Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

Users Online : 19872

AbstractMaterial and MethodsResultsDiscussionConclusionReferencesDOI and Others
Article in PDF How to Cite Citation Manager Readers' Comments (0) Audio Visual Article Statistics Link to PUBMED Print this Article Send to a Friend
Advertisers Access Statistics Resources

Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


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

Important Notice

Original article / research
Year : 2023 | Month : February | Volume : 17 | Issue : 2 | Page : BC01 - BC04 Full Version

Comparison of NGSP Certified Methods and their Cost Analysis for Estimation of HbA1c- A Cross-sectional Study


Published: February 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/58347.17424
Bhasker Mukherjee, Chirag Hooda, Virender Singh, Rajesh Sahu, Mukesh U Singh

1. Professor, Department of Biochemistry, Armed Forces Medical College, Pune, Maharashtra, India. 2. Student, Department of Biochemistry, Armed Forces Medical College, Pune, Maharashtra, India. 3. PhD Scholar, Department of Immunohaematology and Blood Transfusion, Armed Forces Medical College, Pune, Maharashtra, India. 4. Associate Professor, Department of Community Medicine, Armed Forces Medical College, Pune, Maharashtra, India. 5. Resident, Department of Biochemistry, Armed Forces Medical College, Pune, Maharashtra, India.

Correspondence Address :
Bhasker Mukherjee,
Professor, Department of Biochemistry, Diamond Jubilee Block, Armed Forces Medical College, Opposite Race Course, Wanwadi, Pune, Maharashtra, India.
E-mail: bhasker.mukherjee@gmail.com

Abstract

Introduction: Diabetes Mellitus (DM) is a major non communicable disease that adversely impacts the health of the global community, contributing significantly to mortality. Estimation of glycated haemoglobin (HbA1c) is an integral component of diagnosis, treatment and follow-up of cases of DM as the various protocols have included it for therapy. In order to regularise the estimation of HbA1c, it is mandated by American Diabetes Association (ADA) to perform the test on NGSP certified methods only.

Aim: To compare the results of HbA1c analysis by SIEMENS DIMENSION EXL 200 and BIORAD D-10 (NGSP certified methods).

Materials and Methods: This was a cross-sectional observational study done in Department of Biochemistry, Armed Forces Medical College, Pune, Maharashtra, a tertiary care centre. One hundred and twenty blood samples in Ethylene Diaminetetraacetic Acid (EDTA) tubes for haemoglobin variant analysis, received from patients with unexplained anaemia or screening for antenatal care were included in the study. The tests for HbA1c were performed by HPLC based BIORAD D10 and enzymatic based method, SIEMENS DIMENSION EXL 200 analyser. Cost analysis of both the methods was also performed. Students paired t-test was done to look for any significant statistical difference. Kappa coefficient was also calculated to analyse for agreement between values.

Results: HbA1c estimation by SIEMENS DIMENSION EXL200 and BIORAD D-10 (both NGSP certified) showed marginally different results, but it was not significant enough to make a clinical difference (5.308% on BIORAD D10 and 5.211% on SIEMENS DIMENSION EXL 200). On performing the cost analysis, there was a significant difference observed with a figure of Rs 476.05/- per test on the SIEMENS DIMENSION EXL200, while it was significantly cheaper at Rs 266/- per test on the BIORAD D10.

Conclusion: Estimation of HbA1c on SIEMENS DIMENSION EXL200 and BIORAD D10 was not clinically significant. As per cost analysis, BIORAD D10 is a cheaper alternative and suitable for tertiary care or large volume centres.

Keywords

Cost estimation, Diabetes mellitus, Glycated haemoglobin, National glycohaemoglobin standardisation programme

Diabetes Mellitus has a predominant position in the list of non communicable disorders that have a significant impact on health at a global level, contributing significantly to mortality while having a prevalence of 8.5% of the adult population (1). The significant mortality associated with various non communicable diseases e.g., DM has been identified as a goal for reduction by a third, as a part of the Sustainable Development Goals of United Nations by 2030 (2). The National Health Policy of 2017 aims to reduce the number of premature deaths till 2025 by upto 25% (3). The prevalence of DM in India has increased significantly from 26 million cases in 1990 to 65 million cases in 2016 and the prevalence of DM in adults older than 20 years was 7.7% in 2016 (4). In a systematic review and meta-analysis in 2021, from 27 studies of different tribes from various parts of India, the prevalence rate of DM in men, women and children were found to be as 6.04%, 6.48% and 4.94%, respectively (5).

