scholarly journals Clinical diagnosis of COVID-19: a prompt, feasible, and sensitive diagnostic tool for COVID-19 based on a 1,757-patient cohort (The AndroCoV Clinical Scoring for COVID-19 diagnosis)

Author(s):  
Flávio Adsuara Cadegiani ◽  
John McCoy ◽  
Carlos Gustavo Wambier ◽  
Andy Goren

AbstractImportanceIn the COVID-19 pandemic, a limiting barrier for more successful approaches to COVID-19 is the lack of appropriate timing for its diagnosis, during the viral replication stage, when antiviral approaches could demonstrate efficacy, precluding progression to severe stages. Three major reasons that hamper the diagnosis earlier in the disease are the unspecific and mild symptoms in the first stage, the cost- and time-limitations of the rtPCR-SARS-CoV-2, and the insufficient sensitivity of this test as desired for screening purposes during the pandemic. More sensitive and earlier methods of COVID-19 detection should be considered as key for breakthrough changes in the disease course and response to specific therapeutic strategies. Our objective was to propose a clinical scoring for the diagnosis of COVID-19 (The AndroCoV Clinical Scoring for COVID-19 Diagnosis) that has been validated in a large population sample, aiming to encourage the management of patients with high pre-clinical likelihood of presenting COVID-19, at least during the pandemics, independent of a rtPCR-SARS-COV-2 test.Materials and methodsThis is a compounded retrospective and prospective analysis of clinical data prospectively collected from the Pre-AndroCoV and AndroCov Trials that resulted in a clinical scoring for COVID-19 diagnosis based on likelihood of presenting COVID-19 according to the number of symptoms, presence of anosmia, and known positive household contact, in a variety of combinations of scoring criteria, aiming to the detect scorings that provided the highest pre-test probability and accuracy. Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and accuracy were calculated for subjects screened in two different periods and altogether, for females, males, and both, in a total of nine different scenarios, for combinations between one, two, or three or more symptoms, or presence of anosmia in subjects without known positive household contacts, and no symptoms, one, two, or three or more symptoms, or presence of anosmia or ageusia in subjects with known positive household contacts.Results1,757 patients were screened for COVID-19. Among the multiple combinations, requiring two or more symptoms with or without anosmia or ageusia for subjects without known contact and one or more symptoms with or without anosmia or ageusia with known positive contacts presented the highest accuracy (80.4%), and higher pretest probability and accuracy than virtually all rtPCR-SARS-CoV-2 commercially available kit tests.ConclusionThe AndroCoV Clinical Scoring for COVID-19 Diagnosis was demonstrated to be a feasible, quick, inexpensive and sensitive diagnostic tool for clinical diagnosis of COVID-19. A clinical diagnosis of COVID-19 should avoid delays and missed diagnosis, and reduce costs, and should therefore be recommended as a first-line option for COVID-19 diagnosis for public health policies, at least while SARS-CoV-2 is the prevailing circulating virus.Key PointsQuestionIs a clinical diagnosis of COVID-19 sensitive, accurate, and feasible?FindingsThe present analysis of a 1,757-subject cohort of the AndroCoV trials demonstrated that clinical scoring for COVID-19 diagnosis can deliver a more sensitive and prompter diagnosis than the current gold-standard diagnostic method, rtPCR-SARS-CoV-2, with an accuracy above 80%.MeaningA clinical diagnosis of COVID-19 avoids missed diagnosis due to insufficient sensitivity or incorrect timing of the performance of rtPCR-SARS-CoV-2, reduces costs, avoid delays on specific managements, and allows the testing of potentially effective antiviral therapeutic approaches that should work if administered in the early stage of COVID-19

2020 ◽  
Author(s):  
Flavio A. Cadegiani ◽  
John McCoy ◽  
Carlos Gustavo Wambier ◽  
Andy Goren

