CYFRA 21-1 in patients with suspected cancer: evaluation of an optimal cutoff to assess the diagnostic efficacy and prognostic value

Author(s):  
Sonsoles Garcia-Valdecasas Gayo ◽  
Maria Jesus Ruiz-Alvarez ◽  
Daniel Gonzalez-Gay ◽  
Raquel Ramos-Corral ◽  
Eva Marquez-Lietor ◽  
...  

AbstractObjectivesChosen cutoff for cytokeratin 19 fragment antigen (CYFRA 21-1) as a tumor biomarker considerably influences its diagnostic and prognostic usefulness. The aim of the present study is to determine an optimal cutoff value for diagnostic validity of CYFRA 21-1 by Lumipulse® technology in patients with suspected cancer and also to determine if CYFRA 21-1 levels provide prognostic value.MethodsA consecutive 284 patients suggestive of malignant disease from six hospitals of Madrid were enrolled in a retrospective design. Optimal CYFRA 21-1 cutoff value was obtained by receiver operating characteristic curve and Youden test. The diagnostic validity was evaluated according to sensitivity, specificity, predictive values and likelihood ratios. The prognostic value of CYFRA 21-1 was checked using multiple logistic regression. Thirty-two diagnostic cancers were confirmed.ResultsThe most optimal cutoff was 3.15 ng/mL. This cutoff showed a better specificity 93.63% (95% confidence interval [CI], 89.66–96.16), positive predictive value 60.98% (95% CI, 44.54–75.38) and positive likelihood ratio 12.65 (95% CI, 7.64–20.95) than the cutoff recommended by Fujirebio® (1.8 ng/mL) (specificity: 73.71% [95% CI, 67.72–78.95], positive predictive value: 29.79% [95% CI, 21.02–40.23] and positive likelihood ratio 3.43 [95% CI, 2.71–4.35]), improving the current diagnostic accuracy. In multivariate analysis, elevated levels of CYFRA 21-1 (>3.15 ng/mL) was confirmed as an unfavorable prognostic factor.ConclusionsThe best cutoff for CYFRA 21-1 obtained was 3.15 ng/mL in patients with suspected cancer. This new cutoff decreases the false positive rate and improves the diagnostic efficacy of CYFRA 21-1 as a tumor marker as well as its association with death events.

Author(s):  
Muhamad Ramdani Ibnu Taufik ◽  
Dian Ariningrum ◽  
Yusuf Ari Mashuri

The diagnosis of Urinary Tract Infection (UTI) in infants and children is often missed. There have been no studies ondiagnostic tests using automated urine analyzer in pediatric patients. This study aimed to determine the cut-off values ofbacteriuria and leukocyturia using the automated urine analyzer Sysmex UX-2000 to diagnose UTI with the gold standard ofautomated urine culture using VITEK 2 in pediatric patients at Dr. Moewardi Hospital, Surakarta. An observational analyticalstudy with the cross-sectional design was during August-October 2019 at the Clinical Pathology Laboratory and ClinicalMicrobiology Laboratory of Moewardi Hospital, Surakarta. Eighty-four patients sample were collected. This study'sdependent variable was the diagnosis of urinary tract infections in pediatric patients established with positive culture results(bacterial count of ≥ 105 CFU/mL urine). This study's independent variables were the number of urine bacteria (BACT) andthe number of urine leukocytes (WBC) from urinalysis using the Sysmex UX-2000 automated urine analyzer. A diagnostictest was used for data analysis. The best cut-off value for leukocyturia was 37 cells/μL with a 61.1% sensitivity, 63.6%specificity, a positive predictive value of 31.4%; a negative predictive value of 85.7; positive likelihood ratio of 1.64; negativelikelihood ratio of 0.595, and accuracy of 63%. The best cut-off for the number of bacteria was 143 cells/μL with a sensitivityof 66.7%; specificity of 71.2%, the positive predictive value of 38.7%, the negative predictive value of 88.7%; positivelikelihood ratio of 2.14; negative likelihood ratio of 0.432 and an accuracy of 70.2%. A cut-off of 37 cells/μL for leukocyturiaand 143 cells/μL for bacteriuria using an automated urine analyzer can be used for UTI screening in pediatric patients.


2019 ◽  
Vol 25 ◽  
pp. 107602961982631 ◽  
Author(s):  
Junxun Li ◽  
Fan Zhang ◽  
Chujia Liang ◽  
Zhuangjian Ye ◽  
Shaoqian Chen ◽  
...  

