scholarly journals 4345 Two-step Algorithm for Clostridioides difficile is Inadequate for Differentiating Infection from Colonization in Children

2020 ◽  
Vol 4 (s1) ◽  
pp. 150-150
Author(s):  
Maribeth R Nicholson ◽  
Jacob M Parnell ◽  
Irtiqa Fazili ◽  
Sarah C. Bloch ◽  
D. Borden Lacy ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Clinical Care ◽  
Diagnostic Testing ◽  
Neutralization Assay ◽  
Clostridioides Difficile ◽  
Asymptomatic Children ◽  
Study Population ◽  
Step Algorithm ◽  
New Guidelines ◽  
Testing Algorithm

OBJECTIVES/GOALS: In 2017, new guidelines recommended multi-step algorithms for CDI diagnosis, and clinical centers rapidly implemented changes despite limited pediatric data. We assessed a multi-step algorithm using NAAT followed by EIA for ability to differentiate symptomatic CDI from colonization in children. METHODS/STUDY POPULATION: We prospectively enrolled pediatric patients with cancer, cystic fibrosis, or inflammatory bowel disease who were not being tested or treated for CDI and obtained a stool sample for NAAT. If positive by NAAT (colonized), EIA was performed. Children with symptomatic CDI who tested positive by NAAT via the clinical laboratory were also enrolled and EIA performed on residual stool. A functional cell cytotoxicity neutralization assay (CCNA) was performed in addition. RESULTS/ANTICIPATED RESULTS: Of the 138 asymptomatic children enrolled, 24 (17%) were colonized. An additional 37 children with symptomatic CDI were enrolled. Neither EIA positivity (41% versus 21%, P = 0.11) or CCNA positivity (49% versus 46%, P = 0.84) were significantly different between symptomatic versus colonized children. When both EIA and CCNA were positive, children were more commonly symptomatic than colonized (33% versus 13%, P = 0.04). DISCUSSION/SIGNIFICANCE OF IMPACT: A multi-step testing algorithm with NAAT and EIA failed to differentiate symptomatic CDI from colonization in our pediatric cohort. As multi-step algorithms are moved into clinical care, pediatric providers will need to be aware of the continued limitations in diagnostic testing.

scholarly journals High Agreement Between an Ultrasensitive Clostridioides difficile Toxin Assay and a C. difficile Laboratory Algorithm Utilizing GDH-and-Toxin Enzyme Immunoassays and Cytotoxin Testing

2019 ◽  
Vol 58 (2) ◽  
Author(s):  
Marie L. Landry ◽  
Jeffrey E. Topal ◽  
Joel Estis ◽  
Phoebe Katzenbach ◽  
Niamh Nolan ◽  
...  
Keyword(s):  
Standard Of Care ◽  
Neutralization Assay ◽  
High Agreement ◽  
Content Type ◽  
Clostridioides Difficile ◽  
Automated Assay ◽  
Toxin Assay ◽  
Stool Samples ◽  
Testing Algorithm ◽  
Positive Agreement

ABSTRACT The Singulex Clarity C. diff toxins A/B (Clarity) assay is an automated, ultrasensitive immunoassay for the detection of Clostridioides difficile toxins in stool. In this study, the performance of the Clarity assay was compared to that of a multistep algorithm using an enzyme immunoassay (EIA) for detection of glutamate dehydrogenase (GDH) and toxins A and B arbitrated by a semiquantitative cell cytotoxicity neutralization assay (CCNA). The performance of the assay was evaluated using 211 residual deidentified stool samples tested with a GDH-and-toxin EIA (C. Diff Quik Chek Complete; Techlab), with GDH-and-toxin discordant samples tested with CCNA. The stool samples were stored at –80°C before being tested with the Clarity assay. For samples discordant between Clarity and the standard-of-care algorithm, the samples were tested with PCR (Xpert C. difficile; Cepheid), and chart review was performed. The testing algorithm resulted in 34 GDH+/toxin+, 53 GDH−/toxin−, and 124 GDH+/toxin− samples, of which 39 were CCNA+ and 85 were CCNA−. Clarity had 96.2% negative agreement with GDH−/toxin− samples, 100% positive agreement with GDH+/toxin+ samples, and 95.3% agreement with GDH+/toxin−/CCNA− samples. The Clarity result was invalid for one sample. Clarity agreed with 61.5% of GDH+/toxin−/CCNA+ samples, 90.0% of GDH+/toxin−/CCNA+ (high-positive) samples, and 31.6% of GDH+/toxin−/CCNA+ (low-positive) samples. The Singulex Clarity C. diff toxins A/B assay demonstrated high agreement with a testing algorithm utilizing a GDH-and-toxin EIA and CCNA. This novel automated assay may offer an accurate, stand-alone solution for C. difficile infection (CDI) diagnostics, and further prospective clinical studies are merited.

