The  novel biomarker HE4 versus CA125 in detecting endometrial cancer: A case control prospective study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5094-5094
Author(s):  
Francesco Plotti ◽  
Marzio Angelo Zullo ◽  
Michela Angelucci ◽  
Irma Oronzi ◽  
Patrizio Damiani ◽  
...  

5094 Background: In endometrial cancer, there are no markers routinely used in clinical practice. This study prospectively investigates the sensitivity and specificity of new marker HE4 in detection of endometrial cancer. Methods: Serum samples were prospectively obtained 24 hours before surgery from 25 patients with endometrial cancer and from 25 patients with uterine benign pathology, operated from January 2011 to October 2011 at University Campus Bio-Medico of Rome. Preoperative CA125 levels were evaluated by a one-step “sandwich” radioimmunoassay. HE4 levels were determined using the HE4 enzymatic immune assay. The CA125 normal value is considered less than 35 U/mL. Two HE4 cut-off are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the parametric T-Test for comparing the HE4 series and the Mann-Whitney test for the CA125 series. The level of statistical significance is set at p < 0.05. Results: The sensitivity of CA125 in detecting endometrial cancer is 16% whereas the sensitivity of HE4 is 48% and 28 % for 70 pmol/L and 150 pmol/L cut-off respectively. The specificity of HE4 is 100% (positive predictive value = 100%, negative predictive value = 65.79% and 58.14% considering the two HE4 cut-off, respectively), whereas the CA125 specificity is 72 % (positive predictive value = 36.36%, negative predictive value = 46.15%) in detection of endometrial cancer. Conclusions: HE4 has a good sensitivity and a specificity of 100% in detection of endometrial cancer and may be useful for detecting early stage endometrial cancer. In particular the HE4 at cut-off of 70 pmol/L yields the best sensitivity and specificity.

2016 ◽  
Vol 76 (1) ◽  
pp. 119-125 ◽  
Author(s):  
Aase Haj Hensvold ◽  
Thomas Frisell ◽  
Patrik K E Magnusson ◽  
Rikard Holmdahl ◽  
Johan Askling ◽  
...  

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.


2015 ◽  
Vol 51 (5) ◽  
pp. 306-310 ◽  
Author(s):  
Lauren Cunningham ◽  
Audrey Cook ◽  
Andrew Hanzlicek ◽  
Kenneth Harkin ◽  
Joseph Wheat ◽  
...  

The objective of this study was to evaluate the sensitivity and specificity of an antigen enzyme immunoassay (EIA) on urine samples for the diagnosis of histoplasmosis in dogs. This retrospective medical records review included canine cases with urine samples submitted for Histoplasma EIA antigen assay between 2007 and 2011 from three veterinary institutions. Cases for which urine samples were submitted for Histoplasma antigen testing were reviewed and compared to the gold standard of finding Histoplasma organisms or an alternative diagnosis on cytology or histopathology. Sensitivity, specificity, negative predictive value, positive predictive value, and the kappa coefficient and associated confidence interval were calculated for the EIA-based Histoplasma antigen assay. Sixty cases met the inclusion criteria. Seventeen cases were considered true positives based on identification of the organism, and 41 cases were considered true negatives with an alternative definitive diagnosis. Two cases were considered false negatives, and there were no false positives. Sensitivity was 89.47% and the negative predictive value was 95.35%. Specificity and the positive predictive value were both 100%. The kappa coefficient was 0.9207 (95% confidence interval, 0.8131–1). The Histoplasma antigen EIA test demonstrated high specificity and sensitivity for the diagnosis of histoplasmosis in dogs.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4689-4689
Author(s):  
Sriman Swarup ◽  
Somedeb Ball ◽  
Nimesh Adhikari ◽  
Anita Sultan ◽  
Khatrina Swarup ◽  
...  