This study seeks to evaluate the diagnostic value of D-Dimer Plus and Innovance D-Dimer as well as the age-adjusted cutoff value for D-dimer detection in combination with 4 pretest probability (PTP) scores for deep venous thrombosis (DVT). A total of 688 patients referred for lower extremity vascular compression venous ultrasonography for suspected DVT from January 2016 to May 2018 in the First Affiliated Hospital of Sun Yat-sen University underwent D-dimer tests combining with 4 PTP scores. The diagnostic efficacy of the Wells score was the highest of the 4 PTP scores. The diagnostic efficacy of Innovance D-Dimer for DVT was greater than that of D-Dimer Plus, with better sensitivity and negative predictive value, which were both greater than 98%. If the cutoff values were adjusted by age, the Innovation D-Dimer could further improve both the specificity and the positive predictive value, providing better diagnostic performance. When the 2 D-dimer detections were used in combination with 4 PTP scores for DVT diagnosis, separately, both the positive predictive value and the negative predictive value significantly improved for D-Dimer Plus, and the positive predictive values significantly improved for Innovance D-Dimer. However, the sensitivity, specificity, and negative predictive values did not obviously change. For our patients, Wells score had the best diagnostic efficacy for our patients with suspected DVT among the 4 PTP scores. Innovance D-Dimer in combination with age-adjusted cutoff values exhibited increased sensitivity and negative predictive value for DVT diagnosis and was equivalent to the diagnostic efficacy of the Innovance D-Dimer in combination with PTP scores.


2017 ◽  
Vol 45 (5) ◽  
Author(s):  
Noppadol Chaiyasit ◽  
Roberto Romero ◽  
Piya Chaemsaithong ◽  
Nikolina Docheva ◽  
Gaurav Bhatti ◽  
...  

AbstractObjective:Clinical chorioamnionitis is the most common infection/inflammatory process diagnosed in labor and delivery units worldwide. The condition is a syndrome that can be caused by (1) intra-amniotic infection, (2) intra-amniotic inflammation without demonstrable microorganisms (i.e. sterile intra-amniotic inflammation), and (3) maternal systemic inflammation that is not associated with intra-amniotic inflammation. The presence of intra-amniotic inflammation is a risk factor for adverse maternal and neonatal outcomes in a broad range of obstetrical syndromes that includes clinical chorioamnionitis at term. Although the diagnosis of intra-amniotic infection has relied on culture results, such information is not immediately available for patient management. Therefore, the diagnosis of intra-amniotic inflammation could be helpful as a proxy for intra-amniotic infection, while results of microbiologic studies are pending. A rapid test is now available for the diagnosis of intra-amniotic inflammation, based on the determination of neutrophil collagenase or matrix metalloproteinase-8 (MMP-8). The objectives of this study were (1) to evaluate the diagnostic indices of a rapid MMP-8 test for the identification of intra-amniotic inflammation/infection in patients with the diagnosis of clinical chorioamnionitis at term, and (2) to compare the diagnostic performance of a rapid MMP-8 test to that of a conventional enzyme-linked immunosorbent assay (ELISA) interleukin (IL)-6 test for patients with clinical chorioamnionitis at term.Materials and methods:A retrospective cohort study was conducted. A transabdominal amniocentesis was performed in patients with clinical chorioamnionitis at term (n=44). Amniotic fluid was analyzed using cultivation techniques (for aerobic and anaerobic bacteria as well as genital Mycoplasmas) and broad-range polymerase chain reaction (PCR) coupled with electrospray ionization mass spectrometry (PCR/ESI-MS). Amniotic fluid IL-6 concentrations were determined by ELISA, and rapid MMP-8 results were determined by Yoon’s MMP-8 CheckResults:(1) A positive rapid MMP-8 test had a sensitivity of 82.4% (28/34), specificity of 90% (9/10), positive predictive value of 96.6% (28/29), negative predictive value of 60% (9/15), positive likelihood ratio 8.2 (95% CI 1.3–53.2), and negative likelihood ratio 0.2 (95% CI 0.1–0.4) for the identification of intra-amniotic inflammation (prevalence 77.3%); (2) a positive rapid MMP-8 test had a sensitivity of 91.7% (22/24), specificity of 65% (13/20), positive predictive value of 75.9% (22/29), negative predictive value of 86.7% (13/15), positive likelihood ratio of 2.6 (95% CI 1.4–4.8), and negative likelihood ratio of 0.1 (95% CI 0.03–0.5) for the identification of intra-amniotic infection; (3) the rapid MMP-8 test had a significantly higher specificity than the ELISA IL-6 test in the identification of intra-amniotic inflammation as determined by an amniotic fluid WBC count ≥50 cells/mmConclusion:The rapid diagnosis of intra-amniotic inflammation is possible by analysis of amniotic fluid using a point-of-care test for MMP-8. Patients with a positive test are at risk of delivering a neonate affected with systemic inflammation, a risk factor for adverse neonatal outcome.


