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1.
BMC Infect Dis ; 22(1): 810, 2022 Oct 31.
Article in English | MEDLINE | ID: covidwho-2098319

ABSTRACT

BACKGROUND: There is limited information to compare the qualitative and semi-quantitative performance of rapid diagnostic tests (RDT) and serology for the assessment of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Therefore, the objective of the study was (a) to compare the efficacy of SARS-CoV-2 antibody detection between RDT and laboratory serology, trying to identify appropriate semi-quantitative cut-offs for RDT in relation with quantitative serology values and to (b) evaluate diagnostic accuracy of RDT compared to the NAAT gold standard in an unselected adult population. METHODS: SARS-CoV-2 antibodies were simultaneously measured with lateral flow immunochromatographic assays (LFA), the Cellex qSARS-CoV-2 IgG/IgM Rapid Test (by capillary blood), the iFlash-SARS-CoV-2 IgG/IgM chemiluminescent immunoassay (CLIA) (by venous blood) and the nucleic acid amplification test (NAAT) in samples from in- and out-patients with confirmed, suspected and negative diagnosis of coronavirus disease 2019 (COVID-19) attending Udine Hospital (Italy) (March-May 2020). Interpretation of RDT was qualitative (positive/negative) and semi-quantitative based on a chromatographic intensity scale (negative, weak positive, positive). RESULTS: Overall, 720 paired antibody measures were performed on 858 patients. The qualitative and semiquantitative agreement analysis performed in the whole sample between LFA and CLIA provided a Kendall's tau of 0.578 (p < 0.001) and of 0.623 (p < 0.001), respectively, for IgM and IgG. In patients with a diagnosis of COVID-19, accordance between LFA and CLIA was maintained as a function of time from the onset of COVID-19 disease and the severity of disease both for qualitative and semi-quantitative assessments. RDT compared to the NAAT gold standard in 858 patients showed 78.5% sensitivity (95% CI 75.1%-81.7%) and 94.1% specificity (95% CI 90.4%-96.8%), with variable accordance depending on the timing from symptom onset. CONCLUSION: The RDT used in our study can be a non-invasive and reliable alternative to serological tests and facilitate both qualitative and a semi-quantitative antibody detection in COVID-19.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Humans , COVID-19/diagnosis , Prospective Studies , Immunoglobulin M , Sensitivity and Specificity , Antibodies, Viral , Immunoglobulin G , Immunoassay/methods
2.
Int J Med Inform ; 164: 104791, 2022 08.
Article in English | MEDLINE | ID: covidwho-2076188

ABSTRACT

OBJECTIVE: COVID-19 is a novel, severely contagious disease with enormous negative impact on humanity as well as the world economy. An expeditious, feasible tool for detecting COVID-19 remains yet elusive. Recently, there has been a surge of interest in applying machine learning techniques to predict COVID-19 using non-image data. We have therefore undertaken a meta-analysis to quantify the diagnostic performance of machine learning models facilitating the prediction of COVID-19. MATERIALS AND METHODS: A comprehensive electronic database search for the period between January 1st, 2021 and December 3rd, 2021 was undertaken in order to identify eligible studies relevant to this meta-analysis. Summary sensitivity, specificity, and the area under receiver operating characteristic curves were used to assess potential diagnostic accuracy. Risk of bias was assessed by means of a revised Quality Assessment of Diagnostic Studies. RESULTS: A total of 30 studies, including 34 models, met all of the inclusion criteria. Summary sensitivity, specificity, and area under receiver operating characteristic curves were 0.86, 0.86, and 0.91, respectively. The purpose of machine learning models, class imbalance, and feature selection are significant covariates useful in explaining the between-study heterogeneity, in terms of both sensitivity and specificity. CONCLUSIONS: Our study findings show that non-image data can be used to predict COVID-19 with an acceptable performance. Further, class imbalance and feature selection are suggested to be incorporated whenever building models for the prediction of COVID-19, thus improving further diagnostic performance.


Subject(s)
COVID-19 , COVID-19/diagnosis , Humans , Machine Learning , ROC Curve , Sensitivity and Specificity
3.
New Armenian Medical Journal ; 16(2):25-32, 2022.
Article in English | EMBASE | ID: covidwho-2067787

ABSTRACT

Objectives: to assess the effect-related inflammatory and coagulation biomarkers in pregnancy and their connection with the coronavirus disease of 2019 (COVID-19). Method(s): A prospective case-control study was carried out among normal third-trimester pregnant women admitted to the labor room of Dr. Soetomo General Academic Hospital between January until June 2021. Two classified groups of patients were established in accordance with the result of the RT-PCR test. Demographic, clinical and laboratory results data of the two groups were collected and compared. Result(s): Platelet-to-lymphocyte ratio (PLR) was shown to be the only significant biomarkers found in the expectant with COVID-19, which was 35.8% higher compared to the ones free of COVID-19 [212.25 (157.57-269.37) vs 156.29 (128.55-195.3), p=0.048]. Logistic regression analysis of PLR between groups showed that the level of PLR was an independent factor in pregnant women with COVID-19 (OR 4.483, 95%CI 1.262-15.926). The ROC analysis showed that the PLR cut-off among the expectant was 171.335, with both sensitivity and specificity were 66.7% (p=0.021). The result shows no significant differences in leukocyte count, absolute neutrophils - lymphocyte count and percentage, neutrophil-to-lymphocyte ratio (NLR) and D-Dimer level between pregnant women infected with COVID-19 and free of the virus (p>0.05). Conclusion(s): Intriguingly, physiological adaptation during the course of the third trimester of pregnancy found no difference in most inflammation and coagulation markers, both in the condition of infected COVID-19 or not. The evidence from this single-centre study supports the viewpoint that elevated PLR was associated with independent biomarkers and thereby might be helpful to detect expectant with COVID-19. Copyright © 2022, Yerevan State Medical University. All rights reserved.

