Protocol for a diagnostic accuracy study to develop diagnosis algorithm for biliary atresia using MMP-7 (DIABA-7 study): a study recruiting from Chinese Biliary Atresia Collaborative Network

IntroductionBiliary atresia is a severe liver disease in neonates, and the prognosis partially depends on the age at which infants undergo the Kasai procedure. Matrix metalloproteinase-7 (MMP-7) was confirmed to have significant value in the diagnosis of biliary atresia. However, so far, the reference range and its cut-off value for diagnosing biliary atresia have not been established yet.Methods and analysisDIagnosis Algorithm for Biliary Atresia (DIABA-7) is a prospective diagnostic test. Cholestatic infants and normal controls within 150 days of age are recruiting from the Chinese Biliary Atresia Collaborative Network. The serum samples and dried blood spot (DBS) samples are obtained to detect MMP-7 concentrations using an ELISA kit. The reference standard is the intraoperative exploration and subsequent histological examination of liver biopsies. Lambda-Mu-Sigma (LMS) method is used to calculate the normal range of serum MMP-7 of each age group. Receiver operating characteristics (ROC) curves are constructed to calculate the best cut-off point and area under the curve for the index test. The sensitivity, specificity, positive predictive value and negative predictive value are used to show the diagnostic accuracy. Pearson correlation coefficient test is applied to assess the correlation of serum MMP-7 and DBS MMP-7.Ethics and disseminationThis study was reviewed and approved by the Ethics Committee of Children’s Hospital of Fudan University (Number 2020–296). Dissemination will be guided by investigators and patients. The aim is to publish the study results in a high-quality peer-reviewed journal and present the findings at international academic meetings.Trial registration numberChiCTR2000032983.

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Diagnostic accuracy of non-contact infrared thermometers and thermal scanners: a systematic review and meta-analysis

Journal of Travel Medicine ◽

10.1093/jtm/taaa193 ◽

2020 ◽

Vol 27 (8) ◽

Author(s):

Nishant Aggarwal ◽

Mohil Garg ◽

Vignesh Dwarakanathan ◽

Nitesh Gautam ◽

Swasthi S Kumar ◽

...

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Predictive Value ◽

Meta Analysis ◽

World Health ◽

Cochrane Library ◽

Research Database ◽

Index Test ◽

Reference Standard ◽

Operating Characteristics

Abstract Infrared thermal screening, via the use of handheld non-contact infrared thermometers (NCITs) and thermal scanners, has been widely implemented all over the world. We performed a systematic review and meta-analysis to investigate its diagnostic accuracy for the detection of fever. We searched PubMed, Embase, the Cochrane Library, medRxiv, bioRxiv, ClinicalTrials.gov, COVID-19 Open Research Dataset, COVID-19 research database, Epistemonikos, EPPI-Centre, World Health Organization International Clinical Trials Registry Platform, Scopus and Web of Science databases for studies where a non-contact infrared device was used to detect fever against a reference standard of conventional thermometers. Forest plots and Hierarchical Summary Receiver Operating Characteristics curves were used to describe the pooled summary estimates of sensitivity, specificity and diagnostic odds ratio. From a total of 1063 results, 30 studies were included in the qualitative synthesis, of which 19 were included in the meta-analysis. The pooled sensitivity and specificity were 0.808 (95%CI 0.656–0.903) and 0.920 (95%CI 0.769–0.975), respectively, for the NCITs (using forehead as the site of measurement), and 0.818 (95%CI 0.758–0.866) and 0.923 (95%CI 0.823–0.969), respectively, for thermal scanners. The sensitivity of NCITs increased on use of rectal temperature as the reference. The sensitivity of thermal scanners decreased in a disease outbreak/pandemic setting. Changes approaching statistical significance were also observed on the exclusion of neonates from the analysis. Thermal screening had a low positive predictive value, especially at the initial stage of an outbreak, whereas the negative predictive value (NPV) continued to be high even at later stages. Thermal screening has reasonable diagnostic accuracy in the detection of fever, although it may vary with changes in subject characteristics, setting, index test and the reference standard used. Thermal screening has a good NPV even during a pandemic. The policymakers must take into consideration the factors surrounding the screening strategy while forming ad-hoc guidelines.

