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Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."
Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011
Dr. Shankar P.R.
"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."
Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011 Anuradha
Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.
Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020
Original article / research
Full Version
Comparison of Immunochromatographic Test and Electrochemiluminescence Assay with PCR for the Detection of Hepatitis B Virus: A Cross-sectional Study
Correspondence Address :
Dr. Ramya Rengaraj,
Associate Professor, Department of Microbiology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur-603319, Tamil Nadu, India.
E-mail: ramyarengaraj5@gmail.com
Introduction: Hepatitis B Virus (HBV) infection remains a significant public health concern globally, necessitating accurate and timely diagnostic methods. Immunochromatographic Tests (ICTs) and Electrochemiluminescence Assays (ECLIAs) are widely used assays for HBV detection due to their rapidity and cost-effectiveness. However, their diagnostic performance should be evaluated to ascertain their reliability.
Aim: To detect the presence of Hepatitis B Surface Antigen (HBsAg) in the selected samples using ICT and ECLIA and to compare it with HBV Deoxyribonucleic Acid (DNA) using a molecular assay.
Materials and Methods: A cross-sectional study was done with serum samples collected from patients visiting the hospital over a period of six months with prior ethical clearance. Serum samples were obtained from 57 patients suspected of HBV infection. The results of ICT, ECLIA, and HBV DNA viral load (by Polymerase Chain Reaction (PCR)) were cross-tabulated and assessed for differences in diagnostic sensitivity. The positivity and correlation of the ICT and ECLIA with PCR were estimated. All statistical analyses were performed using the R programming language.
Results: Out of 57 samples, 53 (92.98%) tested positive in the ICT card test, and 54 (94.74%) were positive in the ECLIA method. McNemar’s test showed that the sensitivity of ICT and ECLIA differed significantly compared to HBV DNA PCR. There was a significant positive correlation between ECLIA and HBV-DNA PCR (Spearman correlation, r-value=0.28, p-value=0.035).
Conclusion: The findings suggest that in settings where accurate diagnosis is critical, particularly for screening and monitoring treatment efficacy, molecular assays remain the preferred choice despite their higher cost and complexity. However, in resource-limited settings, ECLIAs can still play a valuable role in HBV screening programs.
Chemiluminescence, Immunochromatography, Polymerase chain reaction
India has one of the highest burdens of HBV infection globally. According to estimates from the World Health Organisation (WHO), there are approximately 40 million people living with chronic Hepatitis B infection in India (1). As per published data, about 200 crores of the world’s population have been exposed to HBV, of whom 350 million have a chronic carrier state. India falls in the intermediate endemicity zone with a prevalence rate of 2-7% (2). Timely and accurate diagnosis of Hepatitis B is crucial for effective management and prevention of complications. Various methods are employed to detect HBV infection, ranging from serological tests to molecular assays.
Chemiluminescence methods such as Chemiluminescent Microparticle Immunoassay (CMIA) and ECLIA have the added advantages of high sensitivity and specificity and are also easily done with quantitative results easily (3). These results have been used to predict and evaluate the effect of antiviral drug treatment on positive patients. ECLIA is increasingly being considered by labs and tertiary care centres for diagnosing HBsAg due to its better performance in terms of sensitivity, specificity, and result interpretation (4). In resource-limited settings, ICTs are widely used to detect HBsAg, as they are quick and relatively less costly compared to other diagnostic tests (5). Hence, the factors determining the choice of a specific serological test in screening or diagnosing symptomatic cases depend on cost-effectiveness, prevalence, and the diagnostic performance of the test. There have been few studies done in India to evaluate the role of ECLIA and ICT in HIV and HBV infections (6),(7),(8).
However, studies addressing the comparison of ICT and ECLIA with HBV DNA PCR are limited, which is crucial in resource-limited settings (9),(10). Thus, this study aimed to detect the presence of HBsAg in the selected samples using ICT and ECLIA and to compare it with HBV DNA PCR. The primary objective was to compare and correlate the positivity among different methodological kits for Hepatitis B detection.
