scholarly journals Evaluation of an Antibody Detecting Point of Care Test for Diagnosis of Taenia solium Cysticercosis in a Zambian Rural Community: A Prospective Diagnostic Accuracy Study

Diagnostics ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 2121
Author(s):  
Chishimba Mubanga ◽  
Inge Van Damme ◽  
Chiara Trevisan ◽  
Veronika Schmidt ◽  
Isaac K. Phiri ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Diagnostic Performance ◽  
Point Of Care ◽  
Taenia Solium ◽  
Rapid Diagnostic Tests ◽  
Probabilistic Constraints ◽  
Enzyme Linked Immunosorbent Assay ◽  
Recombinant Glycoprotein ◽  
Point Of Care Test ◽  
Accuracy Study

The lack of cheap, easy-to-use, rapid diagnostic tests has led to the development of several rapid diagnostic tests for cysticercosis. The new prototype two-strip, Taenia solium point of care test (TS POC) detects antibodies against taeniosis (TS POC T) and cysticercosis (TS POC CC). This study evaluated the diagnostic performance of the TS POC CC in the Sinda district in eastern Zambia. A sample of 1254 participants was recruited and tested with the TS POC. Out of the 1249 participants with a valid TS POC result, 177 (14%) tested positive while 1072 (86%) tested negative. All individuals with a positive TS POC and a subset of negative TS POC participants were selected for serum sampling, and were subjected to the recombinant glycoprotein T24H enzyme-linked immunoelectrotransfer blot (rT24H EITB) and the serum B60/158 (serum Ag) enzyme-linked immunosorbent assay (Ag ELISA). Performance characteristics were estimated using a Bayesian approach with probabilistic constraints. Based on 255 complete cases, the estimated sensitivity and specificity of the TS POC CC test were 35% (95% CI: 14–63%) and 87% (95% CI: 83–90%), respectively. The diagnostic performance needs to be improved, possibly by titrating antigen and other reagents’ concentration in the strip to produce a performance similar to existing cysticercosis tests such as the rT24H EITB.

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 Comparative Analysis of the Euroimmun CXCL13 Enzyme-Linked Immunosorbent Assay and the ReaScan Lateral Flow Immunoassay for Diagnosis of Lyme Neuroborreliosis

2020 ◽  
Vol 58 (9) ◽  
Author(s):  
Katharina Ziegler ◽  
Anca Rath ◽  
Christoph Schoerner ◽  
Renate Meyer ◽  
Thomas Bertsch ◽  
...  
Keyword(s):  
Immunosorbent Assay ◽  
Roc Curve ◽  
Point Of Care ◽  
Lateral Flow ◽  
Lyme Neuroborreliosis ◽  
Diagnostic Tools ◽  
Lateral Flow Immunoassay ◽  
Enzyme Linked Immunosorbent Assay ◽  
European Federation ◽  
Point Of Care Test

ABSTRACT Diagnosis of Lyme neuroborreliosis (LNB) is challenging, as long as Borrelia-specific intrathecal antibodies are not yet detectable. The chemokine CXCL13 is elevated in the cerebrospinal fluid (CSF) of LNB patients. Here, we compared the performances of the Euroimmun CXCL13 enzyme-linked immunosorbent assay (CXCL13 ELISA) and the ReaScan CXCL13 lateral flow immunoassay (CXCL13 LFA), a rapid point-of-care test, to support the diagnosis of LNB. In a dual-center case-control study, CSF samples from 90 patients (34 with definite LNB, 10 with possible LNB, and 46 with other central nervous system [CNS] diseases [non-LNB group]) were analyzed with the CXCL13 ELISA and the CXCL13 LFA. Classification of patients followed the European Federation of Neurological Societies (EFNS) guidelines on LNB. The CXCL13 ELISA detected elevated CXCL13 levels in all patients with definite LNB (median, 1,409 pg/ml) compared to the non-LNB controls (median, 20.7 pg/ml; P < 0.0001), with a sensitivity of 100% and a specificity of 84.8% (cutoff value, 78.6 pg/ml; area under the receiver operating characteristic [ROC] curve, 0.93). Similarly, the CXCL13 LFA yielded elevated CXCL13 levels in 31 patients with definite LNB (median arbitrary value, 223.5) compared to the non-LNB control patients (median arbitrary value, 0; P < 0.0001) and had a sensitivity and specificity of 91.2% and 93.5%, respectively (cutoff arbitrary value, 22.5; area under the ROC curve, 0.94). The correlation between the CXCL13 levels obtained by ELISA and LFA was strong (Spearman correlation coefficient r = 0.89; P < 0.0001). The CXCL13 ELISA and the CXCL13 LFA are comparable diagnostic tools for the detection of CXCL13 in the CSF of patients with definite LNB. The advantage of the CXCL13 LFA is the shorter time to result.

