller J, Gangneux J-P, Gibas C, Glasgow H, Gräser Y, Guillot J, Groll AH, Haase G, Hanson K, Harrington A, Hawksworth DL, Hayden RT, Hoenigl M, Hubka V, Johnson K, Kus JV, Li R, Meis JF, Lackner M, Lanternier F, Leal SM Jr, Lee F, Lockhart SR, Luethy P, Martin I, Kwon-Chung KJ, Meyer W, Nguyen MH, Ostrosky-Zeichner L, Palavecino E, Pancholi P, Pappas PG, Procop GW, Redhead SA, Rhoads DD, Riedel S, Stevens B, Sullivan KO, Vergidis P, Roilides E, Seyedmousavi A, Tao L, Vicente VA, Vitale RG, Wang Q-M, Wengenack NL, Westblade L, Wiederhold N, White L, Wojewoda CM, and Zhang SX
- Subjects
- Humans, Phylogeny, Databases, Factual, Fungi genetics
- Abstract
The rapid pace of name changes of medically important fungi is creating challenges for clinical laboratories and clinicians involved in patient care. We describe two sources of name change which have different drivers, at the species versus the genus level. Some suggestions are made here to reduce the number of name changes. We urge taxonomists to provide diagnostic markers of taxonomic novelties. Given the instability of phylogenetic trees due to variable taxon sampling, we advocate to maintain genera at the largest possible size. Reporting of identified species in complexes or series should where possible comprise both the name of the overarching species and that of the molecular sibling, often cryptic species. Because the use of different names for the same species will be unavoidable for many years to come, an open access online database of the names of all medically important fungi, with proper nomenclatural designation and synonymy, is essential. We further recommend that while taxonomic discovery continues, the adaptation of new name changes by clinical laboratories and clinicians be reviewed routinely by a standing committee for validation and stability over time, with reference to an open access database, wherein reasons for changes are listed in a transparent way., Competing Interests: The authors declare no conflict of interest.
- Published
- 2023
- Full Text
- View/download PDF
19. Multicenter Clinical Performance Evaluation of Omadacycline Susceptibility Testing of Enterobacterales on VITEK 2 Systems.
- Author
-
Csiki-Fejer E, Traczewski M, Procop GW, Davis TE, Hackel M, Dwivedi HP, and Pincus DH
- Subjects
- Humans, Reproducibility of Results, Microbial Sensitivity Tests, Klebsiella pneumoniae, Anti-Bacterial Agents pharmacology, Tetracyclines pharmacology
- Abstract
We present the first performance evaluation results for omadacycline on the VITEK 2 and VITEK 2 Compact Systems (bioMérieux, Inc.). The trial was conducted at four external sites and one internal site. All sites were in the United States, geographically dispersed as follows: Indianapolis, IN; Schaumburg, IL; Wilsonville, OR; Cleveland, OH; and Hazelwood, MO. In this multisite study, omadacycline was tested against 858 Enterobacterales on the VITEK 2 antimicrobial susceptibility test (AST) Gram-negative (GN) card, and the results were compared to the Clinical and Laboratory Standards Institute broth microdilution (BMD) reference method. The results were analyzed and are presented as essential agreement (EA), category agreement (CA), minor error (mE) rates, major error (ME) rates, and very major error (VME) rates following the US Food and Drug Administration (FDA) and International Standards Organization (ISO) performance criteria requirements. Omadacycline has susceptibility testing interpretive criteria (breakpoints) established by the FDA only; nevertheless, the analysis was also performed using the ISO acceptance criteria to satisfy the registration needs of countries outside the United States. The analysis following FDA criteria (including only Klebsiella pneumoniae and Enterobacter cloacae) showed the following performance: EA = 97.9% (410/419), CA = 94.3% (395/419), VME = 2% (1/51), with no ME present. The performance following ISO criteria (including all Enterobacterales tested) after error resolutions was EA = 98.1% (842/858) and CA = 96.9% (831/858). No ME or VME were observed. The VITEK 2 test met the ISO and FDA criteria of ≥ 95% reproducibility, and ≥ 95% quality control (QC) results within acceptable ranges for QC organisms. In June 2022, the omadacycline VITEK 2 test received FDA 510(k) clearance (K213931) FDA as a diagnostic device to be used in the treatment of acute bacterial skin and skin-structure infections caused by E. cloacae and K. pneumoniae, and for treatment of community-acquired bacterial pneumonia caused by K. pneumoniae. The new VITEK 2 AST-GN omadacycline test provides an alternative to the BMD reference method testing and increases the range of automated diagnostic tools available for determining omadacycline MICs in Enterobacterales ., Competing Interests: The authors declare no conflict of interest.
- Published
- 2023
- Full Text
- View/download PDF
20. Alpha to Omicron: Disease Severity and Clinical Outcomes of Major SARS-CoV-2 Variants.
- Author
-
Esper FP, Adhikari TM, Tu ZJ, Cheng YW, El-Haddad K, Farkas DH, Bosler D, Rhoads D, Procop GW, Ko JS, Jehi L, Li J, and Rubin BP
- Subjects
- Humans, SARS-CoV-2 genetics, Patient Acuity, Breakthrough Infections, COVID-19
- Abstract
Background: Four severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants predominated in the United States since 2021. Understanding disease severity related to different SARS-CoV-2 variants remains limited., Method: Viral genome analysis was performed on SARS-CoV-2 clinical isolates circulating March 2021 through March 2022 in Cleveland, Ohio. Major variants were correlated with disease severity and patient outcomes., Results: In total 2779 patients identified with either Alpha (n 1153), Gamma (n 122), Delta (n 808), or Omicron variants (n 696) were selected for analysis. No difference in frequency of hospitalization, intensive care unit (ICU) admission, and death were found among Alpha, Gamma, and Delta variants. However, patients with Omicron infection were significantly less likely to be admitted to the hospital, require oxygen, or admission to the ICU (2 12.8, P .001; 2 21.6, P .002; 2 9.6, P .01, respectively). In patients whose vaccination status was known, a substantial number had breakthrough infections with Delta or Omicron variants (218/808 [26.9] and 513/696 [73.7], respectively). In breakthrough infections, hospitalization rate was similar regardless of variant by multivariate analysis. No difference in disease severity was identified between Omicron subvariants BA.1 and BA.2., Conclusions: Disease severity associated with Alpha, Gamma, and Delta variants is comparable while Omicron infections are significantly less severe. Breakthrough disease is significantly more common in patients with Omicron infection., (The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2023
- Full Text
- View/download PDF
21. Implementing laboratory quality management in Africa and central Asia: a model for healthcare improvement.
- Author
-
Mateta P, Procop GW, Mtotela W, Nyakuwocha R, and Fine G
- Subjects
- Humans, Africa, Delivery of Health Care, Asia, Quality Improvement, Laboratories, Accreditation
- Abstract
Background: Optimized laboratory services are recognized as an integral part of high-quality healthcare delivery. However, these services are often unavailable or substandard in resource-limited countries. The implementation of quality management systems (QMSs) in the laboratory can transform laboratory services and ultimately improve patient care in these settings., Methods: The Clinical and Laboratory Standards Institute, through its Global Health Partnerships (GHP) program, has intervened in 32 laboratories to implement QMSs and improve performance. Standardized checklists were used before and after the structured intervention to quantify the impact of this program., Results: QMS implementation resulted in a statistically significant improvement in overall mean checklist scores. All participating laboratories demonstrated improvement in their quality and performance, with 13 laboratories achieving national accreditation within the time frame of this study., Conclusion: A structured program that utilizes well-recognized, standardized checklists and has leadership and laboratory team support, professional training with onsite guidance (i.e. train the trainer) and access to professionals experienced with QMS implementation and maintenance can lead to significant improvements in quality in resource-limited countries., (© The Author(s) 2022. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.)