2015 ◽  
Vol 22 (5) ◽  
pp. 510-515 ◽  
Author(s):  
Linchuan Wang ◽  
Yan Yu ◽  
Wei Chen ◽  
Jin Feng ◽  
Jinyuan Wang ◽  
...  

ABSTRACTThe purpose of this study was to evaluate the characteristics of the T-SPOT.TB test for the diagnosis of active tuberculosis (ATB) and to distinguish ATB from other diseases using a receiver operating characteristic (ROC) curve. A total of 535 patients with suspected active tuberculosis were enrolled in the study and divided into ATB and nonactive tuberculosis (NATB) groups, as well as pulmonary tuberculosis (PTB) and extrapulmonary tuberculosis (EPTB) subgroups. The sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of the T-SPOT.TB test for the diagnosis of ATB were 84.95%, 85.12%, 82.94%, 86.93%, 5.71, and 0.18, respectively. The median number of spot-forming cells (SFCs) in the ATB group was higher than that in the NATB group (71 versus 1;P< 0.0001). The sensitivities in the PTB and EPTB subgroups were 92.31% and 81.77%. The areas under the curve (AUC) for the diagnosis of ATB using the T-SPOT.TB, early secreted antigenic target 6 (ESAT-6), and culture filtrate protein 10 (CFP-10) were 0.906, 0.884, and 0.877, respectively. A cutoff of 42.5 SFCs for ATB yielded a positive predictive value of 100%. Our study shows that the T-SPOT.TB test is useful for the diagnosis of ATB. Utilizing an ROC curve to select an appropriate cutoff made it possible to discriminate ATB from NATB.


2020 ◽  
Vol 7 (6) ◽  
pp. 1225
Author(s):  
Gokul Krishnan R. ◽  
Mangalabharathi S. ◽  
Mohammed Sajjid ◽  
Ramya S.

Background: Endtidalcarbonmonoxide (ETCOc) and Carboxyhemoglobin (COHB) levels correlate well to bilirubin production and an availability of non-invasive point of care (POC) device in predicting significant hyperbilirubinemia is of great advantage when compared to measurement of serum bilirubin. Objective of the study is to measure a value of ETCOc and COHB in the early neonatal period for the prediction of significant hyperbilirubinemia.Methods: This was the descriptive Cross Sectional Study. ETCOc and COHB were measured 12th hourly for 72 hours followed by TSB in whom the TCB was >14mg/dl. Neonates were classified as jaundiced whose TSB values were in phototherapy range as per AAP Recommendations. Receiver Operative Curves (ROC) were created by appropriate statistical software for ETCOc and COHb to predict significant hyperbilirubinemia. The Sensitivity, Specificity, Positive predictive value, Negative predictive value and likelihood ratios of each was determined and the correlation between ETCOc and COHb levels, ETCOc and TCB, COHB and TCB at different hours of age was evaluated.Results: Among the total 320 infants, 156 of them developed significant hyperbilirubinemia. The ETCOc and COHB level at 60 hours of age was the most predictive of significant hyperbilirubinemia by ROC analysis. ETCOc cut-off of 1.65 ppm at 60 hours of age has a sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio of 84.6%, 80.5%, 80.5% and 84.6%, 4.33 and 0.19. COHB cut-off of 1.32 ppm at 60 hours of age has a sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio of 84.6%, 81%, 80% and 84.2%, 4.34 and 0.19.ETCOc had a maximum correlation with COHB at 48 hours of age.Conclusions: An increased level of Endtidalcarbonmonoxide and Carboxyhemoglobin in the early neonatal period is useful as a screening test for prediction of significant hyperbilirubinemia.