scholarly journals The Role of Antigen Rapid Diagnostic Test in COVID-19 Diagnosis

2021 ◽  
Vol 1 (1) ◽  
pp. 108-111
Author(s):  
Ronni Mol Joji ◽  
Mohammad Shahid
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Rapid Diagnostic Tests ◽  
World Health ◽  
Complementary Role ◽  
Reverse Transcription Quantitative Pcr ◽  
Highly Sensitive ◽  
Health Organization ◽  
Random Screening

Since the emergence of a novel infection due to the SARS-CoV-2 virus (COVID-19), the World Health Organization has urged countries to develop diagnostic tests to combat the pandemic. Molecular assays were developed following the release of the gene sequence of the virus in January 2020. Reverse transcription-quantitative PCR (RT-qPCR) is taken as the gold standard for the diagnosis of COVID-19. However, due to its limitations, highly sensitive methods for detecting antigens (antigen rapid diagnostic tests) have been developed that would help in a timely and accurate diagnosis. Antigen rapid diagnostic tests (Ag-RDTs) can help guide patient management at the point of care by random screening, re-testing, and timely decision-making in the field of public health. When the affordability and validity of the diagnostic assay are involved, no assay can show 100% correct results. Further studies need to be done to better understand the response of the Ag-RDTs in different settings. Nevertheless, Ag-RDTs can play a complementary role in the response and case management of COVID-19.

scholarly journals Clinical impact of the rapid molecular detection of RSV and influenza A and B virus in the emergency room

2021 ◽  
Author(s):  
Nicolas Yin ◽  
Marc Van Nuffelen ◽  
Magali Bartiaux ◽  
Thierry Preseau ◽  
Inge Roggen ◽  
...  
Keyword(s):  
Emergency Room ◽  
Clinical Management ◽  
Diagnostic Tests ◽  
Influenza A ◽  
Point Of Care ◽  
Antibiotic Use ◽  
Rapid Diagnostic Tests ◽  
Analytical Performance ◽  
Molecular Test ◽  
The Impact

Introduction: Using respiratory viruses' rapid diagnostic tests in the emergency room (ER) could allow a better and faster clinical management. Point-of-care PCR instruments provide now results in less than 30 minutes. The objective of this study was to assess the impact of the use of the cobas® Influenza A/B & RSV Assay for use on Roche's cobas® Liat® instrument on the clinical management of ER patients. Methods: Patients (adults and children) requiring admission or suffering from an underlying condition at risk of respiratory complication were prospectively recruited in the ER of four hospitals in the Brussels region. Physician's intentions regarding admission, isolation, antibiotic and antiviral use were collected before and after performing a cobas® Influenza A/B & RSV molecular test. Additionally, a comparison of the analytical performance of this test against antigen rapid tests and viral culture was performed as well as a time-to-result evaluation. Results: PCR yielded twice more positive results than antigen rapid diagnostic tests. It allowed a decrease in the overall need for isolation and treatment by limiting the isolation of negative patients and the antibiotic use for positive patients. Meanwhile, antiviral treatments better targeted patients with a positive influenza PCR. Conclusion: The use of a rapid influenza and RSV molecular test improves the clinical management of patients admitted to the ER by providing a fast and reliable result. Their additional cost compared to antigen tests should be balanced with the benefit of their analytical performance, leading to efficient reductions in the need of isolation and antibiotic use.

scholarly journals Diagnostic accuracy of two commercial SARS-CoV-2 Antigen-detecting rapid tests at the point of care in community-based testing centers