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The role of red cell distribution width in the differential diagnosis of iron deficiency anemia and non-transfusion dependent thalassemia patients

Hematology Reports ◽

10.4081/hr.2018.7605 ◽

2018 ◽

Vol 10 (3) ◽

Cited By ~ 3

Author(s):

Pokpong Piriyakhuntorn ◽

Adisak Tantiworawit ◽

Thanawat Rattanathammethee ◽

Chatree Chai-Adisaksopha ◽

Ekarat Rattarittamrong ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Predictive Value ◽

Area Under The Curve ◽

Microcytic Anemia ◽

Deficiency Anemia ◽

Operating Characteristics ◽

Training Set ◽

Distribution Width ◽

Validation Set ◽

Sensitivity Specificity

This study aims to find the cut-off value and diagnostic accuracy of the use of RDW as initial investigation in enabling the differentiation between IDA and NTDT patients. Patients with microcytic anemia were enrolled in the training set and used to plot a receiving operating characteristics (ROC) curve to obtain the cut-off value of RDW. A second set of patients were included in the validation set and used to analyze the diagnostic accuracy. We recruited 94 IDA and 64 NTDT patients into the training set. The area under the curve of the ROC in the training set was 0.803. The best cut-off value of RDW in the diagnosis of NTDT was 21.0% with a sensitivity and specificity of 81.3% and 55.3% respectively. In the validation set, there were 34 IDA and 58 NTDT patients using the cut-off value of >21.0% to validate. The sensitivity, specificity, positive predictive value and negative predictive value were 84.5%, 70.6%, 83.1% and 72.7% respectively. We can therefore conclude that RDW >21.0% is useful in differentiating between IDA and NTDT patients with high diagnostic accuracy

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How well do ACPA discriminate and predict RA in the general population: a study based on 12 590 population-representative Swedish twins

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2015-208980 ◽

2016 ◽

Vol 76 (1) ◽

pp. 119-125 ◽

Cited By ~ 32

Author(s):

Aase Haj Hensvold ◽

Thomas Frisell ◽

Patrik K E Magnusson ◽

Rikard Holmdahl ◽

Johan Askling ◽

...

Keyword(s):

General Population ◽

Positive Predictive Value ◽

Diagnostic Accuracy ◽

Negative Predictive Value ◽

Predictive Value ◽

Blood Donation ◽

Large Population ◽

Serum Samples ◽

Protein Levels

ObjectiveAnti-citrullinated protein antibodies (ACPA) are highly specific for rheumatoid arthritis (RA), but the diagnostic accuracy of ACPA in the general population has not been thoroughly assessed. We aimed to assess the diagnostic accuracy of ACPA for RA in the general population and to further characterise the citrullinated peptide recognition pattern.MethodsSerum samples from a large population-representative twin cohort consisting of 12 590 individuals were analysed for the presence of ACPA using anti-CCP2 ELISA. All ACPA-positive samples were further tested on ELISAs for four peptide-specific ACPA. RA cases were identified by linkage to the Swedish National Patient Register at inclusion and after a median follow-up of 37 months (IQR 31–49).Results350 out of 12 590 individuals had a positive anti-CCP2 test, measuring ACPA. Of these, 103 had an RA diagnosis at the time of blood donation and inclusion. During a median follow-up of 3 years, an additional 21 of the remaining 247 ACPA-positive individuals developed RA. Overall, a positive anti-CCP2 test had a positive predictive value of 29% for prevalent RA at inclusion (negative predictive value of 99.6%). High titres (>3× cut-off) of anti-CCP2 increased the positive predictive value to 48% (negative predictive value of 99.5%). ACPA-positive individuals without RA had lower anti-CCP2 titres and fewer peptide-specific ACPA than ACPA-positive patients with RA and higher C reactive protein levels than ACPA-negative individuals without RA.ConclusionPresence of ACPA and especially high titres of anti-CCP2 have a high diagnostic accuracy for an RA diagnosis in a population setting.