The study was carried out as a cross-sectional study at the Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, a tertiary care hospital present in Melmaruvathur, Tamil Nadu, India. The study involved serum samples obtained from patients over a period of six months, from May 2023 to October 2023. These patients were suspected to have Hepatitis B and were advised by clinicians to undergo HbsAg detection. The study was approved by the Institutional Review Board (Reg No. 206 (5) 2022).
Inclusion criteria: Serum samples collected from both genders were included, irrespective of their age.
Exclusion criteria: Samples obtained from patients who underwent repeated testing for HbsAg detection were excluded from the study.
Sample size: The calculated sample size for this study was 73 samples, with an estimated precision of ±0.2, a 95% confidence interval, and an HbsAg positivity rate of 12.2% (11),(12). However, only 57 samples were included in this study due to financial and time constraints in obtaining and processing the samples.
Study Procedure
The detection of HBsAg was carried out by two methods: rapid antigen testing by immunochromatography test (ICT, HEPA card) and electrochemiluminescence immunoassay (ECLIA, ElecSys HBsAg, Roche Diagnostics). Both techniques detected HBsAg as per the manufacturer’s instructions, using appropriate calibrators and controls. ECLIA results were reported based on the Cut-Off Index (COI), where COI <0.9 represented a negative result, COI between 0.9 and <1.0 represented a borderline result, and COI ≥1.0 represented a reactive result (13). The ICT was a qualitative test, and it was done as per the manufacturer’s instructions, with results reported as either positive or negative (14). Serum samples were kept frozen at -70ºC until further analysis. Viral load, i.e., Hepatitis B Virus DNA testing, was done by Quantitative Polymerase Chain Reaction (Q-PCR) (Artus HBV PCR Kits CE, Qiagen) according to the manufacturer’s instructions. HBV DNA PCR results with <10.21 IU/L or <83.74 copies/mL were reported as “undetected” (1 IU/L equals 8.21 copies/mL, hence the detection limit of 10.21 IU/L corresponds to 83.74 copies/mL) (15).
Statistical Analysis
The data were entered into a Microsoft Excel sheet and analysed using R version 4.1.1. McNemar’s test was done to compare the sensitivity of ELCIA and ICT with HBV DNA PCR. Spearman’s correlation was done to determine the relationship between HBsAg levels detected by ECLIA and HBV DNA levels detected by PCR. A p-value of <0.05 was considered statistically significant.
The total number of subjects recruited for the study was 57, with 20 females (35.09%) and 37 males (64.91%). The comparison of the results of ICT versus HBV DNA PCR is shown in (Table/Fig 1). Among the samples that were reported positive by ICT, the HBV DNA PCR detected the virus in 32 samples (60.38%) (Table/Fig 1). ICT and HBV DNA PCR showed a statistically significant difference in sensitivity (McNemar’s test, p-value=0.0002). The comparison of the results of ECLIA versus HBV DNA PCR is shown in (Table/Fig 2). Among the samples that reported positive by ECLIA, the HBV DNA PCR detected the virus in 34 samples (62.96%) (Table/Fig 2). ECLIA and HBV DNA PCR showed a statistically significant difference in sensitivity (McNemar’s test, p-value=0.00003).
The correlation of ECLIA with HBV DNA PCR was plotted and found to have a significant positive correlation between ECLIA and HBV DNA PCR (Spearman correlation, r-value=0.28, p-value=0.035) (Table/Fig 3).
The results of this study provide valuable insights into the performance and correlation of the ICT and ECLIA methods with the gold standard molecular assay, HBV DNA PCR, for the detection of HBV infection. The high positivity rate of 92.98% observed with the ICT card test proves that it is the best available screening method and strengthens its utility as a rapid and convenient diagnostic tool for HBV screening. However, it is essential to note that among the samples identified as positive by ICT, only 60.38% were confirmed positive by HBV DNA PCR This indicates a considerable rate of false positives with the ICT method, which may lead to misdiagnosis and unnecessary concern among patients, leading to the initiation of treatment or a delay in surgical procedures. Therefore, while ICTs offer quick results and ease of use, their lower specificity compared to molecular assays highlights the importance of confirmatory testing, especially in clinical settings where accuracy is most needed.
