scholarly journals Clinical Utility of the Nonstructural 1 Antigen Rapid Diagnostic Test in the Management of Dengue in Returning Travelers With Fever

2017 ◽  
Vol 4 (1) ◽  
Author(s):  
Ralph Huits ◽  
Patrick Soentjens ◽  
Ula Maniewski-Kelner ◽  
Caroline Theunissen ◽  
Steven Van Den Broucke ◽  
...  

Abstract Background Rapid diagnostic test (RDT) detecting the nonstructural 1 (NS1) antigen is increasingly used for dengue diagnosis in endemic and nonendemic settings, but its clinical utility has not been studied in travel clinic practice. Methods From August 2012 to July 2016, travelers returning from the tropics with fever were evaluated in the Institute of Tropical Medicine (Antwerp, Belgium) with the routine use of NS1 antigen RDT that provided results within 1 hour. We determined the diagnostic performance, assessed the management of patients with a positive RDT result, and compared it with that of historical cases of dengue diagnosed from 2000 to 2006, when only antibody detection assays were available. Results Of 335 travelers evaluated for fever, 54 (16%) were diagnosed with dengue, including 1 severe case. Nonstructural 1 antigen RDT was performed in 308 patients. It was truly positive in 43 of 52 tested dengue cases and falsely positive in only 1 of the 256 nondengue cases; therefore, sensitivity was 82.7% (95% confidence interval [CI], 74.4%–93.0%) and specificity was 99.6% (95% CI, 98.8%–100%). Only 3 (7%) of the 43 febrile travelers “immediately” diagnosed by RDT were admitted, and only 2 (5%) were given empirical antibacterial treatment, without adverse outcome. Admission and antibiotic prescription rates were significantly higher in the historical cases (n = 43) diagnosed by antibody detection (33%, P = .006 and 26%, P = .014, respectively), although the frequency of severe dengue was similar. Conclusions In our practice, the diagnostic performance of NS1 antigen RDT substantially contributed in withholding unnecessary hospitalization and antibiotherapy in dengue patients.

2020 ◽  
Author(s):  
P. J. Ducrest ◽  
A. Freymond ◽  
J.-M. Segura

AbstractThe aim of this study was to evaluate the diagnostic performance of Simtomax® CoronaCheck, a serology rapid diagnostic test (RDT) for the detection of IgG and IgM against SARS-CoV-2. 48 plasma samples positive for SARS-CoV-2 based on RT-PCR and 98 negative control samples were studied. Diagnostic performance of the IgG/IgM RDT was assessed against RT-PCR and the electro-chemiluminescence immunoassay (ECLIA) Elecsys® Anti-SARS-CoV-2 total Ig. Overall, the RDT sensitivity was 92% (95% confidence interval [95%CI]: 79-97), specificity 97% (95% CI: 91-99%), PPV 94% (95% CI: 81-98) and the NPV 96% (95% CI: 89-99). When considering only samples collected ≥ 15 days post-symptoms (DPS), the sensitivity increased to 98% (95%CI: 86-100) and the specificity was 97% (95% CI: 91-99%). Two samples with 180 DPS were still positive for IgG. Globally, this IgG/IgM RDT displayed a high diagnostic accuracy for SARS-CoV-2 IgG/IgM detection in plasma samples in high COVID-19 prevalence settings. It could be effectively used, in absence of facilities for routine diagnostic serology, for samples with a DPS between 15 and 180 days.Highlights–The rapid diagnostic test Simtomax CoronaCheck displays a high sensitivity of 98% and a high specificity of 97% for SARS-CoV-2 IgG/IgM detection in plasma samples after 15 days post-symptoms.–The rapid diagnostic test Simtomax CoronaCheck can detect SARS-CoV-2 antibodies in plasma up to 180 days after symptom onset.–The rapid diagnostic test Simtomax CoronaCheck could be effectively used as an alternative to serological analysis using laboratory facilities.


2021 ◽  
Author(s):  
Adrian Mironas ◽  
David Jarrom ◽  
Evan Campbell ◽  
Jennifer Washington ◽  
Sabine Ettinger ◽  
...  

AbstractAs COVID-19 testing is rolled out increasingly widely, the use of a range of alternative testing methods will be beneficial in ensuring testing systems are resilient and adaptable to different clinical and public health scenarios. Here, we compare and discuss the diagnostic performance of a range of different molecular assays designed to detect the presence of SARS-CoV-2 infection in people with suspected COVID-19. Using findings from a systematic review of 103 studies, we categorised COVID-19 molecular assays into 12 different test classes, covering point-of-care tests, various alternative RT-PCR protocols, and alternative methods such as isothermal amplification. We carried out meta-analyses to estimate the diagnostic accuracy and clinical utility of each test class. We also estimated the positive and negative predictive values of all diagnostic test classes across a range of prevalence rates. Using previously validated RT-PCR assays as a reference standard, 11 out of 12 classes showed a summary sensitivity estimate of at least 92% and a specificity estimate of at least 99%. Several diagnostic test classes were estimated to have positive predictive values of 100% throughout the investigated prevalence spectrum, whilst estimated negative predictive values were more variable and sensitive to disease prevalence. We also report the results of clinical utility models that can be used to determine the information gained from a positive and negative test result in each class, and whether each test is more suitable for confirmation or exclusion of disease. Our analysis suggests that several tests exist that are suitable alternatives to standard RT-PCR and we discuss scenarios in which these could be most beneficial, such as where time to test result is critical or, where resources are constrained. However, we also highlight methodological concerns with the design and conduct of many included studies, and also the existence of likely publication bias for some test classes. Our results should be interpreted with these shortcomings in mind. Furthermore, our conclusions on test performance are limited to their use in symptomatic populations: we did not identify sufficient suitable data to allow analysis of testing in asymptomatic populations.


