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Test Sensitivity

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141. Abiraterone acetate (Zytiga) - for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer

Abiraterone acetate (Zytiga) - for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer 1 Published 13 January 2020 1 SMC2215 abiraterone acetate 500mg film-coated tablets (Zytiga®) Janssen-Cilag Ltd 6 December 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following (...) a full submission assessed under the orphan medicine process abiraterone acetate (Zytiga ® ) is accepted for use within NHSScotland. Indication under review: abiraterone acetate with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer in adult men in combination with androgen deprivation therapy. Abiraterone acetate in combination with prednisone and androgen deprivation therapy demonstrated superiority over androgen deprivation

2020 Scottish Medicines Consortium

142. Cohort study: Nucleic acid amplification tests of self-taken vulvovaginal swabs are more sensitive than clinician taken endocervical culture for gonorrhoea

Cohort study: Nucleic acid amplification tests of self-taken vulvovaginal swabs are more sensitive than clinician taken endocervical culture for gonorrhoea Nucleic acid amplification tests of self-taken vulvovaginal swabs are more sensitive than clinician taken endocervical culture for gonorrhoea | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more (...) about how we use cookies, please see our . Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? Search for this keyword Search for this keyword Main menu Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? You are here Nucleic acid amplification tests of self-taken vulvovaginal swabs are more sensitive than

2013 Evidence-Based Medicine

143. MR-proADM test for use with clinical deterioration scores in cases of suspected infection

MR-proADM test for use with clinical deterioration scores in cases of suspected infection MR-proADM test for use with clinical MR-proADM test for use with clinical deterior deterioration scores in cases of suspected ation scores in cases of suspected infection infection Medtech innovation briefing Published: 11 October 2019 www.nice.org.uk/guidance/mib195 pathways Summary Summary The technology technology described in this briefing is the MR-proADM test. It measures levels of mid- regional (...) proadrenomedullin (MR-proADM), a precursor of adrenomedullin, levels of which can be increased in severe infections. The MR-proADM test is used alongside tools such as the National Early Warning Score (NEWS and NEWS2) to detect clinical deterioration in cases of suspected infection. The inno innovativ vative aspect e aspect is that the test measures a unique biomarker (MR-proADM) that allows more accurate prediction of deterioration. The intended place in ther place in therap apy y would be with NEWS, NEWS2

2019 National Institute for Health and Clinical Excellence - Advice

144. Assessment of food allergies and sensitivities

food sensitivities. Pathophysiology Food allergies can be classified into disorders that are IgE-mediated, cell-mediated, or a combination of the two. Sicherer SH. Food allergy. Lancet. 2002 Aug 31;360(9334):701-10. http://www.ncbi.nlm.nih.gov/pubmed/12241890?tool=bestpractice.com IgE-mediated food allergies result from abnormal sensitisation to a food allergen that results in specific IgE production. However, a positive skin prick test or IgE test on its own does not indicate that a patient has (...) Assessment of food allergies and sensitivities Assessment of food allergies and sensitivities - Differential diagnosis of symptoms | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Assessment of food allergies and sensitivities Last reviewed: February 2019 Last updated: June 2018 Summary Food allergy is defined as an adverse immunological response to a food protein. Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl

2018 BMJ Best Practice

145. Understanding medical tests: A new addition to our toolkit addressing sensitivity, specificity, and other core concepts

Understanding medical tests: A new addition to our toolkit addressing sensitivity, specificity, and other core concepts Understanding medical tests-A new addition to our toolkit on sensitivity, specificity and positive predictive value Note to our followers: Our nearly 13-year run of daily publication of new content on HealthNewsReview.org came to a close at the end of 2018. Publisher Gary Schwitzer and other contributors may post new articles periodically. But all of the 6,000+ articles we (...) have published contain lessons to help you improve your critical thinking about health care interventions. And those will be still be alive on the site for a couple of years. 6093 Posts Menu June 21, 2018 Understanding medical tests: A new addition to our toolkit addressing sensitivity, specificity, and other core concepts Posted By Categories , , Tags Kevin Lomangino is the managing editor of HealthNewsReview.org. He tweets as @KLomangino. Hardly a day goes by without some media outlet making

