Secondary Analysis of an Electronic Surveillance System Combined with Multi-focal Interventions for Early Detection of Sepsis

SummarySummary: To conduct an independent secondary analysis of a multi-focal intervention for early detection of sepsis that included implementation of change management strategies, electronic surveil-lance for sepsis, and evidence based point of care alerting using the POC AdvisorTM application. Methods: Propensity score matching was used to select subsets of the cohorts with balanced covariates. Bootstrapping was performed to build distributions of the measured difference in rates/ means. The effect of the sepsis intervention was evaluated for all patients, and High and Low Risk subgroups for illness severity. A separate analysis was performed patients on the intervention and non-intervention units (without the electronic surveillance). Sensitivity, specificity, and the positive predictive values were calculated to evaluate the accuracy of the alerting system for detecting sepsis or severe sepsis/ septic shock.Results: There was positive effect on the intervention units with sepsis electronic surveillance with an adjusted mortality rate of –6.6%. Mortality rates for non-intervention units also improved, but at a lower rate of –2.9%. Additional outcomes improved for patients on both intervention and non-intervention units for home discharge (7.5% vs 1.1%), total length of hospital stay (-0.9% vs –0.3%), and 30 day readmissions (-6.6% vs –1.6%). Patients on the intervention units showed better outcomes compared with non-intervention unit patients, and even more so for High Risk patients. The sensitivity was 95.2%, specificity of 82.0% and PPV of 50.6% for the electronic surveillance alerts. Conclusion: There was improvement over time across the hospital for patients on the intervention and non-intervention units with more improvement for sicker patients. Patients on intervention units with electronic surveillance have better outcomes; however, due to differences in exclusion criteria and types of units, further study is needed to draw a direct relationship between the electronic surveillance system and outcomes.

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COVID-19 Seroprevalence among Healthcare Workers of a Large COVID-19 Hospital in Rome Reveals Strengths and Limits of Two Different Serological Tests

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052650 ◽

2021 ◽

Vol 18 (5) ◽

pp. 2650

Author(s):

Giuseppe Vetrugno ◽

Daniele Ignazio La Milia ◽

Floriana D’Ambrosio ◽

Marcello Di Pumpo ◽

Roberta Pastorino ◽

...

Keyword(s):

Blood Test ◽

Healthcare Workers ◽

Point Of Care ◽

Venous Blood ◽

Administrative Staff ◽

Serological Tests ◽

Predictive Values ◽

Work From Home ◽

Significant Difference ◽

Sensitivity Specificity

Healthcare workers are at the forefront against COVID-19, worldwide. Since Fondazione Policlinico Universitario A. Gemelli (FPG) IRCCS was enlisted as a COVID-19 hospital, the healthcare workers deployed to COVID-19 wards were separated from those with limited/no exposure, whereas the administrative staff were designated to work from home. Between 4 June and 3 July 2020, an investigation was conducted to evaluate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG) antibodies among the employees of the FPG using point-of-care (POC) and venous blood tests. Sensitivity, specificity, and predictive values were determined with reverse-transcription polymerase chain reaction on nasal/oropharyngeal swabs as the diagnostic gold standard. The participants enrolled amounted to 4777. Seroprevalence was 3.66% using the POC test and 1.19% using the venous blood test, with a significant difference (p < 0.05). The POC test sensitivity and specificity were, respectively, 63.64% (95% confidence interval (CI): 62.20% to 65.04%) and 96.64% (95% CI: 96.05% to 97.13%), while those of the venous blood test were, respectively, 78.79% (95% CI: 77.58% to 79.94%) and 99.36% (95% CI: 99.07% to 99.55%). Among the low-risk populations, the POC test’s predictive values were 58.33% (positive) and 98.23% (negative), whereas those of the venous blood test were 92.86% (positive) and 98.53% (negative). According to our study, these serological tests cannot be a valid alternative to diagnose COVID-19 infection in progress.

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Abstract P533: Incidence and Outcomes of Thrombectomy Rescue Therapies in Acute Basilar Artery Occlusions

Stroke ◽

10.1161/str.52.suppl_1.p533 ◽

2021 ◽

Vol 52 (Suppl_1) ◽

Author(s):

Ronda Lun ◽

Greg B Walker ◽

David Weisenburger-Lile ◽

Bertrand Lapergue ◽

Adrien Guenego ◽

...

