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 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 four HIV/syphilis rapid diagnostic tests

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Annelies Van Den Heuvel ◽  
Hilde Smet ◽  
Irena Prat ◽  
Anita Sands ◽  
Willy Urassa ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation

scholarly journals Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria

2015 ◽  
Vol 130 ◽  
pp. S22-S26 ◽  
Author(s):  
Yue-Ping Yin ◽  
Evelyn Ngige ◽  
Chukwuma Anyaike ◽  
Gbenga Ijaodola ◽  
Taiwo A. Oyelade ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation

scholarly journals Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia

2018 ◽  
Vol 30 (4) ◽  
pp. 323-328 ◽  
Author(s):  
Margaret P Kasaro ◽  
Samuel Bosomprah ◽  
Melanie M Taylor ◽  
Ntazana Sindano ◽  
Caroline Phiri ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Scale Up ◽  
Treponema Pallidum ◽  
Field Performance ◽  
Antenatal Clinic ◽  
Cross Sectional Study ◽  
Rapid Diagnostic Tests ◽  
Cross Sectional ◽  
Active Syphilis ◽  
Field Setting

This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ≥1:4 were used to define active syphilis detection. Acceptability and feasibility were assessed using self-reported questionnaires. For Chembio, the HIV sensitivity was 90.6% (95%CI = 87.4, 93.0) and specificity was 97.2% (95%CI = 96.2, 97.8); syphilis sensitivity was 68.6% (95%CI = 61.9, 74.6) and specificity was 98.5% (95%CI = 97.8, 98.9). For SD Bioline, HIV sensitivity was 89.4% (95%CI = 86.1, 92.0) and specificity was 96.3% (95%CI = 95.3, 97.1); syphilis sensitivity was 66.2% (95%CI = 59.4, 72.4) and specificity was 97.2% (95%CI = 96.4, 97.9). Using the reference for active syphilis, syphilis sensitivity was 84.7% (95%CI = 76.1, 90.6) for Chembio and 81.6% (95%CI = 72.7, 88.1) for SD Bioline. Both rapid diagnostic tests were assessed as highly acceptable and feasible. In a field setting, the performance of both rapid diagnostic tests was comparable to other published field evaluations and each was rated highly acceptable and feasible. These findings can be used to guide further research and proposed scale up in antenatal clinic settings.

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 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 Laboratory evaluation of immunochromatographic rapid diagnostic tests for cholera in Haiti

PLoS ONE ◽  
2017 ◽  
Vol 12 (11) ◽  
pp. e0186710 ◽  
Author(s):  
Wilfredo R. Matias ◽  
Fabrice E. Julceus ◽  
Cademil Abelard ◽  
Leslie M. Mayo-Smith ◽  
Molly F. Franke ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation

Chronic Wasting Disease Options of Surveillance in Carpathian Cervids: from the Identification of Characteristic Microscopic Pathologic Changes to Prionic Seeded Conversion and Amplification Assays

2001 ◽  
Vol 71 (3) ◽  
pp. 480-486
Author(s):  
Florica Barbuceanu ◽  
Stelian Baraitareanu ◽  
Stefania-Felicia Barbuceanu ◽  
Gabriel Predoi
Keyword(s):  
Enzyme Immunoassay ◽  
Diagnostic Tests ◽  
Chronic Wasting Disease ◽  
Rapid Diagnostic Tests ◽  
Diagnostic Methods ◽  
Wasting Disease ◽  
Western Immunoblotting ◽  
Negative Results ◽  
Antigen Capture ◽  
Confirmatory Tests

This paper describes the current diagnostic methods of Chronic Wasting Disease (CWD) in cervides used between 2013 and 2017 in Romania. The active surveillance of CWD involves the targeted groups screening by using rapid diagnostic tests (e.g., antigen capture enzyme immunoassay). If the first test does not provide certain negative results, then the confirmatory methods have been used, i.e. histopathology, immunohistochemistry and Western immunoblotting. These tests did not lead to the detection of CWD prions (PrPCWD) in Romania. This may be due to the absence or insufficient quantity of PrPCWD in samples, below the threshold of confirmatory tests.

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