Evaluation of the Novel HISCL Chemiluminescence Enzyme Immunoassay for Laboratory Screening of Hepatitis C Virus

Feng, Shu; Wei, Bin; Liu, Qianqian; Wang, Tingting; Li, Dongdong; Rao, Chenli; Tao, Chuanmin; Wang, Lanlan

doi:10.1128/cvi.00078-16

Cited by 4 publications

(5 citation statements)

References 9 publications

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“…Similar data on sensitivity and specificity of HISCL was reported by An et al(17). Elecsys anti-HCV II assay showed a sensitivity of 100% and a specificity of 99.66% in 7,726 routine samples from the Asia-Pacific region(18), while research by Feng et al(19) revealed that HISCL anti-HCV assay had a sensitivity of 98.97% and specificity of 100% in 1,048 samples from China. Other studies also indicated that both Elecsys and HISCL had superior performance in the detection of HBsAg and HIV…”

supporting

confidence: 76%

“…Results of seroconversion panel tests demonstrated that Elecsys had a slightly better performance than HISCL in early detection of all pathogen markers except for anti-HCV. Interestingly, Feng et al (19) compared anti-HCV assays of these two systems and found that Elecsys had a superior seroconversion sensitivity to HISCL (detection rate: 64.62% for Elecsys and 46.15% for HISCL). This advantage may be explained by the difference between ECLIA and CLIA in the detection mechanism.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Roche Elecsys and Sysmex HISCL immunoassays for the screening of common blood-borne pathogens

Tong

2019

Ann. Transl. Med.

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Background: We conducted a comprehensive comparison in the sensitivity, specificity, dilution sensitivity, and precision between two immunoassay systems, Roche Elecsys Cobas e 601 and Sysmex HISCL 5000, for the detection of hepatitis B virus surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV), treponemal antibodies (anti-TP), and human immunodeficiency virus (HIV). Methods: One thousand unselected samples and 100 reserved weak reactive samples were tested by the two systems. Sensitivity and specificity were then calculated for each system. Seroconversion panels were used to assess the sensitivity in early stage detection. Dilution sensitivity was evaluated by dilution tests of several seroconversion panel samples. Evaluation of within-run and intermediate precision was conducted following EP-15A protocol. Results: The consistency rates of the two systems for the detection of four pathogens were all over 99% among unselected samples. Both Elecsys and HISCL were observed to have high sensitivity and specificity in unselected samples and weak reactive samples. Seroconversion panel tests showed that Elecsys could identify positive results earlier than HISCL in HBsAg (1 out of 4), anti-TP (1 out of 2) and HIV (1 out of 12) panels. The results of the anti-HCV panels were comparable. In dilution tests, Elecsys could detect lower concentrations than HISCL in two anti-HCV samples and one anti-TP sample. The two systems had similar performance in dilution tests of HBsAg and HIV samples. Both Elecsys and HISCL had qualified intra-assay and inter-assay precision. Conclusions: Both Elecsys and HISCL have good performance in the screening of four common bloodborne pathogens. The two systems are comparable and considered adequate for clinical use.

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supporting

confidence: 76%

Section: Discussionmentioning

confidence: 99%

Comparison of Roche Elecsys and Sysmex HISCL immunoassays for the screening of common blood-borne pathogens

Tong

2019

Ann. Transl. Med.

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“…This study describes a novel quantitative assay using a fully automated immunochemistry analyzer that employs chemiluminescence enzyme immunoassay (CLEIA) methodology 28 , 29 , HISCL (Sysmex Corporation, Kobe, Japan), to simultaneously detect IgG and IgM antibodies against two SARS-CoV-2 antigens, the spike (S) protein and the nucleocapsid (N) protein (N-IgG, S-IgG, N-IgM, and S-IgM). HISCL is widely used in several clinical fields due to its rapid reaction (17 min), wide dynamic ranges, and high reproducibility compared with standard enzyme-linked immunosorbent assay (ELISA).…”

Section: Introductionmentioning

confidence: 99%

A novel highly quantitative and reproducible assay for the detection of anti-SARS-CoV-2 IgG and IgM antibodies

Noda

Matsuda

Yagishita³

et al. 2021

Sci Rep

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The quantitative range and reproducibility of current serological tests for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) are not optimized. Herein, we developed a diagnostic test that detects SARS-CoV-2 IgG and IgM with high quantitativeness and reproducibility and low interference. The system was based on the high-sensitivity chemiluminescence enzyme immunoassay (HISCL) platform and detects IgG and IgM specific to SARS-CoV-2 spike and nucleocapsid proteins. Quantification accuracy and reproducibility were evaluated using serially diluted samples from 60 SARS-CoV-2-infected patients. Assay performance was evaluated using serum samples from the SARS-CoV-2-infected patients and 500 SARS-CoV-2-negative serum samples collected before the emergence of SARS-CoV-2. The system showed high quantification accuracy (range, 102), high reproducibility (within 5%), and no cross-reaction between SARS1- and MERS-S proteins. Detection accuracy was 98.3% and 93.3% for IgG and IgM against spike proteins and 100% and 71.7% for IgG and IgM against nucleocapsid proteins, respectively. Mean antibody levels were > 10 times that in negative samples upon admission and > 100 times that at convalescent periods. Clinical severity upon admission was not correlated with IgG or IgM levels. This highly quantitative, reproducible assay system with high clinical performance may help analyze temporal serological/immunological profiles of SARS-CoV-2 infection and SARS-CoV-2 vaccine effectiveness.