Introduction: Heparin induced thrombocytopenia (HIT) is a severe prothrombotic condition, usually triggered by exposure to heparin products. It is characterized by platelet activation induced by the formation of antibodies to the platelet factor 4 (PF4)/ heparin polyanion complexes. Diagnostic algorithm includes clinical scoring (4T score) alongside serological test for detection of these antibodies (HIT-Ab), while serotonin release assay (SRA) remains the gold- standard for confirmation. The automated latex immunoturbidometric assay (LIA) has recently been FDA approved as a screening tool for HIT and is a potential alternative to the conventional particle immunofiltration assay (PIFA) for time-sensitive detection of HIT-Ab to guide treatment considerations. We recently introduced LIA in our institution. In this study, we present our experience with LIA in comparison to PIFA in the diagnosis of HIT. Methods: We retrospectively reviewed the charts of all the patients on whom a PIFA was ordered between March 2017 and March 2018 in our hospital. We collected information on the results of the PIFA and SRA (if available). We replaced PIFA with LIA for HIT screening. Then, we introduced a structured protocol for diagnosis of HIT in our institution by incorporating 4T scoring alongside LIA order in the electronic medical record (EMR), in December 2018. We reviewed the EMR of all the patients on whom HIT-Ab test (LIA) was ordered between January and June of 2019, and collected similar information as before. All the data were compiled in a single master excel sheet for calculation of performance characteristics (sensitivity, specificity, positive and negative predictive values) for both PIFA and LIA. A patient was considered to have the diagnosis of HIT if the result of SRA was available and positive. Results: In the first phase, a total of 31 orders for SRA was noted against 170 PIFA orders. Five patients had a positive SRA, of whom two were PIFA negative. Half the patients with a negative SRA result were positive for PIFA. Hence, the sensitivity and specificity of PIFA test for our study population were noted to be 60% and 50%, respectively. PIFA had a positive predictive value (PPV) of mere 18.75% for the diagnosis of HIT, whereas the negative predictive value (NPV) was found to be 86.66%. Introduction of structured protocol for HIT diagnosis substantially reduced the number of inappropriate SRA orders in the second phase. On review of data for six months with the new HIT-Ab test LIA, SRA was ordered in only eight patients, to go with 69 orders for the LIA. The result of LIA was positive in all three patients with a positive SRA, whereas it was false positive in four instances. Only one patient was negative for both LIA and SRA during this period. LIA was found to be 100% sensitive and 20% specific for the diagnosis of HIT in our sample. PPV and NPV for LIA were 42.85% and 100%, respectively. Conclusion: The sensitivity and specificity of LIA were found to be 100% and 20%, respectively, in our study population, which is different from the earlier report (Warkentin et al. 2017). The small sample size is a limitation of our study. Higher PPV and NPV for LIA, with its quick turnaround time, make it a useful alternative for the time-sensitive determination of post-test probability for HIT in patients. [HIT- Ab- Heparin Induced Thrombocytopenia Antibody, PIFA- Particle Immunofiltration Assay, LIA- Latex Immunoturbidometric Assay, SRA- Serotonin Release Assay, +ve- Positive, -ve - Negative, PPV- Positive Predictive Value, NPV- Negative Predictive Value] Disclosures No relevant conflicts of interest to declare.


Author(s):  
Dr. Chaturbhuj Prasad Swarnkar ◽  
Dr. Shiv Raj Meena

Background- Rotator cuff tears are one of the most common causes of shoulder pain for which patients seek treatment. As in our daily work, the shoulder joint is the most frequently used, there is higher chance of having shoulder joint injury. The aim of the study is to compare the efficacy of MRI in diagnosing shoulder pathologies in comparison to arthroscopy, considering arthroscopy as the gold standard. Methods- 30 Patient with suspected rotator cuff injury patients, between 18-80 years of age was included in the study. MRI of the shoulder joint was done followed by shoulder arthroscopy. The data collected was analysed for the significant correlation between MRI of shoulder and arthroscopic findings by kappa statistics. Results- The accuracy of MRI in diagnosis of rotator cuff partial tears, was 90%, while sensitivity and specificity was 100.00%, 78.57% and positive predictive value was 84.21% and negative predictive value was 100.00% and accuracy of MRI in diagnosis of rotator cuff full tears, was 86.67%, while sensitivity and specificity was 63.64%, 100.00%) and positive predictive value was 100.00% and negative predictive value was 82.61% in our study. Conclusion- Our study demonstrates a high sensitivity and specificity for the MRI diagnosis of both partial and full thickness rotator cuff tears and good correlation with arthroscopic findings. Keywords: Rotator cuff, Shoulder pain, Arthroscopy, MRI.


2013 ◽  
Vol 20 (8) ◽  
pp. 1150-1154 ◽  
Author(s):  
Elena Tatiana Băguţ ◽  
Ludivine Cambier ◽  
Marie-Pierre Heinen ◽  
Vasile Cozma ◽  
Michel Monod ◽  
...  