Keyword(s):

Primary Outcome ◽

Secondary Analysis ◽

Hematoma Expansion ◽

Primary Analysis ◽

Predictive Values ◽

Previous Definition ◽

Secondary Analyses ◽

Revised Definitions ◽

Definition Of ◽

Sensitivity Specificity

Background: Hematoma expansion (HE) is an important therapeutic target in intracerebral hemorrhage. Recently proposed HE definitions have not been validated, and no previous definition has accounted for withdrawal of care (WOC). Objective: To compare conventional and revised definitions of hematoma expansion (HE), while accounting for WOC. Methods: We analyzed data from the ATACH-2 trial, comparing revised definitions of HE incorporating intraventricular hemorrhage (IVH) expansion to the conventional definition of “≥6 mL or ≥33%”. The primary outcome was modified Rankin Scale of 4-6 at 90-days. We calculated the incidence, sensitivity, specificity, positive and negative predictive values, and c- statistic for all definitions of HE. Definitions were compared using non-parametric methods. Secondary analyses were performed after removing patients who experienced WOC. Results: Primary analysis included 948 patients. Using the conventional definition, the sensitivity was 37.1% and specificity was 83.2% for the primary outcome. Sensitivity improved with all three revised definitions (53.3%, 48.7%, and 45.3%, respectively), with minimal change to specificity (78.4%, 80.5%, and 81.0%, respectively). The greatest improvement was seen with the definition “≥6 mL or ≥33% or any IVH”, with increased c -statistic from 60.2% to 65.9% (p < 0.001). Secondary analysis excluded 46 participants who experienced WOC. The revised definitions outperformed the conventional definition in this population as well, with the greatest improvement in c -statistic using “≥6 mL or ≥33% or any IVH” (58.1% vs 64.1%, p < 0.001). Conclusions: HE definitions incorporating intraventricular expansion outperformed conventional definitions for predicting poor outcome, even after accounting for care limitations.

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Electrochemical Nano-biosensors as Novel Approach for the Detection of Lung Cancer-related MicroRNAs

Current Molecular Medicine ◽

10.2174/1566524019666191001114941 ◽

2019 ◽

Vol 20 (1) ◽

pp. 13-35 ◽

Cited By ~ 1

Author(s):

Roghayeh Sheervalilou ◽

Omolbanin Shahraki ◽

Leili Hasanifard ◽

Milad Shirvaliloo ◽

Sahar Mehranfar ◽

...

Keyword(s):

Lung Cancer ◽

Early Detection ◽

Sequence Similarity ◽

Point Of Care ◽

Cancer Diagnostics ◽

Response To Therapy ◽

Multiple Cancer ◽

Early Diagnosis Of Cancer ◽

Novel Approach ◽

Sensitivity Specificity

In both men and women around the world, lung cancer accounts as the principal cause of cancer-related death after breast cancer. Therefore, early detection of the disease is a cardinal step in improving prognosis and survival of patients. Today, the newly-defined microRNAs regulate about 30 to 60 percent of the gene expression. Changes in microRNA Profiles are linked to numerous health conditions, making them sophisticated biomarkers for timely, if not early, detection of cancer. Though evaluation of microRNAs in real samples has proved to be rather challenging, which is largely attributable to the unique characteristics of these molecules. Short length, sequence similarity, and low concentration stand among the factors that define microRNAs. Recently, diagnostic technologies with a focus on wide-scale point of care have recently garnered attention as great candidates for early diagnosis of cancer. Electrochemical nano-biosensors have recently garnered much attention as a molecular method, showing great potential in terms of sensitivity, specificity and reproducibility, and last but not least, adaptability to point-of-care testing. Application of nanoscale materials in electrochemical devices as promising as it is, brings multiplexing potential for conducting simultaneous evaluations on multiple cancer biomarkers. Thanks to their enthralling properties, these materials can be used to improve the efficiency of cancer diagnostics, offer more accurate predictions of prognosis, and monitor response to therapy in a more efficacious way. This article presents a concise overview of recent advances in the expeditiously evolving area of electrochemical biosensors for microRNA detection in lung cancer.

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Development of an immunochromatographic device to detect antibodies for rapid diagnosis of human angiostrongyliasis

Parasitology ◽

10.1017/s0031182019001495 ◽

2019 ◽

Vol 147 (2) ◽

pp. 194-198 ◽

Cited By ~ 2

Author(s):

Chalermchai Somboonpatarakun ◽

Pewpan M. Intapan ◽

Lakkhana Sadaow ◽

Rutchanee Rodpai ◽

Oranuch Sanpool ◽

...

