scholarly journals Accurate Point-of-Care Detection of Ruptured Fetal Membranes: Improved Diagnostic Performance Characteristics with a Monoclonal/Polyclonal Immunoassay

2016 ◽  
Vol 10 ◽  
pp. CMRH.S38386 ◽  
Author(s):  
Linda C. Rogers ◽  
Laurie Scott ◽  
Jon E. Block
Keyword(s):  
Predictive Value ◽  
Laboratory Tests ◽  
Diagnostic Performance ◽  
Point Of Care ◽  
Performance Characteristics ◽  
Perinatal Morbidity ◽  
Test Sensitivity ◽  
Vaginal Secretions ◽  
Sensitivity Specificity ◽  
Point Of Care Detection

Objective Accurate and timely diagnosis of rupture of membranes (ROM) is imperative to allow for gestational age-specific interventions. This study compared the diagnostic performance characteristics between two methods used for the detection of ROM as measured in the same patient. Methods Vaginal secretions were evaluated using the conventional fern test as well as a point-of-care monoclonal/polyclonal immunoassay test (ROM Plus®) in 75 pregnant patients who presented to labor and delivery with complaints of leaking amniotic fluid. Both tests were compared to analytical confirmation of ROM using three external laboratory tests. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. Results Diagnostic performance characteristics uniformly favored ROM detection using the immunoassay test compared to the fern test: sensitivity (100% vs. 77.8%), specificity (94.8% vs. 79.3%), PPV (75% vs. 36.8%), NPV (100% vs. 95.8%), and accuracy (95.5% vs. 79.1%). Conclusions The point-of-care immunoassay test provides improved diagnostic accuracy for the detection of ROM compared to fern testing. It has the potential of improving patient management decisions, thereby minimizing serious complications and perinatal morbidity.

scholarly journals Predictive Evaluation on Cytological Sample of Metastatic Melanoma: The Role of BRAF Immunocytochemistry in the Molecular Era

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1110
Author(s):  
Andrea Ronchi ◽  
Marco Montella ◽  
Federica Zito Marino ◽  
Michele Caraglia ◽  
Anna Grimaldi ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Molecular Analysis ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Cost Effective ◽  
Needle Aspiration ◽  
Braf V600e ◽  
Mutational Status ◽  
Needle Aspiration Cytology ◽  
Sensitivity Specificity

Background: Cutaneous malignant melanoma is an aggressive neoplasm. In advanced cases, the therapeutic choice depends on the mutational status of BRAF. Fine needle aspiration cytology (FNA) is often applied to the management of patients affected by melanoma, mainly for the diagnosis of metastases. The evaluation of BRAF mutational status by sequencing technique on cytological samples may be inconvenient, as it is a time and biomaterial-consuming technique. Recently, BRAF immunocytochemistry (ICC) was applied for the evaluation of BRAF V600E mutational status. Although it may be useful mainly in cytological samples, data about BRAF ICC on cytological samples are missing. Methods: We performed BRAF ICC on a series of 50 FNA samples of metastatic melanoma. BRAF molecular analysis was performed on the same cytological samples or on the corresponding histological samples. Molecular analysis was considered the gold standard. Results: BRAF ICC results were adequate in 49 out of 50 (98%) cases, positive in 15 out of 50 (30%) cases and negative in 34 out of 50 (68%) of cases. Overall, BRAF ICC sensitivity, specificity, positive predictive value and negative predictive value results were 88.2%, 100%, 100% and 94.1%, respectively. The diagnostic performance of BRAF ICC results was perfect when molecular evaluation was performed on the same cytological samples. Hyperpigmentation represents the main limitation of the technique. Conclusions: BRAF ICC is a rapid, cost-effective method for detecting BRAF V600E mutation in melanoma metastases, applicable with high diagnostic performance to cytological samples. It could represent the first step to evaluate BRAF mutational status in cytological samples, mainly in poorly cellular cases.