ABSTRACTThe aim of this study was to develop an in-house enzyme-linked immunosorbent assay (ELISA) for the serological diagnosis of ringworm infection in cattle. We used available recombinant forms ofTrichophyton rubrumdipeptidyl peptidase V (TruDppV) andT. rubrumleucin aminopeptidase 2 (TruLap2), which are 98% identical toTrichophyton verrucosumorthologues. Field serum samples from 135 cattle with ringworm infection, as confirmed by direct microscopy, fluorescence microscopy, and PCR, and from 55 cattle without any apparent skin lesions or history of ringworm infection that served as negative controls were used. Sensitivities, specificities, and positive and negative predictive values were determined to evaluate the diagnostic value of our ELISA. Overall, the ELISAs based on recombinant TruDppV and TruLap2 discriminated well between infected animals and healthy controls. Highly significant differences (P< 0.0001, Mann-Whitney U test) were noted between optical density values obtained when sera from infected versus control cattle were tested. The ELISA developed for the detection of specific antibodies against DppV gave 89.6% sensitivity, 92.7% specificity, a 96.8% positive predictive value, and a 78.4% negative predictive value. The recombinant TruLap2-based ELISA displayed 88.1% sensitivity, 90.9% specificity, a 95.9% positive predictive value, and a 75.7% negative predictive value. To the best of our knowledge, this is the first ELISA based on recombinant antigens for assessing immune responses to ringworm infection in cattle; it is particularly suitable for epidemiological studies and also for the evaluation of vaccines and/or vaccination procedures.


Neurosurgery ◽  
2012 ◽  
Vol 70 (5) ◽  
pp. 1114-1124 ◽  
Author(s):  
Robert T. Wicks ◽  
Gustavo Pradilla ◽  
Shaan M. Raza ◽  
Uri Hadelsberg ◽  
Alexander L. Coon ◽  
...  

Abstract BACKGROUND: Somatosensory evoked potential (SSEP) monitoring is used during intracranial aneurysm surgery to track the effects of anesthesia, surgical manipulation, and temporary clipping. OBJECTIVE: To present the outcomes of 663 consecutive patients (691 cases) treated surgically for intracranial aneurysms who underwent intraoperative SSEP monitoring and to analyze the sensitivity and specificity of significant SSEP changes in predicting postoperative stroke. METHODS: Of 691 surgeries analyzed, 403 (391 anterior circulation, 12 posterior circulation) were unruptured aneurysms and 288 (277 anterior, 11 posterior) were ruptured. Postoperatively, symptomatic patients underwent computed tomography imaging. Positive predictive value, negative predictive value, sensitivity, and specificity were calculated with a Fisher exact test (2-tailed P value). RESULTS: Changes in SSEP occurred in 45 of 691 cases (6.5%): 16 of 403 (4.0%) in unruptured aneurysms and 29 of 288 (10%) in ruptured aneurysms. In unruptured aneurysms, reversible SSEP changes were associated with a 20% stroke rate, but irreversible changes were associated with an 80% stroke rate. In ruptured aneurysms, however, reversible changes were associated with a 12% stroke rate, and irreversible changes were associated with a 42% stroke rate. The overall accuracy of SSEP changes in predicting postoperative stroke was as follows: positive predictive value, 30%; negative predictive value, 94%; sensitivity, 25%; and specificity, 95%. CONCLUSION: Intraoperative SSEP changes are more reliable in unruptured aneurysm cases than in ruptured cases. Whereas irreversible changes in unruptured cases were associated with an 80% stroke rate, such changes in ruptured cases did not have any adverse ischemic sequelae in 58% of patients. This information is helpful during the intraoperative assessment of reported SSEP changes.


2014 ◽  
Vol 24 (6) ◽  
pp. 1021-1026 ◽  
Author(s):  
Paolo Sala ◽  
Matteo Morotti ◽  
Mario Valenzano Menada ◽  
Elisa Cannavino ◽  
Ilaria Maffeo ◽  
...  