1978 ◽  
Vol 26 (1) ◽  
pp. 22-26 ◽  
Author(s):  
CHARLES MURKOFSKY ◽  
HOPE R. CONTE ◽  
ROBERT PLUTCHIK ◽  
TOKSOZ B. KARASU

2017 ◽  
Vol 89 (7) ◽  
pp. 1146-1150 ◽  
Author(s):  
Mohan K. Shukla ◽  
Neeru Singh ◽  
Ravendra K. Sharma ◽  
Pradip V. Barde

Author(s):  
Nino Guy Cassuto ◽  
Anne Gravier ◽  
Mathilda Colin ◽  
Aurelie Theillay ◽  
Daniela Pires‐Roteira ◽  
...  

Author(s):  
Joseph Osarfo ◽  
Harry Tagbor ◽  
Michael Alifragis ◽  
Pascal Magnuess

Background: The use of malaria rapid diagnostic test(RDT) enables targeted treatment that mitigates against the development of parasite drug resistance. With detection thresholds at ≥200 parasites/μL, their diagnostic performance in pregnant women may be challenging as asymptomatic infections with low parasite densities are common. Few data exist on the performance of histidine-rich protein-2 (HRP2) RDTs in Ghanaian pregnant women considering commonly occurring low parasite densities. Objective: The study sought to contribute more knowledge on test performance on First Response® test kit to guide the continuous evaluation of HRP2 RDTs in pregnancy. Methods: As part of an antimalarial drug trial in pregnancy, First Response® RDT results were compared to microscopy of peripheral blood slides in 1664 women. The diagnostic performance indicators were computed as proportions with 95% confidence intervals. The risk of having a positive RDT result was computed for age, gravidity and parasite density using binomial regression methods. Results: Parasitaemia prevalence by microscopy was 5.71%(n =95/1664) while that by RDT was 21.57%(n = 359/1664). Sensitivity was 82.11% (n=78/95), specificity was 82.09% (n=1288/1569), positive predictive value was 21.73% (n=78/359), and the likelihood ratio for a positive test was 4.58. False-negative RDT results were recorded for low parasite densities as well as densities ≥ 200/ μL while false-positive results were recorded in 281of 1664 tests. Primigravidae and younger aged women were more likely to have positive RDT results compared to multigravidae and women aged ≥ 30 yr. Conclusion: The moderate sensitivity, specificity and other diagnostic parameters reported suggest the First Response® malaria RDT is useful for detecting peripheral parasitaemia in pregnant women but the use of HRP2-only RDTs is limited by the existence of parasites with HRP2 gene deletion. The use of RDTs based on combined antigens continues to be recommended. Further research is needed on RDT performance in pregnant women with declining malaria transmission.


2020 ◽  
Author(s):  
P.J. Ducrest

AbstractThere is an urgent need in rapid diagnostic test (RDT) to detect antibodies against SARS-CoV-2. We have developed a rapid and simple point-of-care lateral flow immunoassay (LFIA) detecting IgM and IgG against SARS-CoV-2 in 10 minutes. The aim of this study is to evaluate the diagnostic performance of this RDT. RT-PCR positive plasma samples (n=35) for SARS-CoV-2 and 97 negative control samples were studied. Diagnostic performance of IgG/IgM RDT was assessed using both gold standard RT-PCR and Electro-chemiluminescence immunoassay (ECLIA) Elecsys® Anti-SARS-CoV-2 total Ig. Overall, RDT sensitivity was 100% (95% confidence interval [95%CI]: 88-100%) and specificity 93% (95% CI: 85-97%). This IgG/IgM RDT done in plasma displays a high diagnostic accuracy for SARS-CoV-2 IgG/IgM in high COVID-19 prevalence settings. Its use could be considered in the absence of routine diagnostic serology facilities for samples collected between 10 and 180 days after symptoms onset.


2020 ◽  
Author(s):  
E.J. Nelson ◽  
J.A. Grembi ◽  
D.L. Chao ◽  
J.R. Andrews ◽  
L. Alexandrova ◽  
...  

ABSTRACTBackgroundA fundamental clinical and scientific concern is how lytic bacteriophage, as well as antibiotics, impact diagnostic positivity.MethodsCholera was chosen as a model disease to investigate this important question. Patients with diarrheal disease were enrolled at two remote hospitals in Bangladesh. Diagnostic performance was assessed as a function of lytic bacteriophage detection, as well as exposure to the first-line antibiotic azithromycin detected by mass spectrometry.ResultsAmong diarrheal samples positive by nanoliter quantitative PCR for Vibrio cholerae (n=78/849), the odds that a rapid diagnostic test (RDT) or qPCR was positive was reduced by 89% (OR 0.108; 95%CI 0.002-0.872) and 87% (OR 0.130; 95%CI 0.022-0.649) when lytic bacteriophage were detected, respectively. The odds that a rapid diagnostic test (RDT) or qPCR was positive was reduced by more than 99% (OR 0.00; 95% CI: 0.00-0.28) and 89% (OR 0.11; 95% CI: 0.03-0.44) when azithromycin was detected, respectively.ConclusionsEstimations of cholera burden may improve by accommodating for the negative effect of antimicrobial exposure on diagnostic positivity. Furthermore, the findings herein challenge our current approach to interpreting and developing bacterial diagnostics given variable rates of lytic bacteriophage and antibiotic exposure.


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