scholarly journals Establishment and Characterization of an Empirical Biomarker SS/PV-ROC Plot Using Results of the UBC® Rapid Test in Bladder Cancer

Entropy ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. 729 ◽  
Author(s):  
Peter Oehr ◽  
Thorsten Ecke

Background: This investigation included both a study of potential non-invasive diagnostic approaches for the bladder cancer biomarker UBC® Rapid Test and a study including comparative methods about sensitivity–specificity characteristic (SS-ROC) and predictive receiver operating characteristic (PV-ROC) curves that used bladder cancer as a useful example. Methods: The study included 289 urine samples from patients with tumors of the urinary bladder, patients with non-evidence of disease (NED) and healthy controls. The UBC® Rapid Test is a qualitative point of care assay. Using a photometric reader, quantitative data can also be obtained. Data for pairs of sensitivity/specificity as well as positive/negative predictive values were created by variation of threshold values for the whole patient cohort, as well as for the tumor-free control group. Based on these data, sensitivity–specificity and predictive value threshold distribution curves were constructed and transformed into SS-ROC and PV-ROC curves, which were included in a single SS/PV-ROC plot. Results: The curves revealed TPP-asymmetric improper curves which cross the diagonal from above. Evaluation of the PV-ROC curve showed that two or more distinct positive predictive values (PPV) can correspond to the same value of a negative predictive value (NPV) and vice versa, indicating a complexity in PV-ROC curves which did not exist in SS-ROC curves. In contrast to the SS-ROC curve, the PV-ROC curve had neither an area under the curve (AUC) nor a range from 0% to 100%. Sensitivity of the qualitative assay was 58.5% and specificity 88.2%, PPV was 75.6% and NPV 77.3%, at a threshold value of approximately 12.5 µg/L. Conclusions: The SS/PV-ROC plot is a new diagnostic approach which can be used for direct judgement of gain and loss of predictive values, sensitivity and specificity according to varied threshold value changes, enabling characterization, comparison and evaluation of qualitative and quantitative bioassays.

2002 ◽  
Vol 48 (9) ◽  
pp. 1546-1550 ◽  
Author(s):  
Antonio Carroccio ◽  
Giustina Vitale ◽  
Lidia Di Prima ◽  
Nadia Chifari ◽  
Salvatore Napoli ◽  
...  

Abstract Background: Most studies of anti-transglutaminase (anti-tTG) assays have considered preselected groups of patients. This study compared the sensitivity, specificity, and predictive value of an immunofluorescence method for anti-endomysial antibodies (EmAs) and two anti-tTG ELISAs, one using guinea pig tTG (gp-tTG) and the other human tTG (h-tTG) as antigen, in consecutive patients investigated for suspected celiac disease (CD). Methods: We studied 207 consecutive patients (99 men, 108 women; age range, 17–84 years) who underwent intestinal biopsy for suspected CD. Patients presented with one or more of the following: weight loss, anemia, chronic diarrhea, abdominal pain, dyspepsia, alternating bowel habits, constipation, pain in the joints, and dermatitis. At entry to the study, an intestinal biopsy was performed and a serum sample was taken for IgA EmAs, anti-gp-tTG, and anti-h-tTG. Results: Intestinal histology showed that 24 patients had partial or total villous atrophy; in these patients the diagnosis of CD was confirmed by follow-up. The remaining 183 patients had villous/crypt ratios that were within our laboratory’s reference values and were considered controls. Serum EmAs, anti-gp-tTG, and anti-h-tTG were positive in all 24 CD patients; in the control group, none were positive for serum EmAs, but 15 of 183 (8.2%) were positive for anti-gp-tTG, and 6 of 183 (3.3%) were positive for anti-h-tTG. Sensitivity was 100% for all assays, whereas specificity was 100% for the EmA, 92% for the anti-gp-tTG, and 97% for the anti-h-tTG assay. The negative predictive value was 100% for all assays; the positive predictive value was 100% for the EmA, 80% [95% confidence interval (CI), 65–95%] for the anti-h-tTG (P = 0.03 vs EmA) and 60% (95% CI, 44–76%) for the anti-gp-tTG assay (P = 0.0002 vs EmA). Areas (95% CIs) under the ROC curves were 0.987 (0.97–1.0) for anti-h-tTG and 0.965 (0.94–0.99) for anti-gp-tTG. Most of the patients testing false positive for anti-tTG had Crohn disease or chronic liver disease. Conclusions: Although both anti-tTG ELISAs showed optimum sensitivity, their lack of specificity yielded positive predictive values significantly lower than those for the EmA assay.