Abstract Importance: In the COVID-19 pandemic, a limiting barrier for more successful approaches to COVID-19 is the lack of appropriate timing for its diagnosis, during the viral replication stage, when antiviral approaches could demonstrate efficacy, precluding progression to severe stages. Three major reasons that hamper the diagnosis earlier in the disease are the unspecific and mild symptoms in the first stage, the cost- and time-limitations of the rtPCR-SARS-CoV-2, and the insufficient sensitivity of this test as desired for screening purposes during the pandemic. More sensitive and earlier methods of COVID-19 detection should be considered as key for breakthrough changes in the disease course and response to specific therapeutic strategies. Our objective was to propose a clinical scoring for the diagnosis of COVID-19 (The AndroCoV Clinical Scoring for COVID-19 Diagnosis) that has been validated in a large population sample, aiming to encourage the management of patients with high pre-clinical likelihood of presenting COVID-19, at least during the pandemics, independent of a rtPCR-SARS-COV-2 test. Materials and methods: This is a compounded retrospective and prospective analysis of clinical data prospectively collected from the Pre-AndroCoV and AndroCov Trials that resulted in a clinical scoring for COVID-19 diagnosis based on likelihood of presenting COVID-19 according to the number of symptoms, presence of anosmia, and known positive household contact, in a variety of combinations of scoring criteria, aiming to the detect scorings that provided the highest pre-test probability and accuracy. Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and accuracy were calculated for subjects screened in two different periods and altogether, for females, males, and both, in a total of nine different scenarios, for combinations between one, two, or three or more symptoms, or presence of anosmia in subjects without known positive household contacts, and no symptoms, one, two, or three or more symptoms, or presence of anosmia or ageusia in subjects with known positive household contacts. Results: 1,757 patients were screened for COVID-19. Among the multiple combinations, requiring two or more symptoms with or without anosmia or ageusia for subjects without known contact and one or more symptoms with or without anosmia or ageusia with known positive contacts presented the highest accuracy (80.4%), and higher pretest probability and accuracy than virtually all rtPCR-SARS-CoV-2 commercially available kit tests. Conclusion: The AndroCoV Clinical Scoring for COVID-19 Diagnosis was demonstrated to be a feasible, quick, inexpensive and sensitive diagnostic tool for clinical diagnosis of COVID-19. A clinical diagnosis of COVID-19 should avoid delays and missed diagnosis, and reduce costs, and should therefore be recommended as a first-line option for COVID-19 diagnosis for public health policies, at least while SARS-CoV-2 is the prevailing circulating virus.


2021 ◽  
Author(s):  
Flavio A. Cadegiani ◽  
Rute Alves Pereira ◽  
Ricardo Ariel Zimerman ◽  
Bruno Campello de Souza ◽  
John McCoy ◽  
...  

Abstract Importance: A major barrier for successful therapeutic approaches to COVID-19 is the inability during the viral replication stage, when drugs with potential antiviral activity could demonstrate efficacy and preclude progression to more severe stages. Reasons that hamper an earlier diagnosis of COVID-19 include the unspecific and mild symptoms during the first stage, the delay in the diagnosis and specific management caused by the requirement of a rtPCR-SARS-CoV-2 for the diagnosis of COVID-19, and the insufficient sensitivity of the a rtPCR-SARS-CoV-2, oppositely to what is recommended for a screening test during an outbreak. More sensitive and earlier diagnostic tools for COVID-19 should be unraveled as a key strategy for an breakthrough change in the disease course and response to specific therapies, particularly those that target the blockage of viral shedding. We aimed to create an accurate, sensitive, easy-to-perform and intuitive clinical scoring for the diagnosis of COVID-19 without the need of a rtPCR-SARS-CoV-2 (termed as The AndroCoV Clinical Scoring for COVID-19 Diagnosis), resulted from a 1,757 population cohort, eo eventually encourage the management of patients with high pre-clinical likelihood of presenting COVID-19, independent of a rtPCR-SARS-COV-2 test, to avoid delays and loss of appropriate timing for potential therapies.Materials and methods: This is a post-hoc analysis of clinical data prospectively collected of the Pre-AndroCoV and AndroCov Trials, that resulted in scorings for clinical diagnosis of COVID-19, based on the likelihood of presenting actual COVID-19 according to the number of symptoms, presence of anosmia, and known positive household contact. Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and accuracy were calculated for subjects screened in two different periods and both periods together, for females, males and both, in a total of nine different scenarios, according to combinations between one, two, or three or more symptoms, or presence of anosmia in subjects without known positive household contacts, and no symptoms, one, two, or three or more symptoms, or presence of anosmia or ageusia in subjects with known positive household contacts. Scorings that yielded the highest pre-test probability, sensitivity and accuracy were selected.Results: Of the 1,757 patients screened, 1,284 were diagnosed for COVID-19. The scoring that required: 1. Two or more symptoms, or anosmia or ageusia alone, for subjects without known contact; or 2. One or more symptoms, including anosmia or ageusia alone, when with known positive contacts presented the highest accuracy (80.4%) among all combinations attempted, and higher sensitivity (85.7%) than rtPCRSARS-CoV-2 commercially available kit tests.Conclusion: The AndroCoV Clinical Scoring for COVID-19 Diagnosis demonstrated to be a feasible, easy, costless, and sensitive diagnostic tool for clinical diagnosis of COVID-19. Because clinical diagnosis of COVID-19 avoids delays in specific treatments, particularly for high-risk populations, prevents false-negative diagnosis, and reduces diagnostic costs, this diagnostic tool should be considered as an option for COVID-19 diagnosis, at least while SARS-CoV-2 is the prevailing circulating virus and vaccination rate is below the required for herd immunity.


