scholarly journals A Rapid Heparin Antibody Detection Assay Performs Better Than 4T's Score in Predicting HIT Diagnosis: A Single Community Medical Center Retrospective Analysis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1457-1457 ◽  
Author(s):  
Srikant Nannapaneni ◽  
Ishan Malhotra ◽  
Michael Simon ◽  
Phone Oo ◽  
Trishala Meghal ◽  
...  

Abstract Introduction: The diagnosis of heparin induced thrombocytopenia (HIT) and thrombosis (HITT) is challenging due to poor availability of the gold standard serotonin releasing assay (SRA) and suboptimal positive predictive value from clinical scoring models such as 4T score. A common algorithm used for diagnosing HIT is: 4T's pretest probability score estimation in cases suspected of HIT; followed by HIT antibody test in the intermediate to high risk groups; followed by confirmation with SRA test in HIT antibody positive patients. Since 2011, a Particle Immune-Filtration Assay (PIFA) Heparin/Platelet Factor 4 Rapid Assay (HPF4-RA) (Akers Bioscience, Inc, Thorofare, NJ) became available in our medical center and test results were available on the same day. We observed that HPF4-RA test was being routinely ordered along with SRA test at the same time. We performed this retrospective analysis to evaluate and compare the predictive performance for SRA positive HIT diagnosis using 4T score or HPF4-RA. We applied a regression analysis model, to calculate area under receiver operating characteristics (ROC) curve. Methods: A list of all consecutive patients who had HIT antibody test and/or SRA test performed between January 2010 and June 2013 was obtained, which consisted of 402 patients. Patients with duplication of tests were deleted from analysis. 283 patients had results reported for both HPF4-RA (positive in n=42, negative in n=241) and SRA tests (positive in n=16 and negative in n=267); and these results were used for calculation of HPF4-RA prediction model. Two patients had HPF4-RA negative result but SRA positive test result. 4T's scores were calculated for 125 patients, consisting of all HPF4-RA positive patients (n=42), and patients randomly selected from the total HPF4-RA negative pool (n=83). Electronic medical records were reviewed for temporal trend of platelet counts, diagnosis, medication use, Doppler tests and competing causes of thrombocytopenia. Persons calculating the 4T's score were blinded to the laboratory test results. Results: Stratification of the patients with 4T's score analysis (n=125) revealed that the distribution of SRA positive patients (n=16) was 31.3% (n=5) in low risk, 31.3% (n=5) in intermediate risk, and 37.5% (n=6) in high risk groups; while the distribution of SRA negative patients (n=109) was 45.9% (n=50) in low risk, 43.1% (n=47) in intermediate risk and 11.0% (n=12) in high risk groups. The area under receiver operating characteristics (ROC) curve for 4T score as a continuous variable to predict SRA positive HIT was 0.659 (95% CI 0.516 - 0.802; p = 0.041), and the area under ROC curve for HPF4-RA to predict SRA positive HIT was 0.818 ( 95% CI 0.712 - 0.924; p = 0.00) (Figure 1). HPF4-RA test also showed better overall prediction parameters for HIT as shown in Table 1. A combination of HIT HPF4-RA positive result and a 4T score ≥ 4 did not increase the area under ROC curve for prediction of SRA positive HIT. Abstract 1457. Table1: Predictive performance of 4T's score and HPF4-RA for HIT (defined by positive SRA) Sensitivity (95% CI) Specificity (95% CI) PPV (95% CI) NPV (95% CI) Number of patients (%) 4T's score ≤ 3 (Low Risk) 0.31 (0.11 – 0.59) 0.72 (0.64 - 0.79) 0.11 (0.03 - 0.23) 0.91 (0.84 - 0.95) 56 (44.8) 4T's score ≥ 4 (Intermediate and High Risk) 0.69 (0.41-0.89) 0.39 (0.29 - 0.48) 0.14 (0.72 - 0.24) 0.89 (0.77 - 0.96) 69 (55.2) 4T's score ≥ 6 (High Risk) 0.37 (0.15-0.65) 0.82 (0.74 - 0.89) 0.24 (0.09 - 0.45) 0.90 (0.82 - 0.95) 17 (13.6) HPF4-RA Test 0.88 (0.62-0.98) 0.86 (0.81- 0.90) 0.26 (0.16 - 0.41) 0.99 (0.96 - 0.99) 283 PPV: Positive Predictive Value. NPV: Negative Predictive Value Figure 1: Receiver Operating Characteristics (ROC) curve of the 4T's score and HPF4-RA test result for determining the presence of HIT (defined by positive SRA). Figure 1:. Receiver Operating Characteristics (ROC) curve of the 4T's score and HPF4-RA test result for determining the presence of HIT (defined by positive SRA). Conclusions: Both 4T's score and HPF4-RA testing predict SRA positive HIT more than chance; however HPF4-RA testing predicts SRA positive HIT better than 4T's scores with higher sensitivity, specificity and NPV. This result challenges the pretesting algorithm for selecting patients for confirmatory SRA testing to diagnose HIT. Instead of using 4T's score as a screening tool for selecting patients for HPF4 antibody testing; rapid HPF4 antibody assays when available, should be considered as upfront screening tool and positive results considered for confirmatory SRA testing for diagnosis of HIT. Further studies are warranted to confirm this data. Disclosures No relevant conflicts of interest to declare.