4.
Pakistan Journal of Medical and Health Sciences ; 16(8):88-91, 2022.
Article in English | EMBASE | ID: covidwho-2067739

ABSTRACT

Background: The COVID-19 first surfaced when cluster of pneumonia patients arose in Wuhan, Hubei Province, China. Although the current gold standard for COVID-19 diagnosis is reverse transcriptase-polymerase chain reaction (RT-PCR), chest x-ray (CXR) and computed tomography (CT) play a vital role in sickness diagnosis due to their limited sensitivity and availability. Aim: To evaluate retrospectively the role of CXR, the main radiological findings in it and its diagnostic accuracy in COVID-19 pneumonia. Methods: This is a cross sectional study involving 264 PCR positive COVID-19 patients with their clinical-epidemiological findings admitted at Ziauddin Hospital from May-July 2020. CXRs were taken as digital radiographs in our emergency department's isolation wards using the same portable X-ray device, according to local norms. CXRs were taken in two directions: antero-posterior (AP) and postero-anterior (PA). The hospitals' database had all of the images. To determine the number of radiological findings, multiple radiologists on duty completed an independent and retrospective examination of each CXR. In the event of disagreement, a mutual agreement was reached. SPSS version 20 was used for statistical analysis. Results: We were able to find 264 patients who met our criteria. With a mean age of 56.4214.89, the majority of individuals were determined to be males 189(71.6%) and females 75(28.4%). (Range of 16 to 87 years). 127 patients (48.1%) had severe illness symptoms and were admitted to the ICU, while the remaining 102(38.6%) had mild to moderate disease 35(13.3%). Diffuse (29.2%) and middle and lower co-existing distribution (25.8%) whereas just lower lobe (13.3%) were the most common predominance in severity. Peripheral involvement was also seen in (8.7%) cases. Conclusion: Both lungs are equally affected with the disease having the consolidation and opacifications while the effusion is the major complication in the severe cases. Diffuse involvement of the lung lobes is seen in the study followed by the middle and lower lobe involvement.

5.
Minerva Dental and Oral Science ; 71(4):206-211, 2022.
Article in English | EMBASE | ID: covidwho-2067530

ABSTRACT

BACKGROUND: Aquick diagnosis is crucial in effectively limiting the spread of SARS-CoV-2. The study aims to assess the prevalence of positive rapid tests in private dental practices. METHOD(S): This is an observational study. 532 COVID-19 rapid nasopharyngeal antigen tests were carried out in the Veneto region of Italy. Patients of 4 dental practices in different cities (Caorle, Montebelluna, Treviso and Vicenza) were screened with a rapid test (Rapid Test COVID-19 Ag immunochromatographic assay, Techno Genetics) throughout November and December 2020. All the positive results from rapid tests were further investigated with a molecular test (PCR). All the patients tested showed no symptoms associated with SARS-CoV-2 infection and had already undergone triage and temperature measurement. In total 532 tests were taken: 202 in Caorle (Venice), 130 in Montebelluna (Treviso), 100 in Treviso, and 100 in Vicenza. Statistical analysis was carried with the computing environment Rversion 3.2.1 (R Foundation for Statistical Computing, Vienna, Austria). In particular, R was used for estimating the P value of the x2 test. The test was considered significant if the P value was lower or equal to 0.05. RESULT(S): The prevalence of the rapid tests that resulted positive was 7.14% (38 out of 532 in total, 22 out of 202 in Caorle, 6 out of 130 in Montebelluna, 4 out of 100 in Treviso and 6 out of 100 in Vicenza). Among these patients, 36 tested positive also with a molecular test (94.74%), in particular, 21 in Caorle, 5 in Montebelluna, 4 in Treviso, and 6 in Vicenza. CONCLUSION(S): The prevalence of positive patients screened with a rapid test in private dental practices stands at 7.14% and it was confirmed in most of the patients with molecular tests. Therefore, in high-risk environments like dental practices, it is imperative to follow all the precautionary measures, and having every patient tested with a rapid test could be taken into consideration to limit the spread of COVID-19 infection. Copyright © 2022 Journal of Korean Ophthalmological Society. All rights reserved.

6.
NeuroQuantology ; 20(9):4484-4490, 2022.
Article in English | EMBASE | ID: covidwho-2067292

ABSTRACT

Artificial intelligence may be used to identify COVID-19 pneumonia (also known as pneumococcal meningitis) (AI). AI algorithms are also under scrutiny for their resilience and vulnerability, as are the datasets and research methods used to get the data. AI-driven COVID-19 pneumonia detectors that use our own data from retrospective clinical studies might help overcome these difficulties. In order to assess statistically the research designs, we optimized five deep learning architectures, applied development techniques by altering data distribution and introduced several detection scenarios to test the durability and diagnostic performance of the models. To a greater extent than the present data volume, detection model performance is influenced by hyper parameter adjustment. Sn, sp, and PPV are the three most important metrics in a two-class detection situation, and a method called InceptionV3 has the best of all three. It was shown that models had improved overall performance, with 91-96 percent Sn and 94-98 percent Sp and 91-96 PPV, compared to three-class detection results. Accuracy, F1 scores and g means are all higher than 96% accurate in InceptionV3, according to InceptionV3. For the identification of COVID-19 pneumonia, InceptionV3 had the greatest results, with an AUC of 99. An AUC of 0.98 distinguishes CoVID-19 pneumonia from other kinds of pneumonia, and a micro-average of 0.99 was achieved for the remaining classes.

7.
Hypertension. Conference: American Heart Association's Hypertension ; 79(Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2064363

ABSTRACT

Background: Connected health technology can enable healthcare professionals to provide multiple solutions to meet the growing demand of care and control of COVID-19 infected patients, by optimizing economic resources and extending the scope of monitoring beyond the hospital. An innovative mobile device, the BioBeat Watch, developed in Israel, with an APP that can be downloaded directly to the Smart Phone, is characterized by sensors already validated according to the regulations of the Food and Drug Administration for vital signs, the ECG track and the European Society Hypertension for the detection of blood pressure. Purpose(s): Wearable medical devices and the BioBeat software platform are appropriate for use in different settings for the management of acute, chronic cardiovascular, respiratory and inflammatory pathology, a tool capable of early identification of the instrumental signs of deterioration even before the exclusively clinical recognition that becomes even more difficult if we consider the patients at home.The aim of this study is to test the sensitivity and specificity of the biobeat wearable system applied in patients with paucisymptomatic COVID-19 infection (group A) and in those with previous SARS-COV2 disease discharged from the hospital who still needed post-acute monitoring (group B) and compared with clinical control, managing to determine early the clinical signs of worsening. Method(s): The data recorded by individual patients are systolic and diastolic blood pressure, heart and respiratory rate, peripheral oxygen saturation and body temperature. The criteria of deterioration or worsening of the clinical condition are represented by the need to hospitalize the patient, alteration of one of the criteria grouped in the ABCDE. Result(s): We calculated the sensitivity of the methodology related to the alerts detected and the outcome of the patients. Sensitivity was 86.3% with a 95% CI of 0.71 to 1.03 and a specificity of 7.7%. Conclusion(s): Continuous monitoring with biobeat watch showed a high sensitivity in detecting early any alerts predictive of worsening of the disease.