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DIAGNOSTIC ACCURACY OF DRUG SCREENING IMMUNOASSAYS IN DRUG FACILITATED CRIMES

Pakistan Armed Forces Medical Journal ◽

10.51253/pafmj.v71i1.3167 ◽

2021 ◽

Vol 71 (1) ◽

pp. 101-06

Author(s):

Sadia Dawood ◽

Ayesha Hafeez ◽

Aamir Ijaz ◽

Summera Moeen ◽

Asif Ali Memon ◽

...

Keyword(s):

Mass Spectrometry ◽

Liquid Chromatography ◽

Diagnostic Accuracy ◽

Drug Screening ◽

Public Transportation ◽

Predictive Value ◽

False Negative ◽

False Negative Rate ◽

Armed Forces ◽

Index Test

Objective: To determine the diagnostic accuracy of immunoassays in drug screening as required in emergency for the rapid diagnosis of drug intoxication in travel related crimes. Study Design: Diagnostic accuracy study. Place and Duration of Study: department of Chemical Pathology and Endocrinology, Armed Forces Institute ofPathology, Rawalpindi Pakistan, from Jul 2017 to Jun 2018. Methodology: Sealed urine specimens of 77 patients with history of suspected intoxication in drugs facilitatedstreet crimes, received for toxicology screening were included in the study. All the specimens were analysed,initially on immunoassay (index test) and then on Triple Quadrupole Liquid chromatography–Mass spectrometry (reference standard). Benzodiazepine being the main class of drugs involved in travel related crimes, diagnostic accuracy of immunoassay technique was assessed for these by calculating its sensitivity, specificity, positive predictive value and negative predictive value. Results: Victims were predominantly males and public transportation was the most common mode of transport. The most commonly used drug was Lorazepam. Immunoassay failed to detect few cases who were shown to be intoxicated with benzodiazepines by liquid-chromatography tandem mass spectrometry. The false negative rate was 4.9%. Only one false positive case was observed. The accuracy was calculated to be 94.8% with sensitivity of 95.08% and specificity of 93.7%. Conclusion: Immunoassay was found reliable for rapid testing in drug facilitated intoxication cases. Howevercritical decision making should be done cautiously keeping in mind the limitations associated with thesescreening procedures.

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The Fast Track FIT study: diagnostic accuracy of faecal immunochemical test for haemoglobin in patients with suspected colorectal cancer

British Journal of General Practice ◽

10.3399/bjgp.2020.1098 ◽

2021 ◽

pp. BJGP.2020.1098

Author(s):

James Turvill ◽

Daniel Turnock ◽

Dan Cottingham ◽

Monica Haritakis ◽

Laura Jeffery ◽

...

Keyword(s):

Colorectal Cancer ◽

Diagnostic Accuracy ◽

Predictive Value ◽

Final Diagnosis ◽

Care Providers ◽

Operating Characteristics ◽

Faecal Immunochemical Test ◽

Characteristics Analysis ◽

Bowel Cancer Screening ◽

Immunochemical Test

Background: The faecal immunochemical test (FIT) is now available to support clinicians in the assessment of patients at low risk of colorectal cancer (CRC) and within the Bowel Cancer Screening Programme. Aim: To determine the diagnostic accuracy of FIT for CRC and clinically significant disease in patients referred because they were judged by their GP to fulfil NICE NG12 criteria for suspected CRC. Design and Setting: Patients referred from primary care with suspected CRC, meeting NG12 criteria, to 12 secondary care providers in Yorkshire and Humber were asked to complete a FIT prior to investigation. Method: The diagnostic accuracy of FIT based upon final diagnosis was evaluated using receiver operating characteristics analysis. Clinicians and patients were blinded to the FIT results. Results: 5040 patients were fully evaluated and CRC was detected in 151 (3%). An optimal cut-off value of 19 g Hb/g faeces for CRC was determined, giving a sensitivity of 85.4% (78.8-90.6%) and specificity of 85.2% (84.1-86.2%). The negative predictive value at this cut-off value was 99.5% (99.2-99.7%) and the positive predictive value 15.1% (12.8-17.7%). Sensitivity and specificity of FIT for CRC and significant premalignant polyps at this cut-off value were 62.9% (57.5-68.0%) and 86.4% (85.4-87.4%) respectively and when including all organic enteric disease were 35.7% (32.9-38.5%) and 88.6% (87.5-89.6%). Conclusions: FIT used in patients fulfilling NICE NG12 criteria should allow for a more personalised CRC risk assessment. FIT should permit effective, patient-centred decision-making to inform the need for, type and timing of further investigation.

