Clinical chorioamnionitis at term VIII: a rapid MMP-8 test for the identification of intra-amniotic inflammation

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.

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Cut-off Values of Bacteriuria and Leukocyturia for the Diagnosis of Urinary Tract Infections in Pediatric Patients

INDONESIAN JOURNAL OF CLINICAL PATHOLOGY AND MEDICAL LABORATORY ◽

10.24293/ijcpml.v27i1.1611 ◽

2020 ◽

Vol 27 (1) ◽

Author(s):

Muhamad Ramdani Ibnu Taufik ◽

Dian Ariningrum ◽

Yusuf Ari Mashuri

Keyword(s):

Urinary Tract ◽

Positive Predictive Value ◽

Negative Predictive Value ◽

Likelihood Ratio ◽

Urinary Tract Infections ◽

Predictive Value ◽

Pediatric Patients ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Tract Infections

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.

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Endtidal carbonmonoxide and carboxyhemoglobin for prediction of significant hyperbilirubinemia in healthy Indian neonates >35 weeks of gestation

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20202058 ◽

2020 ◽

Vol 7 (6) ◽

pp. 1225

Author(s):

Gokul Krishnan R. ◽

Mangalabharathi S. ◽

Mohammed Sajjid ◽

Ramya S.

Keyword(s):

Positive Predictive Value ◽

Negative Predictive Value ◽

Likelihood Ratio ◽

Predictive Value ◽

Neonatal Period ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Likelihood Ratios ◽

Early Neonatal Period ◽

Sensitivity Specificity

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.

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An Ultrasound Evaluation of Breast Lumps with Fine Needle Aspiration Cytology Correlation in a Tertiary Medical Centre at South Bihar

Journal of Evidence Based Medicine and Healthcare ◽

10.18410/jebmh/2021/28 ◽

2021 ◽

Vol 8 (03) ◽

pp. 146-150

Author(s):

Rishav Prasad ◽

Guddakesh Kumar ◽

Prashant Sinha ◽

Dipu Singh

Keyword(s):

Positive Predictive Value ◽

Negative Predictive Value ◽

Likelihood Ratio ◽

Predictive Value ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Needle Aspiration ◽

Breast Lump ◽

Ultrasound Evaluation ◽

Needle Aspiration Cytology

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

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Diagnostic accuracy of septic markers for neonatal sepsis

Paediatrica Indonesiana ◽

10.14238/pi48.5.2008.299-305 ◽

2016 ◽

Vol 48 (5) ◽

pp. 299

Author(s):

Thermiany AS ◽

W Retayasa ◽

M Kardana ◽

IN Lila

Keyword(s):

Blood Culture ◽

Positive Predictive Value ◽

Negative Predictive Value ◽

Likelihood Ratio ◽

Neonatal Sepsis ◽

Predictive Value ◽

Gold Standard ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Suspected Sepsis

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.

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Prediction of difficult airway by thyromental height test- a comparison with modified mallampati test.

Bangladesh Journal of Medical Science ◽

10.3329/bjms.v17i3.37014 ◽

2018 ◽

Vol 17 (3) ◽

pp. 455-461

Author(s):

Md Nurullah ◽

Md Shah Alam ◽

Mahmud Hossen ◽

Marufa Shahnawaz

Keyword(s):

Difficult Airway ◽

Negative Predictive Value ◽

Likelihood Ratio ◽

Predictive Value ◽

Medical Science ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Predictive Values ◽