scholarly journals Prospective evaluation of the BISAP score and its correlation with Marshall score in predicting severity of organ failure in acute pancreatitis

2017 ◽  
Vol 4 (2) ◽  
pp. 534 ◽  
Author(s):  
Kaushik M. R. ◽  
A. P. Dubey ◽  
Rahul Jain ◽  
Anvesh Rathore ◽  
Abhishek Pathak
Keyword(s):  
Acute Pancreatitis ◽  
Organ Failure ◽  
Scoring System ◽  
Clinical Laboratory ◽  
Clinical Care ◽  
Armed Forces ◽  
Tertiary Hospital ◽  
P Value ◽  
Study Population ◽  
Marshall Score

Background: The bedside index for severity in acute pancreatitis (BISAP), a newer prognostic scoring system, has been proposed as a simple and clinically oriented severity scoring system for early identification of patients with acute pancreatitis. This study evaluates the efficacy of BISAP score to predict the severity of organ failure in patients of acute pancretitis and its correlation with Marshall score.Methods: The clinical, laboratory and radiological data for all patients admitted with a diagnosis of acute pancreatitis conducted at tertiary hospital of Armed Forces over a two-year period, was prospectively collected for this study. BISAP score was calculated within 24hrs of presentation. Markers of severity were the development of organ failure and presence of pancreatic necrosis. Outcome at 28 days (viz. recovery, organ failure and mortality) was studied for each patient. BISAP score computed at 24h was correlated with the above and its efficacy to predict the severity of organ failure in Acute Pancreatitis, was assessed.Results: Out of 50 patients in the study group, 41 were male and 9 were female with the mean (±SD) age 43.74±16.85 years. Majority of the study population had alcohol (56%) as the etiology followed by gall stones (28%). Outcome assessed at 28 days revealed recovery of 54%, complication of 36% and mortality of 10% of study population. BISAP score computed within 24 hours of admission of 2 or more significantly predicted the severity and complication with P value <0.001. Statistically significant trends of increasing severity and organ failure (P<0.001) with increasing BISAP was observed.Conclusions: BISAP score is a reliable means of predicting the severity and organ failure and stratifying patients with Acute Pancreatitis within 24 hours of admission. The statistically significant incidence of increasing severity and mortality with increasing BISAP score will help us to risk stratify the patients within 24 hours of admission and help improve clinical care and facilitate necessary interventions as early as possible.

scholarly journals Impact of ribotype on Clostridioides difficile diagnostics

2019 ◽  
Vol 39 (5) ◽  
pp. 847-853 ◽  
Author(s):  
Kristina Rizzardi ◽  
Thomas Åkerlund ◽  
Torbjörn Norén ◽  
Andreas Matussek
Keyword(s):  
Diagnostic Tests ◽  
Diagnostic Performance ◽  
Diagnostic Testing ◽  
Neutralization Assay ◽  
Diagnostic Methods ◽  
Nucleic Acid Amplification ◽  
Predictive Values ◽  
Fecal Samples ◽  
Ribotype 027 ◽  
Clostridioides Difficile

