scholarly journals Laboratory evaluation of the Chembio Dual Path Platform HIV-Syphilis Assay

2016 ◽  
Vol 5 (1) ◽  
Author(s):  
Mireille B. Kalou ◽  
Arnold Castro ◽  
Amy Watson ◽  
Heather Jost ◽  
Stacy Clay ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Diagnostic Tests ◽  
Treponema Pallidum ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation ◽  
Serum Samples ◽  
Operational Characteristics ◽  
High Risk Populations ◽  
Positive Results

Background: Use of rapid diagnostic tests for HIV and syphilis has increased remarkably in the last decade. As new rapid diagnostic tests become available, there is a continuous need to assess their performance and operational characteristics prior to use in clinical settings.Objectives: In this study, we evaluated the performance of the Chembio Dual Path Platform (DPP®) HIV–Syphilis Assay to accurately diagnose HIV, syphilis, and HIV/syphilis co-infection.Method: In 2013, 990 serum samples from the Georgia Public Health Laboratory in Atlanta, Georgia, United States were characterised for HIV and syphilis and used to evaluate the platform. HIV reference testing combined third-generation Enzyme Immunoassay and Western Blot, whereas reference testing for syphilis was conducted by the Treponema pallidum passive particle agglutination method and the TrepSure assay. We assessed the sensitivity and specificity of the DPP assay on this panel by comparing results with the HIV and syphilis reference testing algorithms.Results: For HIV, sensitivity was 99.8% and specificity was 98.4%; for syphilis, sensitivity was 98.8% and specificity was 99.4%. Of the 348 co-infected sera, 344 (98.9%) were detected accurately by the DPP assay, but 11 specimens had false-positive results (9 HIV and 2 syphilis) due to weak reactivity.Conclusion: In this evaluation, the Chembio DPP HIV–Syphilis Assay had high sensitivity and specificity for detecting both HIV and treponemal antibodies. Our results indicate that this assay could have a significant impact on the simultaneous screening of HIV and syphilis using a single test device for high-risk populations or pregnant women needing timely care and treatment.

scholarly journals Laboratory evaluation of the rapid diagnostic tests for the detection of Vibrio cholerae O1 using diarrheal samples

2021 ◽  
Vol 15 (6) ◽  
pp. e0009521
Author(s):  
Goutam Chowdhury ◽  
Tarosi Senapati ◽  
Bhabatosh Das ◽  
Asha Kamath ◽  
Debottam Pal ◽  
...  
Keyword(s):  
Vibrio Cholerae ◽  
Sensitivity And Specificity ◽  
Gold Standard ◽  
Diagnostic Tests ◽  
Diarrheal Disease ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation ◽  
Specificity And Sensitivity ◽  
Stool Samples

Background Cholera, an acute diarrheal disease is a major public health problem in many developing countries. Several rapid diagnostic tests (RDT) are available for the detection of cholera, but their efficacies are not compared in an endemic setting. In this study, we have compared the specificity and sensitivity of three RDT kits for the detection of Vibrio cholerae O1 and compared their efficiency with culture and polymerase chain reaction (PCR) methods. Methods Five hundred six diarrheal stool samples collected from patients from two different hospitals in Kolkata, India were tested using SD Bioline Cholera, SMART-II Cholera O1 and Crystal-VC RDT kits. All the stool samples were screened for the presence of V. cholerae by direct and enrichment culture methods. Stool DNA-based PCR assay was made to target the cholera toxin (ctxAB) and O1 somatic antigen (rfb) encoding genes. Statistical evaluation of the RDTs has been made using STATA software with stool culture and PCR results as the gold standards. The Bayesian latent class model (LCM) was used to evaluate the diagnostic tests in the absence of the gold standard. Results Involving culture technique as gold standard, the sensitivity and specificity of the cholera RDT kits in the direct testing of stools was highest with SAMRT-II (86.1%) and SD-Cholera (94.4%), respectively. The DNA based PCR assays gave very high sensitivity (98.4%) but the specificity was comparatively low (75.3%). After enrichment, the high sensitivity and specificity was detected with SAMRT-II (78.8%) and SD-Cholera (99.1%), respectively. Considering PCR as the gold standard, the sensitivity and specificity of the RDTs remained between 52.3–58.2% and 92.3–96.8%, respectively. In the LCM, the sensitivity of direct and enrichment testing was high in SAMRT-II (88% and 92%, respectively), but the specificity was high in SD cholera for both the methods (97% and 100%, respectively). The sensitivity/specificity of RDTs and direct culture have also been analyzed considering the age, gender and diarrheal disease severity of the patients. Conclusion Overall, the performance of the RDT kits remained almost similar in terms of specificity and sensitivity. Performance of PCR was superior to the antibody-based RDTs. The RTDs are very useful in identifying cholera cases during outbreak/epidemic situations and for making them as a point-of-care (POC) testing tool needs more improvement.