2019 ◽  
Vol 79 (2) ◽  
pp. 169-173 ◽  
Author(s):  
A. L. Cabana ◽  
M. O. Xavier ◽  
J. F. Mendes ◽  
A. J. Teles ◽  
A. M. Martins ◽  
...  

Abstract Even today, an effective diagnostic test for aspergillosis in penguins is unknown, being the gold standard post-mortem examinations. The fungal antigen galactomannan (GM) has been used as a biomarker of disease in humans and is detected by the Platelia Aspergillus EIA (BioRad)®, a commercial kit based on the sandwich ELISA technique. It is standardized for use in neutropenic patients, however studies have demonstrated its usefulness also possible for birds. The aim of our study was to evaluate the effectiveness of Platelia Aspergillus EIA® test (BioRad-US) in the diagnosis of aspergillosis in Magellanic penguins, determining sensitivity, specificity, and positive and negative predictive values for different cut-off points. Were included in the study, blood serum samples (n = 29) Magellanic penguins in captivity that died by aspergillosis. Detection of GM was performed following manufacturer's instructions and the GM index was obtained by dividing the average value of OD of the duplicate of the clinical sample by duplicate OD of the average value of the cut-off sample provided by the kit. Through information database results were obtained for the presence of anti-Aspergillus fumigatus antibodies detected by agar gel immunodiffusion (AGID) for all serum samples. Results were analyzed using chi-square test and Kruskal-Wallis from SPSS 20.0, IBM®. ROC curve was obtained and from this, rates of sensitivity, specificity, positive and negative predictive values were also calculated based on four different cutoff points (0.5, 1.0, 1.5 and 2.0). The serum GM index did not differ between animals of the case and control group (pkw =0.097). In determining the ROC curve for serum GM detection the value of area under the curve was 0.635. From the values determined by the coordinate of the curve, four different cut points (0.5, 1.0, 1.5 and 2.0) were analyzed, resulting in sensitivity rates ranging from 86.2 to 34.5% % and specificity between 87% and 26.1%. By comparing the serum GM index in group case as the presence or absence of antibodies detected by AGID was found p=0.503. The detection of GM the Platelia Aspergillus EIA® test seems is not be useful for the diagnosis of aspergillosis in naturally infected penguins.


Author(s):  
Abha Sharma ◽  
Richa Sharma ◽  
Tannavi Agarwal

Background: Evaluation of urea and creatinine levels in vaginal wash fluid for the diagnosis of premature rupture of membranes.Methods: The study was conducted on150 pregnant patients, 50 in each group. Confirmed PROM and unconfirmed PROM. Per speculum examination was done to look for pooling, pH tested using the Pehanon paper and vaginal wash fluid was collected. Vaginal wash fluid urea and creatinine levels were tested by a kit based on spectrophotometry.Results: The mean urea levels were 26.35 mg/dl in the study Group 1 and 3.12 mg/dl in the control group. ROC curve was plotted and the cut off value of vaginal wash fluid urea was found to be 8.55 mg/dl. The vaginal wash fluid urea levels of >8.55 mg/dl detected PROM with a sensitivity, specificity, negative and positive predictive value of 100%. The mean creatinine levels were 0.62 mg/dl in study Group 1 and 0.20 mg/dl in the control group. ROC curve was plotted and the cut off value of vaginal wash fluid creatinine was found to be 0.405 mg/dl. Vaginal wash fluid creatinine levels detected PROM with a sensitivity of 76% and specificity of 100%. The negative predictive value and positive predictive values were 80.4% and 100%.Conclusions: Urea can be used as a definite marker of PROM and creatinine can be used as a supportive marker.