2018 HealthNewsReview

146. Tests for rapidly identifying bloodstream bacteria and fungi (LightCycler SeptiFast Test MGRADE, SepsiTest and IRIDICA BAC BSI assay)

of bacteraemia is usually higher than in adults and so the sensitivity of detection is not thought to be substantially reduced by a lower blood-to-medium ratio. 2.11 Blood culture bottles should be incubated within 4 hours of the blood sample being taken. Many laboratories now use automated culture systems that alert laboratory staff once growth has been detected. 2.12 When a blood culture has been detected as positive it is recommended that: Gram staining and rapid antigen testing should be done within 2 (...) hours. Direct or automated isolate identification should be done within 24 hours (extending to 48 hours if traditional microbiology techniques such as morphological identification are used). Rapid species identification may be done after blood culture using techniques such as MALDI-TOF mass spectrometry. Identification should be followed by sensitivity testing to determine the antimicrobials that the identified pathogen is susceptible to. If direct or automated sensitivity testing is used, a report

2016 National Institute for Health and Clinical Excellence - Diagnostics Guidance

147. Counseling About Genetic Testing and Communication of Genetic Test Results

variable phenotypes. This discussion of the and of the test result facilitates a discussion of the potential need for follow-up diagnostic testing. For example, discussion of cell-free DNA screening allows the obstetrician–gynecologist or other health care provider the opportunity to discuss the high sensitivity and specificity of this testing while also stressing the positive predictive value and the need for follow-up diagnostic testing. The potential for the discovery of should be addressed (...) affected by a specific disorder. Sensitivity: The proportion of individuals with a condition correctly identified as positive. Specificity: The proportion of individuals without a condition correctly identified as negative. Susceptibility Testing: Determines whether an individual carries a genetic variation that increases the potential for developing a specific condition. Not every person with a genetic variant will develop the condition, but they are at increased risk. An example of susceptibility

2017 American College of Obstetricians and Gynecologists

148. Genome-wide microarray testing for pregnancies with major foetal structual abnormalities detected by ultrasound

and conventional karyotype testing are preceded by amniocentesis or CVS, safety issues from obtaining the sample for testing are the same. 11. Comparative effectiveness Accuracy Analytical validity The CA stated that the reference standard for analytical validity is conventional karyotyping. The Critique considered that it was not appropriate to present sensitivity and specificity for the studies, either individually or pooled, as the reference standard conventional karyotyping 10 is an imperfect reference (...) standard. Thus, it cannot be confidently stated that the abnormal cases identified by GWMA but not conventional karyotyping are ‘false positives’. The Critique identified a systematic review by Saldarriaga et al. 2015 (identified, considered but excluded in the CA) that conducted a meta-analysis of sensitivity and specificity based on studies that compared tests results of the individual tests with the combined test as reference standard (Table 4). Overall the systematic review was of high quality

2020 Medical Services Advisory Committee

149. Cell-Free Circulating Tumour DNA Blood Testing to Detect EGFR T790M Mutation in People With Advanced Non–Small Cell Lung Cancer

biopsy to detect the EGFR T790M resistance mutation demonstrated a positive and negative predictive value of 89% and 61%, respectively, a sensitivity of 68%, and specificity of 86%. No studies examined the clinical utility of liquid biopsy as a triage test. When NSCLC was treated appropriately, progression-free survival was similar in patients with and without the resistance mutation, as ascertained by liquid biopsy. We estimated that it costs about $700 to conduct a liquid biopsy and $2,500 (...) —Summary 41 Table 8: Natural History Inputs Used in Economic Model 53 Table 9: Mean Sensitivity, Specificity, Prevalence, and Positive and Negative Predictive Values Used in Reference Case Analysis 54 Table 10: Distributions Used for Progression-Free and Overall Survival 55 Table 11: Clinical Effectiveness Parameters, Additional Treatment 56 Table 12: Health State Utilities (Annual) Used in Economic Model 58 Table 13: EGFR T790M Testing Costs 61 Table 14: Total Cost Per Biopsy 64 Table 15: Drug