- Published
- 2022
- Full Text
- View/download PDF
22. The Pedal Subcutaneous Phaeohyphomycotic Cyst in an Immunocompetent Adult Man: A Case Report.
- Author
-
Esmaili M, Procop GW, Mirkin G, and Hao X
- Subjects
- Adult, Antifungal Agents therapeutic use, Foot pathology, Fungi, Humans, Male, Middle Aged, Cysts drug therapy, Cysts microbiology, Cysts surgery, Phaeohyphomycosis diagnosis, Phaeohyphomycosis microbiology, Phaeohyphomycosis pathology
- Abstract
Phaeohyphomycosis is a spectrum of subcutaneous and systemic infections caused by a variety of dematiaceous fungi. It is an opportunistic disease with an increased incidence in immunocompromised patients. We report a case of a pedal phaeohyphomycotic cyst in an immunocompetent adult male immigrant with the goal of highlighting its clinical presentation, diagnosis, and optimal treatment. A 57-year-old male immigrant from Panama presented with a painless, gradually increasing, large cystic lesion in his left foot, first intermetatarsal space, which had been present for many years. The patient was treated with surgical excision without antifungal therapy. Histologic analysis showed multiple granulomas composed of fibrin and necrosis in the centers surrounded by proliferative palisading fibroblasts admixed with heavily infiltrated neutrophils, plasma cells, macrophages, lymphocytes, and eosinophils. Periodic acid-Schiff and Fontana-Masson stains revealed sporadic, scattered dematiaceous fungal hyphae and pseudohyphae among granulomatous tissues. The mass was diagnosed as a phaeohyphomycotic cyst. Polymerase chain reaction-based sequencing failed to identify the fungal species because of the rarity of the fungal elements in the granulomatous tissues. The patient had no recurrence at a follow-up of 2 years. A phaeohyphomycotic cyst is a rare entity that needs to be differentiated from other benign and malignant lesions. Multiple modalities, including clinical evaluation, radiography, histologic analysis, microbiological culture, and nucleic acid sequencing, should be used for the final diagnosis. Surgical excision is an optimal treatment. Antifungal therapy should be considered based on the patient's clinical manifestation, surgical excision, and immune functional status.
- Published
- 2022
- Full Text
- View/download PDF
23. Multicenter Clinical Evaluation of Vitek 2 Meropenem-Vaborbactam for Susceptibility Testing of Enterobacterales and Pseudomonas aeruginosa.
- Author
-
Dwivedi HP, Franklin S, Chandrasekaran S, Garner O, Traczewski MM, Beasley D, Procop GW, Tuohy M, Wilson D, Bala Y, and Pincus DH
- Subjects
- Boronic Acids, Humans, Meropenem pharmacology, Microbial Sensitivity Tests, Anti-Bacterial Agents pharmacology, Pseudomonas aeruginosa
- Abstract
The carbapenem/beta-lactamase inhibitor meropenem-vaborbactam (MEV) used to treat complicated urinary tract infections and pyelonephritis in adults was approved in 2017 by the U.S. Food and Drug Administration (FDA). Here, we evaluated Vitek 2 MEV (bioMérieux, Durham, NC) compared to the reference broth microdilution (BMD) method. Of 449 Enterobacterales isolates analyzed per FDA/CLSI breakpoints, the overall performance was 98.2% essential agreement (EA), 98.7% category agreement (CA), and 0% very major errors (VME) or major errors (ME). For 438 FDA intended-for-use Enterobacterales isolates, performance was 98.2% EA, 98.6% CA, and 0% VME or ME. Evaluable EA was 81.0%, but with only 42 on-scale evaluable results. Individual species demonstrated EA and CA rates of ≥90% without any VME or ME. When evaluated using European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints, overall Vitek 2 MEV performance for Enterobacterales and Pseudomonas aeruginosa demonstrated 97.3% EA, 99.2% CA, 2.3% VME, and 0.6% ME (after error resolution: 97.3% EA, 99.4% CA, 2.2% VME, and 0.4% ME) compared to the reference BMD method. Performance for P. aeruginosa included 92.2% EA, 97.4% CA, 0% VME, and 3.0% ME (after error resolution: 92.2% EA, 98.7% CA, 0% VME, and 1.5% ME). Performance for Enterobacterales included 98.2% EA, 99.6% CA, 3.0% VME, and 0.2% ME. Evaluable EA was 80.6% but was based on only 67 evaluable results. These findings support Vitek 2 MEV as an accurate automated system for MEV susceptibility testing of Enterobacterales and P. aeruginosa and could be an alternate solution to the manual-labor-intensive reference BMD method.
- Published
- 2022
- Full Text
- View/download PDF
24. Eumycetoma, A Neglected Tropical Disease in the United States.
- Author
-
Tritto M, Procop GW, Billings ST, Mirkin G, and Hao X
- Subjects
- Antifungal Agents therapeutic use, Foot pathology, Humans, Male, Middle Aged, United States, Hallux pathology, Mycetoma diagnosis, Mycetoma surgery
- Abstract
Eumycetoma, caused by fungi, is a neglected tropical disease. It is endemic in the "mycetoma belt" countries but rare in North America. We report a case of pedal eumycetoma in the state of Maryland. A 51-year-old male immigrant from Guatemala presented with multiple, enlarging nodules on the dorsal surface of his left great toe present for 1 year, and a new one in the left arch area present for 6 months. The nodular lesions were surgically excised in two separate operations. Pathologic evaluation of all nodules revealed eumycetomas characterized by the Splendore-Hoeppli phenomenon, showing an amorphous eosinophilic center filled with numerous fungal hyphae, observed on periodic acid-Schiff-stained slides, with a surrounding cuff of neutrophils. Polymerase chain reaction-based sequencing identified Cladosporium cladosporioides in the tissues. The patient was further treated with oral fluconazole for 2 months. The patient recovered well postoperatively and had no recurrence at 20-month follow-up. In conclusion, even though eumycetoma is regarded as a rare disease in North America, its incidence may be higher than reported because of millions of immigrants from endemic regions in the United States, which highlights the need to raise awareness of this devastating disease in the medical community. Eumycetoma needs to be differentiated from other infectious and noninfectious benign and malignant lesions. Optimal treatment includes surgical excision with antifungal therapy.
- Published
- 2021
- Full Text
- View/download PDF
25. Risks for Recurrent Vulvovaginal Candidiasis Caused by Non-Albicans Candida Versus Candida Albicans .
- Author
-
Boyd Tressler A, Markwei M, Fortin C, Yao M, Procop GW, Soper DE, and Goje O
- Subjects
- Candida, Female, Humans, Pregnancy, Recurrence, Retrospective Studies, Candida albicans, Candidiasis, Vulvovaginal diagnosis, Candidiasis, Vulvovaginal drug therapy, Candidiasis, Vulvovaginal epidemiology
- Abstract
Background: Vulvovaginal candidiasis (VVC) is the second most common vulvovaginitis (VV). About 20% of women will experience recurrent infections in their lifetime with non- albicans Candida (NAC) species being one of the causative agents. Although studies have looked at risk factors for recurrent VVC they are limited in scope. In this study, we explore whether risks of recurrent VVC are increased with NAC infections compared to Candida albicans infections. Methods: Through an institutional review board-approved retrospective chart review, we identified 174 women with positive yeast cultures and followed their charts to assess recurrent visits and treatments. We also assessed several baseline variables such as race, age, body mass index (BMI), obstetric history, probiotic use, contraceptive use, mycological therapy, steroid use, hormone replacement therapy, menopausal status, and medical comorbidities. Results: Women with NAC VV were more likely to have multiple visits for recurring infections compared to women who had C. albicans VV (66% vs. 34%). The women with multiple recurrences were younger, had a lower BMI, had lower parity, and endorsed higher use of probiotics. Conclusion: Women with positive NAC cultures were more likely to have multiple visits to their physicians for VV complaints. Identifying the causative species using vaginal fungal cultures can more accurately guide therapy and lead to better outcomes for these patients.