2020 ◽  
Author(s):  
Alice Berger ◽  
Marie Therese Ngo Nsoga ◽  
Francisco Javier Perez-Rodriguez ◽  
Yasmine Abi Aad ◽  
Pascale Sattonnet-Roche ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Rapid Test ◽  
Diagnostic Value ◽  
Rapid Diagnostic Tests ◽  
Ease Of Use ◽  
Rt Pcr ◽  
Test Device ◽  
Community Based ◽  
Rapid Tests

AbstractBackgroundAntigen-detecting rapid diagnostic tests for SARS-CoV-2 offer new opportunities for the quick and laboratory-independent identification of infected individuals for control of the SARS-CoV-2 pandemic.MethodsWe performed a prospective, single-center, point of care validation of two antigen-detecting rapid diagnostic tests (Ag-RDT) in comparison to RT-PCR on nasopharyngeal swabs.FindingsBetween October 9th and 23rd, 2020, 1064 participants were enrolled. The Panbio™Covid-19 Ag Rapid Test device (Abbott) was validated in 535 participants, with 106 positive Ag-RDT results out of 124 positive RT-PCR individuals, yielding a sensitivity of 85.5% (95% CI: 78.0–91.2). Specificity was 100.0% (95% CI: 99.1–100) in 411 RT-PCR negative individuals. The Standard Q Ag-RDT (SD Biosensor, Roche) was validated in 529 participants, with 170 positive Ag-RDT results out of 191 positive RT-PCR individuals, yielding a sensitivity of 89.0% (95%CI: 83.7–93.1). One false positive result was obtained in 338 RT-PCR negative individuals, yielding a specificity of 99.7% (95%CI: 98.4–100). For individuals presenting with fever 1-5 days post symptom onset, combined Ag-RDT sensitivity was above 95%.InterpretationWe provide an independent validation of two widely available commercial Ag-RDTs, both meeting WHO criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, these assays could be beneficial due to their rapid results, ease of use, and independence from existing laboratory structures. Testing criteria focusing on patients with typical symptoms in their early symptomatic period onset could further increase diagnostic value.FundingFoundation of Innovative Diagnostics (FIND), Fondation privée des HUG, Pictet Charitable Foundation.

scholarly journals Clinical Evaluation of QuickNaviTM-Ebola in the 2018 Outbreak of Ebola Virus Disease in the Democratic Republic of the Congo

Viruses ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 589 ◽  
Author(s):  
Sheila Makiala ◽  
Daniel Mukadi ◽  
Anja De Weggheleire ◽  
Shino Muramatsu ◽  
Daisuke Kato ◽  
...  
Keyword(s):  
West Africa ◽  
Diagnostic Tests ◽  
Ebola Virus ◽  
Democratic Republic ◽  
Virus Disease ◽  
Point Of Care ◽  
Rapid Diagnostic Tests ◽  
Ebola Virus Disease ◽  
Blood Samples ◽  
Republic Of The Congo

The recent large outbreaks of Ebola virus disease (EVD) in West Africa and the Democratic Republic of the Congo (DRC) have highlighted the need for rapid diagnostic tests to control this disease. In this study, we clinically evaluated a previously developed immunochromatography-based kit, QuickNaviTM-Ebola. During the 2018 outbreaks in DRC, 928 blood samples from EVD-suspected cases were tested with QuickNaviTM-Ebola and the WHO-approved GeneXpert. The sensitivity and specificity of QuickNaviTM-Ebola, estimated by comparing it to GeneXpert-confirmed cases, were 85% (68/80) and 99.8% (846/848), respectively. These results indicate the practical reliability of QuickNaviTM-Ebola for point-of-care diagnosis of EVD.

Innovations in point of care testing for bacterial infections: The Longitude Prize with Daniel Berman

2020 ◽  
Author(s):  
Daniel Berman
Keyword(s):  
Antimicrobial Resistance ◽  
Diagnostic Tests ◽  
Bacterial Infections ◽  
Point Of Care ◽  
Rapid Diagnostic Tests ◽  
Public Healthcare ◽  
Point Of Care Testing ◽  
Set Up ◽  
Insight Into

Antimicrobial resistance (AMR) is one of the most serious clinical and public healthcare challenges. In this video Daniel Berman,  Nesta Challenges, provides an overview of the Longitude Prize, why the prize was set up and what the prize hopes to achieve. Daniel also provides insight into some of the rapid diagnostic tests currently in the running for the £8 million prize.

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