Conversely, the ECLIA method showed a positive correlation with HBV DNA PCR, as evidenced by a significant Spearman correlation coefficient of 0.28 (p-value <0.05). This suggests that ECLIA may offer better sensitivity and specificity compared to ICTs, making it a more reliable option for HBV detection, particularly in settings where molecular assays are not readily available or feasible. The correlation observed between ECLIA and HBV DNA PCR indicates that ECLIA results can serve as a useful indicator of HBV infection status, although confirmatory testing may still be warranted in certain cases, especially when clinical suspicion is high or when discordant results are obtained.
The high cost of diagnostic tests, the need for lifelong monitoring, and the stigma attached to accessing healthcare are the various barriers preventing patients from getting guideline-based treatment (16). Furthermore, a mutation in the ORF region that codes for HBsAg can cause a conformational change and result in HBsAg mutants, leading to the risk of a false negative HBsAg result with certain test kits (17). Many studies have evaluated the performance of various methods in different study settings (6),(17),(18),(19),(20). Most of the studies compare Rapid Diagnostic Tests (RDTs) with Enzyme Immunoassays (EIAs) (20). There are only a few studies available that compare RDTs with Nucleic Acid Amplification Tests (NAAT) as reference standards [9,10]. The sensitivity and specificity varied according to the study settings and the kits used. Molecular assays directly detect HBV DNA in serum or plasma, providing quantitative measurement of viral load and assessing viral replication, including PCR. In a meta-analysis conducted by Amini A et al., it was found that the pooled sensitivity and specificity of HBsAg detection by ICT were 90.0% (95% CI: 89.1, 90.8) and 99.5% (95% CI: 99.4, 99.5), respectively, with EIA as the reference standard. The estimates varied among different kits (20). The same study also showed that the pooled sensitivity and specificity of EIA were 88.9% (95% CI: 87.0, 90.6) and 98.4% (95% CI: 97.8, 98.8), respectively, with CLIA as the reference standard (20).
A study conducted by Dembele B et al., compared four different RDTs and reported that the sensitivity varied from 97 to 100%, and the specificity varied between 99 and 100% (5). The clinical significance and correlation of quantitative assays qHBsAg with HBV DNA was first reported by Park et al., (21). A number of studies have documented the positive correlation between qHBsAg and the viral DNA load, indicating that quantification of HBsAg can be used as an inexpensive alternative for monitoring the treatment response (22),(23). But, there are also contraindications in some studies that have reported a lack of correlation between the two, as shown by Mathai F et al., published that there is a weak but significant correlation between HBsAg and HBV DNA (p-value=0.024, r-value=0.171) (24). A comparison of the present study with similar studies has been done in (Table/Fig 4) (5),(6),(20),(23).
Overall, the findings highlight the importance of choosing appropriate diagnostic methods based on their performance characteristics and the clinical context. While rapid tests like ICTs offer quick results and may be suitable for screening purposes, they should be used judiciously, with confirmatory testing performed whenever possible to minimise the risk of false positives. On the other hand, ECLIA remains a reliable and promising diagnostic tool for HBV detection, particularly when access to molecular assays is not available in those areas. Further research is warranted to explore ways to enhance the performance of RDTs while maintaining their ease of use and affordability, ultimately improving the diagnosis and management of HBV infection.
Limitation(s)
The sample size of the study was limited due to financial and time constraints. The sensitivity and specificity could not be calculated due to the smaller sample size, and the study participants included those who had a high index of suspicion for Hepatitis B.
The findings suggest that while ICTs and ECLIAs offer rapid and convenient options for HBV detection, they may exhibit lower sensitivity and specificity compared to molecular assays. Therefore, in settings where accurate diagnosis is critical, particularly for screening purposes and monitoring treatment efficacy, molecular assays remain the preferred choice despite their higher cost and complexity. However, in resource-limited settings where access to molecular assays is limited, ICTs and ECLIAs can still play a valuable role in HBV screening and surveillance programs. Further studies are warranted to explore strategies for improving the performance of RDTs while maintaining their affordability and accessibility.
The authors acknowledge the technical team of Department of Microbiology for their assistance in test assays.
DOI: 10.7860/JCDR/2024/71300.19527
Date of Submission: Apr 16, 2024
Date of Peer Review: Apr 27, 2024
Date of Acceptance: May 17, 2024
Date of Publishing: Jun 01, 2024
AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA
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