Female Ratio ◽

Patent Airway

Background: Management of airway is central to the Practice of anaesthesia. One of the anaesthesiologist fundamental roles is to maintain a patent airway at a all times.Maintaining a patent airway is essential for adequate oxygenation and ventilation and failure to do so, even for a brief period of time, can be life threatening. Recently, thyromental height test (TMHT) has been proposed as one of the highly sensitive and specific bedside tests to predict difficult airway.Objective: To assess the predictivity of thyromental height test in comparison to modified Mallampati test.Methods: This cross sectional study was carried out in Anesthesiology department of ISMCH during the period of January, 2015 to December, 2016. A total number of 139 consecutive patients scheduled for elective surgical procedure under general anaesthesia requiring intubation having American Society of Anesthesiologists grading I-II. Statistical analyses of the results were obtained by SPSS-20. Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of Thyromental height test and Modified mallampati scoring in diagnosis of difficult airway were calculated.Results: Most (74.4) of the patients belonged to age ≤50 years. Male to female ratio was 1.01:1. Majority 91(65.5%) patients had thyromental height of ≥50 mm. In the diagnosis of difficult airway, Thyromental height test was 92.7% sensitivity, 93.5% specificity, 93.5% accuracy and 85.4% positive predictive values, 97.8% negative predictive value, 13.1% positive likelihood ratio, 0.05 negative likelihood ratio. On the other hand Modified mallampati scoring was 48.8% sensitivity, 92.7% specificity, 79.1% accuracy, 75.0% positive predictive values, 80.2% negative predictive value, 6.7% positive likelihood ratio, 0.55 negative likelihood ratio for prediction of difficult airway.Conclusions: It can be concluded that the thyromental height is useful diagnostic modality for predicting difficult airway.Bangladesh Journal of Medical Science Vol.17(3) 2018 p.455-461

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Acute myocardial infarction in patients with syncope

CJEM ◽

10.1017/s148180350001112x ◽

2009 ◽

Vol 11 (02) ◽

pp. 156-160 ◽

Cited By ~ 2

Author(s):

Daniel McDermott ◽

James V. Quinn ◽

Charles E. Murphy

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Negative Predictive Value ◽

Likelihood Ratio ◽

Predictive Value ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

St Segment Elevation ◽

St Segment ◽

High Negative Predictive Value

ABSTRACT Objective: We sought to determine the incidence of acute myocardial infarction (AMI) in emergency department (ED) patients with syncope, the characteristics of these AMIs and how helpful the initial electrocardiogram (ECG) was in identifying these cases. Methods: In a prospective cohort of consecutive patients with syncope, the initial ECG was found to be abnormal using a prespecified definition (any nonsinus rhythm or any new or age-indeterminate abnormalities). Patients were then followed up to identify an AMI diagnosed within 30 days of presentation. Results: There were 1474 consecutive patient visits for syncope or near-syncope over a 45-month period spanning from Jul. 1, 2000, to Feb. 28, 2002, and Jul. 15, 2002, to Aug. 31, 2004, of which 46 (3.1%) were diagnosed with AMI. The majority of the AMI patients (42) had no ST segment elevation. The initial ECG was abnormal in 37 out of 46 cases. The diagnostic performance of the initial ECG was sensitivity 80% (95% confidence interval [CI] 67%–89%), specificity 64% (95% CI 61%–67%), negative predictive value 99% (95% CI 98%–100%), positive predictive value 7% (95% CI 6%–8%), positive likelihood ratio 2.2 (95% CI 1.6–2.5) and negative likelihood ratio 0.3 (95% CI 0.2–0.5). Conclusion: The incidence of AMI in patients presenting with syncope is low. A normal ECG has a high negative predictive value, although its sensitivity is limited.

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Evaluation of the Characteristics of the Enzyme-Linked Immunospot Assay for Diagnosis of Active Tuberculosis in China

Clinical and Vaccine Immunology ◽

10.1128/cvi.00023-15 ◽

2015 ◽

Vol 22 (5) ◽

pp. 510-515 ◽

Cited By ~ 8

Author(s):

Linchuan Wang ◽

Yan Yu ◽

Wei Chen ◽

Jin Feng ◽

Jinyuan Wang ◽

...

Keyword(s):

Positive Predictive Value ◽

Likelihood Ratio ◽

Roc Curve ◽

Predictive Value ◽

Extrapulmonary Tuberculosis ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Median Number ◽

Active Tuberculosis ◽

Sensitivity Specificity

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.