2020 ◽  
Vol 7 (5) ◽  
pp. 1473
Author(s):  
Amulya Aggarwal ◽  
Alok V. Mathur ◽  
Ram K. Verma ◽  
Megha Gupta ◽  
Dheeraj Raj

Background: Pancreatitis can lead to serious complications with severe morbidity and mortality. So an early, quick and accurate scoring system is necessary to stratify the patients according to their severity so as to enable early initiation of required management and care. Scoring system commonly used have some drawbacks. This study aimed to compare bedside index for severity in acute pancreatitis (BISAP) and Ranson’s score to predict severe acute pancreatitis and establish the validity of a simple and accurate clinical scoring system for stratifying patients.Methods: This is a prospective comparative study on 100 patients diagnosed with acute pancreatitis admitted in department of general surgery. Parameters included in the BISAP and Ranson’s criteria were studied at the time of admission and after 48 hours. Result of these two were compared with that of revised Atlanta classification.Results: As per the BISAP score, the sensitivity and specificity were 95.8 % (95% CI, 76.8-99.8), 94.7 % (95% CI, 86.3-98.3) whereas positive likelihood ratio, negative likelihood ratio 18.21 (95% CI, 6.9-47.44), 0.04 (95% CI, 0.01-0.30) and accuracy was 95 % (95% CI, 88.72%-98.36%). On using Ranson’s score, the sensitivity and specificity were 91.6 (95% CI, 71.5-98.5) and 89.4 (95% CI, 79.8-95) with a positive predictive value 8.71 (95% CI, 4.47-18.96) and negative predictive value of 0.09 (95% CI, 0.02-0.35) and accuracy of 90% (95% CI, 82.38%-95.10%)..Conclusions: BISAP score outperformed Ranson’s score in terms of Sensitivity and specificity of prediction of severe pancreatitis. The authors recommend inclusion of BISAP Scoring system in standard treatment protocol of management of acute pancreatitis.


2018 ◽  
Vol 7 (4) ◽  
pp. 504-510 ◽  
Author(s):  
Lauren Bell ◽  
Ann Louise Hunter ◽  
Angelos Kyriacou ◽  
Annice Mukherjee ◽  
Akheel A Syed

Background TSH receptor antibody (TRAb) is considered the gold standard diagnostic test for the autoimmunity of Graves’ disease (GD), which is commonly diagnosed clinically. Aim To evaluate the true positive (sensitivity) and true negative (specificity) rates of clinical diagnosis of GD or non-GD hyperthyroidism compared to the TRAb test. Setting University teaching hospital in North West England. Participants Patients in the Endocrinology service who had a TRAb measurement between December 2009 and October 2015. Methods Electronic patient records were studied retrospectively for a pre-TRAb clinical diagnosis of GD or non-GD hyperthyroidism. We examined descriptive statistics and binary classification tests; Fisher exact test was used to analyse contingency tables. Results We identified 316 patients with a mean age of 45 (range, 17–89) years; 247 (78%) were women. Compared to the TRAb result, clinical diagnosis had a sensitivity of 88%, specificity 66%, positive predictive value 72%, negative predictive value 84%, false negative rate 12%, false positive rate 34%, positive likelihood ratio 2.6 and negative likelihood ratio 0.2 (P < 0.0001). Conclusions Clinicians were liable to both over- and under-diagnose GD. The TRAb test can help reduce the number of incorrect or unknown diagnoses in the initial clinical assessment of patients presenting with hyperthyroidism.


