Evidence map›Paper›PMID 28050368›Full record

ArticleJournal of clinical and diagnostic research : JCDR2016

Comparing Assay Performance of ELISA and Chemiluminescence Immunoassay in Detecting Antibodies to Hepatitis B Surface Antigen.

Mridula Madiyal, Siddharth Sagar, Shashidhar Vishwanath, Barnini Banerjee, Vandana Kalwaje Eshwara, Kiran Chawla

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical and diagnostic research : JCDR, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
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

14 citing papers in PubMed, 33 citations in OpenAlex.

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  12. Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2020
    Article
  13. Article
  14. Method Comparison (Agreement) Studies: Myths and Rationale.Journal of clinical and diagnostic research : JCDR · 2017
    Article
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

6 authors at 1 institution in 1 country.

Mridula MadiyalAssistant Professor, Department of Microbiology, Kasturba Medical College, Manipal University , Manipal, Karnataka, India .
Siddharth SagarTutor, Department of Microbiology, Kasturba Medical College, Manipal University , Manipal, Karnataka, India .
Shashidhar VishwanathAssociate Professor, Department of Microbiology, Kasturba Medical College, Manipal University , Manipal, Karnataka, India .
Barnini BanerjeeAssistant Professor, Department of Microbiology, Kasturba Medical College, Manipal University , Manipal, Karnataka, India .
Vandana Kalwaje EshwaraProfessor, Department of Microbiology, Kasturba Medical College, Manipal University , Manipal, Karnataka, India .
Kiran ChawlaProfessor and Head, Department of Microbiology, Kasturba Medical College, Manipal University , Manipal, Karnataka, India .
Kasturba Medical College, Manipal · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAntibodies to Hepatitis B surface Antigen (Anti-HBs) levels are measured as markers for immune response to vaccination and in decision making for post-exposure prophylaxis against Hepatitis-B. Several immunoassay formats are used to measure Anti-HBs, thus carrying the possibility of variation in measured levels between different assays. This study compares the performance of Chemiluminescence Immunoassay (CLIA) against Enzyme-linked Immunosorbent Assay (ELISA) in measuring Anti-HBs titer by looking into concordance between the two test reports.

aimTo compare the agreement between ELISA and CLIA in measurement of Anti-HBs antibody titers. MATERIALS AND

methodsThis prospective comparative study conducted at Kasturba Medical College, Manipal measured consecutive serum samples (69) sent for anti-HBs levels during May-June 2016 using both CLIA (Abbott Architect) and ELISA (Bio-Rad). Anti-HBs values of ≤10mIU/ml was considered as non-protective and >10mIU/ml as protective. The agreement between the tests in classifying the antibody titers as non-protective or protective was computed using Kappa coefficient, and the difference in individual titer values between the tests compared using Bland-Altman plot on SPSS (v.15).

resultsOut of the 69 samples analysed, 18 samples (26.1%) were of health-care personnel and remaining of patients. Agreement between ELISA and CLIA in identifying the antibody titers as protective and non-protective were 96.5% and 90.9% respectively, resulting in an agreement of 0.84. The coefficient-of-variation of ELISA and CLIA were 74.5% and 113.1%, respectively. Three value based discordant results were noted; two samples deemed protective by ELISA were reported as non-protective by CLIA. One non-protective titer by ELISA was reported as protective by CLIA.

conclusionAnalytical agreement is good between the two immunoassays. However there are some discrepancies in quantitative measurement. This may have been due the variation in the standard calibrators used in each assay. Though CLIA showed more variation in the values, it has the advantage of being automated test with low turn around time. Therefore, both the test methodologies can be reliably used in place of each other for detection of Anti- HBs titer.

Indexed as

Anti HBs titerBland-altman graphNon-protective titerProtective titerQuantitative immunoassay

Identifiers

PMID28050368
PMCPMC5198321
OpenAlexW2558531260

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

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.