- Published
- 2021
- Full Text
- View/download PDF
26. Real-time polymerase chain reaction (PCR) cycle threshold and Clostridioides difficile infection outcomes.
- Author
-
Choi B, Wong KK, Dunn AN, Butler R, Fraser TG, Procop GW, Richter SS, Isada CM, and Deshpande A
- Subjects
- Adult, Humans, Male, Middle Aged, Prospective Studies, Real-Time Polymerase Chain Reaction, Retrospective Studies, Clostridioides, Clostridioides difficile genetics
- Abstract
Objective: Clostridioides difficile infection (CDI) causes significant morbidity and mortality; however, the diagnosis of CDI remains controversial. The primary aim of our study was to evaluate the association of polymerase chain reaction (PCR) cycle threshold (Ct) values with CDI disease severity, recurrence, and mortality among adult patients with CDI., Design: Retrospective cohort study., Setting: Single tertiary-care hospital., Patients: Adult patients diagnosed with hospital-onset, healthcare facility-associated CDI from June 2014 to September 2015., Methods: We performed a retrospective chart review of included patients. Univariate and multivariable logistic regression methods were used to evaluate the association between Ct values and CDI severity, 8-week recurrence, and 30-day mortality., Results: Among 318 included patients, 51% were male and the mean age was 62 years; ~32% of the patients developed severe CDI and 11% developed severe-complicated CDI. The 30-day all-cause mortality rate was 11% and the 8-week recurrence rate was 9.5%. The overall mean Ct value was 32.9 (range, 23-40). Multivariable analyses showed that lower values of PCR Ct were associated with increased odds of 30-day morality (odds ratio [OR] 0.83; 95% confidence interval [CI], 0.72-0.96) but were not independently associated with CDI severity (OR, 0.99; 95% CI, 0.90-1.09) or recurrence (OR, 0.88; 95% CI, 0.77-1.00)., Conclusions: Our findings suggest that PCR Ct values at the time of diagnosis may have a limited predictive value and utility in clinical decision making for inpatients with CDI. Larger, prospective studies across different patient populations are needed to confirm our findings.
- Published
- 2021
- Full Text
- View/download PDF
27. Multicenter evaluation of the VITEK MS matrix-assisted laser desorption/ionization-time of flight mass spectrometry system for identification of bacteria, including Brucella, and yeasts.
- Author
-
Girard V, Monnin V, Giraud D, Polsinelli S, Caillé M, Procop GW, Tuohy M, Wilson D, Richter SS, Kiss K, Clem K, Tolli N, Bridon L, Bradford C, Blamey S, Li J, and Pincus DH
- Subjects
- Bacteria chemistry, Bacteria classification, Brucella chemistry, Brucella classification, Brucella pathogenicity, Databases, Factual statistics & numerical data, Humans, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization methods, Yeasts chemistry, Yeasts classification, Bacteria isolation & purification, Brucella isolation & purification, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization instrumentation, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization standards, Yeasts isolation & purification
- Abstract
The use of matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry has proven to be rapid and accurate for the majority of clinical isolates. Some gaps remain concerning rare, emerging, or highly pathogenic species, showing the need to continuously expand the databases. In this multicenter study, we evaluated the accuracy of the VITEK MS v3.2 database in identifying 1172 unique isolates compared to identification by DNA sequence analysis. A total of 93.6% of the isolates were identified to species or group/complex level. A remaining 5.2% of the isolates were identified to the genus level. Forty tests gave a result of no identification (0.9%) and 12 tests (0.3%) gave a discordant identification compared to the reference identification. VITEK MS is also the first MALDI-TOF MS system that is able to delineate the four members of the Acinetobacter baumannii complex at species level without any specific protocol or special analysis method. These findings demonstrate that the VITEK MS v3.2 database is highly accurate for the identification of bacteria and fungi encountered in the clinical laboratory as well as emerging species like Candida auris and the highly pathogenic Brucella species., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
- Published
- 2021
- Full Text
- View/download PDF
28. Diagnosis of Clostridioides difficile infection by analysis of volatile organic compounds in breath, plasma, and stool: A cross-sectional proof-of-concept study.
- Author
-
John TM, Shrestha NK, Procop GW, Grove D, Leal SM Jr, Jacob CN, Butler R, and Dweik R
- Subjects
- Adult, Aged, Area Under Curve, Biomarkers analysis, Clostridioides difficile growth & development, Clostridioides difficile pathogenicity, Clostridium Infections metabolism, Clostridium Infections microbiology, Cross-Sectional Studies, Diarrhea metabolism, Diarrhea microbiology, Exhalation, Feces chemistry, Feces microbiology, Female, Humans, Male, Mass Spectrometry instrumentation, Middle Aged, Proof of Concept Study, ROC Curve, Breath Tests methods, Clostridioides difficile metabolism, Clostridium Infections diagnosis, Diarrhea diagnosis, Mass Spectrometry methods, Volatile Organic Compounds analysis
- Abstract
Clostridioides difficile infection (CDI) is an important infectious cause of antibiotic-associated diarrhea, with significant morbidity and mortality. Current diagnostic algorithms are based on identifying toxin by enzyme immunoassay (EIA) and toxin gene by real-time polymerase chain reaction (PCR) in patients with diarrhea. EIA's sensitivity is poor, and PCR, although highly sensitive and specific, cannot differentiate infection from colonization. An ideal test that incorporates microbial factors, host factors, and host-microbe interaction might characterize true infection, and assess prognosis and recurrence. The study of volatile organic compounds (VOCs) has the potential to be an ideal diagnostic test. The presence of VOCs accounts for the characteristic odor of stool in CDI but their presence in breath and plasma has not been studied yet. A cross-sectional proof-of-concept study analyzing VOCs using selected ion flow tube mass spectrometry (SIFT-MS) was done on breath, stool, and plasma of patients with clinical features and positive PCR for CDI (cases) and compared with patients with clinical features but a negative PCR (control). Our results showed that VOC patterns in breath, stool, and plasma, had good accuracy [area under the receiver operating characteristic curve (ROC) 93%, 86%, and 91%, respectively] for identifying patients with CDI., Competing Interests: The authors have declared that no competing interests exist.
- Published
- 2021
- Full Text
- View/download PDF
29. Routine testing for herpes simplex virus in bronchoalveolar lavage specimens is unwarranted.
- Author
-
Bruehl FK, Ramsey C, Koval CE, and Procop GW
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Herpes Simplex etiology, Herpes Simplex virology, Herpesvirus 1, Human isolation & purification, Humans, Male, Middle Aged, Molecular Diagnostic Techniques economics, Molecular Diagnostic Techniques methods, Polymerase Chain Reaction economics, Polymerase Chain Reaction standards, Respiratory Tract Infections virology, Bronchoalveolar Lavage Fluid virology, Herpes Simplex diagnosis, Herpesvirus 1, Human genetics, Molecular Diagnostic Techniques standards, Respiratory Tract Infections diagnosis
- Abstract
Herpes simplex virus (HSV) infections of the lung are rare, but HSV is occasionally detected in bronchoalveolar lavage (BAL) specimens. We assessed whether routinely performing HSV PCR tests in BAL specimens is warranted. HSV was detected in 7% (52/722) of BALs. In 47% of HSV-positive patients a typical respiratory virus or pathologic microorganism was identified. Oral HSV reactivation was identified in 27%; however, anti-HSV therapy was initiated in just three patients following the positive HSV test. Patients undergoing BAL for transplant surveillance received anti-HSV prophylaxis more often than those with acute respiratory failure, but both groups did not differ significantly in terms of patient outcome or co-infections. No patient was diagnosed with HSV pneumonia. These findings suggest that positive HSV PCR results in BAL specimens most commonly represents contamination from oral HSV reactivation, and that HSV PCR should be ordered selectively, rather than routinely, as part of a test panel., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
30. Endemic SARS-CoV-2 Polymorphisms Can Cause a Higher Diagnostic Target Failure Rate than Estimated by Aggregate Global Sequencing Data.