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COVID-19 Pneumonia: Inter-Observer Agreement and Diagnostic Accuracy of Chest CT in Patients with Intermediate Clinical Probability

10.21203/rs.3.rs-37489/v1 ◽

2020 ◽

Author(s):

Anne-Laure BRUN ◽

Alexia GENCE-BRENEY ◽

Julie TRICHEREAU ◽

Marie-Christine BALLESTER ◽

Marc VASSE ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Ct Scan ◽

Predictive Value ◽

Chest Ct ◽

Observer Agreement ◽

Kappa Statistics ◽

Operating Characteristics ◽

Rt Pcr ◽

Clinical Probability ◽

Chest Ct Scan

Abstract Objectives To assess inter-reader agreements and diagnostic accuracy of chest CT to identify COVID-19 pneumonia in patients with intermediate clinical probability during an acute disease outbreak.Methods:From March 20 to April 8, consecutive patients with intermediate clinical probability of COVID-19 pneumonia underwent a chest CT scan. Two independent chest radiologists blinded to clinical information and RT-PCR results retrospectively reviewed and classified images on a 1-5 confidence level scale for COVID-19 pneumonia. Agreements between radiologists were assessed with kappa statistics. Diagnostic accuracy of chest CT compared to RT-PCR assay and patient outcomes was measured using receiver operating characteristics (ROC). Positive predictive value (PPV) and negative predictive value (NPV) for COVID-19 pneumonia were calculated.Results: 319 patients with a mean age of 62.3 yo were included. Inter-observer agreement for highly probable (kappa: 0.83 [p < .001]) and highly probable or probable (kappa: 0.82 [p < .001]) diagnosis of COVID-19 pneumonia was very good. RT-PCR tests performed in 307 patients were positive in 173 and negative in 134. Sixteen patients with negative RT-PCR tests and probable or highly probable CT patterns according to both radiologists were reclassified COVID-19 positive after clinical discussion. The areas under the curve (AUC) were 0.94 and 0.92 respectively. With a disease prevalence of 61.6%, PPV were 96.6 % and 94.4%, and NPV 84.3% and 78.2%.Conclusion :During acute COVID-19 outbreak, chest CT scan may be used for triage of patients with intermediate clinical probability with very good inter-observer agreements and diagnostic accuracy.

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Abstract 1122‐000033: Automated Detection of Intracerebral Hemorrhage Using Artificial Intelligence: Pilot Deployment of Viz ICH

Stroke: Vascular and Interventional Neurology ◽

10.1161/svin.01.suppl_1.000033 ◽

2021 ◽

Vol 1 (S1) ◽

Author(s):

Roshini Kalagara ◽

Susmita Chennareddy ◽

Stavros Matsoukas ◽

Emma Reford ◽

Colton Smith ◽

...

Keyword(s):

Artificial Intelligence ◽

Intracerebral Hemorrhage ◽

Diagnostic Accuracy ◽

Likelihood Ratio ◽

Predictive Value ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Index Test ◽