8.
Archives of Disease in Childhood ; 107(Supplement 2):A369-A370, 2022.
Article in English | EMBASE | ID: covidwho-2064047

ABSTRACT

Aims Raised Intracranial Pressure (ICP) is frequently encountered condition amongst children due to neurological and non-neurological etiologies. It contributes towards 20% of the admissions in our PICU at tertiary care institute of North India. Timely diagnosis of raised intracranial pressure is critical for appropriate management. Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is non-invasive point of care tool to recognize raised intracranial pressure however there are very limited studies in pediatric population on this. Aim of this study was to measure the ONSD of children admitted in pediatric intensive care unit (PICU) to identify the difference in ONSD among the pediatric patients with normal and raised ICP and to achieve the cut-off value for diagnosing raised ICP. Methods A Hospital based observational comparative study conducted at PICU of a tertiary care institute of national importance in North India. ONSD measurement of all the patients aged 2-14 years admitted in pediatrics department for >48 hours was done in two phases due to COVID-19 related restrictions in routine admissions for some months. First phase was from 1st January 2020 to 31st March 2021 and second phase started from 15th January 2022. Complete enumeration technique was used for the study. Children receiving treatment for raised ICP based on clinical features (Muir's criteria) and neuroimaging were included in raised ICP group and they were compared with the patients without any signs of raised ICP. Optic nerve sheath diameter was measured in both the groups on Day 1 (i.e. within 24 hours of admission) and Day 2 of admission. Third and last ONSD measurement was done on any day between day 4 and day 7 of admission. On each day, 3 readings were taken from each eye and average of 3 readings was used for final statistical analysis for that particular day. Treating team was unaware of the USG findings throughout the stay of the patient in the department. Results Total 101 patients recruited, among them 16 patients had raised ICP and 85 patients had normal ICP. The mean optic nerve sheath diameter on day 1 was found to be higher in the patients with raised ICP (Mean ONSD = 4.955 +/- 0.80) as compared to those with normal ICP (Mean ONSD = 4.05 +/- 0.43). Their mean difference was 0.90 mm (95% CI 0.07-1.48 p value <0.01). Mean ONSD on day 2 also was higher in raised ICP patients (Mean ONSD = 4.82 +/- 0.73) in comparison to normal ICP patients (Mean ONSD = 4.06 +/- 0.47) which was statistically significant (p value = 0.001). The cut-off ONSD value for detecting the raised ICP was estimated to be 4.35 mm on ROC curve with area under the curve 0.862 (95% CI, 0.721-0.943), sensitivity of 75% and specificity of 76.5%. Conclusion Raised ICP is one of the important neurological entities in children contributing towards significant morbidity. Measurement of ONSD by trans-orbital ultrasound was able to detect raised ICP with excellent discriminatory performance.

9.
Archives of Disease in Childhood ; 107(Supplement 2):A267-A268, 2022.
Article in English | EMBASE | ID: covidwho-2064033

ABSTRACT

Aims To assess if there is any temporal association between the sudden high incidence of newly diagnosed Type 1 Diabetes Mellitus (T1DM) in children and the onset of Coronavirus Disease 2019 (CoviD19) in Harlow, Essex UK. Methods Design An observational study Setting Princess Alexandra Hospital NHS Trust (PAH), District General Hospital Over a period of 6 weeks between end April to start of June 2020, there were 10 cases of new onset T1DM who presented to our paediatric department. We reviewed the demographics, symptomatology and biochemical presentations of these patients (table 1). Bloods including SARS-CoV-2 IgG antibody were taken at first presentation and patients had nasal swabs for SARS-COV-2 PCR. Families of patients provided written consent to take part in the project. Antibody testing with HSL Roche kit (sensitivity of 97% at D14-21 and 100% at D40) was processed at PAH microbiology laboratory. All data collators had updated training in Good Clinical Practice GCP and Consenting in paediatric e-learning modules on NIHR Learning Management Systems platform. Primary outcomes assessed the association of new onset T1DM with COVID-19 IgG positivity. Secondary outcomes assessed the degree of severity of T1DM at presentation through severity of acidosis and level of HbA1c. Clinical presentations were evaluated to assess any patterns through the cases. We also aimed to check for any demographic similarities. We derived interquartile ranges (IQR = Q3-Q1) between Q1 25% to Q3 75% to adjust for outliers in the dataset Results Only one case was detected to have IgG antibodies at the time of presentation (not in DKA). Median age of presentation was 9.5 years. The youngest being 11 months and oldest, 14 years. There were 7 males, and 3 females in the cohort. 50% of cases were not in DKA. Of those who presented with ketosis, 2 were in severe DKA (most severe at pH 6.94). None needed intensive care management. Median HbA1c at presentation was 123.5 mmol/mol. Median duration of symptoms was 23.8 days, with those not in DKA presenting on average 17 days and those in DKA (20%) presenting longer (30 days). Those in severe DKA had higher HbA1c values (143 and 151 mmol/mol). There were comorbidities of previously diagnosed autism and hypothyroidism at diagnosis of T1DM in one solitary case (not in DKA). Covid19 antibody positive patient had a history of parent succumbing to COVID-19. Demographics - 30% cases hailed from Harlow, 20% from Broxbourne and Bishops Stortford. 10% were from Waltham abbey, Waltham cross and Epping areas each. Conclusion Our small study represents an exponential rise (three-fold increase) in cases of new onset T1DM shortly following the first pandemic peak in April 2020. Only one case showed presence of past COVID-19 infection. The sampling of antibodies was limited by lack of widespread rollout of coronavirus testing at the time. Our findings support the observation that delay in diagnosis resulted in increasing patient numbers presenting in DKA. There was no association between CoVId-19 infection and new onset T1DM in children. We look forward to outcomes of larger scale studies examining this issue.