Author(s):  
Samar M. El-Maadawy ◽  
Nesreen Alaaeldin ◽  
Vassil N. Zefov

Abstract Background Meckel diverticulum is the most common congenital abnormality of the gastrointestinal tract. Gastrointestinal bleeding is the most common complication of Meckel diverticulum in the paediatric population; the bleeding mostly occurs in the first 2 years of life. Because the diverticulum is seldom seen in clinical practice, misdiagnosis and delayed diagnosis are not uncommon. CT and nuclear studies are the most used diagnostic tools in clinical practice. However, radiation and sensitivity concerns remain an issue. Ultrasound has been suggested as an alternative diagnostic tool in diagnosing Meckel diverticulum with mixed results. The aim of our study is to assess the value of using a new sonographic sign, the pseudogestational sac sign in diagnosing Meckel diverticulum in children presenting with bleeding per rectum. Ultrasound was performed for all children. Results were correlated with nuclear studies, histopathology and clinical follow-up findings. Results Seventy-three children were included in our study. The pseudogestational sac sign was present in 46 (63%) and absent in 27 (37%) cases. Forty-five children were ultimately diagnosed as Meckel diverticulum. The age ranged from 2 months to 9 years with a mean of 2.3 years. The boy-to-girl ratio was 4.6:1 with 60% of children presenting during their first 2 years of life. The ultrasound performance using the pseudogestational sac sign revealed a sensitivity of 91.1%, specificity of 82.1%, positive predictive value of 89.1%, negative predictive value of 85.2%, positive likelihood ratio of 5.1, negative likelihood ratio of 0.11 and accuracy of 87.7%. Conclusion The sonographic pseudogestational sac sign is a reliable diagnostic tool for diagnosing Meckel diverticulum in children presenting with bleeding per rectum. The sonographic diagnosis of Meckel diverticulum complies with the international standards of “Image Gently”.


2014 ◽  
Vol 25 (2) ◽  
pp. 44-49
Author(s):  
P Das ◽  
R Pramanik ◽  
M Kataruka ◽  
RN Haldar ◽  
S Samanta ◽  
...  

Abstract Introduction Over the years NCS has been used to diagnose and monitor the patients with CTS though USG has several advantages as diagnostic tool. This study has been done to find out the diagnostic accuracy of USG in CTS and to compare the efficacy of USG with standard NCS in CTS. Prospective cross-sectional analytical study was conducted at Dept. of PM&R, IPGME&R, Kolkata from 1st March, 2012 to 31st August 2012 (6 months). Patient with clinical diagnosis of CTS of age >18 year of both sexes were included in this study and on the other hand patient with previous wrist surgery /injury, wrist deformity, diabetes mellitus, anatomical variants of median nerve on ultrasound were excluded from the study. Methodology After getting institutional ethical committee clearance, all patients who fulfil the above criteria were included in the study and further diagnostic conformation done by the standard diagnostic criteria of NCS. The same group of patients have been also screened by ultrasonography (USG). Results At the end of the study, data analysis showed that sensitivity and specificity were 92.3 and 70.0% respectively. Predictive value of +test, predictive value of -test were 88.9 and 77.8% respectively. Kappa value was 0.64 (between 0.5 and 0.7). It signifies that there is good correlation between NCS and USG as diagnostic tool of CTS. The comparison of the numerical values of median latency, amplitude and CSA USG within the groups with the help of ANOVA followed by Tukey's test showed that there was good correlation between latency and amplitude in mild, moderate, severe and profound CTS but unfortunately it was not correlated with the CSA measured by USG. Conclusion USG can be used for screening large population of patients as it is simple, easily available, non-invasive test and has relatively low cost and useful in evaluating and excluding local causes of nerve compression.


2015 ◽  
Vol 5 (2) ◽  
pp. 191-202 ◽  
Author(s):  
Carl-Johan Boraxbekk ◽  
Anders Lundquist ◽  
Annelie Nordin ◽  
Lars Nyberg ◽  
Lars-Göran Nilsson ◽  
...  

