Developments in the HCV Screening Technologies Based on the Detection of Antigens and Antibodies

Warkad, Shrikant Dashrath; Song, Ki-Bong; Pal, Dilipkumar; Nimse, Satish Balasaheb

doi:10.3390/s19194257

Cited by 27 publications

(25 citation statements)

References 126 publications

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“…There is a great amount of evidence-based data in the literature, demonstrating the detection value of immunoglobulin, which can identify cycles of the infectious virology sector [7] , [8] , [9] . This study proposes to link serological information to molecular data and to resolve diagnosis difficulties in a global emergency scenario.…”

Section: Introductionmentioning

confidence: 99%

Comparison of serologic and molecular SARS-CoV 2 results in a large cohort in Southern Tuscany demonstrates a role for serologic testing to increase diagnostic sensitivity

Pancrazzi

Magliocca

Lorubbio

et al. 2020

Clinical Biochemistry

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Background Since February 2020, Italian hospitals registered COVID-19 (COronaVIrus Disease 19) cases more often than the rest of the Europe. During this epidemic, health authorities requested swab tests, while seeking new patient paths. Methods A dual laboratory approach was evaluated, consisting of patient care reports for viral RNA detection on swabs and rapid serological tests in 516 patients (192 symptomatic or paucisymptomatic and 324 asymptomatic). Results We found the molecular positive fraction equal to 12% (23/192) among symptomatic/paucisymptomatic (S/P) and 15.4% (50/324) in asymptomatic (As) sets. Among subsets, we observed serologically positive results, corresponding to 35% (8/23) for S/P and 38% (19/50) for As. Among molecular negative cases, we detected specific Immunoglobulin G or M (Ig G or Ig M) positivity in the S/P cohort equal to 6.6% (11/167) and 6% (15/246) in As cases. For indeterminate molecular results, we found S/P serological positivity equal to 100% (1/1) and 54% (13/24) in As patients. We found higher (p < 0.05) seropositivity in older patients (n = 8) among symptomatic and positives for viral RNA (n.23). Conclusions It has been observed that a dual approach of serological and molecular tests detects a higher absolute number of disease cases in a pandemic context,which could improve monitoring and health surveillance efficacy. The age-related seropositivity frequency in this study, if confirmed, could enhance the validity of serological tests, especially in older patients.In these subjects, molecular positivity accompanied by serological positivity (distinct for M and G immunoglobulins) should help determine disease status and support decisions related to patient management.

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Section: Introductionmentioning

confidence: 99%

Comparison of serologic and molecular SARS-CoV 2 results in a large cohort in Southern Tuscany demonstrates a role for serologic testing to increase diagnostic sensitivity

Pancrazzi

Magliocca

Lorubbio

et al. 2020

Clinical Biochemistry

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show abstract

“…But some low S/CO value specimens may be not fully detected by C, D, and F kit, and the single‐band specimens with only NS4‐1 bands could be missed by few HCV RDT kits, indicating that some HCV RDT kits had low sensitivity for diagnosing low‐titre and/or single‐band samples. This phenomenon may be due to the variability gene sequence of HCV NS4‐1 region, resulting in weak antigen antibody reaction 20 . Therefore, specimens with low‐titre and/or single‐band may be not detected.…”

Section: Discussionmentioning

confidence: 99%

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

Chen

Xu³

et al. 2021

Journal of Viral Hepatitis

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Rapid diagnostic tests as an attractive alternative to enzyme immunoassay could identify hepatitis C virus (HCV) infected persons more expeditiously. The availability of high performing and quality‐assured rapid diagnostic tests are essential to scale‐up HCV screening. The study was undertaken to evaluate the performance of seven domestic HCV rapid diagnostic tests kits. The kits were evaluated by using HCV serum panels, including HCV basic panel, analytical specificity panel, mixed titre performance panel, characteristic panel, seroconversion panel, and genotype qualification panel. The results showed that clinical sensitivity, clinical specificity and analytical specificity of seven rapid diagnostic tests kits ranged from 94% (95% CI: 83.2–98.6) to 100% (95% CI: 91.5–100). Furthermore, specimens with HCV genotypes 1b, 2a, 3a, 4a, 5a, 6 could be detected by HCV rapid diagnostic tests kits, whereas specimens with genotypes 1a and 2b could not be detected. Additionally, most HCV rapid diagnostic tests kits had great performance in diagnosing different titres and/or different bands samples, but some low S/CO value specimens may not be fully detected by few rapid diagnostic test kits. In conclusion, seven HCV rapid diagnostic tests reagents presented high sensitivity, specificity, good anti‐interference and detection ability of early infection, which could meet the requirements of clinical HCV antibody screening.

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“…In this system, the recombinant core protein was named c22-3, the recombinant NS3 (c33c) and NS4 (c100-3) proteins were fused into a new protein c200. c22-3, c200 and NS5 recombinant antigens were coated on microplates to form the anti-HCV detection platform [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

A study based on four immunoassays: Hepatitis C virus antibody against different antigens may have unequal contributions to detection

Jiang

Chang

Yan

et al. 2021

Virol J

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Background All commercial Hepatitis C virus antibody (anti-HCV) assays use a combination of recombinant antigens to detect antibody response. Antibody responses to individual antigenic regions (core, NS3/4 and NS5) used in assays have not been investigated. Methods In this study, we quantified HCV viral load, tested anti-HCV with four commercial assays (Ortho-ELISA, Murex-ELISA, Architect-CMIA and Elecsys-ECLIA) in 682 plasma specimens. In antigenic region ELISA platform, microwells were coated with three antigens: core (c22-3), NS3/4 (c200) and NS5 individually. The signal-to-cutoff (S/Co) values of different assays, and antibody responses to individual antigens were compared. The specimens were divided into HCV RNA positive group, anti-HCV consistent group, and anti-HCV discrepant group. Results Anti-core and anti-NS3/4 were simultaneously detected in 99.2% of HCV RNA positive specimens and showed great consistency with total anti-HCV signals. Responses to the core region were more robust than those to the NS3/4 region in anti-HCV consistent group (p < 0.001). Anti-NS5 only occurred in companying with responses to the core and NS3/4 antigens, and failed to affect the final anti-HCV positive signals. In anti-HCV discrepant group, 39.0% of positive signals could not be traced back to any single antigenic region. Conclusion Antibody responses to the core and NS3/4 antigens were stronger, whereas responses to the NS5 antigen were the weakest, indicating that individual antigenic regions played different roles in total anti-HCV signals. This study provides an impetus for optimizing commercial anti-HCV assays.

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Developments in the HCV Screening Technologies Based on the Detection of Antigens and Antibodies

Cited by 27 publications

References 126 publications

Comparison of serologic and molecular SARS-CoV 2 results in a large cohort in Southern Tuscany demonstrates a role for serologic testing to increase diagnostic sensitivity

Comparison of serologic and molecular SARS-CoV 2 results in a large cohort in Southern Tuscany demonstrates a role for serologic testing to increase diagnostic sensitivity

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

A study based on four immunoassays: Hepatitis C virus antibody against different antigens may have unequal contributions to detection

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