ObjectiveThe aim of this study was to investigate the frozen section (FS) accuracy in tailoring the surgical staging of patients affected by endometrial cancer, using 2 different risk classifications.Methods/MaterialsA retrospective analysis of 331 women affected by type I endometrial cancer and submitted to FS assessment at the time of surgery. Pathologic features were examined on the frozen and permanent sections according to both the GOG33 and the Mayo Clinic algorithms. We compared the 2 models through the determination of Landis and Koch kappa statistics, concordance rate, sensitivity, specificity, positive predictive value, and negative predictive value for each risk algorithm, to assess whether there are differences in FS accuracy depending on the model used.ResultsThe observed agreement between the frozen and permanent sections was respectively good (k = 0.790) for the GOG33 and optimal (k = 0.810) for the Mayo classification. Applying the GOG33 algorithm, 20 patients (6.7%) were moved to an upper risk status, and 20 (6.7%) were moved to a lower risk status on the permanent section; the concordance rate was 86.5%. With the Mayo Clinic algorithm, discordant cases between frozen and permanent sections were 19 (7.6%), and the risk of lymphatic spread was underestimated only in 1 case (0.4%); the concordance rate was 92.4%. The sensitivity, specificity, positive predictive value, and negative predictive value for the GOG33 were 92%, 94%, 92%, and 93%, whereas with the Mayo algorithm, these were 98%, 91%, 77%, and 99%, respectively.ConclusionsAccording to higher correlation rate and observed agreement (92.4% vs 86.5% and k = 0.810 vs 0.790, respectively), the Mayo Clinic algorithm minimizes the number of patients undertreated at the time of surgery than the GOG33 classification and can be adopted as an FS algorithm to tailor the surgical treatment of early-stage endometrial cancer even in different centers.


2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Anselm Bräuer ◽  
Sebastian Gassner ◽  
Jochim Koch ◽  
Daniel Heise ◽  
Michael Quintel

Background. Perioperative hypothermia is still a major problem. Therefore, it would be useful to predict which warming method would prevent perioperative hypothermia in a particular patient. Methods. The simulation software “ThermoSim Vers. 5.07” was validated using the data of two prospective, randomized, and controlled studies. The diagnostic effectiveness was assessed by calculating sensitivity and specificity, positive predictive value (PPV), and negative predictive value (NPV) in the detection of perioperative hypothermia. Results. Sensitivity of the software was 100% (Study 1) and 94% (Study 2), specificity was 67% (Study 1) and 38% (Study 2), PPV was 60% (Study 1) and 50% (Study 2), and NPV was 100% (Study 1) and 90% (Study 2). Conclusions. The software is helpful in predicting which warming method is necessary to prevent perioperative hypothermia. Thermal treatment based on the prediction of the software will lead to some overtreatment, but will prevent perioperative hypothermia reliably.


2021 ◽  
Vol 5 (4) ◽  
pp. 1067-1073
Author(s):  
Heriyadi Manan ◽  
Edo Rezaldy Edward

Background.  Endometriosis is a benign disorder defined by the presence of endometrial glands and stroma outside the uterus. Endometriosis occurs in 10-15% of women during their reproductive years. Angiogenesis and the inflammatory response are important factors in the development of endometriosis. The formation of a new blood supply is a crucial step in the formation of endometrial lesions. Angiogenesis is induced by a growth factor peptide, namely vascular endothelial growth factor A (VEGF-A). VEGF-A is known as a vascular permeability factor that plays an important role in the pathological angiogenesis process and is a more specific and prominent angiogenesis factor among the VEGF family. The purpose of this study was to determine the sensitivity and specificity of examination    VEGF-A   of menstrual blood in diagnosing endometriosis compared to laparoscopy. Methods. This diagnostic test research has been carried out at the gynecology polyclinic, especially the division of Fertility, Endocrinology and Reproduction, Faculty of Medicine, Sriwijaya University- Dr. Central General Hospital. Mohammad Hoesin from August to November 2018, there were 45 patients who met the inclusion criteria. VEGF-A examination in instrumental blood based on ELISA examination. Data analysis to measure sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy using Medcalc statistics. Results. From the results of this study, it is known that the majority of the study samples were aged 31.69 years (24-38 years) 75.6%, body mass index (BMI) 51.1% with normal BMI, experienced infertility by 82.2% of the sample, most of the samples did not smoke (95.6%) and most experienced mild pain 55.6% using the VAS pain scale. From this study, it is known that 84.4% or 38 of the study samples had endometriosis with a cut off point value of VEGF-A > 347 pg/mL. From the results of this study, it is known that the sensitivity of VEGF-A in diagnosing endometriosis is 84.2%, specificity is 85.7%, positive predictive value is 97%, negative predictive value is 50% and accuracy is 84%. Conclusion. VEGF-A menstrual blood can be used as a diagnostic tool for endometriosis.


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