10.
American Journal of Transplantation ; 22(Supplement 3):647, 2022.
Article in English | EMBASE | ID: covidwho-2063508

ABSTRACT

Purpose: Advanced age is associated with impaired humoral immune response to SARS-CoV-2 mRNA vaccines in kidney transplant recipients (KTR), however mechanisms are poorly understood. Frailty syndrome assessment in geriatric KTR may reveal the most vulnerable population. Method(s): This is the subcohort analysis of prospective study (NCT04832841) dealing with seroconversion after SARS-CoV-2 mRNA vaccination. In 101 KTR aged 70+ who were SARS-CoV-2 naive, the Fried frailty components were evaluated. Antibodies against S1 and S2 subunit of SARS-CoV-2 were evaluated >14 days after second dose of mRNA vaccines using immunochemiluminescent assay (cut off 9.5 AU/ml, sensitivity of 91.2% and specificity of 90.2%). The clinical variables affecting the humoral response were analyzed by multivariable binary regression model based on results of univariable analysis. Result(s): The seroconversion after SARS-CoV-2 vaccination was observed in 33 out of 101 (33%) KTR. In the univariable regression model, eGFR (OR=1.03, p=0.001), MMF-free immunosuppression (OR=4.32, p=0.002), physical inactivity (OR=0.36, p=0.039), grip strength (OR=1.05, p=0.045), male gender (OR=2.09, p=0.09), and Fried frailty score (OR=0.74, p=0.09) were associated with seroconversion. Multivariable binary logistic regression model adjusted for KTR age and gender retained as independent significant predictors for seroconversion the Fried frailty cumulative score (OR=0.6, p=0.048), eGFR (OR=1.05, p<0.001), MMF-free immunosuppression (OR=8.25, p=0.001) and longer follow-up from transplantation (OR=1.01, p=0.021). Conclusion(s): The frailty but not age itself is associated with impaired humoral response to SARS-CoV-2 mRNA vaccines in KTR. Intervention to reduce physical inactivity prior to vaccination may improve seroconversion rate in elderly KTR.

11.
Microbiol Spectr ; : e0169522, 2022 Oct 13.
Article in English | MEDLINE | ID: covidwho-2063983

ABSTRACT

Biomedical personnel can become contaminated with nonhazardous reagents used in the laboratory. We describe molecular studies performed on nasal secretions collected longitudinally from asymptomatic laboratory coworkers to determine if they were infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) circulating in the community or with SARS-CoV-2 DNA from a plasmid vector. Participants enrolled in a prospective study of incident SARS-CoV-2 infection had nasal swabs collected aseptically by study staff at enrollment, followed by weekly self-collection of anterior nasal swabs. SARS-CoV-2 diagnosis was performed by a real-time PCR test targeting the nucleocapsid gene. PCR tests targeting SARS-CoV-2 nonstructural protein 10 (nsp10), nsp14, and envelope and three regions of the plasmid vector were performed to differentiate amplification of SARS-CoV-2 RNA from the plasmid vector's DNA. Nasal swabs from four asymptomatic coworkers with positive real-time PCR results for the SARS-CoV-2 nucleocapsid targets were negative when tested for SARS-CoV-2 nsp10, nsp14, and envelope protein. However, nucleic acids extracted from these nasal swabs amplified DNA regions of the plasmid vector used by the coworkers, including the ampicillin and neomycin/kanamycin resistance genes, the promoter-nucleocapsid junction, and unique codon-optimized regions. Nasal swabs from these individuals tested positive repeatedly, including during isolation. Longitudinal detection of plasmid DNA with SARS-CoV-2 nucleocapsid in nasal swabs suggests persistence in nasal tissues or colonizing bacteria. Nonviral plasmid vectors, while regarded as safe laboratory reagents, can interfere with molecular diagnostic tests. These reagents should be handled using proper personal protective equipment to prevent contamination of samples or laboratory personnel. IMPORTANCE Asymptomatic laboratory workers who tested positive for SARS-CoV-2 for days to months were found to harbor a laboratory plasmid vector containing SARS-CoV-2 DNA, which they had worked with in the past, in their nasal secretions. While prior studies have documented contamination of research personnel with PCR amplicons, our observation is novel, as these individuals shed the laboratory plasmid over days to months, including during isolation in their homes. This suggests that the plasmid was in their nasal tissues or that bacteria containing the plasmid had colonized their noses. While plasmids are generally safe, our detection of plasmid DNA in the nasal secretions of laboratory workers for weeks after they had stopped working with the plasmid shows the potential for these reagents to interfere with clinical tests and emphasizes that occupational exposures in the preceding months should be considered when interpreting diagnostic clinical tests.

12.
Curr Opin Environ Sci Health ; : 100396, 2022 Oct 06.
Article in English | MEDLINE | ID: covidwho-2061025

ABSTRACT

Wastewater-Based Epidemiological Monitoring (WBEM) is an efficient surveillance tool during the COVID-19 pandemic as it meets all requirements of a complete monitoring system including early warning, tracking the current trend, prevalence of the disease, detection of genetic diversity as well asthe up-surging SARS-CoV-2 new variants with mutations from the wastewater samples. Subsequently, Clinical Diagnostic Test is widely acknowledged as the global gold standard method for disease monitoring, despite several drawbacks such as high diagnosis cost, reporting bias, and the difficulty of tracking asymptomatic patients (silent spreaders of the COVID-19 infection who manifest nosymptoms of the disease). In this current reviewand opinion-based study, we first propose a combined approach) for detecting COVID-19 infection in communities using wastewater and clinical sample testing, which may be feasible and effective as an emerging public health tool for the long-term nationwide surveillance system. The viral concentrations in wastewater samples can be used as indicatorsto monitor ongoing SARS-CoV-2 trends, predict asymptomatic carriers, and detect COVID-19 hotspot areas, while clinical sampleshelp in detecting mostlysymptomaticindividuals for isolating positive cases in communities and validate WBEM protocol for mass vaccination including booster doses for COVID-19.