Keyword(s):

Point Of Care ◽

Central Nervous System Disease ◽

Enzyme Linked Immunosorbent Assay ◽

Predictive Values ◽

Remote Areas ◽

System Disease ◽

Epidemiological Surveys ◽

Sophisticated Equipment ◽

Diagnostic Values ◽

Sensitivity Specificity

AbstractCerebral angiostrongyliasis is a central nervous system disease caused by Angiostrongylus cantonensis and can produce eosinophilic meningitis or meningoencephalitis in humans. Sero-immunological techniques, such as the enzyme-linked immunosorbent assay (ELISA) and immunoblotting, are most commonly used for the diagnosis of human angiostrongyliasis. However, diagnosis in remote areas remains problematic because sophisticated equipment and specialized skills are required. To overcome, we have developed the immunochromatographic test (ICT) kit for rapid serological diagnosis of angiostrongyliasis through the detection of anti-A. cantonensis-specific antibodies in human serum. A recombinant A. cantonensis galectin-2 (rAcGal2) from young adult female worms was used as an antigen for the ICT kit development. Diagnostic values were evaluated and compared using the ELISA. The sensitivity, specificity and positive and negative predictive values of the ICT kit were 87.0, 96.5, 94.6 and 91.4%, respectively, and those of the ELISA were 91.0, 97.2, 95.8 and 94.0%, respectively. The concordance of the ICT kit was 93.9%. We, thus, determined that the ICT kit is sensitive and specific and provides reliable diagnostic results. It is rapid and simple to perform and can be utilized for both point-of-care diagnosis in the bedside laboratory and epidemiological surveys in endemic regions where access to diagnostic equipment is limited.

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Increasing the Reliability of Fully Automated Surveillance for Central Line–Associated Bloodstream Infections

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2015.199 ◽

2015 ◽

Vol 36 (12) ◽

pp. 1396-1400 ◽

Cited By ~ 5

Author(s):

Rachael E. Snyders ◽

Ashleigh J. Goris ◽

Kathleen A. Gase ◽

Carole L. Leone ◽

Joshua A. Doherty ◽

...

Keyword(s):

Surveillance System ◽

Secondary Infection ◽

Bloodstream Infections ◽

Central Line ◽

Skin Wound ◽

Blood Cultures ◽

Electronic Surveillance ◽

Predictive Values ◽

Routine Surveillance ◽

Automated Surveillance

OBJECTIVETo increase reliability of the algorithm used in our fully automated electronic surveillance system by adding rules to better identify bloodstream infections secondary to other hospital-acquired infections.METHODSIntensive care unit (ICU) patients with positive blood cultures were reviewed. Central line–associated bloodstream infection (CLABSI) determinations were based on 2 sources: routine surveillance by infection preventionists, and fully automated surveillance. Discrepancies between the 2 sources were evaluated to determine root causes. Secondary infection sites were identified in most discrepant cases. New rules to identify secondary sites were added to the algorithm and applied to this ICU population and a non-ICU population. Sensitivity, specificity, predictive values, and kappa were calculated for the new models.RESULTSOf 643 positive ICU blood cultures reviewed, 68 (10.6%) were identified as central line–associated bloodstream infections by fully automated electronic surveillance, whereas 38 (5.9%) were confirmed by routine surveillance. New rules were tested to identify organisms as central line–associated bloodstream infections if they did not meet one, or a combination of, the following: (I) matching organisms (by genus and species) cultured from any other site; (II) any organisms cultured from sterile site; (III) any organisms cultured from skin/wound; (IV) any organisms cultured from respiratory tract. The best-fit model included new rules I and II when applied to positive blood cultures in an ICU population. However, they didn’t improve performance of the algorithm when applied to positive blood cultures in a non-ICU population.CONCLUSIONElectronic surveillance system algorithms may need adjustment for specific populations.Infect. Control Hosp. Epidemiol. 2015;36(12):1396–1400

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Evaluation of the Rapidec Carba NP Test Kit for Detection of Carbapenemase-Producing Gram-Negative Bacteria

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01783-15 ◽

2015 ◽

Vol 59 (12) ◽

pp. 7870-7872 ◽

Cited By ~ 21

Author(s):

Atul Garg ◽

Jaya Garg ◽

G. C. Upadhyay ◽

Anurag Agarwal ◽

Amitabha Bhattacharjee

Keyword(s):

Early Detection ◽

Rapid Detection ◽

Multidrug Resistant ◽

Gram Negative Bacteria ◽

Predictive Values ◽

Gram Negative ◽

Practical Solution ◽

Test Kit ◽

Sensitivity Specificity

ABSTRACTRecently, bioMérieux, France, introduced the Rapidec Carba NP test kit for rapid detection of carbapenemase-producing Gram-negative bacteria. This kit was evaluated in this study, and we report sensitivity, specificity, and positive and negative predictive values of 92.6%, 96.2%, 95.83%, and 92.6%, respectively. The test was easy to perform and interpret and relatively inexpensive ($5/Rs 300 per test) and provides a practical solution for early detection of carbapenemase-producing, multidrug-resistant Gram-negative bacteria.