scholarly journals Comparison of Coombs Gel Test with ELISA and Standard Tube Agglutination Tests Used in Serological Diagnosis of Brucellosis

2020 ◽  
Vol 2 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Cigdem Akalan Kuyumcu ◽  
Serpil Erol ◽  
Rıza Adaleti ◽  
Seniha Senbayrak ◽  
Secil Deniz ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Diagnostic Tests ◽  
Serological Test ◽  
High Sensitivity ◽  
Serological Diagnosis ◽  
Control Groups ◽  
Serum Samples ◽  
Serological Tests ◽  
Reliable Test ◽  
And Control

Objective: Serological tests are the most commonly used tests in the diagnosis of brucellosis; however, each serological test has some drawbacks. In this study, we aimed to determine the value of the Brucella Coombs gel test (BCGT) in the serological diagnosis of brucellosis in comparison with Standard tube agglutination (STA) and ELISA tests. Materials and Methods: The study included 42 patients who were considered to have brucellosis as a preliminary diagnosis. BCGT, Brucella-IgM/IgG ELISA, and STA tests were performed from serum samples of the patients. The correlation of the diagnostic tests was analyzed using Cohen’s Kappa Analysis.  Results: Twenty-seven (64.2%) of 42 patients were diagnosed with brucellosis according to their medical history and clinical and serological tests. The sensitivity and specificity of BCGT to diagnose brucellosis was 96.2%, and 100%, respectively. The sensitivity and specificity for the diagnosis of brucellosis 62.9% and 100% for STA, respectively; 33.3% and 66.6% for Brucella-IgM; and 66.6% and 100% for Brucella-IgG. BCGT was significantly correlated with STA (κ= 0.590) and Brucella-IgG (κ=0.539) Conclusion: BCGT can be utilized as a simple and reliable test in the diagnosis of brucellosis with high sensitivity and specificity. Nevertheless, the sensitivity and specificity of BCGT should be demonstrated by comprehensive studies, including culture-confirmed cases and control groups.

scholarly journals Sensitivity and specificity of commercially available rapid diagnostic tests for viral hepatitis B and C screening in serum samples

PLoS ONE ◽  
2020 ◽  
Vol 15 (7) ◽  
pp. e0235036
Author(s):  
Ganbolor Jargalsaikhan ◽  
Miriam Eichner ◽  
Delgerbat Boldbaatar ◽  
Purevjargal Bat-Ulzii ◽  
Oyungerel Lkhagva-Ochir ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Viral Hepatitis ◽  
Sensitivity And Specificity ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Serum Samples ◽  
Viral Hepatitis B

scholarly journals A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study

2021 ◽  
Vol 15 (2) ◽  
pp. e0009159
Author(s):  
Janejira Dinhuzen ◽  
Umaporn Limothai ◽  
Sasipha Tachaboon ◽  
Panadda Krairojananan ◽  
Bangon Laosatiankit ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Medical Science ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Case Definition ◽  
Serum Samples ◽  
Thai Population ◽  
Low Sensitivity ◽  
A Prospective Study ◽  
Post Onset