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Results of proteinuria measurement using semiquantitative dipstick in children with fever or nephrotic syndrome

Paediatrica Indonesiana ◽

10.14238/pi48.1.2008.10-4 ◽

2008 ◽

Vol 48 (1) ◽

pp. 10

Author(s):

Chatidjah Alaydrus ◽

Yati Soenarto ◽

M. P. Damanik

Keyword(s):

Negative Predictive Value ◽

Diagnostic Test ◽

Likelihood Ratio ◽

Predictive Value ◽

Quantitative Measurement ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Diagnostic Value ◽

Urine Collection ◽

Nephrotic Proteinuria

Background Proteinuria is a major determinant of the progressionof renal disease. Quantitative measurement of proteinuria withina 24-hour period of urine collection was the accepted method ofevaluation, but is tedious and prone to error in the absence of areliable collection. We evaluated the diagnostic value of AUTIONSticks 10 TA to diagnose proteinuria in children with fever andnephrotic syndrome.Methods This study was conducted at the pediatric ward of SardjitoHospital. Proteinuria levels were measured using semiquantitativedipstick methods with AUTION Sticks 10 TA using a 24-hoururine sample collected at the first examination until the followingday. Proteinuria level was also measured by Esbach method as goldstandard.Results A total of 120 children aged 16 years old were recruited. Inthe fever group, AUTION Sticks 10 TA couldn’t be used for thediagnostic test. AUTION Sticks 10 TA +2 to diagnose intermediateproteinuria produced a sensitivity of 60%, a specificity of 89%, apositive predictive value of 43% , a negative predictive value of94%, a positive likelihood ratio of 5.4, a negative likelihood ratio of0.45. To diagnose nephrotic proteinuria, AUTION Sticks 10 TA+3/+4 produced a sensitivity of 90%, a specificity of 91%, a positivepredictive value of 96%, a negative predictive value of 77%, apositive likelihood ratio of 10, a negative likelihood ratio of 0.11.Conclusion AUTION Sticks 10 TA +2 is sufficiently accuratefor a diagnostic test of intermediate proteinuria (Esbach value)while +3/+4 is sufficiently accurate for a diagnostic test ofnephrotic proteinuria (Esbach value) in children. In the fevergroup, dipstick result can not explain the Esbach value.

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Diagnostic accuracy of Schistoso ma ICT Ig G - IgM and comparison to other used techniques screening urinary schistosomiasis in Nigeria

Advances in Laboratory Medicine / Avances en Medicina de Laboratorio ◽

10.1515/almed-2020-0093 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Robert Soumay Houmsou ◽

Binga Emmanuel Wama ◽

Hemen Agere ◽

John Ador Uniga ◽

Timothy Jerry Jerry ◽

...

Keyword(s):

Positive Predictive Value ◽

Diagnostic Accuracy ◽

Negative Predictive Value ◽

Likelihood Ratio ◽

Predictive Value ◽

Statistical Significance ◽

Positive Likelihood Ratio ◽

Youden Index ◽

P Value ◽

Urinary Schistosomiasis

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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Circulating tumour DNA methylation in hepatocellular carcinoma diagnosis using digital droplet PCR

Journal of International Medical Research ◽

10.1177/0300060521992962 ◽

2021 ◽

Vol 49 (3) ◽

pp. 030006052199296

Author(s):

Juan Wang ◽

Liu Yang ◽

Yanjun Diao ◽

Jiayun Liu ◽

Jinjie Li ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Dna Methylation ◽

Likelihood Ratio ◽

Predictive Value ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Control Group ◽

Control Subjects ◽

Droplet Pcr ◽

Healthy Control

Objective To evaluate the performance of a DNA methylation-based digital droplet polymerase chain reaction (ddPCR) assay to detect aberrant DNA methylation in cell-free DNA (cfDNA) and to determine its application in the detection of hepatocellular carcinoma (HCC). Methods The present study recruited patients with liver-related diseases and healthy control subjects. Blood samples were used for the extraction of cfDNA, which was then bisulfite converted and the extent of DNA methylation quantified using a ddPCR platform. Results A total of 97 patients with HCC, 80 healthy control subjects and 46 patients with chronic hepatitis B/C virus infection were enrolled in the study. The level of cfDNA in the HCC group was significantly higher than that in the healthy control group. For the detection of HCC, based on a cut-off value of 15.7% for the cfDNA methylation ratio, the sensitivity and specificity were 78.57% and 89.38%, respectively. The diagnostic accuracy was 85.27%, the positive predictive value was 81.91% and the negative predictive value was 87.20%. The positive likelihood ratio of 15.7% in HCC diagnosis was 7.40, while the negative likelihood ratio was 0.24. Conclusions A sensitive methylation-based assay might serve as a liquid biopsy test for diagnosing HCC.

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