AbstractThis study investigates the performance of diagnostic methods for detection of Clostridioides difficile infection in Sweden, including impact of PCR ribotype on diagnostic performance. Between 2011 and 2016, a total of 17,878 stool samples from 26 laboratories were tested by either well-type enzyme immunoassays (EIAs), membrane bound EIAs, cell cytotoxicity neutralization assay (CTA), or nucleic acid amplification tests (NAATs) and subsequently cultured for C. difficile. Roughly half of the samples (9454/17878) were subjected to diagnostic testing both on the fecal sample and on the 1323 isolated C. difficile strains. All C. difficile isolates were typed by PCR ribotyping, and the isolates were classified as toxigenic or non-toxigenic based on the empirical knowledge of the association between toxin-positivity and ribotype. The overall sensitivity, specificity, and positive and negative predictive values were highest for NAATs and membrane EIAs. Ribotype-specific sensitivity varied greatly between methods and ribotypes. All methods had 100% sensitivity against ribotype 027 and 013. For other types, the sensitivity ranged from 33 to 85% in fecal samples and from 78 to 100% on isolates. For the most prevalent ribotypes (014, 020, and 001), the sensitivity varied between 38 and 100% in the fecal samples, with the lowest sensitivity observed for well-type EIAs and CTA. The large variation in diagnostic sensitivity implies that type distribution significantly affects the outcome when evaluating diagnostic performance. Furthermore, performing comparative studies of diagnostic tests in settings with high prevalence of ribotype 027 will overestimate the general performance of diagnostic tests.

scholarly journals 2353. Easy Does It: Decreasing and Sustained Hospital-Onset (HO) CDI Lab-ID Event Incidence Through a Series of Interventions

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S809-S810
Author(s):  
Rachael A Lee ◽  
Jeremey Walker ◽  
Elizabeth Freeze ◽  
Rashida Khalid ◽  
Bernard Camins
Keyword(s):  
Care Center ◽  
Tertiary Care ◽  
Diagnostic Testing ◽  
Computer Assisted ◽  
Oncology Patient ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
The Difference ◽  
Testing Algorithm ◽  
Main Component

Abstract Background Clostridioides difficile infection (CDI) Laboratory (Lab) identified (ID) events are reportable to CMS through the CDC’s NHSN. Prevention of transmission has been the main component of interventions; however, avoiding false-positive laboratory diagnoses can also lead to decreased incidence. Methods A retrospective analysis of HO-CDI Lab-ID events was conducted to evaluate the results of a series of interventions at the University of Alabama Hospital, a 1150-bed tertiary care center in Birmingham, AL. The study period was from the first quarter of 2013 (1Q 2013) until 1Q of 2019. Interventions were implemented in sequential order were: (i) CDI prevention bundle education (3Q 2014); (ii) two-step laboratory testing algorithm (2Q 2015); (iii) selective enhanced environmental disinfection on oncology units (2Q 2016); (iv) diagnostic stewardship by reminding providers to reconsider testing if the patient received a laxative within 48 hours (4Q 2016). Results At the beginning of the study period, the HO CDI Lab ID Event SIR was 0.96. The standard infection ratio (SIR) over the time period is shown in Figure 1. We observed a slight decrease in HO-CDI Lab ID event SIR after implementation of the CDI prevention bundle (0.96 vs. 0.77). A change in the diagnostic testing from PCR-based to a two-step algorithm (EIA testing for GDH and Toxin confirmed by PCR) resulted in a slight increase although not statistically significant (0.77 vs. 0.83). A downward trend was observed when selective enhanced terminal disinfection with hydrogen peroxide vapor was performed on all oncology patient rooms vacated by patients with CDI (0.83 vs. 0.72). The largest and sustained impact was observed after implementation of a computer-assisted diagnostic stewardship in which providers were reminded if the patient was administered any stool softener or laxative within 48 hours of the order for CDI testing (0.72 vs. 0.32). The institutions SIR value became significant in 2Q 2016 (P = 0.0014) and significance was maintained since that time. The difference between expected and observe HO-CDI Lab ID events is demonstrated in Figure 2. Conclusion Through a series of interventions, we observed a decrease in HO-CDI event rates. Diagnostic stewardship with academic detailing resulted in the most impactful and sustained improvement. Disclosures All authors: No reported disclosures.