13.
Chest ; 162(4):A2671-A2672, 2022.
Article in English | EMBASE | ID: covidwho-2060981

ABSTRACT

SESSION TITLE: Late Breaking Investigations From Pulmonary and Critical Care SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/18/2022 01:30 pm - 02:30 pm PURPOSE: Although spirometry is the standard lung functional test, it requires the patient to perform a series of maneuvers correctly, which is difficult for elderly, children, and patients with severe lung impairments. Furthermore, spirometry lacks regional assessment for detecting and monitoring subtle changes in lung diseases, e.g., chronic obstructive pulmonary disease (COPD) and potentially COVID-19. We aim to establish a home-based imaging system, portable electrical impedance tomography (EIT), that can detect lung function deterioration and monitor its recovery through a close-to-effortless breathing paradigm. METHODS: We developed a palm-sized EIT system and a novel guided breathing paradigm that consists of a periodic inhalation and exhalation at 12 breaths per minute. We validated them on healthy subjects (n=23) performing different breathing efforts (deep vs shallow), then on patients with ILD (n=2), COPD (n=8), asthma (n=4) and bronchiectasis (n=4) against healthy (n=8) cross-sectionally, and last monitored a COVID-19 discharged subject with two age- and gender-matched healthy controls longitudinally. We further applied machine learning to distinguish between healthy and patients, and calculated its sensitivity and specificity. RESULTS: We detected higher amplitude during deep breathing compared to shallow (p < 0.001) in healthy subjects, with right lung having more activated voxels and higher total amplitude than the left lung (p < 0.001), likely due to the position of the heart. Cross-sectionally, we observed lower amplitude in patients compared to healthy (p < 0.01), while coefficient of variation (CV) of the amplitude in the lungs is higher in patients (p < 0.05). Note that CV is a parameter reflecting inhomogeneity which is indicative of lung function deterioration. Longitudinally, the COVID-19 discharged subject had higher CV in the left lung (p < 0.001) which decreased across time (p < 0.01), suggesting a functional deterioration at the beginning followed by a recovery. Regional analysis further pin-pointed the potential deterioration and recovery was in the anterior left lung. Separately, despite the small sample size, the sensitivity and specificity for detecting patients using a machine learning classifier were 76% and 62%, respectively, and will likely increase with a larger sample. CONCLUSIONS: Home-based portable EIT with close-to-effortless guided breathing paradigm can map global and regional lung function deterioration and recovery cross-sectionally and longitudinally. More importantly, it can potentially be deployed as a screening tool for various lung diseases through the application of machine learning. CLINICAL IMPLICATIONS: Portable EIT with guided breathing paradigm enables lung function diagnostic screening and treatment monitoring at home, advancing telemedicine and lowering hospital burden. DISCLOSURES: no disclosure on file for Peng Cao;Owner/Founder relationship with Gense Technologies Ltd Please note: Since 2017 Added 06/06/2022 by Russell Chan, value=Ownership interest No relevant relationships by Wang Chun Kwok No relevant relationships by Wei-Ning Lee No relevant relationships by Terence Tam Employee relationship with Gense Technologies Please note: Setpember 2021 - Now Added 06/07/2022 by Adrien Touboul, value=Salary contractor relationship with Gense Technologies Ltd Please note: since Apr 2021 Added 06/06/2022 by Eddie Wong, value=Consulting fee Employee relationship with Gense Technologies Please note: since 2020 Added 06/06/2022 by Fedi Zouari, value=Royalty

14.
Chest ; 162(4 Supplement):A2106-A2107, 2022.
Article in English | EMBASE | ID: covidwho-2060900

ABSTRACT

SESSION TITLE: Lung Nodule Biopsy: Yield and Accuracy SESSION TYPE: Original Investigations PRESENTED ON: 10/16/2022 10:30 am - 11:30 am PURPOSE: Atypia is common on biopsy specimens of peripheral pulmonary lesions (PPLs) and may result from inflammation or inadequate sampling of a malignancy. The significance of atypical cells on PPLs biopsies has not been well described. In addition, recent studies of navigational bronchoscopy have variably considered atypia on biopsies as diagnostic. METHOD(S): We analyzed a prospective database of consecutive PPLs sampled via navigational bronchoscopy at our institution (IRB: 212187). Search terms "atypia" and "atypical" were applied to pathology reports generated by these procedures. Manual inspection ensured atypia was present in the PPL itself. Definitive PPL diagnosis was established during a two-year routine clinical follow-up. Bronchoscopy diagnostic yield was defined as histopathological findings which readily explained a nodule (malignancy, organizing pneumonia, frank purulence, granulomatous inflammation) and permitted management of the patient without an immediate additional diagnostic intervention. Atypia was considered nonspecific and, therefore, nondiagnostic. RESULT(S): From 11/2017 to 4/2019, 461 biopsied PPLs were identified. Eleven cases, none exhibited atypia, lacked complete two-year follow-up, and were excluded. Ultimately, 274 of 450 (61%) analyzed PPLs were malignant. Diagnostic biopsies were obtained in 331 (73.5%) cases. Atypical cells were present in 33 PPLs (7% of overall cohort, 28% of the 119 nondiagnostic cases). Two-thirds (22 of 33) were eventually determined to be malignant. Lung adenocarcinoma was the most common ultimate malignant diagnosis (10 cases). Most benign PPLs with atypia regressed on follow-up imaging without further pathological data (5 cases). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of atypia for an eventual diagnosis of malignancy among the 223 PPLs not diagnosed as malignant at index bronchoscopy were 46% (95% CI 31-61%), 94% (89-97%), 92% (85-96%), and 53% (46-60%), respectively, with positive likelihood ratio (+LR) of 7.3 (3.8-14). CONCLUSION(S): The presence of atypical cells was a common finding, found in 28% of PPLs without a specific diagnosis after bronchoscopy. Two-thirds of PPLs with atypia were ultimately malignant, with a high PPV (92%) for malignant diagnosis in this cohort with an overall prevalence of malignancy of 61%. CLINICAL IMPLICATIONS: Atypia not diagnostic of malignancy in bronchoscopic biopsy specimens is a nonspecific finding, which may be due to inadequate sampling of a malignant PPL or inflammation. However, the high PPV and +LR of atypia for ultimate malignant PPL diagnosis suggest that in populations with a similar prevalence of malignancy and/or in the clinical context of a high pre-test probability of malignancy, atypical findings might prompt repeat biopsy or definitive PPL management (resection or ablation). DISCLOSURES: No relevant relationships by Robert Lentz No relevant relationships by Kaele Leonard No relevant relationships by See-Wei Low PI ofan investigator-initiated study relationship with Medtronic Please note: >$100000 by Fabien Maldonado, value=Grant/Research Support PI on investigator-initiated relationship with Erbe Please note: $5001 - $20000 by Fabien Maldonado, value=Grant/Research Support Consulting relationship with Medtronic Please note: $5001 - $20000 by Fabien Maldonado, value=Honoraria co-I industry-sponsored trial relationship with Lung Therapeutics Please note: $5001 - $20000 by Fabien Maldonado, value=Grant/Research Support Board of director member relationship with AABIP Please note: $1-$1000 by Fabien Maldonado, value=Travel Consultant relationship with Medtronic/Covidien Please note: $1001 - $5000 by Otis Rickman, value=Consulting fee No relevant relationships by Briana Swanner Copyright © 2022 American College of Chest Physicians

