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 Evaluation of five rapid diagnostic tests for detection of antibodies to hepatitis C virus (HCV): A step towards scale-up of HCV screening efforts in India

PLoS ONE ◽  
2019 ◽  
Vol 14 (1) ◽  
pp. e0210556 ◽  
Author(s):  
Arati Mane ◽  
Jilian Sacks ◽  
Sadhya Sharma ◽  
Harpreet Singh ◽  
Alexandra Tejada-Strop ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Diagnostic Tests ◽  
Scale Up ◽  
Rapid Diagnostic Tests ◽  
Hcv Screening

scholarly journals Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan

Diagnostics ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1354
Author(s):  
Adeel Abid ◽  
Murad Uddin ◽  
Taj Muhammad ◽  
Safia Awan ◽  
Tanya Applegate ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Sensitivity And Specificity ◽  
Resource Limited Setting ◽  
Hcv Infection ◽  
Confirmatory Test ◽  
Core Antigen ◽  
Hcv Rna ◽  
Resource Limited ◽  
Limited Setting

The diagnosis of Hepatitis C virus (HCV) infection can be challenging due to its cost and a lack of access to centralized testing. There is an urgent need to develop simplified HCV testing algorithms. The aim of this study was to evaluate the performance characteristics of a Hepatitis C core antigen (HCVcAg) assay in a decentralized, resource-limited setting. This is a descriptive cross-sectional study from a highly endemic area of Karachi, Pakistan. Between October 2019 and July 2020, subjects aged 12 years and above who screened positive for HCV antibodies were simultaneously tested for HCV RNA (Xpert HCV Viral Load, GeneXpert® IV, Cepheid, France) and HCVcAg (ARCHITECT HCV Ag assay, Abbott® Diagnostics) to confirm active HCV infection. An Abbott ARCHITECT® i1000SR Immunoassay Analyser was installed at a local district hospital as a point-of-care (POC) facility for HCVcAg testing, while samples for HCV RNA were tested in a central lab. Two hundred individuals (mean age 46.4 ± 14.5 years, 71.5% females), who screened positive for HCV antibody, were included in the study. HCV RNA was detected in 128 (64.0%) while HCVcAg was reactive in 119 (59.5%) cases. Performance of the Immunoassay Analyser was excellent with a higher throughput and quicker readout value compared to the GeneXpert System. The sensitivity and specificity of HCVcAg (≥10 fmol/L) at HCV RNA thresholds of ≥12 was 99.1% (95% CI: 95–100%) and 87.6% (95%CI: 78.4–94%). A strong agreement was observed between the HCVcAg assay and HCV RNA. The ARCHITECT HCV Ag assay showed high sensitivity and specificity compared to HCV RNA in a decentralized, resource-limited setting. It can therefore be used as a confirmatory test in HCV elimination programs, particularly for low-income countries such as Pakistan.

Evaluation of seven rapid diagnostic tests for detection of hepatitis C virus antibodies in China

2021 ◽  
Author(s):  
Bing Chen ◽  
Zhong‐Hui Ma ◽  
Bing Xu ◽  
Hao Chang ◽  
Xiao‐Xia He ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests

Performance of rapid diagnostic tests for the detection of antibodies to hepatitis C virus in whole blood collected on dried blood spots

2016 ◽  
Vol 23 (5) ◽  
pp. 399-401 ◽  
Author(s):  
L. Poiteau ◽  
A. Soulier ◽  
I. Rosa ◽  
F. Roudot-Thoraval ◽  
C. Hézode ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Whole Blood ◽  
Diagnostic Tests ◽  
Dried Blood Spots ◽  
Rapid Diagnostic Tests ◽  
Blood Spots

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 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.

Diagnostik der Hepatitis C Virus Infektion: Rolle des HCV-Core Antigen Assay

2015 ◽  
Vol 41 (08) ◽  
Author(s):  
HL Tillmann ◽  
J Wiegand ◽  
I Glomb ◽  
A Jelineck ◽  
G Picchio ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Core Antigen ◽  
Hcv Core Antigen ◽  
Antigen Assay

Role of Hepatitis C Virus Core Antigen Assay in Blood Donors Screening at Zagazig University Hospitals

2018 ◽  
Vol 8 (1) ◽  
pp. 48-54
Author(s):  
Rashed Hassan ◽  
Abdelmonem Elshamy ◽  
Sameh Abdel Monem ◽  
Emad Moustafa ◽  
Essam Wahab
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Blood Donors ◽  
Core Antigen ◽  
University Hospitals ◽  
Virus Core ◽  
Antigen Assay
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