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“…In this study, 13 anti-HCV detection kits were enrolled: ARCHITECT Anti-HCV (ARCHITECT-Ab; Abbott Japan, Tokyo, Japan) (Yoo et al, 2015;Shepherd et al, 2020;Nam et al, 2021), Alinity i Anti-HCV (Alinity-Ab; Abbott Japan) (Shepherd et al, 2020;Nam et al, 2021), Lumipulse HCV (Lumipulse-Ab; Fujirebio, Tokyo, Japan), Lumipulse Presto HCV (Lumipulse Presto-Ab; Fujirebio), Lumipulse II Ortho HCV (Ortho-Ab; Fujirebio), Lumipulse Presto Ortho HCV (Ortho Presto-Ab; Fujirebio), Elecsys Anti-HCV II (Elecsys-Ab; Roche Diagnostics, Tokyo, Japan) (Yoo et al, 2015;Feng et al, 2016;Xu et al, 2019), Accuraseed HCV [II], (Accuraseed-Ab; Sanyo Chemical Industries, Kyoto, Japan), ADVIA Centaur anti-HCV assay (Centaur-Ab; Siemens Healthcare Diagnostics, Tokyo, Japan) (Dwyer, 2004;Yoo et al, 2015), HISCL Anti-HCV Assay Kit (HISCL-Ab; Sysmex, Kobe, Japan) (Feng et al, 2016), HISCL Anti-HCV II Assay Kit (HISCL II-Ab; Sysmex) (Xu et al, 2019), CL AIA-PACK HCVAb (CL AIA-Ab; TOSOH, Tokyo, Japan), and E Test 'TOSOH' II HCVAb (AIA-Ab; TOSOH). Of these anti-HCV detection kits, Lumipulse-Ab, Lumipulse Presto-Ab, Ortho-Ab, Ortho Presto-Ab, Accuraseed-Ab, HISCL-Ab, and CL AIA-Ab provide classification titers.…”

Section: Evaluation Of Hcv Detection Kitsmentioning

confidence: 99%

Performance Evaluation of In Vitro Screening and Diagnostic Kits for Hepatitis C Virus Infection

Murayama

Momose

Yamada

et al. 2022

Front. Cell. Infect. Microbiol.

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AimA reliable kit with high sensitivity and specificity is indispensable for diagnosing hepatitis C virus (HCV) infection. Detection kits for anti-HCV antibodies (anti-HCV) are used for screening, and quantification kits for HCV RNA and HCV antigen (Ag) are used for the definite diagnosis of HCV infection or the evaluation of the pathological condition of and therapeutic effects in patients with chronic hepatitis C. Several kits are currently available for these purposes and are provided for clinical use in Japan. In this study, we aimed to evaluate the performance of these kits.MethodsWe used International Standards for HCV RNA and HCV Ag and a regional reference panel to evaluate the performance of thirteen anti-HCV, five HCV RNA, and two HCV Ag kits.ResultsAll specimens in the regional reference panel were diagnosed correctly by all anti-HCV kits, although the distributions of the quantified values varied, and the ratios of titer classification were not identical across kits. All HCV RNA kits quantified the International Standard with minimum deviation and diagnosed the specimens of the reference panel correctly. The quantified values of the International Standard by two HCV Ag kits were inconsistent. HCV Ag titers of some specimens were underestimated owing to the amino acid polymorphisms in comparison with HCV RNA titers.ConclusionsThe evaluation with International Standards and the regional reference panel was useful for assessing the quality of screening and diagnostic kits for HCV infection, and such quality control is essential for the clinical usage of these kits.

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Evaluation of the Novel HISCL Chemiluminescence Enzyme Immunoassay for Laboratory Screening of Hepatitis C Virus

Cited by 4 publications

References 9 publications

Comparison of Roche Elecsys and Sysmex HISCL immunoassays for the screening of common blood-borne pathogens

Comparison of Roche Elecsys and Sysmex HISCL immunoassays for the screening of common blood-borne pathogens

A novel highly quantitative and reproducible assay for the detection of anti-SARS-CoV-2 IgG and IgM antibodies

Performance Evaluation of In Vitro Screening and Diagnostic Kits for Hepatitis C Virus Infection

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