2015 ◽  
Vol 28 (2) ◽  
pp. 189
Author(s):  
Ana Salselas ◽  
Inês Pestana ◽  
Francisco Bischoff ◽  
Mariana Guimarães ◽  
Joaquim Aguiar Andrade

<strong>Introduction:</strong> Pregnant women with thromboembolic diseases, previous thrombotic episodes or thrombophilia family history were supervised in a multidisciplinary Obstetrics/ Hematology consultation in Centro Hospitalar São João EPE, Porto, Portugal. For the evaluation and medication of these women, a risk stratification scale was used.<br /><strong>Purposes:</strong> The aim of this study was to validate a Risk Stratification Scale and thromboprophylaxis protocol by means of comparing it with a similar scale, developed and published by Sarig.<br /><strong>Material and Methods:</strong> We have compared: The distribution, by risk groups, obtained through the application of the two scales on pregnant women followed at Centro Hospitalar São João, Porto, Portugal, consultation; the sensibility and specificity for each one of the scales (DeLong scale, applied to Receiver Operating Characteristic) curves; the outcomes in pregnancies followed in Hospital São João, Porto, Portugal<br /><strong>Results:</strong> According to our Hema-Obs risk stratification scale, 29% were allocated to low-risk, 47% to high-risk and 24% to very-high-risk groups. According to Galit Sarig risk stratification scale, 24% were considered low-risk, 53% moderate, 16% high-risk and 7% as very high-risk group. In our study we observed 9% of spontaneous abortions, in comparison with 18% in the Galit Sarig cohort. From the application of Receiver Operating Characteristic curve to both risk stratification scales, the results of the calculated areas were 58,8% to our Hema-Obs risk stratification scale and 38,7% to Galit Sarig risk stratification scale, with a Delong test significancie of p = 0.0006.<br /><strong>Conclusions:</strong> We concluded that Hema-Obs risk stratification scale is an effective support for clinical monitoring of therapeutic strategies.


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 379-379
Author(s):  
Lucia Nappi ◽  
Marisa Thi ◽  
Neetu Saxena ◽  
Maryam Soleimani ◽  
Bernhard J. Eigl ◽  
...  