scholarly journals 746. Clinical and Microbiological Characteristics of Clostridioides difficile Infection After a Change in Diagnostic Testing Algorithm

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S470-S471
Author(s):  
Andrew S Crone ◽  
Andrew M Skinner ◽  
Adam Cheknis ◽  
Stuart Johnson ◽  
Susan M Pacheco
Keyword(s):  
Diagnostic Testing ◽  
Laboratory Data ◽  
Panel Member ◽  
Restriction Endonuclease Analysis ◽  
Review Panel ◽  
Cycle Threshold ◽  
Clostridioides Difficile ◽  
Microbiological Characteristics ◽  
Clostridioides Difficile Infection ◽  
Testing Algorithm

Abstract Background There is a lack of consensus on the most appropriate testing for C. difficile infection (CDI). The objective of this study was to determine the clinical and microbiological characteristics of CDI following a switch from stool PCR testing only to PCR reflexed to toxin testing. Figure 1. PCR Cycle Threshold Values Methods We reviewed the characteristics and outcomes of 50 consecutive patients who tested positive for CD by PCR (Xpert CD, Cepheid) between October 2019 and January 2020 at the Hines VA Hospital. Cases were defined by results of reflex toxin testing (Cdiff quick check complete, Alere/TechLab) after a positive PCR result. Baseline characteristics, symptoms, initial laboratory data, and treatments were compared as well as patient outcomes, including hospital readmission due to CDI at 30 days, and recurrent CDI (rCDI) at 30 and 90 days. The cycle threshold for the stool PCR result was recorded. Stools were cultured anaerobically for CD, and restriction endonuclease analysis (REA) strain typing was performed on the recovered CD isolates. Results Toxin testing was positive in 19/50 (38%) cases. Compared to stool toxin-negative cases, toxin-positive cases were older (95% vs. 71% were age ≥ 65, p = 0.06), more likely to have a history of CDI (37% vs. 23%, p = 0.34), and have ≥ 1 CDI episodes within 6 months (37% vs. 19%, p = 0.26). Treatment for CDI was more common in patients who had a positive toxin text. (95% vs 61%, p= 0.009). Among the 38 patients that received treatment, 33 received vancomycin (87%) and 8 patients (21%) had rCDI at 30 days. Of the 8 patients with rCDI, 2 were re-admitted to the hospital for CDI. The average PCR cycle threshold was lower in the toxin-positive stools compared to toxin-negative stools (24.46 and 29.96, p&lt; 0.001; Fig. 1) The endemic REA group Y was the most common CD strain recovered (30%) and the previously epidemic and virulent REA group BI strain was recovered in 11% of the cases. Conclusion CDI cases diagnosed by positive stool PCR and positive toxin tests had more typical risk factors for CDI, a lower PCR cycle threshold and were more likely to have been treated for CDI. Outcomes were similar in this setting where infection with the virulent BI strain was uncommon. Disclosures Stuart Johnson, MD, Acurx Pharmaceuticals (Advisor or Review Panel member)Bio-K+ (Advisor or Review Panel member)Ferring Pharmaceutical (Advisor or Review Panel member)

Gastroesophageal Reflux Disease: A Gastroenterologist's Perspective

2011 ◽  
Vol 21 (3) ◽  
pp. 89-99
Author(s):  
Michael F. Vaezi
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Best Practice ◽  
Clinical Care ◽  
Diagnostic Testing ◽  
Diagnostic Tools ◽  
Swallowing Function ◽  
Atypical Symptoms

Gastroesophageal reflux disease (GERD) is a commonly diagnosed condition often associated with the typical symptoms of heartburn and regurgitation, although it may present with atypical symptoms such as chest pain, hoarseness, chronic cough, and asthma. In most cases, the patient's reduced quality of life drives clinical care and diagnostic testing. Because of its widespread impact on voice and swallowing function as well as its social implications, it is important that speech-language pathologists (SLPs) understand the nature of GERD and its consequences. The purpose of this article is to summarize the nature of GERD and GERD-related complications such as GERD-related peptic stricture, Barrett's esophagus and adenocarcinoma, and laryngeal manifestations of GERD from a gastroenterologist's perspective. It is critical that SLPs who work with a multidisciplinary team understand terminology, diagnostic tools, and treatment to ensure best practice.