Glycation is the process by which glucose or its derivatives are non enzymatically added to the amino acids of haemoglobin molecule in a permanent manner. The N-terminal valine, of the β chain of the globin molecule is the usual site of addition of glucose, and then it is termed as HbA1c (6). This is the commonest site for addition of the glucose, though it may attach to other amino acids at other sites on both α and β chains (7). The significance of HbA1c in the diagnosis and management of DM and Gestational Diabetes Mellitus (GDM) is understood by its inclusion in the diagnostic criteria for DM (8). Due to the diagnostic and therapeutic significance of HbA1c, the method of its estimation becomes extremely significant. There are multiple known methods for the estimation of HbA1c; while one set of methods physically separate the different fractions of haemoglobin from each other by using various techniques, while in the next set of methods, it is estimated by chemical reactions (8). The analytical methods for glycated haemoglobin are based on charge differences on glycated and non glycated haemoglobin: cation exchange chromatography, electrophoresis and iso electro focusing. The analytical methods for analysis based on the differences in structures of the glycated haemoglobin include boronate affinity chromatography and various immunoassays (8). The boronate affinity chromatography method is capable of detecting glycation in α and β chains N-terminal valine, as well as on lysine residues (8). There is a slight difference in the products measured by boronate affinity chromatography as compared to other methods of analysis, as this method estimates the total glycated haemoglobin (9). The reference method for estimation of glycated haemoglobin in the DCCT trial was cation exchange chromatography. The National Glycohaemoglobin Standardisation Programme (NGSP) was established in 1996, in order to standardise the values of glycated haemoglobin among the various laboratories analysing HbA1c to the DCCT method (6). It is recommended by American Diabetes Association (ADA) that only NGSP certified methods be used for the analysis of HbA1c (8). For any method of analysis to be NGSP certified, it has to have a total imprecision (CV%) of <4% and the 95% CI with a reference laboratory should fall within the clinically significant limits of ±1% HbA1c (10). Various factors are known to influence the levels of glycated haemoglobin, including various haemoglobinopathies that reduce RBC survival, Vit C and Vit E use, Iron deficiency anaemia, hypertriglyceridaemia, hyperbilirubinaemia, uraemia, chronic alcoholism, chronic ingestion of salicylates and opiate addiction (11),(12),(13),(14),(15). The interpretation of HbA1c in some cases varies with the race and ethnicity, G6PD deficiency (Glucose 6 Phosphate Dehydrogenase), sickle cell anaemia, pregnancy (second and third trimesters), recent blood loss, haemodialysis, postpartum period, blood transfusion or erythropoietin therapy (16),(17),(18),(19),(20),(21),(22),(23),(24). The presence of various different chains in haemoglobin alters the rate of glycation of haemoglobin hence the interpretation of HbA1c becomes complicated in case of haemoglobin variants (9).

Multiple studies have been done in India in order to compare the results of HbA1c by different methods but none has been done on the enzymatic method, which is routinely used by there clinical chemistry laboratory (25),(26),(27). The methods available in present setting include cation exchange chromatography on BIORAD D10 analyser as well as enzymatic methods on SIEMENS DIMENSION EXL 200, both of which are NGSP certified. Cost analysis of any analyte is an inescapable part of administrative task of the healthcare centre as it helps the administration in determining which method of analysis is suitable at a particular scale of operations. This study was planned in order to compare the results of HbA1c by these analysers and to perform the cost analysis of both methods.

Material and Methods

This cross-sectional observational study was undertaken in Department of Biochemistry, Armed Forces Medical College, Pune, Maharashtra. The duration of the study was from February 2021 to July 2021. A total of 120 samples were selected following inclusion criteria. As this was a Short-term Studentship project of ICMR (STS Reference 2020-01582) and had to be completed in a short duration, the sample size was kept at 120 (as approximately 20 patients reported monthly). The duration of the study was initially planned to be the case load for three months, but due to reduced patient load during COVID-19 pandemic, the duration had to be increased.

Inclusion criteria:

• All samples received for estimation of HbA1c, irrespective of their glycaemic or haemoglobin variant status.

Exclusion criteria:

• Any recipient of blood transfusions in the previous 12 weeks.
• Samples with inadequate blood volume.

Study Procedure

Blood samples were collected in EDTA vacuum evacuated tubes (2 mL) and stored at -20°C, until analysis was done. As per protocol, the samples were collected every day and processed weekly.