2020 Health Quality Ontario

150. Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer

was 63.0%, 89.2%, 89.2%, and 100% for EndoPredict, MammaPrint, Oncotype DX, and Prosigna, respectively. Sensitivity analyses showed our results were robust to variation in subgroups considered (i.e., LN+ and premenopausal), discount rates, age, and utilities. However, cost parameter assumptions did influence our results. Our scenario analysis comparing tests showed Oncotype DX was likely cost-effective compared with MammaPrint, and Prosigna was likely cost-effective compared with EndoPredict. When (...) Analysis 60 Discussion 61 Conclusions 62 PRIMARY ECONOMIC EVALUATION 63 Research Question 63 Methods 63 Analysis 63 Target Population 63 Perspective 64 Test Strategies 64 Discounting and Time Horizon 64 Model Structure 64 Risk Classification and Adjuvant Chemotherapy Decision 65 Health States in the Markov Model 65 Main Assumptions 66 Clinical Outcomes Parameters 67 Cost Parameters 73 Analysis 77 Results 80 Reference Case Analysis 80 Sensitivity Analysis 83 Scenario Analyses 85 Discussion 90 Strengths

2020 Health Quality Ontario

151. Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy Full Text available with Trip Pro

. It was out of the scope for these guidelines to address all existing screening options. The panel decided to include the most commonly used options with the most solid evidence base. Randomised trials with sufficient follow-up for estimation of screening benefits have studied only sigmoidoscopy and guaiac faecal occult blood testing (gFOBT). However, today the most widely practiced screening tests are faecal immunochemical test (FIT) and colonoscopy. FIT has a higher sensitivity and is more acceptable (...) Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy: a clinical practice guideline | The BMJ Intended for healthcare professionals Username * Password * Edition: Search form Search Search Colorectal cancer... Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy: a clinical practice guideline (Published 02 October 2019) Cite

2019 BMJ Rapid Recommendations

152. Routine Human Papilloma Virus (HPV) Testing in Squamous Cell Head and Neck Cancer

of Key Evidence for Recommendation 3 ? The above recommendations are based on a comparison of HPV diagnostic testing methods published in the literature. Thirteen retrospective cohort studies (14-26) were included in this guideline. The evidence suggests that, in patients with OPSCC, the performance of the three main techniques – PCR-based amplification, DNA ISH, and p16 IHC – is comparable. o PCR amplification of HPV DNA showed a sensitivity of 97% and specificity of 87% o DNA ISH showed (...) a sensitivity that ranged from 83% to 93% and a specificity that ranged from 88% to 100% o IHC staining for p16 showed a sensitivity and specificity that ranged from 89% to 100% and 38% to 94%, respectively p16 IHC Moderate to strong & diffuse cytoplasmic & nuclear staining in =50% of tumour cells AND tumour displays basaloid or nonkeratinizing morphology All other p16 outcomes No cytoplasmic & nuclear staining in tumour cells AND tumour displays keratinizing morphology HPV Positive No further testing

2020 Cancer Care Ontario

153. Lead-I ECG devices for detecting symptomatic atrial fibrillation using single time point testing in primary care

) P Pooled sensitivity ooled sensitivity % (95% CI) % (95% CI) P Pooled specificity ooled specificity % (95% CI) % (95% CI) Lead-I ECG devices for detecting symptomatic atrial fibrillation using single time point testing in primary care (DG35) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 15 of 40All devices a,c Kardia Mobile (3 b,d ), Zenicor-ECG (1 e ) 93.9 (86.2 to 97.4) 96.5 (90.4 to 98.8) All devices a,c (...) interpreted by the device eted by the device's algorithm 's algorithm 4.11 Four studies that reported sensitivity and specificity of the lead-I ECG device when the trace was interpreted by the device's algorithm alone were included in meta-analyses. Two studies reported data for MyDiagnostick alone (Tieleman et Lead-I ECG devices for detecting symptomatic atrial fibrillation using single time point testing in primary care (DG35) © NICE 2019. All rights reserved. Subject to Notice of rights (https