Diagnostic Performance of Nanoparticle-Enhanced Magnetic Resonance Imaging in the Diagnosis of Lymph Node Metastases in Patients With Endometrial and Cervical Cancer

2005 ◽  
Vol 23 (12) ◽  
pp. 2813-2821 ◽  
Author(s):  
Andrea G. Rockall ◽  
Syed A. Sohaib ◽  
Mukesh G. Harisinghani ◽  
Syed A. Babar ◽  
Naveena Singh ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Lymph Node ◽  
Magnetic Resonance ◽  
Lymph Node Metastases ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Resonance Imaging ◽  
Lymph Node Sampling ◽  
Node Metastases ◽  
Sensitivity Specificity

Purpose Lymph node metastases affect management and prognosis of patients with gynecologic malignancies. Preoperative nodal assessment with computed tomography or magnetic resonance imaging (MRI) is inaccurate. A new lymph node–specific contrast agent, ferumoxtran-10, composed of ultrasmall particles of iron oxide (USPIO), may enhance the detection of lymph node metastases independent of node size. Our aim was to compare the diagnostic performance of MRI with USPIO against standard size criteria. Methods Forty-four patients with endometrial (n = 15) or cervical (n = 29) cancer were included. MRI was performed before and after administration of USPIO. Two independent observers viewed the MR images before lymph node sampling. Lymph node metastases were predicted using size criteria and USPIO criteria. Lymph node sampling was performed in all patients. Results Lymph node sampling provided 768 pelvic or para-aortic nodes for pathology, of which 335 were correlated on MRI; 17 malignant nodes were found in 11 of 44 patients (25%). On a node-by-node basis, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) by size criteria were 29%*, 99%, 56%, and 96%, and by USPIO criteria (reader 1/reader 2) were 93%/82%* (*P = .008/.004), 97%/97%, 61%/59%, and 100%/99%, respectively (where [*] indicates the statistical difference of P = x/x between the two results marked by the asterisk). On a patient-by-patient basis, sensitivity, specificity, PPV, and NPV by size criteria were 27%*, 94%, 60%, and 79%, and by USPIO criteria (reader 1/reader 2) were 100%/91%* (*P = .031/.06), 94%/87%, 82%/71%, and 100%/96%, respectively. The κ statistic was 0.93. Conclusion Lymph node characterization with USPIO increases the sensitivity of MRI in the prediction of lymph node metastases, with no loss of specificity. This may greatly improve preoperative treatment planning.

scholarly journals Factors Impacting the Performance Characteristics of Bile Duct Brushings: A Clinico-Cytopathologic Analysis of 253 Patients

2018 ◽  
Vol 142 (7) ◽  
pp. 863-870 ◽  
Author(s):  
Ezgi Hacihasanoglu ◽  
Bahar Memis ◽  
Burcin Pehlivanoglu ◽  
Vaidehi Avadhani ◽  
Alexa A. Freedman, ◽  
...  
Keyword(s):  
Bile Duct ◽  
Predictive Value ◽  
High Specificity ◽  
Daily Practice ◽  
Performance Characteristics ◽  
Lower Sensitivity ◽  
Current State ◽  
Risk Of Malignancy ◽  
Low Sensitivity ◽  
Sensitivity Specificity