The HbA1c was estimated on both the analysers BIORAD D10 analyser as well as by enzymatic methods on SIEMENS DIMENSION EXL 200.The HPLC analyser BIORAD D10 is routinely used for performing haemoglobin variant analysis in patients as it is widely used for this clinical purpose, and it performs HbA1c analysis by default in all the samples. Proper quality control was performed on both the systems, as per the protocols already laid down. The cost analysis was done by including the cost of the kits for performing the tests as per the instructions (SIEMENS DIMENSION HbA1c flex and BIORAD D-10 Recorder Pack), different consumables (SIEMENS DIMENSION A1C calibrator) and quality controls (BIORAD LYPHOCHECK Diabetes Control Level 1 and 2) , that were used for performing all these tests.

Statistical Analysis

The data was analysed using SPSS version 23.0 software. The qualitative data was analysed for frequencies. Mean with standard deviation of HbA1c was calculated for both methods. Kappa statistics was measured to see the degree of agreement between two methods of estimation of HbA1c. Student’s paired t-test was used to check whether mean HbA1c measured by two methods was statistically different or not, for which p<0.05 was taken as significant.

Results

Out of 120, 65% (n=78) of the subjects were predominantly female with mean age of 25.4 years (Table/Fig 1). The mean HbA1c on BIORAD D10 was 5.308±0.8986, while by SIEMENS DIMENSION EXL200, it was 5.211±0.9022. The association between the mean by these two methods was 0.936, which was not statistically significant (Table/Fig 2). Kappa coefficient statistics measuring the agreement between the results on nominal scale (Yes/No) by two methods was found to be 0.561 which was statistically significant. This showed that, there was moderate strength of agreement between two methods. Samples came for patients with unexplained anaemia or screening for antenatal care and it was found that Ante Natal Care (ANC) samples were 30 and there were 35 samples of anaemia. The haemoglobin variant status showed anaemia and ANC to be in highest cases (Table/Fig 3). The highest levels of foetal haemoglobin seen in the present study was 5.2%.

The cost analysis was performed on both the methods. For performing the cost analysis, the cost of the kit was factored, along with the cost of all consumables, including quality control, whenever it was run on the analysers (Table/Fig 4).

The basic cost of the test of HbA1c by both methods was close to each other, as seen in (Table/Fig 4). However, on addition of the quality control that is supposed to be run every time the samples were processed, the final figures showed that BIORAD D10 was cheaper as compared to SIEMENS DIMENSION EXL 200.

Discussion

The dilemma faced by clinical laboratories regarding the use of a suitable NGSP certified method for HbA1c analysis, is due to negligible information available regarding the cost incurred in performing the tests by different methods. Additionally, whether there is any clinical difference in HbA1c results by different methods doesn’t have significant data. The comparison of HbA1c by different methods has been done multiple times (28),(29). In a study of 110 samples, HPLC based method had higher mean as compared to the immunoturbidometric mean. They also found a higher variation of HbA1c by immunoturbidometric methods, though it was within the acceptable range (30). In a similar study from India with 137 samples, the mean HbA1c was higher with HPLC based method as compared to immunoturbidometric method, though conversely HPLC had a higher variation in the results (17).

High concentrations of HbF (Foetal haemoglobin), beyond 15% may interfere with HbA1c estimation with the SIEMENS DIMENSION EXL200, but not on the BIORAD D10 (31), hence in the present study, no interference by foetal haemoglobin was seen. This study was done to compare the results of HbA1c analysis on the analysers available in present setting, i.e., SIEMENS DIMENSION EXL200 and BIORAD D10, both of which are NGSP certified methods. By virtue of being NGSP certified, both the methods are recommended for clinical use and are supposed to give comparable results. In this study, the mean HbA1c, the mean by BIORAD D10 was found to be 5.308%, while on the SIEMENS DIMENSION EXL200 was 5.211%. This difference can be accepted as both the methods are NGSP certified.

The other significant component of the study was the cost analysis of both the methods. The cost per kit is easily available as the cost is mentioned on all the kits by the actual manufacturers of the kits. The basic cost per test by SIEMENS DIMENSION EXL200 was Rs 162.16/-, while on the BIORAD D10 was Rs 162.5/-. There was hardly any cost-difference noted per kit initially. The cost of the quality control used routinely for assessing the quality of results generated by each method was subsequently added to the cost by each method. Finally, the cost seen on SIEMENS DIMENSION EXL200 was Rs 476.05/- per test while on the BIORAD D10 were Rs 266/ test. In a study of cost analysis of lab parameters by Declerck B et al., of 156 parameters, it was seen that high volume and automated tests had lower costs (32). This was also similar to the findings of Mouseli A et al., from a comparison of rates from 34 laboratories in a city (33). In a study by Gujral S et al., in a haematopathology laboratory, suggested that all laboratories would have separate cost per test and the cost decreased with the increase in volume of the tests (34). Unnikrishnan R and Mohan V also suggested that the interpretation of HbA1c in India by clinicians should be done meticulously keeping in mind the history of drug intake, distribution of haemoglobinopathies in different geographical locations or anaemia in the patient (35).

