scholarly journals Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1138
Author(s):  
Inge Van Damme ◽  
Chiara Trevisan ◽  
Kabemba E. Mwape ◽  
Veronika Schmidt ◽  
Pascal Magnussen ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Taenia Solium ◽  
Diagnostic Accuracy Study ◽  
Community Settings ◽  
Two Stage ◽  
Stage Design ◽  
Point Of Care Test ◽  
Accuracy Study ◽  
Two Stage Design

Field-applicable, high-quality, and low-cost diagnostic tools are urgently needed for Taenia solium. The aim of this paper is to describe the design, challenges, and rationale for the design of a diagnostic accuracy study in low-resource community settings in Zambia. The trial was designed as a prospective study with a two-stage design to evaluate a new point-of-care test (TS POC) for the detection of taeniosis and (neuro)cysticercosis. Participants within randomly selected households were tested with the TS POC test (index test). Participants who tested TS POC positive for taeniosis and/or cysticercosis and a subset of the negatives were requested to give blood and stool samples for reference testing, and to undergo clinical examination and a cerebral CT scan. The difficulties of conducting a clinical trial in settings with limited research and neuroimaging infrastructure as well as peculiarities specifically related to the disease (low prevalence of taeniosis and the lack of a gold standard) were taken into consideration for the design of this study. The two-stage design increased the efficiency of the study by reducing the number of samples, clinical examinations, and CT scans. Simplified flows and sampling processes were preferred over complex follow-up and randomization systems, aiming to reduce bias and increase the generalizability of the study.

scholarly journals Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study

2020 ◽  
Vol 1 (7) ◽  
pp. e300-e307 ◽  
Author(s):  
Malick M Gibani ◽  
Christofer Toumazou ◽  
Mohammadreza Sohbati ◽  
Rashmita Sahoo ◽  
Maria Karvela ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Diagnostic Accuracy Study ◽  
Point Of Care Test ◽  
Accuracy Study

scholarly journals Novel lipoarabinomannan point-of-care tuberculosis test for people with HIV: a diagnostic accuracy study

2019 ◽  
Vol 19 (8) ◽  
pp. 852-861 ◽  
Author(s):  
Tobias Broger ◽  
Bianca Sossen ◽  
Elloise du Toit ◽  
Andrew D Kerkhoff ◽  
Charlotte Schutz ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Diagnostic Accuracy Study ◽  
Accuracy Study

scholarly journals Blood-based host biomarker diagnostics in active case finding for pulmonary tuberculosis: a diagnostic accuracy study

2021 ◽  
Author(s):  
Flora Martinez Figueira Moreira ◽  
Renu Verma ◽  
Paulo Cesar Pereira dos Santos ◽  
Alessandra Leite ◽  
Andrea da Silva Santos ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Screening Program ◽  
Point Of Care ◽  
Case Finding ◽  
National Council ◽  
Active Case Finding ◽  
Diagnostic Accuracy Study ◽  
Active Case ◽  
Accuracy Study ◽  
Triage Test

SummaryBackgroundThere is a need to identify scalable tuberculosis screening strategies among high burden populations. The WHO has identified a non-sputum-based triage test as a development priority.MethodsWe performed a diagnostic accuracy study of point-of-care C-reactive protein (CRP) and Xpert-MTB-Host-Response (Xpert-MTB-HR) assays in the context of a mass screening program for tuberculosis in two prisons in Brazil. Incarcerated individuals irrespective of symptoms were screened by sputum Xpert-MTB/RIF and sputum culture. CRP was quantified in serum by a point-of-care assay (iChroma-II) and a 3-gene expression score was quantified from whole blood using the Xpert-MTB-HR cartridge. We evaluated receiver operating characteristic area under the curve (AUC) and assessed specificity at 90% sensitivity and sensitivity at 70% specificity, consistent with WHO target product profile (TPP) benchmarks.FindingsTwo hundred controls controls and 100 culture- or Xpert-positive tuberculosis cases were included. Half of tuberculosis cases and 11% of controls reported any tuberculosis symptoms. AUC for CRP was 0.79 (95% CI: 0.73-0.84) and for Xpert-MTB-HR was 0.84 (95% CI: 0.79-0.89). At 90% sensitivity, Xpert-MTB-HR had significantly higher specificity (53.0%, 95% CI: 45.0-69.0%) than CRP (28.1%, 95% CI: 20.2-41.8%) (p=0.003). Among individuals with medium or high sputum Xpert semi-quantitative load, sensitivity (at 70% specificity) of CRP (90.3%, 95% CI: 74.2-98.0) and Xpert-MTB-HR (96.8%, 95% CI: 83.3-99.9%) was higher.InterpretationFor active case finding in this high tuberculosis-burden setting, CRP and Xpert-MTB-HR did not meet TPP benchmarks for a triage test. However, Xpert-MTB-HR was highly sensitive in detecting individuals with medium or high sputum bacillary burden.FundingNational Institutes of Health (R01 AI130058 and R01 AI149620) and Brazilian National Council for Scientific and Technological Development (CNPq-404182/2019-4). Xpert-MTB-HR cartridges were provided by Cepheid.

scholarly journals Protocol for Accuracy of Point of Care (POC) or In-Office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)

2010 ◽  
Vol 1;13 (1;1) ◽  
pp. E1-E22
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Diagnostic Accuracy ◽  
Prescription Drugs ◽  
Drug Testing ◽  
Illicit Drugs ◽  
Point Of Care ◽  
Diagnostic Accuracy Study ◽  
Controlled Substances ◽  
Urine Drug Testing ◽  
Urine Drug ◽  
Accuracy Study

Background: Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing. Study Design: A diagnostic accuracy study of urine drug testing. Study Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objective: To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample. Methods: The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized. Results: Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated. Limitations: The limitations include lack of availability of POC testing with lower cutoff levels. Conclusion: This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics. Clinical Trial Registration: NCT 01052155 Key words: Controlled substances, opioids, benzodiazepines, illicit drugs, abuse, diversion, adherence monitoring, prescription monitoring programs

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