Context.— Literature on factors impacting bile duct brushings (BDBs) performance characteristics remain limited. Objective.— To capture the current state of daily practice with BDB sign-out. Design.— Two hundred fifty-three of 444 BDBs signed out by more than 7 cytopathologists, with histopathologic and/or clinical follow-up of at least 18 months, were examined. Results.— One hundred thirty-five of 253 BDBs (53%) had histologically confirmed malignancies, 22 (9%) had cancer-related deaths, and 96 (38%) were benign. Cytologic diagnoses in the 444 BDBs were nondiagnostic (11 [2.5%]), negative (284 [64%]), atypical (62 [13.9%]), suspicious (34 [7.7%]), and malignant (53 [11.9%]). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of malignancy detection were 35%, 100%, 100%, 58%, and 66%, respectively. When atypical, suspicious, and malignant (ASM) categories were combined, sensitivity increased (58%), specificity and PPV dropped (97%), and accuracy increased (73%). Carcinoma type (bile-duct versus pancreatic-ductal) had no effect on accuracy (P = .60) or diagnostic class (P = .84), nor did time of performance (first 7.5 versus latter 7.5 years, P = .13). Interestingly, ThinPrep + cell block (n = 41) had higher sensitivity (61%) and lower specificity (80%) than ThinPrep only (versus 51% and 100%, respectively). Sensitivity and specificity were higher (47% and 100%) in nonstented than stented specimens (59% and 97%). Relative risk of malignancy for “suspicious” (2.30) and “atypical” (2.28) categories was lower but not very different from that of “malignant” category (2.41). Conclusions.— Bile duct brushings had fairly low sensitivity but high specificity and PPV with no false positives. Sensitivity almost doubled and specificity dipped minimally when ASM categories were combined, highlighting the need for better classification criteria for atypical/suspicious cases. Higher specificity, PPV, NPV, and accuracy but lower sensitivity in stented BDBs suggest that they be called malignant only when evidence is overwhelmingly convincing.

scholarly journals Diagnostic Performance of Procalcitonin for the Early Identification of Sepsis in Patients with Elevated qSOFA Score at Emergency Admission

2021 ◽  
Vol 10 (17) ◽  
pp. 3869
Author(s):  
Myrto Bolanaki ◽  
Martin Möckel ◽  
Johannes Winning ◽  
Michael Bauer ◽  
Konrad Reinhart ◽  
...  
Keyword(s):  
Predictive Value ◽  
Early Identification ◽  
Patient Population ◽  
Diagnostic Performance ◽  
Point Of Care ◽  
Area Under The Curve ◽  
Emergency Admission ◽  
Failure Assessment ◽  
Study Population ◽  
Qsofa Score

Infectious biomarkers such as procalcitonin (PCT) can help overcome the lack of sensitivity of the quick Sequential Organ Failure Assessment (qSOFA) score for early identification of sepsis in emergency departments (EDs) and thus might be beneficial as point-of-care biomarkers in EDs. Our primary aim was to investigate the diagnostic performance of PCT for the early identification of septic patients and patients likely to develop sepsis within 96 h of admission to an ED among a prospectively selected patient population with elevated qSOFA scores. In a large multi-centre prospective cohort study, we included all adult patients (n = 742) with a qSOFA score of at least 1 who presented to the ED. PCT levels were measured upon admission. Of the study population 27.3% (n = 202) were diagnosed with sepsis within the first 96 h. The area under the curve for PCT for the identification of septic patients in EDs was 0.86 (95% confidence interval (CI): 0.83–0.89). The resultant sensitivity for PCT at a cut-off of 0.5 µg/l was 63.4% (95% CI: 56.3–70.0). Furthermore, specificity was 89.2% (95% CI: 86.3–91.7), the positive predictive value was 68.8% (95% CI: 62.9–74.2), and the negative predictive value was 86.7% (95% CI: 84.4–88.7). The early measurement of PCT in a patient population with elevated qSOFA score served as an effective tool for the early identification of sepsis in ED patients.

scholarly journals Comparison of GeneXpert and Line Probe Assay for Detection of Mycobacterium tuberculosis and Rifampicin-Mono resistance at the National Tuberculosis Reference Laboratory, Kenya

2019 ◽  
Author(s):  
S.A. Aricha ◽  
Leonard King'wara ◽  
N.W. Mwirigi ◽  
Linda Chaba ◽  
T. Kiptai ◽  
...  
Keyword(s):  
Predictive Value ◽  
Performance Characteristics ◽  
Reference Laboratory ◽  
Drug Resistant ◽  
Line Probe Assay ◽  
Perfect Agreement ◽  
Predictive Values ◽  
National Tuberculosis ◽  
Probe Assay ◽  
Sensitivity Specificity