For any healthcare establishment, the choice of platform to perform an analysis depends on the cost of the analyser as well as the recurring cost per test. WHO has brought out the laboratory test costing tool in order to facilitate each laboratory to calculate the cost of a specific test (36). Since all healthcare establishments have to charge the patients for the test, it becomes extremely important that the cost analysis should be performed. In case there is a drastic difference in the sensitivity of the different methods or equipments, then a difference in the cost per test would be acceptable, otherwise a significant cost difference is not justifiable. In this case, there was a significant difference in the cost analysis of the both NGSP certified methods and it may vary in other centres, depending on the protocols of quality control being followed, as well as by the types of the quality control material being used by them.

Limitation(s)

The sample size could have been higher and other types of patients if included, may have given a wider picture.

Conclusion

Present study has shown that HbA1c estimation by both methods (both NGSP certified) had marginally different results, but it is not significant enough to make a clinical difference. On performing the cost analysis, there was a high difference observed in both the methods as BIORAD D10 was found to be cheaper than SIEMENS DIMENSION EXL200. Hence BIORAD D-10 is a commercially viable platform for estimation of HbA1c, especially for large or tertiary care centres.

References

1.
Global report on diabetes. World Health Organization. Geneva: WHO Press; 2016. 83.
2.
Report of the Inter Agency and Expert Group on Sustainable Development Goal Indicators. United Nations Economic and Social Council. 2016. 62.E/CN.3/2016/2/Rev.1.
3.
National Health Policy 2017. Ministry of Health and Family Welfare. Delhi: Government of India; 2017.28.
4.
Tandon N, Anjana RM, Mohan V, Kaur T, Afshin A, Ong K, et al. The increasing burden of diabetes and variations among the states of India: The global burden of disease study 1990–2016. Lancet Glob Health. 2018;6(12):e1352-62. [crossref] [PubMed]
5.
Hazarika CR, Babu VB. Prevalence of diabetes mellitus in Indian tribal population: A systematic review and meta-analysis. Ethnicity and Health. 2022:01-18. [crossref] [PubMed]
6.
Goodall I. HbA1c Standardisation destination– global ifcc standardisation how, why, where and when. Clin Biochem Rev. 2005;26(1):05-19.
7.
Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM, et al. Tests of glycemia in diabetes. Diabetes Care. 2004;27(7):13. [crossref] [PubMed]
8.
American Diabetes Association. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes. 2019. Diabetes Care. 2019;42(1):13-28. [crossref] [PubMed]
9.
Weykamp C. HbA1c: A review of analytical and clinical aspects. Ann of Lab Med. 2013;33:393-400. [crossref] [PubMed]
10.
Penttilä I, Penttilä K, Holm P, Laitinen H, Ranta P, Törrönen J, et al. Methods, units and quality requirements for the analysis of haemoglobin A1c in diabetes mellitus. World J Methodol. 2016;6(2):133-42. [crossref] [PubMed]
11.
Banerjee S. HbA1c result, does it depend on the testing method? Journal of the Association of Physicians of India. 2014;62:09-14.
12.
Tarim O, Kucukerdogan A, Gunay U, Eralp O, Ercan I. Effects of iron deficiency anaemia on hemoglobin A1c in type 1 diabetes mellitus. Pediatr Int. 1999;41:357-62. [crossref] [PubMed]
13.
Nathan DM, Francis TB, Palmer JL. Effect of aspirin on determinations of glycosylated hemoglobin. Clin Chem. 1983;29:466-69. [crossref] [PubMed]
14.
Stevens VJ, Fantl WJ, Newman CB, Sims RV, Cerami A, Peterson CM. Acetaldehyde adducts with hemoglobin. J Clin Invest. 1981;67:362-69. [crossref] [PubMed]
15.
Ceriello A, Giugliano D, Dello Russo P, Sgambato S, D’Onofrio F. Increased glycosylated haemoglobin A1 in opiate addicts: Evidence for a hyperglycaemic effect of morphine (Letter). Diabetologia. 1982;22:379. [crossref]
16.