15.
Chest ; 162(4 Supplement):A2087-A2088, 2022.
Article in English | EMBASE | ID: covidwho-2060897

ABSTRACT

SESSION TITLE: Lung Nodule Biopsy: Yield and Accuracy SESSION TYPE: Original Investigations PRESENTED ON: 10/16/2022 10:30 am - 11:30 am PURPOSE: A variety of endpoints have been used to evaluate the diagnostic performance of navigational bronchoscopy for sampling peripheral pulmonary lesions (PPLs), including diagnostic yield (rate of biopsies with a specific diagnosis that facilitates clinical decisions) and diagnostic accuracy (yield plus a follow-up to assess for false negative/positive initial results). There is also significant variation in what non-malignant findings are considered diagnostic, especially regarding nonspecific inflammatory changes. We hypothesized a diagnostic yield definition excluding nonspecific findings as diagnostic would lead to few false negative PPL biopsies. METHOD(S): Our center maintains a prospective cohort of consecutive PPLs targeted via navigational bronchoscopy. Diagnostic yield was defined as specific findings readily explaining the presence of a PPL (malignancy, organizing pneumonia, granulomatous inflammation, frank purulence, other specific finding) permitting management without immediate additional diagnostic intervention. "Other specific finding" required pulmonologist and lung pathologist agreement. All other findings were considered non-diagnostic. RESULT(S): A total of 450 PPLs biopsied 2017-2019 with complete two-year follow-up were included in the analysis. Ultimately, 274 of 450 (60.9%) PPLs were determined to be malignant. Diagnostic biopsies were obtained in 331 cases (73.6%). There was a single false-positive among 228 malignant biopsies (0.4%, carcinoid tumor on cytopathology, alveolar adenoma on resection surgical pathology). Among 223 PPLs without malignant diagnosis at initial bronchoscopy, 48 were later determined to be malignant. Most (n=39) exhibited nonspecific abnormalities on initial pathology. Two of 104 specific benign biopsies were false negative (1.9%). Both demonstrated organizing pneumonia on initial pathology but re-biopsy months after index bronchoscopy revealed Hodgkin's lymphoma and metastatic renal cell carcinoma, respectively. The sensitivity, specificity, and positive predictive value of specific benign findings for an ultimately benign nodule were 58% (95% CI, 51-66%), 95% (86-99%), and 90% (70-97%). The sensitivity, specificity, and positive predictive value of nonspecific benign findings for an ultimately benign PPL diagnosis were 32% (95% CI, 25-39%), 19% (9-33%), and 20% (16-24%). CONCLUSION(S): A definition of diagnostic yield excluding nonspecific benign findings had low false positive/negative rates. If bronchoscopy is not diagnostic of malignancy, a specific benign finding was highly predictive of an ultimately benign PPL, while nonspecific findings poorly predicted benignity. CLINICAL IMPLICATIONS: This definition of diagnostic yield could be used as the primary outcome in future studies, permitting distribution of reliable diagnostic results without requiring years of follow-up. DISCLOSURES: No relevant relationships by Joyce Johnson No relevant relationships by Robert Lentz No relevant relationships by Kaele Leonard No relevant relationships by See-Wei Low PI ofan investigator-initiated study relationship with Medtronic Please note: >$100000 by Fabien Maldonado, value=Grant/Research Support PI on investigator-initiated relationship with Erbe Please note: $5001 - $20000 by Fabien Maldonado, value=Grant/Research Support Consulting relationship with Medtronic Please note: $5001 - $20000 by Fabien Maldonado, value=Honoraria co-I industry-sponsored trial relationship with Lung Therapeutics Please note: $5001 - $20000 by Fabien Maldonado, value=Grant/Research Support Board of director member relationship with AABIP Please note: $1-$1000 by Fabien Maldonado, value=Travel Consultant relationship with Medtronic/Covidien Please note: $1001 - $5000 by Otis Rickman, value=Consulting fee No relevant relationships by Briana Swanner Copyright © 2022 American College of Chest Physicians