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Investigation of a measles outbreak in Zimbabwe, 2010: potential of a point of care test to replace laboratory confirmation of suspected cases

Epidemiology and Infection ◽

10.1017/s0950268815000540 ◽

2015 ◽

Vol 143 (16) ◽

pp. 3442-3450 ◽

Cited By ~ 10

Author(s):

A. SHONHAI ◽

L. WARRENER ◽

D. MANGWANYA ◽

R. SLIBINSKAS ◽

K. BROWN ◽

...

Keyword(s):

Point Of Care ◽

N Gene ◽

Predictive Values ◽

Point Of Care Test ◽

Measles Outbreak ◽

Laboratory Confirmation ◽

High Level ◽

Sensitivity Specificity ◽

Level Of Agreement

SUMMARYBlood and oral fluid (OF) samples were collected from 103 suspected measles cases between February and November 2010 during a nationwide measles outbreak in Zimbabwe. Siemens measles IgM enzyme immunoassay (EIA) on serum, Microimmune measles IgM capture EIA on OF, real-time haemagglutinin (H) gene PCR and nested nucleocapsid (N) gene PCR on OF were performed, confirming 75 measles cases. These samples were then used to evaluate a newly developed point of care test (POCT) for measles and determine its potential for identifying measles cases in outbreaks. After performing POCTs on OF samples, nucleic acid was extracted from the used test strips and the measles H and N genes amplified by RT–PCR. The sensitivity, specificity, positive and negative predictive values of the POCT for IgM in OF was 75·0% [95% confidence interval (CI) 63·4–84·5], 96·2% (95% CI 80·4–99·9), 98·2% (95% CI 90·3–100) and 58·1% (95% CI 42·1–73·0), respectively. The N gene sequences showed high level of agreement between original OF and corresponding POCT strips. Measles genotype B3 was identified in all cases. We conclude that the measles POCT has the potential to be used, at the point of contact, in outbreak situations and provide molecular characterization of the virus at a later date.

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Evaluation of the Access Bio CareStartTM rapid SARS-CoV-2 antigen test in asymptomatic individuals tested at a community mass-testing program in Western Massachusetts

10.1101/2021.06.17.21259109 ◽

2021 ◽

Author(s):

Sara Suliman ◽

Wilfredo R. Matias ◽

Isabel R Fulcher ◽

Francisco J. Molano ◽

Shannon Collins ◽

...

Keyword(s):

Point Of Care ◽

Quantitative Polymerase Chain Reaction ◽

High Specificity ◽

Antigen Test ◽

Predictive Values ◽

Prevalence Estimates ◽

Moderate Sensitivity ◽

Testing Site ◽

Asymptomatic Individuals ◽

Sensitivity Specificity

Background: Point-of-care antigen-detecting rapid diagnostic tests (RDTs) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) represent a scalable tool for SARS-CoV-2 infections surveillance. Data on their performance in real-world community settings is paramount for their implementation. Method: We evaluated the accuracy of CareStartTM COVID-19 Antigen test (CareStart) in a testing site in Holyoke, Massachusetts. We compared CareStart to a SARS-CoV-2 reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) reference, using anterior nasal swab samples. We calculated the sensitivity, specificity, and expected positive and negative predictive values at different SARS-CoV-2 prevalence estimates. Results: We performed 666 tests on 591 unique individuals. 573 (86%) were asymptomatic. There were 52 positive tests by RT-qPCR. The sensitivity of CareStart was 49.0% (95% Confidence Interval (CI): 34.8 - 63.4) and specificity was 99.5% (95% CI: 98.5 - 99.9). Among positive RT-qPCR tests, the median cycle threshold (Ct) was significantly lower in samples that tested positive on CareStart. Using a Ct ≤ 30 as a benchmark for positivity increased the sensitivity to 64.9% (95% CI: 47.5 - 79.8). Conclusions: CareStart has a high specificity and moderate sensitivity. The utility of RDTs, such as CareStart, in mass implementation should prioritize use cases in which a higher specificity is more important.