Background Rapid diagnostic tests (RDTs) have become widely used in low-resource settings for leptospirosis diagnostic. This study aims to evaluate the diagnostic performance of the five commercially available RDTs to detect human IgM against Leptospira spp. in Thai population. Methodology/Principal findings Ninety-nine serum samples from Leptospirosis suspicious patients were tested with five RDTs, including Medical Science Public Health, Leptocheck-WB, SD bioline, TRUSTline, and J.Mitra. The case definition was based on MAT, qPCR, and culture results. Diagnostic accuracy was determined based on the first day of enrollment in an overall analysis and stratified according to days post-onset of fever. The five RDTs had overall sensitivity ranging from 1.8% to 75% and specificity ranging from 52.3% to 97.7%. Leptocheck-WB had high sensitivity of 75.0%. The sensitivity of five RDTs increased on days 4–6 post-onset of fever, while the specificity of all tests remained relatively stable at different days post-onset of fever. Conclusions/Significance The tested RDTs showed low sensitivity. Therefore, based on the present study, five commercially available RDTs might not be an appropriate test for acute leptospirosis screening in the Thai population.

scholarly journals Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study

2020 ◽  
Author(s):  
Beatrice N Vetter ◽  
Elena Ivanova Reipold ◽  
Stefano Ongarello ◽  
Rosemary Audu ◽  
Fehintola A Ige ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Sensitivity And Specificity ◽  
Diagnostic Tests ◽  
Target Population ◽  
Evaluation Study ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation ◽  
Core Antigen ◽  
Hiv Coinfection

Abstract Background Hepatitis C virus (HCV) screening is critical to HCV elimination efforts. Simplified diagnostics are required for low-resource settings and difficult-to-reach populations. This retrospective study assessed performance of rapid diagnostic tests (RDTs) for detection of HCV antibodies. Methods Two lots of 13 RDTs were evaluated at 3 laboratories using archived plasma samples from 4 countries (Nigeria, Georgia, Cambodia, and Belgium). HCV status was determined using 3 reference tests according to a composite algorithm. Sensitivity and specificity were evaluated in HIV-infected and HIV-uninfected populations. Operational characteristics were also assessed. Results In total, 1710 samples met inclusion criteria. In HIV-uninfected samples (n = 384), the majority of RDTs had sensitivity ≥98% in 1 or both lots and most RDTs had specificity ≥99%. In HIV-infected samples (n = 264), specificity remained high but sensitivity was markedly lower than in HIV-uninfected samples; only 1 RDT reached >95%. The majority of HIV-infected samples for which sensitivity was low did not have detectable HCV viral load/core antigen. Interreader variability, lot-to-lot variability, and rate of invalid runs were low for all RDTs (<2%). Conclusions HCV RDTs should be evaluated in the intended target population, as sensitivity can be impacted by population factors such as HIV status. Clinical Trials Registration NCT04033887

scholarly journals Study protocol for a cluster-randomized split-plot design trial to assess the effectiveness of targeted active malaria case detection among high-risk populations in Southern Lao PDR (the AcME-Lao study)

2019 ◽  
Vol 3 ◽  
pp. 1730 ◽  
Author(s):  
Andrew A. Lover ◽  
Emily Dantzer ◽  
Sophia Hocini ◽  
Ronaldo Estera ◽  
Francois Rerolle ◽  
...  
Keyword(s):  
High Risk ◽  
Diagnostic Tests ◽  
Lao Pdr ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Case Detection ◽  
Test And Treat ◽  
High Risk Populations ◽  
Cluster Randomized ◽  
Plot Design

Introduction: Novel interventions are needed to accelerate malaria elimination, especially in areas where asymptomatic parasitemia is common, and where transmission generally occurs outside of village-based settings. Testing of community members linked to a person with clinical illness (reactive case detection, RACD) has not shown effectiveness in prior studies due to the limited sensitivity of current point-of-care tests. This study aims to assess the effectiveness of active case finding in village-based and forested-based settings using novel high-sensitivity rapid diagnostic tests in Lao People’s Democratic Republic (Lao PDR). Methods and analysis: This study is a cluster-randomized split-plot design trial. The interventions include village-based mass test and treat (MTAT), focal test and treat in high-risk populations (FTAT), and the combination of these approaches, using high-sensitivity rapid diagnostic tests (HS-RDTs) to asses P. falciparum infection status. Within four districts in Champasak province, Lao PDR fourteen health center-catchment areas will be randomized to either FTAT or control; and within these HCCAs, 56 villages will be randomized to either MTAT or control. In intervention areas, FTAT will be conducted by community-based peer navigators on a routine basis, and three separate rounds of MTAT are planned. The primary study outcome will be PCR-based Plasmodium falciparum prevalence after one year of implementation. Secondary outcomes include malaria incidence; interventional coverage; operational feasibility and acceptability; and cost and cost- effectiveness. Ethics and dissemination: Findings will be reported on clinicaltrials.gov, in peer-reviewed publications and through stakeholder meetings with Ministry of Health and community leaders in Lao PDR and throughout the Greater Mekong Subregion. Trial registration: clinicaltrials.gov NCT03783299 (21/12/2018)