379 Background: miR371a-3p (miR371) is overexpressed in seminoma (S) and nonseminoma (NS) active germ cell malignancy (aGCM) and easily detectable in blood. We previously described1 a remarkably high accuracy of miR371 in detecting aGCM in early and advanced stages germ cell tumor (GCT) patients (pts). We here present the updated miR371 expression data with a longer follow-up, particularly relevant to assess miR371 clinical utility to predict GCT relapse in clinical stage I (CSI) and stage IIA pts. Methods:119 samples from 99 pts enrolled in the GU biobank program at the British Columbia Cancer – Vancouver were analyzed. The pts were divided according to their risk of aGCM in low (CSIA NS and CSI S), moderate (CSIB NS, stage IIA markers negative/low elevated S and NS), and high risk (definitively metastatic aGCM) groups. Blood of the low and moderate risk pts was collected post orchiectomy and at the time of the clinical relapse; prior to/post-chemotherapy in the high risk group. Plasma miR371 expression was evaluated by RT-PCR and quantified by ΔΔCT method. Sensitivity, specificity, negative and positive predictive values (NPV, PPV) and AUC of the ROC curve were analyzed. Results: Five (2 moderate - 3 low risks) pts were lost at follow-up and 1 high risk pt had deceased. Overall, 113 samples (50, 36, 27 in the low, moderate, and high risk groups, respectively) were analyzed. The median follow-up from study entry was 30 (6-51), 28 (20-52), and 29 (7-53) months for the low, moderate and high risk, respectively. Seven more relapses occurred: 4 in the low risk (3 S and 1 NS) and 3 in the moderate risk groups (2 NS and 1 S). miR371 was found falsely negative post-orchiectomy in 4 pts and truly negative in 3 relapsed pts (2 pure teratoma and 1 unconfirmed relapse). Serial analysis of the false negative relapsed pts showed that miR371 became detectable at the time of clinical relapse. The operating characteristics of miR371 are summarized in the table below. Conclusions: Our follow-up has exceeded the expected time of relapse even in the low risk pts. The high accuracy of miR371 in detecting aGCM was confirmed with a longer follow up. However, the few false negatives in relapsed pts and the serial analysis suggest a lack of sensitivity in the detection of microscopic disease post-orchiectomy with the current methodology while miR371 high sensitivity was confirmed in presence of radiologic measurable disease (≥ 1 cm). The definitive operating characteristics of miR371 post-orchiectomy and during the follow-up of stages I/ IIA pts will be prospectively validated by the S1823 study that is actively recruiting pts. [Table: see text]


2021 ◽  
Author(s):  
Rongchang Zhao ◽  
Dan Ding ◽  
Yan Ding ◽  
Rongbo Han ◽  
Xiujuan Wang ◽  
...  

Abstract Background Multiple factors affect the survival time of patients with lung adenocarcinoma (LUAD). Specifically, the therapeutic effect of medicines and the disease recurrence probability differs among patients with the same stage of LUAD. Thus, effective prognostic predictors need to be identified. Methods Based on the tumor mutation burden (TMB) data obtained by TCGA, LUAD was divided into high and low groups, and the differentially expressed glycolysis-related genes between the two groups were screened out. Cox regression was used to obtain a prognostic model. A receiver operating characteristic (ROC) curve and calibration curve were generated to evaluate the nomogram that was constructed based on clinicopathological characteristics and the risk score. Two datasets (GSE68465 and GSE11969) from Gene Expression Omnibus (GEO) were used to verify the prognostic performance of the gene. Furthermore, differences in immune cell distribution, immune-related molecules and drug susceptibility were assessed for their relationship with the risk score. Results We confirmed a 5-gene signature (FKBP4, HMMR, B4GALT1, ERO1L, ENO1) capable of dividing patients into two risk groups. There was a significant difference in overall survival (OS) times between the high-risk group and the low-risk group (P = 1.085e-4), with the low-risk group having a better survival outcome. Through multivariate Cox analysis, the risk score was confirmed to be an independent prognostic factor (HR = 1.289, 95% CI = 1.202-1.383, P < 0.001), and the ROC curve and nomogram exhibited accurate prediction performance. Validation of the data obtained in the GEO database yielded similar results. Additionally, there were significant differences in cisplatin, paclitaxel, gemcitabine, docetaxel, gefitiniband erlotinib sensitivity between the low-risk and high-risk groups. Conclusions Our results reveal that glycolysis-related gene are feasible predictors of LUAD patient survival and response to therapeutics.


2021 ◽  
Vol 8 (4) ◽  
pp. 279-288
Author(s):  
Min Jae Kim ◽  
Sang Ook Ha ◽  
Young Sun Park ◽  
Jeong Hyeon Yi ◽  
Won Seok Yang ◽  
...  