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Evaluation of a novel, rapid antigen detection test for the diagnosis of SARS-CoV-2

PLoS ONE ◽

10.1371/journal.pone.0259527 ◽

2021 ◽

Vol 16 (11) ◽

pp. e0259527

Author(s):

Rainer Thell ◽

Verena Kallab ◽

Wolfgang Weinhappel ◽

Wolfgang Mueckstein ◽

Lukas Heschl ◽

...

Keyword(s):

Emergency Departments ◽

Point Of Care ◽

Gain Control ◽

Rapid Test ◽

High Viral Load ◽

Rt Pcr ◽

Likelihood Ratios ◽

Predictive Values ◽

Rapid Antigen Detection Test ◽

Sensitivity Specificity

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19) is currently finally determined in laboratory settings by real-time reverse-transcription polymerase-chain-reaction (rt-PCR). However, simple testing with immediately available results are crucial to gain control over COVID-19. The aim was to evaluate such a point-of-care antigen rapid test (AG-rt) device in its performance compared to laboratory-based rt-PCR testing in COVID-19 suspected, symptomatic patients. Methods For this prospective study, two specimens each of 541 symptomatic female (54.7%) and male (45.3%) patients aged between 18 and 95 years tested at five emergency departments (ED, n = 296) and four primary healthcare centres (PHC, n = 245), were compared, using AG-rt (positive/negative/invalid) and rt-PCR (positive/negative and cycle threshold, Ct) to diagnose SARS-CoV-2. Diagnostic accuracy, sensitivity, specificity, positive predictive values (PPV), negative predictive value (NPV), and likelihood ratios (LR+/-) of the AG-rt were assessed. Results Differences between ED and PHC were detected regarding gender, age, symptoms, disease prevalence, and diagnostic performance. Overall, 174 (32.2%) were tested positive on AG-rt and 213 (39.4%) on rt-PCR. AG correctly classified 91.7% of all rt-PCR positive cases with a sensitivity of 80.3%, specificity of 99.1%, PPV of 98.3, NPV of 88.6%, LR(+) of 87.8, and LR(-) of 0.20. The highest sensitivities and specificities of AG-rt were detected in PHC (sensitivity: 84.4%, specificity: 100.0%), when using Ct of 30 as cut-off (sensitivity: 92.5%, specificity: 97.8%), and when symptom onset was within the first three days (sensitivity: 82.9%, specificity: 99.6%). Conclusions The highest sensitivity was detected with a high viral load. Our findings suggest that AG-rt are comparable to rt-PCR to diagnose SARS-CoV-2 in COVID-19 suspected symptomatic patients presenting both at emergency departments and primary health care centres.

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Murmur clinic: validation of a new model for detecting heart valve disease

Heart ◽

10.1136/heartjnl-2018-313393 ◽

2018 ◽

Vol 105 (1) ◽

pp. 56-59 ◽

Cited By ~ 7

Author(s):

Jane Draper ◽

Sheila Subbiah ◽

Rikki Bailey ◽

John B Chambers

Keyword(s):

General Practitioners ◽

Total Population ◽

Point Of Care ◽

Valve Disease ◽

Heart Valve Disease ◽

Second Phase ◽

Transthoracic Echocardiogram ◽

Predictive Values ◽

Sensitivity Specificity ◽

Community Patients

ObjectivesWe aimed to determine if auscultation or a point-of-care scan could reduce the need for standard echocardiography (transthoracic echocardiogram (TTE)) in community patients with asymptomatic murmurs.MethodsRequests from general practitioners were directed to a new murmur clinic. Auscultation and a point-of-care scan were performed by a cardiologist between 1 October 2013 and 31 December 2014 and by a scientist between 21 July 2015 and 9 May 2017.ResultsIn the first phase (cardiologist), there were 75 patients, mean age 54 (56 women), and in the second phase there were 100 patients, mean age 60 (76 women). In the total population of 175, abnormalities were shown on TTE in 52 (30%), on point-of-care scan in 52 (30%) and predicted on auscultation in 45 (26%) (p=0.125; 95% CI −0.02 to 0.29). The sensitivity of auscultation was not significantly different for the cardiologist (91%) as for the scientist (83%) (p=0.18; 95% CI −0.22 to 0.175) and the specificity was 100% for both. Accuracy was 97% for the cardiologist and 95% for the scientist. For the point-of-care scan, the sensitivity, specificity, positive and negative predictive values and accuracy were 100% for both cardiologist and scientist.ConclusionMost patients in a specialist murmur clinic had normal auscultation and point-of-care scans and no additional valve disease was detected by standard echocardiography. This suggests that a murmur clinic is a valid model for reducing demand on hospital echocardiography services.

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