- Author
-
Rhoads DD, Plunkett D, Nakitandwe J, Dempsey A, Tu ZJ, Procop GW, Bosler D, Rubin BP, Loeffelholz MJ, and Brock JE
- Subjects
- Genome, Viral, Humans, RNA, Viral, COVID-19, SARS-CoV-2
- Published
- 2021
- Full Text
- View/download PDF
31. Molecular Diagnosis of SARS-CoV-2: Assessing and Interpreting Nucleic Acid and Antigen Tests.
- Author
-
Zimmerman PA, King CL, Ghannoum M, Bonomo RA, and Procop GW
- Abstract
In this review, we summarize the current status of nucleic acid and antigen testing required for diagnosing SARS-CoV-2 infection and COVID-19 disease. Nucleic acid amplification (NAAT) and antigen-detection (Ag) tests occupy a critically important frontline of defense against SARS-CoV-2 in clinical and public health settings. In early stages of this outbreak, we observed that identifying the causative agent of a new illness of unknown origin was greatly accelerated by characterizing the nucleic acid signature of the novel coronavirus. Results from nucleic acid sequencing led to the development of highly sensitive RT-PCR testing for use in clinical settings and to informing best practices for patient care, and in public health settings to the development of strategies for protecting populations. As the current COVID-19 pandemic has evolved, we have seen how NAAT performance has been used to guide and optimize specimen collection, inform patient triage decisions, reveal unexpected clinical symptoms, clarify risks of transmission within patient care facilities, and guide appropriate treatment strategies. For public health settings during the earliest stages of the pandemic, NAATs served as the only tool available for studying the epidemiology of this new disease by identifying infected individuals, studying transmission patterns, modeling population impacts, and enabling disease control organizations and governments to make challenging disease mitigation recommendations to protect the expanding breadth of populations at risk. With time, the nucleic acid signature has provided the information necessary to understand SARS-CoV-2 protein expression for further development of antigen-based point-of-care (POC) diagnostic tests. The advent of massive parallel sequencing (ie, next generation sequencing) has afforded the characterization of this novel pathogen, informed the sequences best adapted for RT-PCR assays, guided vaccine production, and is currently used for tracking and monitoring SARS-CoV-2 variants., Competing Interests: Mahmoud Ghannoum and Robert A. Bonomo serve as Senior Editors for Pathogens and Immunity. The authors report no competing financial interests., (Copyright © Pathogens and Immunity 2021.)
- Published
- 2021
- Full Text
- View/download PDF
32. Recognition of Diagnostic Gaps for Laboratory Diagnosis of Fungal Diseases: Expert Opinion from the Fungal Diagnostics Laboratories Consortium (FDLC).
- Author
-
Zhang SX, Babady NE, Hanson KE, Harrington AT, Larkin PMK, Leal SM Jr, Luethy PM, Martin IW, Pancholi P, Procop GW, Riedel S, Seyedmousavi S, Sullivan KV, Walsh TJ, and Lockhart SR
- Subjects
- Canada, Clinical Laboratory Techniques, Expert Testimony, Humans, Laboratories, Mucorales
- Abstract
Fungal infections are a rising threat to our immunocompromised patient population, as well as other nonimmunocompromised patients with various medical conditions. However, little progress has been made in the past decade to improve fungal diagnostics. To jointly address this diagnostic challenge, the Fungal Diagnostics Laboratory Consortium (FDLC) was recently created. The FDLC consists of 26 laboratories from the United States and Canada that routinely provide fungal diagnostic services for patient care. A survey of fungal diagnostic capacity among the 26 members of the FDLC was recently completed, identifying the following diagnostic gaps: lack of molecular detection of mucormycosis; lack of an optimal diagnostic algorithm incorporating fungal biomarkers and molecular tools for early and accurate diagnosis of Pneumocystis pneumonia, aspergillosis, candidemia, and endemic mycoses; lack of a standardized molecular approach to identify fungal pathogens directly in formalin-fixed paraffin-embedded tissues; lack of robust databases to enhance mold identification with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry; suboptimal diagnostic approaches for mold blood cultures, tissue culture processing for Mucorales, and fungal respiratory cultures for cystic fibrosis patients; inadequate capacity for fungal point-of-care testing to detect and identify new, emerging or underrecognized, rare, or uncommon fungal pathogens; and performance of antifungal susceptibility testing. In this commentary, the FDLC delineates the most pressing unmet diagnostic needs and provides expert opinion on how to fulfill them. Most importantly, the FDLC provides a robust laboratory network to tackle these diagnostic gaps and ultimately to improve and enhance the clinical laboratory's capability to rapidly and accurately diagnose fungal infections.
- Published
- 2021
- Full Text
- View/download PDF
33. Dynamics and predisposition of respiratory viral co-infections in children and adults.
- Author
-
Mandelia Y, Procop GW, Richter SS, Worley S, Liu W, and Esper F
- Subjects
- Adolescent, Adult, Child, Coinfection, Cross-Sectional Studies, Humans, Retrospective Studies, Young Adult, Respiratory Tract Infections virology
- Abstract
Objectives: The epidemiology of respiratory co-infection pairings is poorly understood. Here we assess the dynamics of respiratory viral co-infections in children and adults and determine predisposition for or against specific viral pairings., Methods: Over five respiratory seasons from 30 November 2013 through 6 June 2018, the mono-infection and co-infection prevalence of 13 viral pathogens was tabulated at The Cleveland Clinic. Employing a model to proportionally distribute viral pairs using individual virus co-infection rate with prevalence patterns of concurrent co-circulating viruses, we compared predicted occurrence with observed occurrence of 132 viral pairing permutations using binomial analysis., Results: Of 30 535 respiratory samples, 9843 (32.2%) were positive for at least one virus and 1018 (10.8%) of these were co-infected. Co-infected samples predominantly originated from children. Co-infection rate in paediatric population was 35.0% (2068/5906), compared with only 5.8% (270/4591) in adults. Adenovirus C (ADVC) had the highest co-infection rate (426/623, 68.3%) while influenza virus B had the lowest (55/546, 10.0%). ADVC-rhinovirus (HRV), respiratory syncytial virus A (RSVA)-HRV and RSVB-HRV pairings occurred at significantly higher frequencies than predicted by the proportional distribution model (p < 0.05). Additionally, several viral pairings had fewer co-infections than predicted by our model: notably metapneumovirus (hMPV)-parainfluenza virus 3, hMPV-RSVA and RSVA-RSVB., Conclusions: This is one of the largest studies on respiratory viral co-infections in children and adults. Co-infections are substantially more common in children, especially under 5 years of age, and the most frequent pairings occurred at a higher frequency than would be expected by random. Specific pairings occur at altered rates compared with those predicted by proportional distribution, suggesting either direct or indirect interactions result between specific viral pathogens., (Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