Background/Aims: Early dementia diagnosis is a considerable challenge. The present study examined the predictive value of cognitive performance for a future clinical diagnosis of late-onset Alzheimer's disease or vascular dementia in a random population sample. Methods: Cognitive performance was retrospectively compared between three groups of participants from the Betula longitudinal cohort. Group 1 developed dementia 11-22 years after baseline testing (n = 111) and group 2 after 1-10 years (n = 280); group 3 showed no deterioration towards dementia during the study period (n = 2,855). Multinomial logistic regression analysis was used to investigate the predictive value of tests reflecting episodic memory performance, semantic memory performance, visuospatial ability, and prospective memory performance. Results: Age- and education-corrected performance on two free recall episodic memory tests significantly predicted dementia 10 years prior to clinical diagnosis. Free recall performance also predicted dementia 11-22 years prior to diagnosis when controlling for education, but not when age was added to the model. Conclusion: The present results support the suggestion that two free recall-based tests of episodic memory function may be useful for detecting individuals at risk of developing dementia 10 years prior to clinical diagnosis.


2020 ◽  
Vol 112 (2) ◽  
pp. 178-184
Author(s):  
Rodrigo A. Gasque ◽  
◽  
Walter A. Moreno ◽  
Gabriel E. Vigilante

Background: Acute appendicitis (AA) is the most common surgical emergency worldwide. Its correct and early diagnosis is essential to avoid unnecessary surgeries and complications associated with its natural history. Objective: The aim of this study was to determine the diagnostic sensitivity and specificity of the RIPASA score in patients with suspected AA. Material and methods: This analytical, cross-sectional, observational and retrospective study included appendectomy specimens of patients of both sexes > 18 years operated on with clinical diagnosis of AA between January 1 and December 31, 2017. The histopathological examination of the appendectomy specimens was considered the gold standard diagnostic test. A score of 7.5 for the RIPASA score was chosen as cut-off value. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated. Results: A total of 68 appendectomies were included; 57 (83.82%) specimens were positive for acute appendicitis. Mean age was 43.32 years. The histological diagnosis of AA was present in 32 (84.21%) men and in 25 (83.33%) women. For the RIPASA score, 54 patients had a true positive result (cut-off point ≥ 7.5 and positive histology for AA) with a sensitivity of 93%, specificity of 40%, PPV of 90%, NPV of 50%, positive likelihood ratio of 1.55 and negative likelihood ratio of 0.175. Conclusion: The RIPASA score has demonstrated excellent sensitivity and specificity for the clinical diagnosis of AA in a fast, simple and non-invasive fashion.


Author(s):  
Uwe Schneider ◽  
Inse Graß ◽  
Martin Laudien ◽  
Joachim Quetz ◽  
Hendrik Graefe ◽  
...  

Abstract Introduction Squamous cell Carcinoma of the Head and Neck (HNSCC) is the most common tumor entity of malignant processes in the head and neck area. Due to the metastasizing behavior of these tumors, the staging is indispensable for the treatment planning and requires imaging techniques, which are sensitive, specific, and as far as possible cost-effective, to benefit ultimately the patient and to ensure optimal care. Objectives The aim of the present study is to compare the clinical examination including palpation, ultrasound and computed tomography (CT)/magnetic resonance imaging (MRI) for the diagnosis of neck metastases to make the correct indication for a neck dissection. Methods Data from 286 patients with HNSCC were analyzed for neck metastases to determine which diagnostic tool is the best to answer the question if a neck dissection is necessary or not. Each study method was examined retrospectively by comparing sensitivity, specificity, the positive/negative predictive value, the positive likelihood ratio and the diagnostic accuracy. Results The ultrasound showed a sensitivity of 91.52%, a specificity of 61.67%, a positive/negative predictive value of 76.65%/84.09%, a positive likelihood ratio of 2.39 and a diagnostic accuracy of 78.95%. The clinical examination showed a sensitivity of 75.76%, a specificity of 66.12%, a positive/negative predictive value of 75.30%/66.67%, a positive likelihood ratio of 2.24 and a diagnostic accuracy of 71.68%. The CT/MRI showed a sensitivity of 78.66%, a specificity of 62.50%, a positive/negative predictive value of 74.14%/68.18%, a positive likelihood ratio of 2.10 and a diagnostic accuracy of 71.83%. Radiographically, ultrasound, as well as the clinical examination, could be judged to be free from radiation load and side effects from the contrast medium. The high dependence on the investigator when using ultrasound made reproducibility of the results difficult. Conclusions It could be shown that ultrasound was the diagnostic tool with the highest sensitivity, positive/negative predictive value, positive likelihood ratio and diagnostic accuracy by detecting and interpreting metastases in the head and neck region correctly. Whether a neck dissection should be performed depends to a large extent on the ultrasound findings.


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