A Hexagonal (II) Phase Phospholipid Neutralization Assay for Lupus Anticoagulant Identification

1993 ◽  
Vol 70 (05) ◽  
pp. 787-793 ◽  
Author(s):  
Douglas A Triplett ◽  
Linda K Barna ◽  
Gail A Unger
Keyword(s):  
Hemophilia A ◽  
Clinical Laboratory ◽  
Neutralization Assay ◽  
Confirmatory Test ◽  
Specific Factor ◽  
Clinical Settings ◽  
Drug Induced ◽  
Variable Screening ◽  
Routine Clinical Laboratory

SummaryLupus anticoagulants (LAs) are immunoglobulins (IgG, IgM, or both) which interfere with in vitro phospholipid (PL) dependent tests of coagulation (e.g. APTT, dilute PT, dilute Russell Viper Venom Time). These antibodies may be identified in a wide variety of clinical settings. With the exception of heparinized patient samples, the presence of LAs is often the most common cause of an unexplained APTT in a routine clinical laboratory. The diagnosis of LAs is difficult due to variable screening reagent sensitivity and intrinsic heterogeneity of LAs. Recently, Rauch and colleagues have shown human monoclonal hybridoma LAs were inhibited by hexagonal (II) phase PLs. In contrast, lamellar phase PLs had no effect. We have evaluated a new assay system, Staclot LA®, which utilizes a hexagonal (II) phase PL (egg phosphatidylethanolamine [EPE]) as a confirmatory test for LAs. Plasma samples from the following patient populations were studied: LA positive, heparinized, oral anticoagulated, hemophilia A and B, and specific factor inhibitors (factors V, VIII, IX). Unlike previous studies, the LA positive patients were a mixed population including: autoimmune diseases, drug-induced, and post-infection. Our findings confirm the specificity of hexagonal (II) phase PL neutralization of LAs.

scholarly journals Indispensability of Clinical Bioinformatics for Effective Implementation of Genomic Medicine in Pathology Laboratories

ACI Open ◽  
2020 ◽  
Vol 04 (02) ◽  
pp. e167-e172
Author(s):  
Srikar Chamala ◽  
Siddardha Majety ◽  
Shesh Nath Mishra ◽  
Kimberly J. Newsom ◽  
Shaileshbhai Revabhai Gothi ◽  
...  
Keyword(s):  
Patient Care ◽  
Clinical Laboratory ◽  
Clinical Care ◽  
Genomic Medicine ◽  
Clinical Pathology ◽  
Genetic Mutation ◽  
Genomic Research ◽  
Pathology Laboratory ◽  
Clinical Bioinformatics ◽  
Effective Implementation

AbstractPatient care is rapidly evolving toward the inclusion of precision genomic medicine when genomic tests are used by clinicians to determine disease predisposition, prognosis, diagnosis, and improve therapeutic decision-making. However, unlike other clinical pathology laboratory tests, the development, deployment, and delivery of genomic tests and results are an intricate process. Genomic technologies are diverse, fast changing, and generate massive data. Implementation of these technologies in a Clinical Laboratory Improvement Amendments-certified and College of American Pathologists-accredited pathology laboratory often require custom clinical grade computational data analysis and management workflows. Additionally, accurate classification and reporting of clinically actionable genetic mutation requires well-curated disease/application-specific knowledgebases and expertise. Moreover, lack of “out of the box” technical features in electronic health record systems necessitates custom solutions for communicating genetic information to clinicians and patients. Genomic data generated as part of clinical care easily adds great value for translational research. In this article, we discuss current and future innovative clinical bioinformatics solutions and workflows developed at our institution for effective implementation of precision genomic medicine across molecular pathology, patient care, and translational genomic research.

scholarly journals Use of patient complaints to identify diagnosis-related safety concerns: a mixed-method evaluation