2009 ◽  
Vol 13 (2) ◽  
pp. 181-186 ◽  
Author(s):  
Kayoung Lee

AbstractObjectiveTo investigate the ability of each metabolic syndrome (MetS) criterion, defined by the International Diabetes Federation, to predict insulin resistance (IR).DesignA cross-sectional study. IR was defined as homeostasis model assessment of IR (HOMA-IR) ≥3·04. The MetS criteria considered were TAG ≥ 1·69 mmol/l, HDL cholesterol (HDL-C) <1·29 mmol/l, blood pressure (BP) ≥130/85 mmHg and fasting glucose (FG) ≥5·6 mmol/l.SettingBusan, South Korea.SubjectsNinety-six apparently healthy Korean women (mean age 42 (sd 10·6) years) with abdominal obesity (waist circumference (WC) ≥80 cm) were studied.ResultsOf the ninety-six obese women, 11 % were insulin-resistant and 33 % fulfilled the criteria for IDF-defined MetS. Glucose and TAG were more likely to predict IR than BP and HDL-C when assessed using receiver-operating characteristic curves, multiple regression and multiple logistic regression analyses. Of the variation in HOMA-IR, TAG, FG, WC and age explained 42 %. High FG was independently associated with the presence of IR (OR = 8·6, 95 % CI 1·8, 41·8) even after adjusting for other components of MetS. The positive predictive value and positive likelihood ratio to detect IR were the highest for the FG criterion (33 % and 3·9, respectively), followed by TAG (28 %, 3·0), BP (19 %, 1·8) and HDL-C criteria (18 %, 1·7). The IDF definition of MetS exhibited a positive predictive value of 29 % and a positive likelihood ratio of 3·1.ConclusionsOf the MetS criteria, high FG and high TAG seem to be more suitable for identifying obese women with IR than high BP and low HDL-C.


2021 ◽  
Vol 8 (03) ◽  
pp. 146-150
Author(s):  
Rishav Prasad ◽  
Guddakesh Kumar ◽  
Prashant Sinha ◽  
Dipu Singh

BACKGROUND In clinical practice, breast lump is a very common presentation of numerous breast diseases which ranges from benign cysts to malignant lesions. The difference between benign and malignant is very important for patient care and proper management. The diagnosis of breast lump includes clinical examination supplemented by imaging. Various literature has concluded that ultrasound evaluation with fine needle aspiration cytology (FNAC) correlation has comparable sensitivity and specificity to histopathology. Our aim was to study the ultrasonographic characteristics of breast lesions in patients and compare the sensitivity of ultrasonography in diagnosing benign and malignant breast lesions with FNAC. METHODS This is a diagnostic validation study, conducted at Department of Radiodiagnosis and Department of Pathology, Narayan Medical College and Hospital. All females more than 30 years coming for routine breast screening, found to have Breast Imaging Reporting and Data System (BI-RADS) 2 and above were subjected to ultrasonography and FNAC under ultrasonography (USG) guidance, and compared with histopathology. Data was collected, entered and analysed using Microsoft Excel, Epi Info, and SPSS software. Sensitivity and specificity with correlation, positive predictive value (PPV), negative predictive value (NPV) was calculated to compare the two diagnostic modalities. RESULTS USG had 83.3 % sensitivity, 97.56 % specificity, 95.24 % positive predictive value, 90.91 % negative predictive value, 33.32 % positive likelihood ratio and 17.13 % negative likelihood ratio. FNAC had 96.67 % sensitivity, 97.56 % specificity, 96.67 % positive predictive value, 97.56 % negative predictive value, 38.66 % positive likelihood ratio and 3.42 % negative likelihood ratio. CONCLUSIONS Breast ultrasound and FNAC both are important diagnostic tools for breast lesion. Sensitivity, specificity and other features are better for FNAC than ultrasound for breast lump. KEYWORDS Breast Lump, FNAC, USG, Adenocarcinoma, Squamous Cell Carcinoma


2016 ◽  
Vol 48 (5) ◽  
pp. 299
Author(s):  
Thermiany AS ◽  
W Retayasa ◽  
M Kardana ◽  
IN Lila