Diagnostics ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. 109 ◽  
Author(s):  
Ukweh ◽  
Ugbem ◽  
Okeke ◽  
Ekpo

Background: Ultrasound is operator-dependent, and its value and efficacy in fetal morphology assessment in a low-resource setting is poorly understood. We assessed the value and efficacy of fetal morphology ultrasound assessment in a Nigerian setting. Materials and Methods: We surveyed fetal morphology ultrasound performed across five facilities and followed-up each fetus to ascertain the outcome. Fetuses were surveyed in the second trimester (18th–22nd weeks) using the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) guideline. Clinical and surgical reports were used as references to assess the diagnostic efficacy of ultrasound in livebirths, and autopsy reports to confirm anomalies in terminated pregnancies, spontaneous abortions, intrauterine fetal deaths, and still births. We calculated sensitivity, specificity, positive and negative predictive values, Area under the curve (AUC), Youden index, likelihood ratios, and post-test probabilities. Results: In total, 6520 fetuses of women aged 15–46 years (mean = 31.7 years) were surveyed. The overall sensitivity, specificity, and AUC were 77.1 (95% CI: 68–84.6), 99.5 (95% CI: 99.3–99.7), and 88.3 (95% CI: 83.7–92.2), respectively. Other performance metrics were: positive predictive value, 72.4 (95% CI: 64.7–79.0), negative predictive value, 99.6 (95% CI: 99.5–99.7), and Youden index (77.1%). Abnormality prevalence was 1.67% (95% CI: 1.37–2.01), and the positive and negative likelihood ratios were 254 (95% CI: 107.7–221.4) and 0.23 (95% CI: 0.16–0.33), respectively. The post-test probability for positive test was 72% (95% CI: 65–79). Conclusion: Fetal morphology assessment is valuable in a poor economics setting, however, the variation in the diagnostic efficacy across facilities and the limitations associated with the detection of circulatory system anomalies need to be addressed.


Cancers ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 1551 ◽  
Author(s):  
Edyta Marta Borkowska ◽  
Tomasz Konecki ◽  
Michał Pietrusiński ◽  
Maciej Borowiec ◽  
Zbigniew Jabłonowski

Bladder cancer (BC) is still characterized by a very high death rate in patients with this disease. One of the reasons for this is the lack of adequate markers which could help determine the biological potential of the tumor to develop into its invasive stage. It has been found that some microRNAs (miRNAs) correlate with disease progression. The purpose of this study was to identify which miRNAs can accurately predict the presence of BC and can differentiate low grade (LG) tumors from high grade (HG) tumors. The study included 55 patients with diagnosed bladder cancer and 30 persons belonging to the control group. The expression of seven selected miRNAs was estimated with the real-time PCR technique according to miR-103-5p (for the normalization of the results). Receiver operating characteristics (ROC) curves and the area under the curve (AUC) were used to evaluate the feasibility of using selected markers as biomarkers for detecting BC and discriminating non-muscle invasive BC (NMIBC) from muscle invasive BC (MIBC). For HG tumors, the relevant classifiers are miR-205-5p and miR-20a-5p, whereas miR-205-5p and miR-182-5p are for LG (AUC = 0.964 and AUC = 0.992, respectively). NMIBC patients with LG disease are characterized by significantly higher miR-130b-3p expression values compared to patients in HG tumors.