scholarly journals Laboratory Evaluation of Three Rapid Diagnostic Tests for Dual Detection of HIV and Treponema pallidum Antibodies

2014 ◽  
Vol 52 (12) ◽  
pp. 4394-4397 ◽  
Author(s):  
R. M. Humphries ◽  
J. S. Woo ◽  
J. H. Chung ◽  
A. Sokovic ◽  
C. C. Bristow ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Treponema Pallidum ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation ◽  
Dual Detection

scholarly journals Evaluation of the Elecsys Syphilis Immunoassay for Detection of Syphilis in Populations at Risk of Disease in the US and Argentina

2018 ◽  
Vol 3 (1) ◽  
pp. 89-99 ◽  
Author(s):  
Robert H Christenson ◽  
Marvin Lessig ◽  
Gabrielle Miles ◽  
Silke Luebcke ◽  
Cheryl Stillions ◽  
...  
Keyword(s):  
At Risk ◽  
Sensitivity And Specificity ◽  
Treponema Pallidum ◽  
High Sensitivity ◽  
Primary Objective ◽  
Screening Assay ◽  
Syphilis Infection ◽  
Populations At Risk ◽  
The Us ◽  
Testing Algorithm

Abstract Background The Elecsys® syphilis immunoassay is an automated, qualitative immunoassay that uses a double-antigen sandwich format to detect antibodies to Treponema pallidum in human serum and plasma. We aimed to validate performance of the immunoassay in various populations at risk for syphilis infection in the US and Argentina. Methods Samples were obtained for a number of study cohorts, including participants from routine syphilis testing at high or low risk for syphilis, HIV-positive patients, pregnant women, and patients in various stages of syphilis infection. The primary objective was to validate the Elecsys syphilis immunoassay by comparing it with a composite testing algorithm using US Food and Drug Administration (FDA)-approved tests, including the predicate IMMULITE 2000 syphilis screening assay, the rapid plasma reagin, and the T. pallidum particle agglutination assay. Results Complete algorithm testing was performed on all 2660 collected samples. Acceptable precision was demonstrated in all samples. Comparison of the Elecsys syphilis immunoassay with the final syphilis status for all samples yielded a diagnostic sensitivity of 99.5% (95% CI, 98.21–99.94) and a diagnostic specificity of 99.2% (95% CI, 98.69–99.49). Overall, the lower limit of the 95% CIs for sensitivity and specificity met the expected performance of ≥95%. Conclusion This is the first study that confirms the high sensitivity and specificity of the Elecsys syphilis immunoassay in US and Argentinian cohorts and highlights the assay's usefulness as an alternative to current tests for the diagnosis of syphilis infection in a broad range of participant cohorts.

scholarly journals EVALUATION OF ELEVEN IMMUNOCHROMATOGRAPHIC ASSAYS FOR SARS-CoV-2 DETECTION: INVESTIGATING DENGUE CROSS-REACTION

2020 ◽  
Author(s):  
Beatriz Araujo Oliveira ◽  
Lea Campos de Oliveira ◽  
Franciane Mendes de Oliveira ◽  
Geovana Maria Pereira ◽  
Regina Maia de Souza ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
High Sensitivity ◽  
Diagnostic Techniques ◽  
Cross Reactivity ◽  
Cross Reaction ◽  
List Type ◽  
Rt Pcr ◽  
Serum Samples ◽  
Igm Antibodies ◽  
Good Agreement