16.
Chest ; 162(4):A838-A839, 2022.
Article in English | EMBASE | ID: covidwho-2060702

ABSTRACT

SESSION TITLE: Sepsis: Beyond 30cc/kg and Antibiotics SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/19/2022 11:15 am - 12:15 pm PURPOSE: The Sepsis Prediction Model (SPM) is a proprietary decision support tool created by Epic Systems. The basis of the SPM is a Predicting Sepsis Score (PSS) calculated from demographic, comorbidity, vitals, labs, medication, and procedural data. We assessed the diagnostic accuracy and timeliness of the PSS for sepsis as defined by Centers for Disease Control (CDC) Adult Sepsis Event (ASE) criteria. The performance of the PSS was compared to, Systemic Inflammatory Response Syndrome (SIRS), quick Sequential Organ Failure Assessment (qSOFA), and SOFA scores. METHODS: Retrospective review of 62,460 adults admitted to 4 Wake Forest Baptist Health System hospitals from June 1, 2019 through December 31, 2020 with PSS scores calculated every 15 minutes. A sepsis event was defined as receipt of 4 or more days of antimicrobials, blood cultures collected within 48 hours of initial antimicrobial administration, and at least one organ dysfunction. This definition of sepsis was modified to also include Covid-19 infection with organ dysfunction. Time zero was defined as time of first contact for the healthcare encounter. 30-day readmissions, facility transfers, and deaths in the Emergency Department were excluded. RESULTS: The prevalence of sepsis in the sample was 4.5%. The optimal PSS threshold based on Youden’s J statistic was a score of 8 (sensitivity 0.72, specificity 0.74, Youden’s J 0.46). SIRS (sensitivity 0.90, specificity 0.42), qSOFA (sensitivity 0.64, specificity 0.69), and SOFA (sensitivity 0.89, specificity 0.43) had a Youden’s J statistic for sepsis of 0.32, 0.33, and 0.32, respectively. At a PSS score of ≥ 8, median time to score positivity among those who reached that score (28.4% of sample) was 217 minutes (IQR 74-1477 minutes). For SIRS, qSOFA and SOFA, median time to score positivity was 54 minutes (IQR 24-456), 360 minutes (IQR 53-1593) and 107 minutes (IQR 39-474), respectively. CONCLUSIONS: Discrimination of the PSS for detection of sepsis was highest at a threshold score of 8. Overall, the PSS discriminated better than SIRS, qSOFA and SOFA. Positive SIRS and SOFA scores occurred at an earlier time-point than PSS score. The time to positivity appears to limit the tool’s best expected performance to improve time to initial antimicrobial and compliance with the 3-hour sepsis bundle. CLINICAL IMPLICATIONS: Clinical application of the Epic SPM to improve adherence with sepsis treatment goals is constrained by time to positive screen as compared to other screening tools. DISCLOSURES: No relevant relationships by Alain Bertoni No relevant relationships by Kristin Lenoir No relevant relationships by Beverly Levine No relevant relationships by Morgana Mongraw-Chaffin No relevant relationships by Adam Schertz Stock Ownership Interest relationship with Johnson & Johnson Please note: years Added 04/15/2022 by Karl Thomas, value=Ownership interest stock ownership relationship with Gilead Sciences Please note: years Added 04/15/2022 by Karl Thomas, value=Ownership Stock ownership interest relationship with Bristol-Myers Squibb Please note: years Added 04/15/2022 by Karl Thomas, value=Ownership interest Stock Ownership Interest relationship with Pfizer Please note: years Added 04/15/2022 by Karl Thomas, value=Ownership interest Stock Ownership Interest relationship with Doximity Please note: 1 year Added 04/15/2022 by Karl Thomas, value=Ownership interest No relevant relationships by Brian Wells No relevant relationships by Jack White

17.
Chest ; 162(4):A365, 2022.
Article in English | EMBASE | ID: covidwho-2060575

ABSTRACT

SESSION TITLE: Critical Care Presentations of TB SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/18/2022 12:25 pm - 01:25 pm INTRODUCTION: TNFα plays a pivotal role in inflammation and maintenance of immune response against tuberculosis. The use of TNF inhibitors (TNFi) is associated with a significant increase in the incidence of tuberculosis (TB). TNFi may cause drug-induced lupus (ATIL) presenting as constitutional symptoms, rashes, pericardial and pleural effusions with positive autoantibodies. We present a case of pleural TB masquerading as drug-induced lupus. CASE PRESENTATION: A 68y/o woman with a history of ulcerative colitis (on infliximab, mesalamine), hypertension, T2DM, CAD, complained of low-grade fever, rashes, left-sided chest pain, dyspnea, and arthralgias for two weeks. Chest pain- worse with inspiration and cough. She emigrated from India to the USA 40 years ago. Six months before infliximab therapy, Quantiferon gold was negative. Exam: faint hyperpigmentation over shins, minimal swelling of MCPs and ankles, dullness to percussion over the left chest with decreased breath sounds. Labs: CRP 101 mg/dL, Hb 10.8 iron deficient, rheumatoid factor and anti-CCP negative, ANA 1:40, dsDNA 1:640, a reminder of ENA negative, anti-histone negative, C3/C4 normal, UA bland, protein/Cr 0.4 mg/gm, negative blood cultures, SPEP and LDH normal. CXR: opacification of the left lung up to midfield. CT chest: moderate left and small right pleural effusions, enlarged mediastinal lymph nodes. COVID and Quantiferon: negative. Thoracentesis: 850 ml of exudative fluid (2 out of 3 Light's criteria), lymphocytic predominance (76% of 4148 nucleated cells), adenosine deaminase (ADA) 42 U/L, gram stain, culture, acid-fast and MTB PCR negative, cytology negative. Thoracoscopy with biopsy of the parietal pleura: necrotizing granulomatous pleuritis with acid-fast bacilli. Sensitivity: pan-sensitive M. tuberculosis. Sputum: negative for TB. She was discharged on RIPE treatment for reactivation of TB. DISCUSSION: The incidence of infliximab-induced lupus is approximately 0.19% and confirming the diagnosis is challenging. The immunogenicity of infliximab is high, 66% of patients develop positive ANA. Anti-histone antibodies are less commonly associated with ATIL as opposed to classic drug-induced lupus and dsDNA is positive in up to 90% of cases of ATIL. Renal involvement is rare. The diagnostic usefulness of ADA (over 40 U/L) in lymphocytic pleural effusions for the diagnosis of tuberculosis in an immunosuppressed individual is demonstrated here. In countries with low TB burden, such as the USA, the positive predictive value of ADA in pleural fluid declines but the negative predictive value remains high. CONCLUSIONS: Tuberculous pleuritis is not always easily diagnosed since AFB smears and sputum may remain negative. When ADA level in lymphocytic pleural fluid is not low thorough search for TB with thoracoscopy and biopsy is justified. Reference #1: Shovman O, Tamar S, Amital H, Watad A, Shoenfeld Y. Diverse patterns of anti-TNF-α-induced lupus: case series and review of the literature. Clin Rheumatol. 2018 Feb;37(2):563-568. Reference #2: Benucci, M., Gobbi, F. L., Fossi, F., Manfredi, M. & Del Rosso, A. (2005). Drug-Induced Lupus After Treatment With Infliximab in Rheumatoid Arthritis. JCR: Journal of Clinical Rheumatology, 11 (1), 47-49. Reference #3: Valdés L, San José ME, Pose A, Gude F, González-Barcala FJ, Alvarez-Dobaño JM, Sahn SA. Diagnosing tuberculous pleural effusion using clinical data and pleural fluid analysis A study of patients less than 40 years-old in an area with a high incidence of tuberculosis. Respir Med. 2010 Aug;104(8):1211-7. DISCLOSURES: No relevant relationships by Adam Adam No relevant relationships by Moses Bachan No relevant relationships by Chen Chao No relevant relationships by Zinobia Khan No relevant relationships by Milena Vukelic