2019 National Institute for Health and Clinical Excellence - Diagnostics Guidance

154. Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer

Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer T T umour profiling tests to guide adjuvant umour profiling tests to guide adjuvant chemother chemotherap apy decisions in early breast y decisions in early breast cancer cancer Diagnostics guidance Published: 19 December 2018 nice.org.uk/guidance/dg34 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our (...) of implementing NICE recommendations wherever possible. Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (DG34) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 56Contents Contents 1 Recommendations 4 2 Clinical need and practice 6 The problem addressed 6 The condition 7 The diagnostics and care pathways 7 3 The diagnostic tests 9 The interventions 9 The comparator 13 4 Evidence 14

2019 National Institute for Health and Clinical Excellence - Diagnostics Guidance

155. Rapid tests for group A streptococcal infections in people with a sore throat

in sensitivity (67.9% to 100%), and specificity (73.3% to 100%) of the rapid tests. There was a wide variation in accuracy estimates even for the same test. For example, the sensitivity of the Alere T estPack Plus cassette ranged from 73% (95% confidence interval [CI] 45% to 92%) to 96% (95% CI 91% to 99%). Its specificity ranged from 86% Rapid tests for group A streptococcal infections in people with a sore throat (DG38) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk (...) /terms-and- conditions#notice-of-rights). Page 14 of 47(95% CI 81% to 91%) to 100% (95% CI 96% to 100%) across 10 studies. Data from the manufacturer and FDA submissions consistently provided higher estimates of sensitivity and specificity than peer-reviewed studies. 3.11 Head-to-head comparison of the diagnostic accuracy of different tests was only reported in 4 studies. These studies suggested there is some variation in accuracy between tests. Because of the large degree of inter-study variability

2019 National Institute for Health and Clinical Excellence - Diagnostics Guidance

156. Can a Negative High-Sensitivity Troponin Result Rapidly Rule Out Acute Myocardial Infarction?

Can a Negative High-Sensitivity Troponin Result Rapidly Rule Out Acute Myocardial Infarction? TAKE-HOME MESSAGE A single, undetectable, high-sensitivity, cardiac troponin T (hs-cTnT) test in combination with a nonischemic ECG result may effectively rule out acute myocardial infarction in emergency department (ED) patients presenting greater than 3 hours after symptom onset. Can a Negative High-Sensitivity Troponin Result Rapidly Rule Out Acute Myocardial Infarction? EBEM Commentators Nathan M (...) -cTnTtestingintheassessmentofacutemyocardialinfarctionandmajor adverse cardiac events. Outcome Sensitivity, % (95% CI) Speci?city, % (95% CI) LR– (95% CI) I 2 ,%* AMI (LoD) 98.7 (96.6–99.5) 60.2 (46.5–72.5) 0.04 (0.02–0.08) 90.3 AMI (LoB) 99.1 (97.4–99.7) 19.4 (8–39.9) † N/P N/P MACE 98.0 (94.7–99.3) 60.2 (46.5–72.5) N/P N/P CI, Con?dence interval; LR–, negative likelihood ratio; AMI, acute myocardial infarction; LoD, level of detection, hs-cTnT less than 0.005 mg/L; LoB, level of blank, hs-cTnT less than 0.003 mg/L; N/P, not provided; MACE, major adverse

2018 Annals of Emergency Medicine Systematic Review Snapshots

157. Utility, reliability, sensitivity and validity of an online test system designed to monitor changes in cognitive function in clinical trials. Full Text available with Trip Pro