Abstract Introduction The dual challenge of low diagnostic sensitivity of microscopy test and technical challenge of performing a TB culture test poses a problem for case detection and initiation of Tuberculosis (TB) second-line treatment. There is thus need for a rapid, reliable and easily accessible assay. This comparative analysis was performed to assess diagnostic performance characteristics of GeneXpert MTB/RIF and Line Probe Assay (LPA) Methods 329 sputum samples of patients across the 47 counties in Kenya suspected to have drug resistant TB were picked and subjected to GeneXpert, LPA and Culture MGIT at the National TB Reference Laboratory. Sensitivity, specificity and predictive values were then determined to assess the performance characteristics of various assays. Results GeneXpert had a sensitivity, specificity, positive predictive value, and negative predictive value of 78.5%, 64.9%, 59.4% and 82.2% respectively while LPA had 98.4%, 66.0%, 65.4% and 98.4%. For diagnosis of rifampicin mono-resistance GeneXpert had a moderate agreement (Kappa=0.59, P<0.01) (sensitivity= 62.50%, specificity = 96.50%) while LPA that had almost perfect agreement (Kappa= 0.89, p<0.01) with a (sensitivity= 90.0% and specificity= 99.1%). Conclusion LPA has a better performance characteristic to GeneXpert and an alternative to culture with regards to detection of RIF’s mono-resistance.

scholarly journals Spiral Flow Fube for Contrast Medium Reduction in Coronary CT Angiography

2017 ◽  
Vol 9 ◽  
Author(s):  
Nobuo Tomizawa ◽  
Yayoi Hayakawa ◽  
Shinichi Inoh ◽  
Takeshi Nojo ◽  
Satoshi Uemura ◽  
...  
Keyword(s):  
Contrast Medium ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Left Main ◽  
Spiral Flow ◽  
Flow Tube ◽  
Coronary Ct ◽  
Shaped Tube ◽  
Significant Difference ◽  
Sensitivity Specificity

<p align="left"><strong>Objectives</strong></p><p align="left">To assess the diagnostic performance and enhancement of coronary CT with reduced contrast medium using the spiral flow tube compared with the T-shaped tube.</p><p align="left"><strong>Methods</strong></p><p align="left">We retrospectively included 444 patients who underwent catheter examination within 2 months after coronary CT. The first 222 patients received 21.0 mgI/kg/s of contrast medium using the T-shaped tube and the injected contrast medium was reduced by 6% (19.8 mgI/kg/s) in the last 222 patients using the spiral flow tube. We compared the per vessel diagnostic performance for detecting obstructive stenosis (≥50%) by catheter examination and the enhancement of proximal coronary arteries.</p><p align="left"><strong>Results</strong></p><p align="left">The sensitivity, specificity, positive predictive value, negative predictive value and accuracy was 96%, 84%, 72%, 98% and 87% using the spiral flow tube and 93%, 83%, 68%, 97% and 86% using the T-shaped tube, respectively, without significance. The enhancement of left main (spiral flow vs T-shape, 407 ± 53 vs 407 ± 62 HU, <em>p</em> = 0.95) and right coronary (419 ± 58 vs 415 ± 61 HU, <em>p</em> = 0.49) arteries did not show significant difference.</p><p align="left"><strong>Conclusions</strong></p><p align="left">The spiral flow tube would maintain the diagnostic performance and coronary enhancement with reduced contrast medium compared with the T-shaped tube.</p>

scholarly journals Comparison of Point-of-Care Ultrasonography and Radiography in the Diagnosis of Long-Bone Fractures

