Performance of rapid hepatitis C virus antibody assays among high- and low-risk populations (original) (raw)
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Health Science Reports, 2021
Background and Aims: To enhance screening and diagnosis in those at-risk of hepatitis C virus (HCV), efficient and improved sampling and testing is required. We investigated the performance of point-of-care (POC) tests and dried blood spots (DBS) for HCV antibody and HCV RNA quantification in individuals at higher risk for HCV (people who use and inject drugs, sex workers and men who have sex with men) in seven South African cities. Methods: Samples were screened on the OraQuick HCV POC test (471 whole blood and 218 oral fluid); 218 whole blood and DBS paired samples were evaluated on the ARCHITECT HCV antibody (Abbott) and HCV viral load (COBAS Ampliprep/COBAS TaqMan version 2) assays. For HCV RNA quantification, 107 dB were analyzed with and without normalization coefficients. Results: POC on either whole blood or oral fluid showed an overall sensitivity of 98.5% (95% CI 97.4-99.5), specificity of 98.2% (95% CI 98.8-100) and accuracy of 98.4% (95% CI 96.5-99.3). On the antibody immunoassay, DBS showed a sensitivity of 96.0% (95% CI 93.4-98.6), specificity of 97% (95% CI 94.8-99.3) and accuracy of 96.3% (95% CI 93.8-98.8). A strong correlation (R 2 = 0.90) between viral load measurements for DBS and plasma samples was observed. After normalization, DBS viral load results showed an improved bias from 0.5 to 0.16 log10 IU/mL. Conclusion: The POC test performed sufficiently well to be used for HCV screening in at-risk populations. DBS for diagnosis and quantification was accurate and should be considered as an alternative sample to test. POC and DBS can help scale up hepatitis services in the country, in light of our elimination goals.
PLoS ONE, 2020
Background This study evaluated performance of two hepatitis C virus (HCV) rapid diagnostic tests (RDTs) performed by intended users in resource-limited settings. Methods Testing was conducted at three facilities in two countries (Georgia, Cambodia) using matched fingerstick whole blood, plasma and serum samples. Investigational RDTs were compared with a composite reference standard (CRS) comprised of three laboratory tests, and a reference RDT. Results In matched samples from 489 HCV positive and 967 HCV negative participants, specificity with both investigational RDTs was high using either reference method (≥98.4% in all sample types). Sensitivity was lower in whole blood versus plasma and serum for both RDTs compared with the CRS (86.5–91.4% vs 97.5–98.0% and 97.3–97.1%) and reference RDT (93.6–97.8% vs 100% and 99.4%). Sensitivity improved when considering only samples with detectable HCV viral load. Conclusion Sensitivity was highest in serum and plasma versus whole blood. The ...
Evaluation of a rapid on-site anti-HCV test as a screening tool for hepatitis C virus infection
European Journal of Gastroenterology & Hepatology, 2013
Background In settings such as needle-stick injuries or intravenous drug abuse, immediate knowledge of the anti-hepatitis C virus (HCV) serostatus instead of waiting for the results of a laboratory-based test can be important to guide further medical procedures and appropriate hygienic advises. Thus, a rapid on-site anti-HCV test was evaluated in daily clinical routine and compared with a laboratory-based certified assay. Patients and methods Ten microliters of serum or EDTA whole blood was analyzed using a chromatographic immunoassay (Toyo anti-HCV test). Results were available on-site 5-15 min after sample centrifugation. The Architect anti-HCV test served as a reference method. Results Sera of 189 patients were analyzed (without HCV infection: n = 105; HCV infection: n = 84). The assay was evaluable in 185 cases (98%). The sensitivity and specificity were 99 and 88%, respectively. With EDTA whole blood, the test was evaluable in 47/52 samples (90%). Forty-six of 47 evaluable EDTA tests were concordant with serum results. The one HCV patient with an unevaluable serum test was diagnosed correctly with the EDTA sample. Conclusion The rapid chromatographic anti-HCV immunoassay has limited specificity, which impairs clinical practicability. A positive result warrants re-evaluation with a certified serologic assay.
The SD BIOLINE Rapid Test for Detection of Antibodies to HCV among High-Risk Patients
2015
Introduction: Hepatitis C virus (HCV) infections are a public health problem throughout the world: the World Health Organization (WHO) estimates that over 180 million people are currently infected. The aim of this study is to determine the prevalence of anti-HCV in patients at high risk of infection through using a rapid test with capillary blood and confirmation of infection by PCR testing in real time. Method: Patients were enrolled in the study from among those treated in the gastroenterology unit of the Hospital Universitario de La Samaritana. This is one of the principal referral centers in the department of Cundinamarca, but it cares for patients from across the country. Hepatitis C risk factors identified included previous history of hepatitis C, transfusions, hemodialysis, major surgery (SNC, thorax, abdomen, orthope- dic), drug addiction, tattooing, piercing, acupuncture, time in prison, experience as a sex worker, HIV/AIDS, sexually transmitted diseases, health care work, ...
