Evidence map›Paper›PMID 31148296›Full record

ArticleJournal of clinical laboratory analysis2019

Clinical diagnostic performance of light-initiated chemiluminescent assay compared with the Architect chemiluminescence immunoassay for detection of HCV antibody.

Shuo Yang, Ruifeng Yang, Siyu Zhang, Di Liu, Jiansuo Zhou, Tiancheng Wang, Liyan Cui

Abstract readComparative Study
In one paragraph

Article in Journal of clinical laboratory analysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Shuo YangDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, China.ORCID https://orcid.org/0000-0001-6894-0793
Ruifeng YangBeijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Peking University Hepatology Institute, Peking University People's Hospital, Beijing, China.
Siyu ZhangDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, China.
Di LiuDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, China.
Jiansuo ZhouDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, China.ORCID https://orcid.org/0000-0003-1879-5377
Tiancheng WangDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, China.
Liyan CuiDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, China.

Funding

National Natural Science Foundation of China 61771022
6 · The paper itself

Abstract

backgroundHepatitis C virus antibody (anti-HCV) test had been approved as a preliminary screening test for HCV infection. Light-initiated chemiluminescent assay (LiCA) was a homogenous method. We aimed to assess the clinical diagnostic performance of LiCA and compare it with that of chemiluminescence immunoassay (CLIA) which was widely used in clinical laboratories.

methodsA total of 10 772 patients from the Peking University Third Hospital were enrolled. The serum samples were detected on the ChIVD LiCA500 and Abbott Architect i2000SR platforms. Recombinant immunoblot assay (RIBA) and HCV RNA assay were used for confirmation.

resultsThe negative agreement rate between ChIVD LiCA anti-HCV assay and Abbott Architect anti-HCV assay was 99.91%, the positive agreement rate was 37.31%, the total agreement rate was 98.74%, and the kappa coefficient (κ) was 0.519. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ChIVD LiCA anti-HCV assay were 96.39%, 99.95%, 89.58%, and 99.97%, respectively, which were superior to those of Abbott Architect anti-HCV assay (93.98%, 99.25%, 51.90%, and 99.95%, respectively).

conclusionChIVD LiCA anti-HCV assay was a highly sensitive, specific homogenous method with good diagnostic performance, and was applicable for the routine screening of HCV infection in clinical laboratories.

Indexed as

LightHepatitis C AntibodiesHumansImmunoassayLuminescent MeasurementsReagent Kits, DiagnosticReproducibility of ResultsRNA, ViralHepatitis C AntibodiesReagent Kits, DiagnosticRNA, ViralAbbott Architect anti-HCV assayChIVD LiCA 500 analyzerHCV antibodyHCV RNAhepatitis Crecombinant immunoblot assay

Identifiers

PMID31148296
PMCPMC6757125

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.