Medicina ◽  
2019 ◽  
Vol 55 (7) ◽  
pp. 355 ◽  
Author(s):  
Avci ◽  
Kozaci ◽  
Tulubas ◽  
Caliskan ◽  
Yuksel ◽  
...  
Keyword(s):  
Predictive Value ◽  
Bone Fractures ◽  
Point Of Care ◽  
High Sensitivity ◽  
Long Bone ◽  
Imaging Method ◽  
Fracture Characteristics ◽  
Point Of Care Ultrasonography ◽  
Sensitivity Specificity

Background and objectives: In this study, the accuracy of point-of-care ultrasonography (POCUS) was compared to radiography (XR) in the diagnosis of fractures, the determination of characteristics of the fractures, and treatment selection of fractures in patients admitted to the emergency department (ED) due to trauma and suspected long bone (LB) fractures. Materials and Methods: The patients were included in the study, who were admitted to ED due to trauma, and had physical examination findings suggesting the presence of fractures in LB (humerus, radius, ulna, femur, tibia, and fibula). The patients were evaluated by two emergency physicians (EP) in ED. The first EP examined LBs with POCUS and the second EP examined them with XR. LBs were evaluated on the anterior, posterior, medial, and lateral surfaces and from the proximal joint to the distal one (shoulder, elbow, wrist, hip, knee, and ankle joint) in both longitudinal and transverse axes with POCUS. Results: A total of 205 patients with suspected LB fractures were included in the study. LB fractures were determined in 99 patients with XR and in 105 patients with POCUS. The sensitivity, specificity, positive predictive value, negative predictive value of POCUS in determining the fractures were 99%, 93%, 93%, and 99%, respectively, compared to XR. Compared to XR, POCUS was able to determine 100% of fissure type fractures (kappa (κ) value: 0.765), 83% of linear fractures (κ: 0.848), 92% of fragmented fractures(κ: 0.756), 67% of spiral fractures (κ:0.798), 75% of avulsion type fractures (κ: 0.855), and 100% of full separation type fractures (κ: 0.855).Conclusions: This study has demonstrated that POCUS has a high sensitivity in diagnosing LB fractures. POCUS has a high sensitivity in identifying fracture characteristics. POCUS can be used as an alternative imaging method to XR in the diagnosis of LB fractures and in the determination of fracture characteristics.

The Use of the NMP22 BladderChek Test for Bladder Cancer to Optimise Investigations in a One-Stop Haematuria Clinic

2008 ◽  
Vol 1 (3) ◽  
pp. 126-130 ◽  
Author(s):  
Simon Bott ◽  
Malek Chanawani ◽  
Hugh Mostafid
Keyword(s):  
Predictive Value ◽  
Point Of Care ◽  
Financial Impact ◽  
General Anaesthetic ◽  
Genitourinary System ◽  
Flexible Cystoscopy ◽  
Number Of Patients ◽  
Urothelial Malignancy ◽  
One Stop ◽  
Sensitivity Specificity

Objective: We assessed the value of the NMP22 BladderChek point-of-care (POC) test (Kyowa Hakko UK Ltd., Slough, UK) in a one-stop haematuria clinic to optimise the choice of further investigations. Patients and methods: Over 34 months from 2005 until 2007, 590 patients presenting to a haematuria clinic were initially assessed with the NMP22 POC test. Patients with a positive NMP22 were counselled and offered further investigation with upper tract imaging and a general anaesthetic cystoscopy without first undergoing flexible cystoscopy (FC). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the NMP22 POC test in this setting were calculated. The financial impact of this policy was assessed. Results: In total 58 of 590 men were NMP22 positive. Urothelial malignancy was identified in 22 patients and 5 had a non-urothelial malignancy of the genitourinary system. The sensitivity of the NMP22 test in detecting urothelial malignancy in newly presenting patients was 56.4%, specificity 93.5%, PPV 38.0% and NPV 97.0%. Eleven had no abnormality and none have subsequently developed a malignancy. The number of patients requiring FC fell by 10% resulting in significant financial savings. Conclusion: The NMP22 POC test can be used as the first test in a haematuria clinic to optimise the choice of subsequent investigations resulting in financial savings.