34. Genomic Epidemiology of SARS-CoV-2 Infection During the Initial Pandemic Wave and Association With Disease Severity.
- Author
-
Esper FP, Cheng YW, Adhikari TM, Tu ZJ, Li D, Li EA, Farkas DH, Procop GW, Ko JS, Chan TA, Jehi L, Rubin BP, and Li J
- Subjects
- Adult, COVID-19 epidemiology, COVID-19 virology, Cross-Sectional Studies, Female, Genome, Viral genetics, Humans, Male, Middle Aged, Pandemics prevention & control, Severity of Illness Index, COVID-19 genetics, Pandemics statistics & numerical data, SARS-CoV-2
- Abstract
Importance: Understanding of SARS-CoV-2 variants that alter disease outcomes are important for clinical risk stratification and may provide important clues to the complex virus-host relationship., Objective: To examine the association of identified SARS-CoV-2 variants, virus clades, and clade groups with disease severity and patient outcomes., Design, Setting, and Participants: In this cross-sectional study, viral genome analysis of clinical specimens obtained from patients at the Cleveland Clinic infected with SARS-CoV-2 during the initial wave of infection (March 11 to April 22, 2020) was performed. Identified variants were matched with clinical outcomes. Data analysis was performed from April to July 2020., Main Outcomes and Measures: Hospitalization, intensive care unit (ICU) admission, mortality, and laboratory outcomes were matched with SARS-CoV-2 variants., Results: Specimens sent for viral genome sequencing originated from 302 patients with SARS-CoV-2 infection (median [interquartile range] age, 52.6 [22.8 to 82.5] years), of whom 126 (41.7%) were male, 195 (64.6%) were White, 91 (30.1%) required hospitalization, 35 (11.6%) needed ICU admission, and 17 (5.6%) died. From these specimens, 2531 variants (484 of which were unique) were identified. Six different SARS-CoV-2 clades initially circulated followed by a rapid reduction in clade diversity. Several variants were associated with lower hospitalization rate, and those containing 23403A>G (D614G Spike) were associated with increased survival when the patient was hospitalized (64 of 74 patients [86.5%] vs 10 of 17 patients [58.8%]; χ21 = 6.907; P = .009). Hospitalization and ICU admission were similar regardless of clade. Infection with Clade V variants demonstrated higher creatinine levels (median [interquartile range], 2.6 [-0.4 to 5.5] mg/dL vs 1.0 [0.2 to 2.2] mg/dL; mean creatinine difference, 2.9 mg/dL [95% CI, 0.8 to 5.0 mg/dL]; Kruskal-Wallis P = .005) and higher overall mortality rates (3 of 14 patients [21.4%] vs 17 of 302 patients [5.6%]; χ21 = 5.640; P = .02) compared with other variants. Infection by strains lacking the 23403A>G variant showed higher mortality in multivariable analysis (odds ratio [OR], 22.4; 95% CI, 0.6 to 5.6; P = .01). Increased variants of open reading frame (ORF) 3a were associated with decreased hospitalization frequency (OR, 0.4; 95% CI, 0.2 to 0.96; P = .04), whereas increased variants of Spike (OR, 0.01; 95% CI, <0.01 to 0.3; P = .01) and ORF8 (OR, 0.03; 95% CI, <0.01 to 0.6; P = .03) were associated with increased survival., Conclusions and Relevance: Within weeks of SARS-CoV-2 circulation, a profound shift toward 23403A>G (D614G) specific genotypes occurred. Replaced clades were associated with worse clinical outcomes, including mortality. These findings help explain persistent hospitalization yet decreasing mortality as the pandemic progresses. SARS-CoV-2 clade assignment is an important factor that may aid in estimating patient outcomes.
- Published
- 2021
- Full Text
- View/download PDF
35. Clinical Significance and Histologic Characterization of Histoplasma Granulomas.
- Author
-
Demkowicz R and Procop GW
- Subjects
- Granuloma etiology, Histoplasma, Humans, Retrospective Studies, Granuloma pathology, Histoplasmosis pathology
- Abstract
Objectives: To clarify the clinical significance and degree of resolution (ie, grade) of Histoplasma granulomas in routinely reviewed surgical pathology specimens and the clinical outcomes of patients with this diagnosis, with an emphasis on those not receiving antifungal therapy., Methods: We performed a retrospective medical record, laboratory data, and surgical pathology slide review of patients with Histoplasma granulomas following institutional review board approval., Results: Clinical, pathologic, and laboratory data from 62 patients with Histoplasma granulomas were available for review. Of these, 1 of 19 (5%) fungal cultures, 4 of 12 (33%) fungal serologic studies, 0 of 9 Histoplasma urinary antigen tests, and 0 of 2 Histoplasma serum antigen tests were positive. All but 3 of the Histoplasma granulomas were either in the resolving (grade 2) or resolved (grade 3) stage of resolution. None of the patients, including those who did not receive antifungal therapy after the histologic diagnosis, developed progressive or disseminated histoplasmosis., Conclusions: These findings, which are supportive of clinical guidelines, suggest that patients with old, hyalinized Histoplasma granulomas do not benefit from further laboratory studies or antifungal therapy. The proposed grading of Histoplasma granulomas informs clinicians of the stage of resolution of an excised lesion, which informs therapeutic decisions and thus is recommended., (© American Society for Clinical Pathology, 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2021
- Full Text
- View/download PDF
36. Asymptomatic Patient Testing After 10:1 Pooling Using the Xpert Xpress SARS-CoV-2 Assay.
- Author
-
Procop GW, Tuohy M, Ramsey C, Rhoads DD, Rubin BP, and Figler R
- Subjects
- COVID-19 virology, False Negative Reactions, Feasibility Studies, Humans, Reverse Transcriptase Polymerase Chain Reaction, Sensitivity and Specificity, Viral Load, Asymptomatic Infections, COVID-19 diagnosis, COVID-19 Nucleic Acid Testing methods, Specimen Handling methods
- Abstract
Objectives: Pool testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) preserves testing resources at the risk of missing specimens through specimen dilution., Methods: To determine whether SARS-CoV-2 specimens would be missed after 10:1 pooling, we identified 10 specimens with midrange (ie, 25-34 cycles) and 10 with late (ie, >34-45 cycles) crossing threshold (Ct) values and tested these both neat and after 10:1 pooling. Final test results and Ct changes were compared., Results: Overall, 17 of 20 specimens that contained SARS-CoV-2 were detected after 10:1 pooling with the Xpert Xpress SARS-CoV-2 Assay (Cepheid), rendering an 85% positive percentage of agreement. All 10 of 10 specimens with an undiluted Ct in the mid-Ct range were detected after 10:1 pooling, in contrast to 7 of 10 with an undiluted Ct in the late-Ct range. The overall Ct difference between the neat testing and the 10:1 pool was 2.9 cycles for the N2 gene target and 3 cycles for the E gene target. The N2 gene reaction was more sensitive than the E gene reaction, detecting 16 of 20 positive specimens after 10:1 pooling compared with 9 of 20 specimens., Conclusions: An 85% positive percentage of agreement was achieved, with only specimens with low viral loads being missed following 10:1 pooling. The average impact on both reverse transcription polymerase chain reactions within this assay was about 3 cycles., (© American Society for Clinical Pathology, 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2021
- Full Text
- View/download PDF
37. Operationalizing COVID-19 testing: Who, what, when, where, why, and how.
- Author
-
Reddy AJ, Fraser TG, Grover P, Weathers AL, Cruise M, Foxx MA, Babiuch CM, Henricks WH, Meldon SW, Muenzenmeyer A, Pengel SL, Simon JF, and Procop GW
- Abstract
The authors review the rationale behind and approaches to testing for COVID-19, the quality of currently available tests, the role of data analytics in strategizing testing, and using the electronic medical record and other programs designed to steward COVID-19 testing and follow-up of patients., (Copyright © 2021 The Cleveland Clinic Foundation. All Rights Reserved.)
- Published
- 2021
- Full Text
- View/download PDF
38. Home testing for COVID-19: Benefits and limitations.
- Author
-
Procop GW, Kadkhoda K, Rhoads DD, Gordon SG, and Reddy AJ
- Abstract
The home test kits for detecting SARS-CoV-2 infection with Food and Drug Administration emergency use authorization primarily use either isothermal nucleic acid amplification or antigen detection, and each test has advantages and limitations in terms of sensitivity and specificity, cost, results reporting, and results turnaround time. In clinical studies, these tests provide accurate positive results in symptomatic individuals, although negative results are less accurate. There are also accuracy concerns for positive results in asymptomatic individuals. These factors have implications for their clinical interpretation and use., (Copyright © 2021 The Cleveland Clinic Foundation. All Rights Reserved.)
- Published
- 2021
- Full Text
- View/download PDF
39. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid contamination of surfaces on a coronavirus disease 2019 (COVID-19) ward and intensive care unit.