Journal of Virological Methods, 2011
The availability of a highly accurate, rapid, point-of-care test for hepatitis C virus (HCV) may be useful in addressing the problem of under-diagnosis of HCV, by increasing opportunities for testing outside of traditional clinical settings. A new HCV rapid test device (OraQuick ® HCV Rapid Antibody Test), approved recently in Europe for use with venous blood, fingerstick blood, serum, plasma, or oral fluid was evaluated in a multi-center study and performance compared to established laboratory-based tests for detection of HCV. The HCV rapid test was evaluated in prospective testing of subjects with signs and/or symptoms of hepatitis, or who were at risk for hepatitis C using all 5 specimen types. Performance was assessed relative to HCV serostatus established by laboratory methods (EIA, RIBA and PCR) approved in Europe for diagnosis of hepatitis C infection. Sensitivity to antibody in early infection was also compared to EIA in 27 seroconversion panels. In addition, the reliability of the oral fluid sample for accurate detection of anti-HCV was assessed by studying the impact of various potentially interfering conditions of oral health, use of oral care products and consumption of food and drink. In this large study of at-risk and symptomatic persons, the overall specificities of the OraQuick ® HCV Rapid Antibody Test were equivalent (99.6-99.9%) for all 5 specimen types and the 95% CIs substantially overlapped. Overall sensitivities were virtually identical for venous blood, fingerstick blood, serum and plasma (99.7-99.9%). Observed sensitivity was slightly lower for oral fluid at 98.1% though the upper CI (99.0%) was equal to the lower CI for venous blood and fingerstick blood. Most of the HCV positive subjects which gave nonreactive results in oral fluid had serological and virological results consistent with resolved infection. Sensitivity for anti-HCV in early seroconversion was virtually identical between the HCV rapid test and EIA. Detection of anti-HCV in oral fluid appeared generally robust to conditions of oral health, consumption of food and drink and use of oral care products. The OraQuick ® HCV Rapid Antibody Test demonstrated clinical performance that was equivalent to current laboratory-based EIA. This new, HCV rapid test appears suitable as an aid in the diagnosis of HCV infection and may increase testing opportunities due to its simplicity and flexibility to use multiple specimen types, including fingerstick blood and oral fluid.
Sensitivity of a rapid immuno-chromatographic test for Hepatitis C antibodies detection
Journal of Clinical Virology, 2008
Background and objectives: Enzyme-linked immunoassays (ELISA) are the most widely used anti-hepatitis C virus (HCV) screening tests but simple, instrument and electricity-free screening tests have been developed with results available in a few minutes. Methods: The sensitivity of a rapid immuno-chromatographic assay for the detection of anti-HCV antibodies was evaluated on 421 HCV RNA-positive samples from chronic carriers and compared with ELISA method. Results: The sensitivity of the ELISA method was 99.3% and the sensitivity of the rapid test was 95.5%. False negative results were independent of HCV genotype, but were associated with human immunodeficiency virus (HIV)-positive status. Among HIV-negative people, sensitivities of the rapid test and the EIA assay were 99.2% and 100%, respectively. Whereas among HIV-positive people, sensitivities were 77.5% and 96.3%.
2020
Objectives: Hepatitis C Virus (HCV) infection misdiagnosis has become a common finding in many hospitals and blood transfusion centres in Nigeria. This observational, crosssectional study determined the performance characteristics of three rapid test kits for the detection of HCV antibodies. Methods: Three anti-HCV rapid diagnostic tests (RDTs) kits, Aria®, LabAcon® and GLOBAL® were evaluated using a panel of known anti-HCV positive and negative samples obtained from consenting blood donors (n= 365) attending University of Abuja Teaching Hospital, Gwagwalada Abuja. The positive (n=53) and negative (n=36) samples were obtained by using ELISA and polymerase chain reaction (PCR). The sensitivity, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the 3 RDTs were assessed. Results: The sensitivity and specificity of Aria, LabAcon and GLOBAL were 83%, 81%, 75% and 64.9%, 86.1% and 86.1%% respectively. The PPV and NPV of Aria, LabAcon and Global were 77.2%, 88.6%, 88.9% and 71.9%, 68.9% and 70.5% respectively. The study observed no statistically significant difference in the sensitivity (p=0.343) but significant difference in the specificity (p<0.0001) comparing the 3 RDTs in the detection of hepatitis C virus antibodies. Conclusion: The sensitivities and specificities of the 3 rapid test kits evaluated were low indicating the superiority of ELISA over the 3 rapid test kits. The use of these 3 rapid test kits in testing blood donors and patients in hospitals could lead to false positive or negative results. This necessitates for evaluation of other rapid test kits for the detection of HCV antibodies in Nigeria.