18.
Embase; 2022.
Preprint in English | EMBASE | ID: ppcovidwho-344887

ABSTRACT

The COVID-19 pandemic highlighted the critical need for rapid and accurate molecular diagnostic testing. The Cue COVID-19 Point of Care Test (Cue POCT) is a nucleic acid amplification test (NAAT), authorized by Health Canada and FDA as a POCT for SARSCoV-2 detection. Cue POCT was deployed at a network of clinics in Ontario, Canada with n=13,848 patrons tested between July 17, 2021 to January 31, 2022. The clinical performance and operational experience with Cue POCT was examined for this testing population composed mostly of asymptomatic individuals (93.7%). A head-to-head prospective clinical verification was performed between July 17 to October 4 for all POCT service clients (n= 3037) with paired COVID-19 testing by Cue and RT-PCR. Prospective verification demonstrated a clinical sensitivity of 100% and clinical specificity of 99.4% for Cue COVID-19 POCT. The lack of false negatives and low false positive rate (0.64%), underscores the high accuracy (99.4%) of Cue POCT to provide rapid PCR quality results. Low error rates (cancellation rate of 0% and invalid rate of 0.63%) with the current software version were additionally noted. Together these findings highlight the value of accurate molecular COVID-19 POCT in a distributed service delivery model to rapidly detect cases in the community with the potential to curb transmission in high exposure settings (i.e. inflight, congregate workplace and social events). The insights gleaned from this operational implementation are readily transferable to future POCT diagnostic services. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.

19.
Embase; 2020.
Preprint in English | EMBASE | ID: ppcovidwho-344376

ABSTRACT

The increasing frequency and magnitude of viral outbreaks in recent decades, epitomized by the current COVID-19 pandemic, has resulted in an urgent need for rapid and sensitive diagnostic methods. Here, we present a methodology for virus detection and identification that uses a convolutional neural network to distinguish between microscopy images of single intact particles of different viruses. Our assay achieves labeling, imaging and virus identification in less than five minutes and does not require any lysis, purification or amplification steps. The trained neural network was able to differentiate SARS-CoV-2 from negative clinical samples, as well as from other common respiratory pathogens such as influenza and seasonal human coronaviruses. Additionally, we were able to differentiate closely related strains of influenza, as well as SARS-CoV-2 variants. Single-particle imaging combined with deep learning therefore offers a promising alternative to traditional viral diagnostic and genomic sequencing methods, and has the potential for significant impact. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

20.
Investigative Ophthalmology and Visual Science ; 63(7):1381-A0077, 2022.
Article in English | EMBASE | ID: covidwho-2058693

ABSTRACT

Purpose : Age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma are vision-threatening diseases (VTDs) affecting 36 million people in the USA. With 5.7 ophthalmologists per 100,000 Americans, over 50% of VTDs go undetected. We assessed deep learning Artificial Intelligence (DLAI) in VTD detection in community and clinical settings. Methods : 223 subjects (mean age 54.6, 58% male) from community screenings (A) and clinic (B) underwent 45-degree retinal imaging. In A (non-dilated), an onsite telemedicine reader (R1) and remote ophthalmologist (R2) graded image quality (gamma and alignment, 1-5 scale) and referable VTD using the international grading scales for AMD and DR, and cup-to-disc ratio and nerve fiber layer for glaucoma. In B (dilated), gradings were collected from R1 and the clinical diagnosis (d). A senior ophthalmologist (R3) adjudicated disputed findings. In A, DLAI VTD referral was compared to R1/R2/R3 consensus (S);in B, overall referral was compared to R1/d/R3 consensus (C). Images were uploaded to a cloud-based DLAI (SELENA+, EyRIS Pte Ltd) (Fig 1). Cohen's kappa assessed intergrader agreement. Results : R1 and R2 found 4.7% eyes ungradable. DLAI marked 55.6% ungradable;74.6% of them were for AMD. Of the DLAI ungradable eyes, image quality was ≤ 3, and 56.2% had ≥ 1+ cataract (R1). Compared to in A, in B DLAI had higher sensitivity (97.1% vs. 63.2%) and positive predictive value (69.4% vs. 32%). In A, DLAI had higher specificity (94.5% vs.16.7%) and negative predictive value (98.4% vs. 75.0%) (Table 1). In A, Cohen's kappa was 0.946 between R1 and R2, with a 13% disagreement rate. In 56% of the disagreements, R3 agreed with R1. In B, Cohen's kappa was 0.874 for R1 and d;R1 referred more than d. In A and B, DLAI referred more than R1, R2, and H/C. DLAI referred all eyes with > 1 VTD (1%) for further examination. Grading times for DLAI, R1, and R2 were 30, 129, and 68 seconds. Conclusions : DLAI performed best in DR and glaucoma detection;a potential solution for the high ungradable rate can be for DLAI to re-center uploaded images. DLAI can increase efficiency and accessibility of screenings for multiple VTDs, in both underserved populations and clinic. The ability to minimize direct contact confers an advantage during COVID-19. Further studies will investigate DLAI use in VTD progression.

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