- Author
-
Redmond SN, Dousa KM, Jones LD, Li DF, Cadnum JL, Navas ME, Kachaluba NM, Silva SY, Zabarsky TF, Eckstein EC, Procop GW, and Donskey CJ
- Subjects
- COVID-19 virology, Clothing, Disinfection methods, Equipment Contamination, Hospitals, Veterans, Humans, Ohio, Real-Time Polymerase Chain Reaction, COVID-19 transmission, Environmental Pollution analysis, Intensive Care Units, Patients' Rooms, SARS-CoV-2 isolation & purification
- Abstract
On coronavirus disease 2019 (COVID-19) wards, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid was frequently detected on high-touch surfaces, floors, and socks inside patient rooms. Contamination of floors and shoes was common outside patient rooms on the COVID-19 wards but decreased after improvements in floor cleaning and disinfection were implemented.
- Published
- 2021
- Full Text
- View/download PDF
40. A Comparison of Five SARS-CoV-2 Molecular Assays With Clinical Correlations.
- Author
-
Procop GW, Brock JE, Reineks EZ, Shrestha NK, Demkowicz R, Cook E, Ababneh E, and Harrington SM
- Subjects
- Adult, Aged, COVID-19 Nucleic Acid Testing standards, Cohort Studies, False Negative Reactions, Female, Humans, Logistic Models, Male, Middle Aged, Sensitivity and Specificity, COVID-19 diagnosis, COVID-19 Nucleic Acid Testing methods
- Abstract
Objectives: Comparative assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular assays that have been operationalized through the US Food and Drug Administration's Emergency Use Authorization process are warranted to assess real-world performance. Characteristics such as sensitivity, specificity, and false-negative rate are important to inform clinical use., Methods: We compared five SARS-CoV-2 assays using nasopharyngeal and nasal swab specimens submitted in transport media; we enriched this cohort for positive specimens, since we were particularly interested in the sensitivity and false-negative rate. Performance of each test was compared with a composite standard., Results: The sensitivities and false-negative rates of the 239 specimens that met inclusion criteria were, respectively, as follows: Centers for Disease Control and Prevention 2019 nCoV Real-Time RT-PCR Diagnostic Panel, 100% and 0%; TIB MOLBIOL/Roche z 480 Assay, 96.5% and 3.5%; Xpert Xpress SARS-CoV-2 (Cepheid), 97.6% and 2.4%; Simplexa COVID-19 Direct Kit (DiaSorin), 88.1% and 11.9%; and ID Now COVID-19 (Abbott), 83.3% and 16.7%., Conclusions: The assays that included a nucleic acid extraction followed by reverse transcription polymerase chain reaction were more sensitive than assays that lacked a full extraction. Most false negatives were seen in patients with low viral loads, as extrapolated from crossing threshold values., (© American Society for Clinical Pathology, 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2021
- Full Text
- View/download PDF
41. Distribution of Transmission Potential During Nonsevere COVID-19 Illness.
- Author
-
Shrestha NK, Marco Canosa F, Nowacki AS, Procop GW, Vogel S, Fraser TG, Erzurum SC, Terpeluk P, and Gordon SM
- Subjects
- Health Personnel, Humans, SARS-CoV-2, Serologic Tests, Viral Load, COVID-19
- Abstract
Background: Patients recovering from coronavirus disease 2019 (COVID-19) often continue to test positive for the causative virus by polymerase chain reaction (PCR) even after clinical recovery, thereby complicating return-to-work plans. The purpose of this study was to evaluate transmission potential of COVID-19 by examining viral load with respect to time., Methods: Health care personnel (HCP) at Cleveland Clinic diagnosed with COVID-19, who recovered without needing hospitalization, were identified. Threshold cycles (Ct) for positive PCR tests were obtained and viral loads calculated. The association of viral load with days since symptom onset was examined in a multivariable regression model, which was reduced by stepwise backward selection to only keep variables significant at a level of .05. Viral loads by day since symptom onset were predicted using the model and transmission potential evaluated by examination of a viral load-time curve., Results: Over 6 weeks, 230 HCP had 528 tests performed. Viral loads declined by orders of magnitude within a few days of symptom onset. The only variable significantly associated with viral load was time since onset of symptoms. Of the area under the curve (AUC) spanning symptom onset to 30 days, 96.9% lay within the first 7 days, and 99.7% within 10 days. Findings were very similar when validated using split-sample and 10-fold cross-validation., Conclusions: Among patients with nonsevere COVID-19, viral loads in upper respiratory specimens peak by 2 or 3 days from symptom onset and decrease rapidly thereafter. The vast majority of the viral load-time AUC lies within 10 days of symptom onset., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
- Published
- 2020
- Full Text
- View/download PDF
42. Multicenter evaluation of the RAPIDEC® CARBA NP assay for the detection of carbapenemase production in clinical isolates of Enterobacterales and Pseudomonas aeruginosa.
- Author
-
McMullen AR, Wallace MA, LaBombardi V, Hindler J, Campeau S, Humphries R, Procop GW, Richter SS, Wise MG, and Burnham CD
- Subjects
- Antimicrobial Stewardship, Bacteriological Techniques, Humans, Sensitivity and Specificity, United States, Bacterial Proteins metabolism, Carbapenem-Resistant Enterobacteriaceae metabolism, Pseudomonas aeruginosa metabolism, beta-Lactamases metabolism
- Abstract
Carbapenem-resistant Gram-negative bacilli are a major public health problem. Accurate and rapid detection of carbapenemase-producing organisms can facilitate appropriate infection prevention measures. The objective was to evaluate the performance of the RAPIDEC® CARBA NP assay (RAPIDEC), a screening assay that utilizes a pH indicator to detect carbapenem hydrolysis within 2 h. A multicenter study evaluated 306 clinical bacterial strains of Enterobacterales (n = 257) and Pseudomonas aeruginosa (n = 49). The RAPIDEC was compared to a composite reference standard-the Clinical Laboratory Standards Institute (CLSI) Carba NP assay, PCR for specific carbapenemase genes (bla
KPC , blaNDM , blaOXA-48-like , blaVIM and blaIMP ), and phenotypic carbapenem susceptibility testing. The assay was evaluated using two culture incubation times for the bacterial isolates: "routine"(cultures incubated 18-24 h) and "short" (cultures incubated 4-5 h). For the routine incubation, the overall percent agreement was 98.7% with a positive percent agreement (PPA) of 99.6% and a negative percent agreement (NPA) of 97.4%; there were five false positives and one false negative. For the short incubation, the overall percent agreement was 98.0% with a PPA of 98.5% and a NPA of 97.3%; there were five false positives and four false negatives. RAPIDEC results for the P. aeruginosa isolates were 100% concordant with the reference standard for both incubation times. The RAPIDEC assay is an accurate and rapid (≤ 2 h) assay for the detection of the most common carbapenemases in clinical isolates. Growth from a short incubation culture may be used to reliably detect carbapenemase production in clinical strains.- Published
- 2020
- Full Text
- View/download PDF
43. A Direct Comparison of Enhanced Saliva to Nasopharyngeal Swab for the Detection of SARS-CoV-2 in Symptomatic Patients.