Scan Time ◽

Initial Care

Introduction : Stroke is a major cause of morbidity and mortality. Hemorrhagic strokes are often more severe and associated with higher mortality when compared to ischemic stroke and account for approximately 13% of all strokes. Initial care for patients with intracerebral hemorrhage (ICH) is in part guided by neuroimaging findings. Non‐contrast computed tomography (NCCT) is often the first imaging obtained in the work up of the acute stroke patient given its diagnostic accuracy for hemorrhage, ubiquity, low cost, and short scan time. Immediate evaluation of imaging by stroke experts, such as neurologists, neurosurgeons, and radiologists, is essential. Artificial intelligence tools can help to expedite image assessment and careteam coordination thereby accelerating time to treatment. In this study, we report on the use of Viz ICH, an AI‐enhanced ICH detection platform, to identify ICH on initial CT and coordinate emergent care in an urban health system with an ICH Center. Methods : All consecutive stroke codes presenting with ICH from May 2019 to August 2019 were eligible for analysis. Non‐contrast CT (NCCT) was conducted for each patient and submitted to the Viz ICH in a prospective fashion. An automated volumetric analysis of these NCCTs was conducted by Viz ICH and assessment was conducted for potential ICH. If suspected ICH was detected, Viz ICH sent an automated prompt to the stroke care team for review. CT impressions provided by radiologists served as the clinical reference standard test and Viz ICH output served as the index test. Diagnostic accuracy tests were then performed. Results : A total of 682 patients were analyzed for ICH, out of which 28 patients were positive for intracerebral hemorrhage (ICH) (4%) and 654 were negative for hemorrhage (96%) based on radiology impressions. Viz ICH was able to correctly identify hemorrhages in 25/28 patients and non‐hemorrhages in 650/654 patients. Overall, the software had high diagnostic accuracy with 89.3% sensitivity, 99.4% specificity, and an overall accuracy of 99.0%. The software also had a positive predictive value of 86.2%, a negative predictive value of 99.5%, a positive likelihood ratio of 145.98, and a negative likelihood ratio of 0.108. Conclusions : Viz ICH is an AI‐enhanced platform that may help in the diagnosis and detection of ICH, with a sensitivity of 89.3 and a specificity of 99.4% in this preliminary study. Though future validation studies with a larger cohort of patients positive for each type of hemorrhage must be conducted for true diagnostic accuracy data, Viz ICH has the potential to be an adjunct tool to streamline ICH triage, reduce treatment delays, and improve outcomes of patients presenting with ICH.

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Dia gnostic accuracy of the R-Factor in diff erentiating between neonatal hepatitis and biliary atresia in infants

Gastroenterologie a hepatologie ◽

10.48095/ccgh2021143 ◽

2021 ◽

Vol 75 (2) ◽

pp. 143-148

Author(s):

Seyed Mohsen Dehghani ◽

Sadegh Mohammadi ◽

Iraj Shahramian ◽

Fateme Parooie ◽

Hadi Mirzaie ◽

...

Keyword(s):

Liver Biopsy ◽

Diagnostic Accuracy ◽

Biliary Atresia ◽

Predictive Value ◽

Gold Standard ◽

Roc Analysis ◽

Neonatal Hepatitis ◽

P Value ◽

R Factor ◽

Significant Difference

Introduction: Liver function test is a part of safe and aff ordable routine blood biochemical tests and provides useful information for the diagnosis and management of liver dysfunction. In this study we evaluated the value of the R factor in distinguishing between intrahepatic and extrahepatic causes of infant cholestasis. Methods: Receiver operating characteristic (ROC) analysis was performed to evaluate the diagnostic value of the R factor in each group in comparison with liver biopsy as the gold standard of diagnosis. The data were analyzed using SPSS statistical software and P < 0.05 indicated a significant difference. Results: The study included 37 neonatal hepatitis patients (group A) and 25 biliary atresia patients (group B). The R factor was calculated using the (ALT patient/ULN)/(ALP patient/ULN) formula; ROC analysis revealed that if the R factor was ≤ 0.09 the patient diagnosis would be biliary atresia with high sensitivity (92%) (p-value = 0.001). The corresponding specificity, positive predictive value (PPV), negative predictive value (NPV), diagnostic accuracy and area under the ROC curve (AUC) were 75.7%, 72%, 93%, 82% and 0.87, respectively. Conclusion: The study revealed that the R factor is a good diagnostic marker for differentiating between the most common intrahepatic and extrahepatic causes of infant cholestasis and has good diagnostic accuracy, sensitivity, specificity, PPV and NPV, in comparison with liver biopsy as the gold standard of diagnosis.