AbstractBackgroundCOVID-19 disease (Coronavirus disease 2019) caused by SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) is widespread worldwide, affecting more than 11 million people globally (July 6th, 2020). Diagnostic techniques have been studied in order to contain the pandemic. Immunochromatographic (IC) assays are feasible and low cost alternative for monitoring the spread of COVID-19 in the population.MethodsHere we evaluate the sensitivity and specificity of eleven different immunochromatographic tests in 98 serum samples from confirmed cases of COVID-19 through RT-PCR and 100 negative serum samples from blood donors collected in February 2019. Considering the endemic situation of Dengue in Brazil, we also evaluated the cross-reactivity with Dengue using 20 serum samples from patients with confirmed diagnosis for Dengue collected in early 2019 through four different tests.ResultsOur results demonstrated agreement between immunochromatographic assays and RT-PCR, especially after 10 days since the onset of symptoms. The evaluation of IgG and IgM antibodies combined demonstrated a strong level of agreement (0.85) of IC assays and RT-PCR. It was observed cross-reactivity between Dengue and COVID-19 using four different IC assays for COVID-19 diagnosis. The specificity of IC assays to detected COVID-19 IgM antibodies using Dengue serum samples varied from 80% to 85%; the specificity of IgG detection was 100% and total antibody was 95%.ConclusionsWe found high sensitivity, specificity and good agreement of IC assays, especially after 10 days onset of symptoms. However, we detected cross-reactivity between Dengue and COVID-19 mainly with IgM antibodies demonstrating the need for better studies about diagnostic techniques for these diseases.HighlightsImmunochromatographic assays demonstrated high sensitivity and specificity and good agreement with the gold-standard RT-PCR;Increase in sensitivity and specificity of assays using samples collected after the 10th day of symptoms;Cross-reaction with Dengue serology in evaluation of IgM.

Serum metabolomics reveals dysregulation and diagnostic potential of oxylipins in tumor-induced osteomalacia

2021 ◽  
Author(s):  
Yiyi Gong ◽  
Xiaolin Ni ◽  
Chenxi Jin ◽  
Xiang Li ◽  
Yujie Wang ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Fibroblast Growth Factor 23 ◽  
Tumor Resection ◽  
High Sensitivity ◽  
Leukotriene B4 ◽  
Arachidonic Acid Metabolism ◽  
Serum Samples ◽  
Diagnostic Potential ◽  
Liquid Chromatography Tandem Mass ◽  
Diagnostic Panel

Abstract Context Excessive production of fibroblast growth factor 23 (FGF23) by tumor was considered as the main pathogenesis in tumor-induced osteomalacia (TIO). Despite its importance to comprehensive understanding of pathogenesis and diagnosis, the regulation of systemic metabolism in TIO remains unclear. Objectives We aimed to systematically characterize the metabolome alteration associated with TIO. Methods By means of liquid chromatography-tandem mass spectrometry (LC-MS) based metabolomics, we analyzed the metabolic profile from 96 serum samples (32 initial diagnosis TIO patients, pairwise samples after tumor resection and 32 matched healthy control subjects). In order to screen and evaluate potential biomarkers, statistical analyses, pathway enrichment and receiver operating characteristic (ROC) were performed. Results Metabolomic profiling revealed distinct alterations between TIO and HC cohort. Differential metabolites were screened and conducted to functional clustering and annotation. Significantly enriched pathway was found involved in arachidonic acid metabolism. A combination of 5 oxylipins, 4-HDoHE, leukotriene B4, 5-HETE, 17-HETE and 9,10,13-TriHOME, demonstrated a high sensitivity and specificity panel for TIO prediction screened by random forest (RF) algorithm (AUC=0.951, 95% confidence interval, CI 0.827-1). Supported vector machine (SVM) model and partial least-squares (PLS) model were conducted to validate the predictive capabilities of the diagnostic panel. Conclusions Metabolite profiling of TIO altered significant compared with HC. A high sensitivity and specificity panel with 5 oxylipins were tested as diagnostic predictor. For the first time, we provide the global profile of metabolomes and identify potential diagnostic biomarkers of TIO. The present work may offer novel insights into the pathogenesis of TIO.

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