2021 ◽  
pp. bmjqs-2020-011593
Author(s):  
Traber D Giardina ◽  
Saritha Korukonda ◽  
Umber Shahid ◽  
Viralkumar Vaghani ◽  
Divvy K Upadhyay ◽  
...  
Keyword(s):  
Medical Record ◽  
Clinical Care ◽  
Diagnostic Testing ◽  
Diagnostic Errors ◽  
Diagnostic Error ◽  
Diagnostic Process ◽  
Healthcare Organisation ◽  
Safety Concerns ◽  
Patient Complaints ◽  
Malpractice Claims

BackgroundPatient complaints are associated with adverse events and malpractice claims but underused in patient safety improvement.ObjectiveTo systematically evaluate the use of patient complaint data to identify safety concerns related to diagnosis as an initial step to using this information to facilitate learning and improvement.MethodsWe reviewed patient complaints submitted to Geisinger, a large healthcare organisation in the USA, from August to December 2017 (cohort 1) and January to June 2018 (cohort 2). We selected complaints more likely to be associated with diagnostic concerns in Geisinger’s existing complaint taxonomy. Investigators reviewed all complaint summaries and identified cases as ‘concerning’ for diagnostic error using the National Academy of Medicine’s definition of diagnostic error. For all ‘concerning’ cases, a clinician-reviewer evaluated the associated investigation report and the patient’s medical record to identify any missed opportunities in making a correct or timely diagnosis. In cohort 2, we selected a 10% sample of ‘concerning’ cases to test this smaller pragmatic sample as a proof of concept for future organisational monitoring.ResultsIn cohort 1, we reviewed 1865 complaint summaries and identified 177 (9.5%) concerning reports. Review and analysis identified 39 diagnostic errors. Most were categorised as ‘Clinical Care issues’ (27, 69.2%), defined as concerns/questions related to the care that is provided by clinicians in any setting. In cohort 2, we reviewed 2423 patient complaint summaries and identified 310 (12.8%) concerning reports. The 10% sample (n=31 cases) contained five diagnostic errors. Qualitative analysis of cohort 1 cases identified concerns about return visits for persistent and/or worsening symptoms, interpersonal issues and diagnostic testing.ConclusionsAnalysis of patient complaint data and corresponding medical record review identifies patterns of failures in the diagnostic process reported by patients and families. Health systems could systematically analyse available data on patient complaints to monitor diagnostic safety concerns and identify opportunities for learning and improvement.

scholarly journals Prevalence of vitamin D level in the serum of patients living in Erbil city, Iraq, referred to private clinical laboratory and effect of age and sex on it

2018 ◽  
Vol 91 (1) ◽  
Author(s):  
Rabar M. Abdulrahman ◽  
Balen Muhsin Abdul Rahman
Keyword(s):  
Vitamin D ◽  
Clinical Laboratory ◽  
Mediterranean Country ◽  
Hydroxyvitamin D ◽  
Vitamin D Levels ◽  
Study Population ◽  
25 Hydroxyvitamin D ◽  
Country People ◽  
Effect Of Age ◽  
Age And Sex

This retrospective study aimed to determine the levels of 25- hydroxyvitamin D [25-(OH) D] in the individuals that have been referred to two laboratories (Bio Lab and King Lab) and to around 50 private side laboratories that use both Bio Lab and King Lab as a referral lab for their tests, in Erbil city, Iraq. Then show the range of deficiency and its relation with sunlight exposure, sex and age. Out of the total number of cases (N=10823), large percentage (nearly 78%) referred to both clinical laboratory based in Erbil city were found to have a deficiency in vitamin D levels, which means they had 25-(OH) D levels lower than 20 μg/L. This study found the percentage of vitamin D level in the serum of groups insufficient, deficient, adequate, optimal; intoxication were 52.8, 24.1, 11, 12 and 0.2% respectively. When the records have been compared according to gender, the results suggested that there was no difference between male and female within the study population (P>0.05), while there was difference in the grouped ages (P<0.05). Our results indicate that although Erbil is located in a Mediterranean country, people living there should periodically check their 25-(OH) D levels, in order to get appropriate supplements of vitamin D, which eventually prevents secondary chronic disease due to vitamin D deficiency.

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