Background Neonatal sepsis is a major cause of morbidity andmortality. A positive blood culture is the gold standard fordiagnosis of neonatal sepsis. The signs and symptoms suggestingneonatal sepsis are non-specific. There is no rapid and reliablelaboratory test findings for confirmation of etiologic diagnosis.Clinical signs, symptoms, and laboratory examinations are notperceived as sensitive or specific for diagnosis of sepsis.Objective The purpose of this study was to evaluate the accuracyof the septic markers for diagnosis of neonatal sepsis.Methods Blood culture was used as gold standard to compareseptic markers to diagnose neonatal sepsis. Sensitivity, specificity,positive predictive value (PPV), negative predictive value (NPV),positive and negative likelihood ratio (LR), and accuracy werecalculated.Results We identified 130 cases suspected of neonatal sepsis duringSeptember 2005 until March 2006. Four patients were excludedbecause of major congenital anomalies. The mean age was 2.2 daysand 51.6% were boys. We found fifty six (44.4%) neonates havepositive blood culture. All of septic markers had sensitivity morethan 80%. Immature to Total Neutrophil ratio (Iff) ratio had thehighest sensitivity (96.4%) and C-Reactive Protein (CRP) had thelowest sensitivity (80.4o/o). Combination among leukocyte count,thrombocyte, and Iff ratio had the highest sensitivity (sensitivitywas 85. 7%, specificity was 97.1 o/o, positive predictive value was95.9%, negative predictive value was 89.5%, accuracy was 94.4%,and positive likelihood ratio was 30.0).Conclusion Septic markers can be used in the diagnosticevaluation of neonates with suspected sepsis.


Author(s):  
Janti Tri Habsari ◽  
Aryati Aryati ◽  
Dwi Reno Pawarti

The detection of allergen types is very helpful in allergic rhinitis (AR) management. Some methods had been performed to examinethe specific IgE due to HDM such as ELISA and immunoblot methods. The aim of this research is to know the difference of specificIgE diagnostic value due to HDM between ELISA and immunoblot in allergic rhinitis method which is expected to be used as in vitroalternative method which is safe, fast, effective, with a high sensitivity and specificity by provement. The samples were allergic rhinitisand non-allergic rhinitis patients at ENT of Head and Neck Out patients Clinic of Dr. Soetomo Hospital Surabaya. The sera was examinedfor specific IgE due to HDM by ELISA and immunoblot methods and then analyzed for its diagnostic value using the 2 x 2 table with a95% confidence interval. The comparation between both methods were analyzed with Wilcoxon test. The diagnostic value of the specificHDM IgE with immunoblot method showed sensitivity of 90% and 80% specificity, positive predictive value 90% and the negative 80%and diagnostic efficiency 86.67%. The positive likelihood ratio 4.5 and the negative one 0.125. The diagnostic value of the specific IgEHDM/D.p with ELISA showed a sensitivity of 75% and specificity 75%, the positive predictive value 85.71% and the negative one 0%and diagnostic efficiency 75%. The positive likelihood ratio was 3 and the negative one 0.33. The diagnostic value of the specific IgEHDM with immunoblot showed a sensitivity of 90% and specificity 80%, the positive predictive value 90% and the negative one 80%and the diagnostic efficiency 86.67%. The positive likelihood ratio was 4.5 and the negative one 0.125. The difference of diagnostic valuein both methods revealed that the p value was 0.013. It can be concluded in this study that there was a significant difference of specificIgE due to HDM between ELISA and immunoblot methods in allergic rhinitis.


Author(s):  
Robert Soumay Houmsou ◽  
Binga Emmanuel Wama ◽  
Hemen Agere ◽  
John Ador Uniga ◽  
Timothy Jerry Jerry ◽  
...  

Abstract Objectives Schistosomiasis is a blood fluke parasitic illness affecting human lives in rural endemic areas. This study evaluated the performance of Schistosoma ICT Ig G - IgM for screening urinary schistosomiasis in Nigeria. Methods Three hundred and seventy four (374) urine samples were examined. Reagent strips, urine filtration and Schistosoma ICT Ig G - IgM were used for analysis. Schistosoma ICT Ig G - IgM used 2 mL of each serum for serological examination. Then, 3 mL of each preserved serum was sent to LDBIO Diagnostics, France for re-examination with Schistosoma ICT IgG-IgM and confirmation with SCHISTO Western blot (WB) IgG. The performance of the index tests was determined using sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV) and positive likelihood ratio (PLR). The Youden index (YI) and diagnostic accuracy (DA) were used to determine the accuracy of each test. The statistical significance was at p-value ≤0.05. Results The test had a sensitivity of 94.9%, specificity of 63.9%, positive predictive value of 72.4%, negative predictive value of 92.6%, and positive likelihood ratio of 2.62. Schistosoma ICT Ig G - IgM had a good Cohen’s kappa index (κ=0.68), good Youden index (YI=0.58) and good diagnostic accuracy (DA=0.78). Conclusions Schistosoma ICT Ig G - IgM has proven to be the best technique for the screening of urinary schistosomiasis in Nigeria.


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