Objective This study aimed to clarify the relative prognostic value of each History, Electrocardiography, Age, Risk Factors, and Troponin (HEART) score component for major adverse cardiac events (MACE) within 3 months and validate the modified HEART (mHEART) score.Methods This study evaluated the HEART score components for patients with chest symptoms visiting the emergency department from November 19, 2018 to November 19, 2019. All components were evaluated using logistic regression analysis and the scores for HEART, mHEART, and Thrombolysis in Myocardial Infarction (TIMI) were determined using the receiver operating characteristics curve.Results The patients were divided into a derivation (809 patients) and a validation group (298 patients). In multivariate analysis, age did not show statistical significance in the detection of MACE within 3 months and the mHEART score was calculated after omitting the age component. The areas under the receiver operating characteristics curves for HEART, mHEART and TIMI scores in the prediction of MACE within 3 months were 0.88, 0.91, and 0.83, respectively, in the derivation group; and 0.88, 0.91, and 0.81, respectively, in the validation group. When the cutoff value for each scoring system was determined for the maintenance of a negative predictive value for a MACE rate >99%, the mHEART score showed the highest sensitivity, specificity, positive predictive value, and negative predictive value (97.4%, 54.2%, 23.7%, and 99.3%, respectively).Conclusion Our study showed that the mHEART score better detects short-term MACE in high-risk patients and ensures the safe disposition of low-risk patients than the HEART and TIMI scores.


Diagnostica ◽  
2019 ◽  
Vol 65 (3) ◽  
pp. 179-190 ◽  
Author(s):  
Vincent Mustapha ◽  
Renate Rau

Zusammenfassung. Cut-Off-Werte ermöglichen eine ökonomische, binäre Beurteilung von Summenscores. Für Beanspruchungsfragebögen, die personenbezogene Merkmale erfragen, sind Cut-Off-Werte häufig vorhanden und in der klinischen Diagnostik unerlässlich. Für die Bewertung von Arbeitsmerkmalen sind Cut-Off-Werte ebenfalls wünschenswert. Bislang fehlen sie jedoch für die Beurteilung von Arbeitsmerkmalen wie Arbeitsintensität und Tätigkeitsspielraum. Zwischen 2006 und 2016 wurden daher in verschiedenen Branchen 801 objektive Arbeitsplatzanalysen durchgeführt, welche eine Unterteilung in gut und schlecht gestalteten Tätigkeitsspielraum sowie gut und schlecht gestaltete Arbeitsintensität nach DIN EN ISO 6385 (2016) ermöglichen. Anhand dieser Unterteilung wurden mit der Receiver-Operating-Characteristics-Analyse Cut-Off-Werte für den subjektiv-bedingungsbezogen Fragebogen zum Erleben von Arbeitsintensität und Tätigkeitsspielraum (FIT; Richter et al., 2000 ) ermittelt. Für den Tätigkeitsspielraum weisen Summenscores ≤ 22 und für die Arbeitsintensität Summenscores ≥ 15 auf eine schlechte Gestaltung des jeweiligen Arbeitsmerkmals hin. Anhand einer weiteren Stichprobe von 1 076 Arbeitenden konnte gezeigt werden, dass Arbeitende mit schlecht gestaltetem Tätigkeitspielraum vital erschöpfter sowie weniger engagiert sind und Arbeitende mit schlecht gestalteter Arbeitsintensität eine höhere Erholungsunfähigkeit sowie vitale Erschöpfung aufweisen.


2020 ◽  
Author(s):  
Adnan Budak ◽  
Emrah Beyan ◽  
Abdurrahman Hamdi Inan ◽  
Ahkam Göksel Kanmaz ◽  
Onur Suleyman Aldemir ◽  
...  

Abstract Aim We investigate the role of preoperative PET parameters to determine risk classes and prognosis of endometrial cancer (EC). Methods We enrolled 81 patients with EC who underwent preoperative F-18 FDG PET/CT. PET parameters (SUVmax, SUVmean, MTV, TLG), grade, histology and size of the primary tumor, stage of the disease, the degree of myometrial invasion (MI), and the presence of lymphovascular invasion (LVI), cervical invasion (CI), distant metastasis (DM) and lymph node metastasis (LNM) were recorded. The relationship between PET parameters, clinicopathological risk factors and overall survival (OS) was evaluated. Results The present study included 81 patients with EC (mean age 60). Of the total sample, 21 patients were considered low risk (endometrioid histology, stage 1A, grade 1 or 2, tumor diameter < 4 cm, and LVI negative) and 60 were deemed high risk. All of the PET parameters were higher in the presence of a high-risk state, greater tumor size, deep MI, LVI and stage 1B-4B. MTV and TLG values were higher in the patients with non-endometrioid histology, CI, grade 3 and LNM. The optimum cut-off levels for differentiating between the high and low risk patients were: 11.1 for SUVmax (AUC = 0.757), 6 for SUVmean (AUC = 0.750), 6.6 for MTV(AUC = 0.838) and 56.2 for TLG(AUC = 0.835). MTV and TLG values were found as independent prognostic factors for OS, whereas SUVmax and SUVmean values were not predictive. Conclusions The PET parameters are useful in noninvasively differentiating between risk groups of EC. Furthermore, volumetric PET parameters can be predictive for OS of EC.


Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1128
Author(s):  
Jeanne Hersant ◽  
Pierre Ramondou ◽  
Francine Thouveny ◽  
Mickael Daligault ◽  
Mathieu Feuilloy ◽  
...  

The level of pulse amplitude (PA) change in arterial digital pulse plethysmography (A-PPG) that should be used to diagnose thoracic outlet syndrome (TOS) is debated. We hypothesized that a modification of the Roos test (by moving the arms forward, mimicking a prayer position (“Pra”)) releasing an eventual compression that occurs in the surrender/candlestick position (“Ca”) would facilitate interpretation of A-PPG results. In 52 subjects, we determined the optimal PA change from rest to predict compression at imaging (ultrasonography +/− angiography) with receiver operating characteristics (ROC). “Pra”-PA was set as 100%, and PA was expressed in normalized amplitude (NA) units. Imaging found arterial compression in 23 upper limbs. The area under ROC was 0.765 ± 0.065 (p < 0.0001), resulting in a 91.4% sensitivity and a 60.9% specificity for an increase of fewer than 3 NA from rest during “Ca”, while results were 17.4% and 98.8%, respectively, for the 75% PA decrease previously proposed in the literature. A-PPG during a “Ca+Pra” test provides demonstrable proof of inflow impairment and increases the sensitivity of A-PPG for the detection of arterial compression as determined by imaging. The absence of an increase in PA during the “Ca” phase of the “Ca+Pra” maneuver should be considered indicative of arterial inflow impairment.


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Ehsan Zamanzade ◽  
Xinlei Wang

AbstractRanked set sampling (RSS), known as a cost-effective sampling technique, requires that the ranker gives a complete ranking of the units in each set. Frey (2012) proposed a modification of RSS based on partially ordered sets, referred to as RSS-t in this paper, to allow the ranker to declare ties as much as he/she wishes. We consider the problem of estimating the area under a receiver operating characteristics (ROC) curve using RSS-t samples. The area under the ROC curve (AUC) is commonly used as a measure for the effectiveness of diagnostic markers. We develop six nonparametric estimators of the AUC with/without utilizing tie information based on different approaches. We then compare the estimators using a Monte Carlo simulation and an empirical study with real data from the National Health and Nutrition Examination Survey. The results show that utilizing tie information increases the efficiency of estimating the AUC. Suggestions about when to choose which estimator are also made available to practitioners.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Nan Ma ◽  
Lu Si ◽  
Meiling Yang ◽  
Meihua Li ◽  
Zhiyi He

AbstractThere is an urgent need to identify novel biomarkers that predict the prognosis of patients with NSCLC. In this study,we aim to find out mRNA signature closely related to the prognosis of NSCLC by new algorithm of bioinformatics. Identification of highly expressed mRNA in stage I/II patients with NSCLC was performed with the “Limma” package of R software. Survival analysis of patients with different mRNA expression levels was subsequently calculated by Cox regression analysis, and a multi-RNA signature was obtained by using the training set. Kaplan–Meier estimator, log-rank test and receiver operating characteristic (ROC) curves were used to analyse the predictive ability of the multi-RNA signature. RT-PCR used to verify the expression of the multi-RNA signature, and Westernblot used to verify the expression of proteins related to the multi-RNA signature. We identified fifteen survival-related mRNAs in the training set and classified the patients as high risk or low risk. NSCLC patients with low risk scores had longer disease-free survival than patients with high risk scores. The fifteen-mRNA signature was an independent prognostic factor, as shown by the ROC curve. ROC curve also showed that the combined model of the fifteen-mRNA signature and tumour stage had higher precision than stage alone. The expression of fifteen mRNAs and related proteins were higher in stage II NSCLC than in stage I NSCLC. Multi-gene expression profiles provide a moderate prognostic tool for NSCLC patients with stage I/II disease.


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