scholarly journals Performance of an immunochromatography test for vivax malaria in the Amazon region, Brazil

2003 ◽  
Vol 37 (3) ◽  
pp. 390-392 ◽  
Author(s):  
Alberto Ferreira Figueiredo Filho ◽  
Maria Cristina Figueredo ◽  
José Maria Nascimento ◽  
Vanja Suely Pachiano Calvosa ◽  
Marinete Marins Póvoa ◽  
...  
Keyword(s):  
Predictive Value ◽  
Vivax Malaria ◽  
Diagnostic Performance ◽  
Malaria Diagnosis ◽  
Blood Film ◽  
Amazon Region ◽  
Test Sensitivity ◽  
Thick Blood Film ◽  
Different Temperatures ◽  
C 30

The study was carried out to evaluate the diagnostic performance of the ICT malaria Pf/PvTM test for vivax malaria diagnosis in Belém, Amazon region, Brazil. The results of blood malaria parasites examination using an immunochromatography test were compared with thick blood film (TBF) examination. It was also evaluated the performance of this test storaged at three different temperatures (25°C, 30°C, and 37°C) for 24 hours before use. Overall sensitivity of ICT Pf/PvTM was 61.8% with a specificity of 100%, positive and negative predictive value of 100% and 71.8%, respectively and accuracy of 80.6%. The test sensitivity was independent of the parasite density. This test needs to be further reviewed in order to have better performance for P. vivax malaria diagnosis.

scholarly journals Multiple Cross Displacement Amplification-a more applicable technique in detecting Pseudomonas Aeruginosa of Ventilator-associated Pneumonia ( VAP)

2020 ◽  
Author(s):  
Juxiang Wang ◽  
Huimin Chen ◽  
Xiaomin Lin ◽  
Chengyi Ji ◽  
Bin Chen
Keyword(s):  
Pseudomonas Aeruginosa ◽  
Predictive Value ◽  
Limit Of Detection ◽  
Point Of Care ◽  
Lavage Fluid ◽  
Rapid Identification ◽  
Ventilator Associated Pneumonia ◽  
Color Changes ◽  
Sensitivity Specificity ◽  
Bacteria Culture

Abstract Background Early and rapid identification of Pseudomonas aeruginosa (P. aeruginosa) in patients with suspected ventilator-associated pneumonia (VAP) provides theoretical clinical advantages in therapeutic optimization strategies.Methods The PA-MCDA assay was conducted at an isothermal temperature during the amplification stage, and products were visually detected by color changes. The entire process was completed within 1 h. A total of 77 strains, including P. aeruginosa species and various other species of non-P. aeruginosa were used to evaluate PA-MCDA assays. Bronchoalveolar lavage fluid (BALF) of suspected VAP patients were examined by the MCDA assay. Results The MCDA assay exhibited a 100 percent analytical specificity in detecting PA from all 77 strains, and the limit of detection were as low as 100 fg DNA per reaction. A temperature of 65ºC was recommended as standard during the amplification stage. The agreement between PA-MCDA and bacteria culture was 91.18% (κ= 0.787; p =0.000) in identification of P. aeruginosa in BALF from suspected VAP. The PA-MCDA assay showed values of 92.31%, 90.78%, 77.41% and 97.18% for sensitivity, specificity, positive predictive value and negative predictive value, respectively. PA-MCDA had higher detective rate of P. aeruginosa than bacteria culture in patients with antipseudomonal therapy.Conclusions The instrument-free platform of the MCDA assay makes it a simple, rapid and applicable procedure for “on-site” diagnosis and point-of-care testing for the presence of P. aeruginosa without the need for specific bacterial culture.

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