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Rapid Review: Diagnostic Accuracy of Pooled Testing versus Individual Testing Using RT-PCR for SARS-CoV-2 for Screening and Surveillance of Individuals with Suspected COVID-19

Acta Medica Philippina ◽

10.47895/amp.v54i0.3316 ◽

2021 ◽

Author(s):

Rowena Natividad F. Genuino ◽

Beatrice J. Tiangco ◽

John Jefferson V. Besa ◽

Howell Henrian G. Bayona

Keyword(s):

Positive Predictive Value ◽

Diagnostic Accuracy ◽

Subgroup Analysis ◽

Predictive Value ◽

Pool Size ◽

Rapid Review ◽

Index Test ◽

Rt Pcr ◽

Pooled Testing ◽

Screening And Surveillance

Background. Pooled testing has been implemented on a limited scale, mainly for screening and surveillance in populations with a low prevalence of COVID-19 to save on limited resources. Objective. To determine the diagnostic accuracy of pooled compared with individual RT-PCR testing for SARS-CoV-2 in individuals suspected of COVID-19. Methods. We searched websites of living CPGs on COVID-19 (Australian COVID-19, COVID NMA, CEBM Oxford), Philippine DOH HTA, databases (PubMed, CENTRAL, medRXIV/bioRXIV), and Clinicaltrials.gov for studies that used pooled testing on individuals suspected of COVID-19. When appropriate, we pooled data for sensitivity and specificity and obtained the range and median of other data, such as positive predictive value and resource savings. We did a priori subgroup analysis for pool size, presence or absence of symptoms and use case, type of specimen, cutoff for positivity, type of kit, and post hoc subgroup analysis for method of pooling and timing of processing. Results. We included 21 studies: 6 diagnostic accuracy studies, and 15 clinical validation studies. Studies had varying populations, index test kit and performance characteristics, positivity rate (0.02 to 15%), and pool size (5 to 16). There was moderate pooled sensitivity, 81% (95% CI 72, 88; I2=73.6%; 6 studies, 776 pools) and high pooled specificity, 99% (95% CI, 98 to 100; I2=1.84%; 5 studies, 666 pools). Positive predictive value based on 21 studies ranged from 67% to 100%. Resource savings in the number of test kits used ranged from 49 to 89%. Identified harms of pooled testing were delayed turnaround time for positive samples and laboratory errors. Conclusion. There is moderate sensitivity and high specificity with pooled testing for the screening of individuals with suspected COVID-19. We recommend further studies to validate the utility based on community prevalence and other test variables.

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Performance characteristics and costs of serological tests for brucellosis in a pastoralist community of northern Tanzania

Scientific Reports ◽

10.1038/s41598-021-82906-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

AbdulHamid S. Lukambagire ◽

Ângelo J. Mendes ◽

Rebecca F. Bodenham ◽

John A. McGiven ◽

Nestory A. Mkenda ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Standardized Testing ◽

Predictive Value ◽

Sub Saharan Africa ◽

Enzyme Linked Immunosorbent Assay ◽

Human Brucellosis ◽

Index Test ◽

Serological Tests ◽

Pastoralist Community ◽

Northern Tanzania

AbstractThe control of brucellosis across sub-Saharan Africa is hampered by the lack of standardized testing and the use of tests with poor performance. This study evaluated the performance and costs of serological assays for human brucellosis in a pastoralist community in northern Tanzania. Serum collected from 218 febrile hospital patients was used to evaluate the performance of seven index tests, selected based on international recommendation or current use. We evaluated the Rose Bengal test (RBT) using two protocols, four commercial agglutination tests and a competitive enzyme-linked immunosorbent assay (cELISA). The sensitivity, specificity, positive predictive value, negative predictive value, Youden’s index, diagnostic accuracy, and per-sample cost of each index test were estimated. The diagnostic accuracy estimates ranged from 95.9 to 97.7% for the RBT, 55.0 to 72.0% for the commercial plate tests, and 89.4% for the cELISA. The per-sample cost range was $0.69–$0.79 for the RBT, $1.03–$1.14 for the commercial plate tests, and $2.51 for the cELISA. The widely used commercial plate tests performed poorly and cost more than the RBT. These findings provide evidence for the public health value of discontinuing the use of commercial agglutination tests for human brucellosis in Tanzania.

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