- Author
-
Procop GW, Shrestha NK, Vogel S, Van Sickle K, Harrington S, Rhoads DD, Rubin BP, and Terpeluk P
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Betacoronavirus genetics, COVID-19, Female, Humans, Male, Middle Aged, Molecular Diagnostic Techniques, Pandemics, Real-Time Polymerase Chain Reaction, SARS-CoV-2, Specimen Handling, Viral Load, Young Adult, Betacoronavirus isolation & purification, Coronavirus Infections diagnosis, Nasopharynx virology, Pneumonia, Viral diagnosis, Saliva virology
- Abstract
The ongoing coronavirus disease 2019 (COVID-19) pandemic has resulted in shortages of nasopharyngeal swabs (NPS) and viral transport media, necessitating the search for alternate diagnostic specimens, such as saliva. We directly compared matched saliva and NPS specimens from symptomatic patients suspected of having COVID-19. An enhanced saliva specimen (i.e., strong sniff, elicited cough, and collection of saliva/secretions) was collected without transport medium prior to collection of NPS from 224 patients with symptoms deemed consistent with COVID-19. Both specimens were tested with the CDC 2019 nCoV real-time RT-PCR diagnostic panel (4 February 2020 version), with the NPS result used as the reference standard. For the 216 patients included in the final analysis, there was 100% positive agreement (38/38 positive specimens) and 99.4% negative agreement (177/178 negative specimens). The one discrepant specimen had the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed in the saliva specimen using an alternate FDA EUA assay. The overall mean difference in cycle threshold ( C
T ) values for the positive NPS and saliva specimens was -3.61 (95% confidence interval [CI], -5.78 to -1.44; P = 0.002). An enhanced saliva specimen performed as well as NPS for the qualitative detection of SARS-CoV-2 in symptomatic patients, although the overall mean viral load in saliva was lower., (Copyright © 2020 American Society for Microbiology.)- Published
- 2020
- Full Text
- View/download PDF
44. Association of Use of Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers With Testing Positive for Coronavirus Disease 2019 (COVID-19).
- Author
-
Mehta N, Kalra A, Nowacki AS, Anjewierden S, Han Z, Bhat P, Carmona-Rubio AE, Jacob M, Procop GW, Harrington S, Milinovich A, Svensson LG, Jehi L, Young JB, and Chung MK
- Subjects
- Adult, COVID-19, COVID-19 Testing, Clinical Laboratory Techniques, Critical Care, Female, Hospitalization, Humans, Hypertension complications, Hypertension drug therapy, Male, Middle Aged, Pandemics, Respiration, Artificial, Retrospective Studies, Risk Factors, SARS-CoV-2, Angiotensin Receptor Antagonists therapeutic use, Angiotensin-Converting Enzyme Inhibitors therapeutic use, Betacoronavirus, Coronavirus Infections diagnosis, Coronavirus Infections epidemiology, Pneumonia, Viral diagnosis, Pneumonia, Viral epidemiology
- Abstract
Importance: The role of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB) in the setting of the coronavirus disease 2019 (COVID-19) pandemic is hotly debated. There have been recommendations to discontinue these medications, which are essential in the treatment of several chronic disease conditions, while, in the absence of clinical evidence, professional societies have advocated their continued use., Objective: To study the association between use of ACEIs/ARBs with the likelihood of testing positive for COVID-19 and to study outcome data in subsets of patients taking ACEIs/ARBs who tested positive with severity of clinical outcomes of COVID-19 (eg, hospitalization, intensive care unit admission, and requirement for mechanical ventilation)., Design, Setting, and Participants: Retrospective cohort study with overlap propensity score weighting was conducted at the Cleveland Clinic Health System in Ohio and Florida. All patients tested for COVID-19 between March 8 and April 12, 2020, were included., Exposures: History of taking ACEIs or ARBs at the time of COVID-19 testing., Main Outcomes and Measures: Results of COVID-19 testing in the entire cohort, number of patients requiring hospitalizations, intensive care unit admissions, and mechanical ventilation among those who tested positive., Results: A total of 18 472 patients tested for COVID-19. The mean (SD) age was 49 (21) years, 7384 (40%) were male, and 12 725 (69%) were white. Of 18 472 patients who underwent COVID-19 testing, 2285 (12.4%) were taking either ACEIs or ARBs. A positive COVID-19 test result was observed in 1735 of 18 472 patients (9.4%). Among patients who tested positive, 421 (24.3%) were admitted to the hospital, 161 (9.3%) were admitted to an intensive care unit, and 111 (6.4%) required mechanical ventilation. Overlap propensity score weighting showed no significant association of ACEI and/or ARB use with COVID-19 test positivity (overlap propensity score-weighted odds ratio, 0.97; 95% CI, 0.81-1.15)., Conclusions and Relevance: This study found no association between ACEI or ARB use and COVID-19 test positivity. These clinical data support current professional society guidelines to not discontinue ACEIs or ARBs in the setting of the COVID-19 pandemic. However, further study in larger numbers of hospitalized patients receiving ACEI and ARB therapy is needed to determine the association with clinical measures of COVID-19 severity.
- Published
- 2020
- Full Text
- View/download PDF
45. Cytopathology milestones: can you get to level 5?
- Author
-
Dyhdalo KS, Oshilaja O, Chute DJ, Booth CN, Suchy P, Smith K, Procop GW, and Reynolds JP
- Subjects
- Accreditation, Humans, Interviews as Topic, Patient Care Team, Self-Assessment, Surveys and Questionnaires, Clinical Competence, Education, Medical, Graduate, Fellowships and Scholarships, Pathologists education, Pathologists psychology
- Abstract
Introduction: ACGME Milestones describe 6 areas of proficiency, indicating readiness for practice. Each is divided into 5 levels of mastery; Level 1 (new trainees) through Levels 4 (graduation) and 5 (aspirational). Milestones reporting began Spring 2016. We used Milestones to assess graduated fellows., Materials and Methods: We conducted phone interviews with previous fellows and collected demographic information including practice setting. We asked graduates if they fulfilled each example of mastery and recorded their answers., Results: A total of 22 fellows graduated from 2010 to 2017; 15 responded (10 academic, 5 private). Milestones in which nearly all respondents performed well (Level 4+) were: PC1, MK1, SBP2, SBP4, PROF1-4, ICS1-3. Some were more challenging (PC2, MK2, SBP1/3/5, PBL1). For PC2, 2 respondents achieved Level 1 (did not perform fine-needle aspirations). For MK2, 2 respondents achieved Level 1 (did not evaluate Papanicolaou). For SBP1, 80% in private practice achieved Level 5; 50% in academics achieved Level 3. For SBP3, 80% in private practice achieved Level 4+; 100% in academics achieved maximum Level 2. For SBP5, 60% of all respondents achieved maximum Level 3; only 1 achieved Level 5., Conclusions: Many Milestones are attainable. Eleven of 18 yielded Level 4+ from most respondents. Three (PC2, MK1, MK2) yielded rare Level 1 due to scope of practice. Others (SBP1, SBP3) reflect more of an all-or-nothing phenomenon. For SBP5, most respondents achieved Level 3; only 1 achieved Level 5. Some Milestones are highly dependent on practice setting, and others remain aspirational., (Copyright © 2020 American Society of Cytopathology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
- Full Text
- View/download PDF
46. Dermatofibrosarcoma Protuberans: Update on the Diagnosis and Treatment.
- Author
-
Hao X, Billings SD, Wu F, Stultz TW, Procop GW, Mirkin G, and Vidimos AT
- Abstract
Dermatofibrosarcoma protuberans (DFSP) is a slow growing, low- to intermediate-grade dermal soft-tissue tumor. It has a high local recurrence rate but low metastatic potential. It is characterized by a uniform spindle cell arrangement, classically with a storiform pattern and CD34 immunoreactivity. The histomorphology and immunophenotype overlap with a broad range of other neoplasms. The standard treatment is complete surgical excision. The surgical procedures include wide local excision (WLE) with tumor free margins, Mohs micrographic surgery (MMS) and amputation. Unresectable DFSPs are treated with radiation therapy and/or targeted therapy. DFSP has characteristic t(17; 22) (q22; q13), resulting in a COL1A1- PDGFB fusion transcripts in more than 90% of DFSPs. Molecular detection of the gene rearrangement or fusion transcripts is helpful for the diagnosis of patients with atypical morphology and for screening candidates for targeted therapy with tyrosine kinase inhibitors. The aims of the present review are to update the clinical presentation, tumorigenesis and histopathology of DFSP and its variants for diagnosis and differential diagnosis from other benign and malignant tumors, to compare the advantages and drawbacks of WLE and MMS, to propose the baseline for selecting surgical procedure based on tumor's location, size, stage and relationship with surrounding soft tissue and bone structures, and to provide a biologic rationale for the systemic therapy. We further propose a modified clinical staging system of DFSP and a surveillance program for the patients after surgical excision.