2022 ◽  
Vol 17 (1) ◽  
Author(s):  
Bachar Alabdullah ◽  
Amir Hadji-Ashrafy

Abstract Background A number of biomarkers have the potential of differentiating between primary lung tumours and secondary lung tumours from the gastrointestinal tract, however, a standardised panel for that purpose does not exist yet. We aimed to identify the smallest panel that is most sensitive and specific at differentiating between primary lung tumours and secondary lung tumours from the gastrointestinal tract. Methods A total of 170 samples were collected, including 140 primary and 30 non-primary lung tumours and staining for CK7, Napsin-A, TTF1, CK20, CDX2, and SATB2 was performed via tissue microarray. The data was then analysed using univariate regression models and a combination of multivariate regression models and Receiver Operating Characteristic (ROC) curves. Results Univariate regression models confirmed the 6 biomarkers’ ability to independently predict the primary outcome (p < 0.001). Multivariate models of 2-biomarker combinations identified 11 combinations with statistically significant odds ratios (ORs) (p < 0.05), of which TTF1/CDX2 had the highest area under the curve (AUC) (0.983, 0.960–1.000 95% CI). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 75.7, 100, 100, and 37.5% respectively. Multivariate models of 3-biomarker combinations identified 4 combinations with statistically significant ORs (p < 0.05), of which CK7/CK20/SATB2 had the highest AUC (0.965, 0.930–1.000 95% CI). The sensitivity, specificity, PPV, and NPV were 85.1, 100, 100, and 41.7% respectively. Multivariate models of 4-biomarker combinations did not identify any combinations with statistically significant ORs (p < 0.05). Conclusions The analysis identified the combination of CK7/CK20/SATB2 to be the smallest panel with the highest sensitivity (85.1%) and specificity (100%) for predicting tumour origin with an ROC AUC of 0.965 (p < 0.001; SE: 0.018, 0.930–1.000 95% CI).


2018 ◽  
Vol 5 (3) ◽  
pp. 796
Author(s):  
Vamsavardhan Pasumarthi ◽  
C. P. Madhu

Background: The RIPASA Score is a new diagnostic scoring system developed for the diagnosis of Acute Appendicitis which showed higher sensitivity, specificity and diagnostic accuracy compared to ALVARADO Score, particularly when applied to Asian population. Not many studies have been conducted to compare RIPASA and ALVARADO scoring systems. Hence, author want to compare prospectively Alvarado and RIPASA score by applying them to the patients attending the hospital with right iliac fossa pain that could probably be acute appendicitis.Methods: A prospective analysis of 116 cases admitted with RIF pain during a 2 years period was performed. Patients between 15-60 years were scored as per Alvarado and RIPASA scoring system. Histopathological reports of the cases were collected and compared with the scores. ROC curve area analysis was performed to examine diagnostic accuracy of RIPASA and ALVARADO scores.Results: The sensitivity of ALVARADO score is estimated to be 52.08 for a cut off of 6. The specificity is 80%, positive predictive value is 92.59, negative predictive value is 25.81. The Diagnostic accuracy of ALVARADO scoring is found to be 56.9. The sensitivity, specificity, positive predictive value and negative predictive values of RIPASA scoring system are 75%, 65%, 91.14%, 35.14%. The diagnostic accuracy of RIPASA score is 73.28.Conclusions: The difference in the diagnostic accuracy between ALVARADO and RIPASA scoring system is significant indicating that the RIPASA score is a much better diagnostic tool for the diagnosis of acute appendicitis. When the ROC curve was observed the area under the curve is high for RIPASA scoring system.


2018 ◽  
Vol 13 (1) ◽  
pp. 456-462
Author(s):  
Qiang Guo ◽  
Chuanqin Xu ◽  
Chao Sun ◽  
Yubao Zhao ◽  
Weifu Zhang

AbstractThe timely and accurate diagnosis of ascites is of great significance for early treatment and prognostication. This study explored the value of soluble myeloid triggering receptor expressed on myeloid cell 1 (sTREM-1) and C-reactive protein (CRP) for assessing ascites. A total of 133 patients with ascites who received treatment at the Affiliated Hospital of Taishan Medical University between September 2015 and September 2017 were retrospectively analyzed. The ascites in 22, 45, 33 and 33 patients were tuberculous, bacterial, tumorous, and transudative, respectively. Healthy volunteers (n=30) who received a health examination at the same hospital during the same period constituted the control group. Before treatment, both ascitic sTREM-1 and CRP showed significant differences among the ascites subgroups (P<0.001), with the highest levels in the bacterial subgroup. Serum sTREM-1 and CRP also showed significant differences among the groups. A correlation analysis showed a positive correlation between sTREM-1 and CRP. ROC curves of the bacterial subgroup showed that when the optimal cutoff point was set to 20.2, the sensitivity, specificity, positive predictive value, and negative predictive value of the serum sTREM-1 index were 0.933, 0.955, 0.914, and 0.965, respectively. sTREM-1 may provide more diagnostic value than CRP for the diagnosis of bacterial ascites.