Utility, reliability, sensitivity and validity of an online test system designed to monitor changes in cognitive function in clinical trials. The advent of long-term remotely conducted clinical trials requires assessments which can be administered online. This paper considers the utility, reliability, sensitivity and validity of an internet-based system for measuring changes in cognitive function which is being used in one such trial.The Platform for Research Online to investigate Genetics (...) and Cognition in Ageing is a 10-year longitudinal and entirely remote study launched in November 2015. The CogTrackTM System is being used to monitor changes in important aspects of cognitive function using tests of attention, information processing and episodic memory. On study entry, the participants performed CogTrackTM up to three times over seven days, and these data are evaluated in this paper.During the first six months of the study, 14 531 individuals aged 50 to 94 years enrolled and performed

2017 International Journal of Geriatric Psychiatry

158. A Sensitive ALK Immunohistochemistry Companion Diagnostic Test Identifies Patients Eligible for Treatment with Crizotinib. Full Text available with Trip Pro

A Sensitive ALK Immunohistochemistry Companion Diagnostic Test Identifies Patients Eligible for Treatment with Crizotinib. The availability of high-quality, rigorously validated diagnostic tests that can be broadly implemented is necessary to efficiently identify patients with anaplastic lymphoma kinase (ALK)-positive NSCLC who can potentially benefit from treatment with crizotinib. Here we present data on the recently approved Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Tucson, AZ (...) ), the only immunohistochemistry (IHC)-based assay linked to treatment outcome.NSCLC specimens prospectively tested for anaplastic lymphoma receptor tyrosine kinase gene (ALK) status by flourescent in situ hybridization (FISH) in the PROFILE 1014 clinical trial of crizotinib versus chemotherapy (N = 1018, including 179 ALK-positive and 754 ALK-negative specimens) were evaluated using the ALK (D5F3) CDx assay. Hazard ratios for progression-free survival comparing crizotinib and chemotherapy for ALK IHC

2017 Journal of Thoracic Oncology

159. Systematic drug sensitivity testing reveals synergistic growth inhibition by dasatinib or mTOR inhibitors with paclitaxel in ovarian granulosa cell tumor cells. Full Text available with Trip Pro

Systematic drug sensitivity testing reveals synergistic growth inhibition by dasatinib or mTOR inhibitors with paclitaxel in ovarian granulosa cell tumor cells. Resistance to standard chemotherapy poses a major clinical problem in the treatment of ovarian cancer patients. Adult-type granulosa cell tumor (AGCT) is a unique ovarian cancer subtype for which efficient treatment options are lacking in advanced disease. To this end, systematic drug response and transcriptomics profiling were (...) performed to uncover new therapy options for AGCTs.The responses of three primary and four recurrent AGCTs to 230 anticancer compounds were screened in vitro using a systematic drug sensitivity and resistance testing (DSRT) platform, coupled with mRNA sequencing. The responses of the AGCTs were compared with those of human granulosa luteal cells and bone marrow mononuclear cells.Patient-derived AGCT cells showed selective sensitivity to the Src family tyrosine kinase inhibitor dasatinib. A combination

2017 Gynecologic Oncology

160. Clinical performance evaluation of a sensitive, rapid low-throughput test for KRAS mutation analysis using formalin-fixed, paraffin-embedded tissue samples. Full Text available with Trip Pro

Clinical performance evaluation of a sensitive, rapid low-throughput test for KRAS mutation analysis using formalin-fixed, paraffin-embedded tissue samples. Testing for KRAS mutations in metastatic colorectal cancer (mCRC) on formalin-fixed, paraffin embedded (FFPE) tumor tissue has become standard of care. Different molecular methods exist to determine hotspot KRAS mutations in exon 2, 3 and 4, but testing is often limited by the sensitivity and the speed of analysis. The aim (...) of this retrospective study was to establish the clinical performance of the Idylla™ KRAS Mutation Test on FFPE tumor samples of patients with mCRC.KRAS mutation analysis was performed using the therascreen KRAS on the RotorGene Q platform (CE-IVD; Qiagen) and results were subsequently compared to the Idylla™ KRAS Mutation Test. Discordant result testing was performed with massive parallel sequencing or alternative routine approaches.Data from 182 samples were used to show that the overall agreement between the two

2017 BMC Cancer

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