- Published
- 2020
- Full Text
- View/download PDF
47. The Impact of Transit Times on the Detection of Bacterial Pathogens in Blood Cultures: A College of American Pathologists Q-Probes Study of 36 Institutions.
- Author
-
Procop GW, Nelson SK, Blond BJ, Souers RJ, and Massie LW
- Subjects
- Bacteremia blood, Bacteremia diagnosis, Benchmarking, Humans, Laboratories, Pathologists, Pathology, Clinical, Societies, Medical, Surveys and Questionnaires, Time Factors, United States, Bacteremia microbiology, Bacteria isolation & purification, Blood Culture, Blood Specimen Collection methods
- Abstract
Context.—: Consolidation of clinical microbiology laboratory services has resulted in extended transit time for blood cultures from service points distant from the laboratory. Sepsis is critical; delays in identification of etiologic agents of diseases could adversely impact patient care., Objective.—: To examine the effect of total preanalytic time and blood culture volume on the instrument time-to-detection for bacterial pathogens in blood cultures. A secondary objective was to obtain relevant blood culture information by questionnaire., Design.—: Participants in this Q-Probes study recorded date, time, and volume information for the first 50 positive blood cultures collected during the 12-week study period. Additional information regarding blood culture collection practices was obtained through questionnaire., Results.—: Prolonged overall time-to-detection was secondary to prolonged preanalytic time, particularly prolonged transit time, rather than slower organism growth once bottles were placed on the instrument. Among 1578 blood cultures, the overall time from collection to positive result was significantly less for blood cultures collected on-site than for off-site locations. Most institutions lack sufficient training programs and do not monitor preanalytic time metrics associated with blood cultures. Four hundred fifty-six of the 1580 blood cultures with blood volume adequacy reported (28.9%) were inadequately filled., Conclusions.—: Overall process time (specimen collection to positive blood culture detection) is predicted to be higher for blood cultures collected off-site. Transit time is a variable that can be reduced to decrease overall time to detection. Thus, improved training and closer attention to preanalytic metrics associated with blood cultures could decrease hospital stays and mortality rates.
- Published
- 2020
- Full Text
- View/download PDF
48. Diagnosis of Mycobacterium abscessus/chelonae complex cutaneous infection: Correlation of tissue culture and skin biopsy.
- Author
-
Sardiña LA, Kaw U, Jour G, Knabel D, Dyck RM, Procop GW, Bergfeld WF, Harrington S, Demkowicz R, and Piliang MP
- Subjects
- Adult, Aged, Biopsy, Female, Humans, Male, Middle Aged, Retrospective Studies, Tissue Culture Techniques, Mycobacterium Infections, Nontuberculous diagnosis, Mycobacterium Infections, Nontuberculous metabolism, Mycobacterium Infections, Nontuberculous microbiology, Mycobacterium Infections, Nontuberculous pathology, Mycobacterium abscessus metabolism, Mycobacterium chelonae metabolism, Skin metabolism, Skin microbiology, Skin pathology, Skin Diseases, Bacterial diagnosis, Skin Diseases, Bacterial metabolism, Skin Diseases, Bacterial microbiology, Skin Diseases, Bacterial pathology
- Abstract
Mycobacterium abscessus and M. chelonae belong to the rapid-growing nontuberculous mycobacteria (NTM) group, which are defined by their ability to form visible colonies on agar within 7 days of subculture. Cutaneous infections by this complex show a heterogeneous clinical presentation with varied histopathologic findings. However, the presence of vacuoles in many specimens has been reported as a specific histologic finding. Herein, we correlate the histopathology of patients with tissue-culture positive M. abscessus/M. chelonae complex in order to identify features that may prompt a rapid categorization of the infectious etiology. The cohort includes 33 skin punch biopsy specimens from 28 patients who had associated positive tissue cultures. The most frequent clinical presentation was a single or multiple nodule. Twenty-seven specimens (81.81%) were found to have vacuoles. The observation of certain histologic features (ie, polymorphonuclear microabscesses and epithelioid granuloma formation) should raise the possibility of infection by NTM. In addition to these findings, we believe the presence of vacuoles in the dermal and subcutaneous inflammation should raise suspicion for NTM., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
- Published
- 2020
- Full Text
- View/download PDF
49. An Electronic Strategy for Eliminating Unnecessary Duplicate Genetic Testing.
- Author
-
Riley JD, Stanley G, Wyllie R, Burt HL, Horwitz SB, Cooper DD, and Procop GW
- Subjects
- Decision Support Systems, Clinical, Humans, Cost Savings, Genetic Testing economics, Unnecessary Procedures economics
- Abstract
Objectives: To determine the impact of an electronic intervention designed to block duplicate constitutional genetic tests., Methods: We constructed, implemented, and studied an electronic intervention that stopped duplicate genetic tests. The activation frequency, types of tests affected, and cost savings achieved with this intervention were determined. The frequency and justification of override requests were also studied., Results: This intervention stopped 710 unnecessary duplicate genetic tests over a 3-year period and saved $98,596. The tests with the highest numbers of alerts were those used for screening presurgical or transplant patients and were commonly part of an order set or test panel. Most override requests were justified because of the lack of exclusion codes in the initial programming., Conclusions: Electronic interventions that stop duplicate genetic testing, if properly constructed, can reduce waste, save health care dollars, and facilitate patient care by directing the provider to a test that has already been performed., (© American Society for Clinical Pathology, 2019. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2020
- Full Text
- View/download PDF
50. Optimal Timing of Repeat Multiplex Molecular Testing for Respiratory Viruses.
- Author
-
Mandelia Y, Procop GW, Richter SS, Worley S, Liu W, and Esper F
- Subjects
- Adult, Child, Preschool, Cohort Studies, Community-Acquired Infections diagnosis, Community-Acquired Infections virology, Humans, Infant, Influenza A virus genetics, Influenza A virus isolation & purification, Logistic Models, Middle Aged, Nasopharynx virology, Respiratory Syncytial Viruses genetics, Respiratory Syncytial Viruses isolation & purification, Time Factors, Viruses genetics, Molecular Diagnostic Techniques methods, Multiplex Polymerase Chain Reaction methods, Respiratory Tract Infections diagnosis, Respiratory Tract Infections virology, Viruses isolation & purification
- Abstract
Determining whether and when multiplex nucleic acid amplification tests (NAATs) for respiratory viruses should be repeated is difficult. We analyzed 5 years of results for a multiplex NAAT targeting 14 respiratory viruses, to determine how often repeat tests were ordered and the time period in which results were likely to change. Results for NAATs performed on nasopharyngeal specimens and repeated within 90 days after initial testing were analyzed. Logistic regression models were used to compare time periods between tests with respect to the odds of a change in the sample result. During the study period, 21,819 nasopharyngeal specimens from 16,779 individuals were submitted. Of these, 8,807 samples (40%) were positive for at least one viral pathogen. Among this cohort, 2,583 specimens (12%) collected from 1,473 patients (9%) were repeat tests performed within 90 days after an initial test. If repeated within 90 days, 71% of tests (1,833 tests) did not have a change in result. Initially negative tests typically remained negative, whereas initially positive tests mostly remained positive until 11 to 15 days. The odds of result change plateaued after 20 days. The odds of result change for tests repeated within 20 days were only 0.52 times the odds (95% confidence interval, 0.43 to 0.62) for those repeated at 21 to 90 days ( P < 0.001). Multiplex tests for respiratory viruses that are repeated within short periods lead to redundant results at additional costs. Repeat testing of nasopharyngeal specimens before 20 days demonstrates little change. These results provide a vital component for use in laboratory stewardship to curtail unnecessary respiratory viral testing., (Copyright © 2020 American Society for Microbiology.)
- Published
- 2020
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.