2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Marius Bill ◽  
Krzysztof Mrózek ◽  
Brian Giacopelli ◽  
Jessica Kohlschmidt ◽  
Deedra Nicolet ◽  
...  

AbstractRecently, a novel knowledge bank (KB) approach to predict outcomes of individual patients with acute myeloid leukemia (AML) was developed using unbiased machine learning. To validate its prognostic value, we analyzed 1612 adults with de novo AML treated on Cancer and Leukemia Group B front-line trials who had pretreatment clinical, cytogenetics, and mutation data on 81 leukemia/cancer-associated genes available. We used receiver operating characteristic (ROC) curves and the area under the curve (AUC) to evaluate the predictive values of the KB algorithm and other risk classifications. The KB algorithm predicted 3-year overall survival (OS) probability in the entire patient cohort (AUCKB = 0.799), and both younger (< 60 years) (AUCKB = 0.747) and older patients (AUCKB = 0.770). The KB algorithm predicted non-remission death (AUCKB = 0.860) well but was less accurate in predicting relapse death (AUCKB = 0.695) and death in first complete remission (AUCKB = 0.603). The KB algorithm’s 3-year OS predictive value was higher than that of the 2017 European LeukemiaNet (ELN) classification (AUC2017ELN = 0.707, p < 0.001) and 2010 ELN classification (AUC2010ELN = 0.721, p < 0.001) but did not differ significantly from that of the 17-gene stemness score (AUC17-gene = 0.732, p = 0.10). Analysis of additional cytogenetic and molecular markers not included in the KB algorithm revealed that taking into account atypical complex karyotype, infrequent recurrent balanced chromosome rearrangements and mutational status of the SAMHD1, AXL and NOTCH1 genes may improve the KB algorithm. We conclude that the KB algorithm has a high predictive value that is higher than those of the 2017 and 2010 ELN classifications. Inclusion of additional genetic features might refine the KB algorithm.


2020 ◽  
Author(s):  
Caroline Santos Silva ◽  
Ueslei Menezes de Araujo ◽  
Mateus Andrade Alvaia ◽  
Kátia Santana Freitas ◽  
Cristiano Mendes Gomes ◽  
...  

ABSTRACTOBJECTIVETo validate a new simplified score for the assessment of men with LUTS (LUTS-V).METHODSWe made adjustments to the VPSS, resulting in a new simplified instrument (LUTS visual score – LUTS-V). In a pilot study, LUTS-V was administered to 50 men to identify interpretation issues. We used the International Prostate Symptom Score (IPSS) as the gold standard to validate the new tool in 306 men. The total IPSS and LUTS-V scores for each subject were evaluated and we used Bland-Altman analysis and Pearson’s correlation plot to assess the agreement between the scores. A ROC curve was utilized to determine the diagnostic accuracy of LUTS-V and its diagnostic properties were described in terms of sensitivity, specificity, positive and negative predictive values.RESULTSMedian age was 59 [52-67] years and, according to the IPSS, 26 (8.7%) patients had severe symptoms, while 99 (33%) had moderate symptoms, and 175 (58.3%) had mild symptoms. We found a positive correlation between the IPSS and LUTS-V (r = 0.72; p < 0.0001). Bland-Altman analysis showed good agreement between the two questionnaires. We found LUTS-V to have a diagnostic accuracy to detect more severe cases of 83% (95% CI: [78-87%]; p < 0.001), as estimated by the area under the ROC curve. The cut-off value of ≥ 4 points was the best threshold, with a sensitivity of 74% and a specificity of 78%, which resulted in a negative predictive value of 81% and a positive predictive value of 71% in this scenario. Median completion time was 0.51 [0.41-1.07] min for LUTS-V and 2.5 [2.2-3.4] min for the IPSS (p < 0.0001). In addition, 91.5% of patients completed the questionnaires with no help, while the other 8.5% were interviewed.CONCLUSIONLUTS-V is a simple, self-administered tool with a significant discriminating power to identify patients with moderate to severe symptoms.


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