Herman WH, Ma Y, Uwaifo G, Haffner S, Kahn SE, Horton ES, et al. Diabetes Prevention Program Research Group. Differences in A1C by race and ethnicity among patients with impaired glucose tolerance in the Diabetes Prevention Program. Diabetes Care. 2007;30:2453-57. [crossref] [PubMed]
17.
Kim C, Bullard KM, Herman WH, Beckles GL. Association between iron deficiency and A1C levels among adults without diabetes in the National Health and Nutrition Examination Survey, 1999-2006. Diabetes Care. 2010;33:780-85. [crossref] [PubMed]
18.
Paterson AD. HbA1c for type 2 diabetes diagnosis in Africans and African Americans: Personalized medicine. NOW! PLoS Med. 2017;14:e1002384. [crossref] [PubMed]
19.
Cappellini MD, Fiorelli G. Glucose-6- phosphate dehydrogenase deficiency. Lancet. 2008;371:64-74. [crossref] [PubMed]
20.
Picón MJ, Murri M, Muñoz A, Fernández-García JC, Gomez-Huelgas R, Tinahones FJ. Hemoglobin A1c versus oral glucose tolerance test in postpartum diabetes screening. Diabetes Care. 2012;35:1648-53. [crossref] [PubMed]
21.
G¨obl CS, Bozkurt L, Yarragudi R, Tura A, Pacini G, Kautzky-Willer A. Is early postpartum HbA1c an appropriate risk predictor after pregnancy with gestational diabetes mellitus? Acta Diabetol. 2014;51:715-22. [crossref] [PubMed]
22.
Megia A, N¨af S, Herranz L, Serrat N, Yañez R, Simón I et al. The usefulness of HbA1c in postpartum reclassification of gestational diabetes. BJOG 2012;119:891-94. [crossref] [PubMed]
23.
Welsh KJ, Kirkman MS, Sacks DB. Role of glycated proteins in the diagnosis and management of diabetes: Research gaps and future directions. Diabetes Care. 2016;39:1299-306. [crossref] [PubMed]
24.
Edelson PK, James KE, Leong A, Arenas J, Cayford M, Callahan MJ, et al. Longitudinal changes in the relationship between hemoglobin a1c and glucose tolerance across pregnancy and postpartum. The Journal of Clinical Endocrinology and Metabolism. 2020;105(5):1999-2007. [crossref] [PubMed]
25.
Sahu A, Gupta T, Sarkar PD. Comparative Study of Nitro Blue Tetrazolium (NBT) reduction method for estimation of glycated haemoglobin with glycated hba1c estimated on DCA2000+Analyzer (Immunoagglutination Inhibition). JAPI. 2010;58:20-22.
26.
Lekharu R, Tolani J, Pradhan R. A comparative study of quantitative estimation of HbA1c using HPLC and Immunoturbidometric method. Global Journal for Research Analysis. 2018;7(2):71-72.
27.
Sudhakar B, Reddy AS, Fallerio JJJ. Comparison of three methods for measurement of blood HbA1c as to reliability. International Journal of Bioassays. 2014;3(5):3000-04.
28.
Hawkins RC. Comparison of four point–of–care HbA1c analytical system against central laboratory analysis. Singapore Med J. 2003;44:08-11.
29.
Beaune G, Ducrnet J, Ducruet J, Jund J, Favre S. Evaluation of HBA1C measurement on Architect CI8200 (Abbott Diagnostic). Comparison with HPLC D-10 Bio-Rad assay. Ann Biol Clin. 2009;67:101-07. [crossref] [PubMed]
30.
Yasmeen F, Mumtaz A, Adhami S, Qureshi SA. Comparison of cation exchage HPLC and immunoturbidimetric method for determination of HbA1c. Biomedica. 2011;27:161-65.
31.
National Glycohemoglobin Standardisation Programme. Factors that interfere with HbA1c test results. Missouri. (updated 21/8/2019).
32.
Declerck B, Swaak M, Martin M, Kesteloot K. Activity based cost analysis of laboratory tests in clinical chemistry. Clinical Chemistry and Lab Medicine. 2021;59(8):1369-75. [crossref] [PubMed]
33.
Mouseli A, Barouni M, Amiresmaili M, Samiee SM, Vali L. Cost-price estimation of clinical laboratory services based on activity-based costing: A case study from a developing country. Electronic Physician. 2017;9:4077-83. [crossref] [PubMed]
34.
Gujral S, Dongre K, Bhindare S, Subramanian PG, Narayan HKV, Mahajan A, et al. Activity based cost methodology as tool for costing in hematopathology laboratory. Indian Journal of Pathology and Microbiology. 2010;53(1):68. [crossref] [PubMed]
35.
Unnikrishnan R, Mohan V. Challenges in estimation of glycated hemoglobin in India. Diabetes Technology and Therapeutics. 2013;15(10): 897-99. [crossref] [PubMed]
36.
Laboratory Test Costing Tool User Manual. World Health Organisation. Copenhagen: WHO Regional Office for Europe; 2019 17.

DOI and Others

DOI: 10.7860/JCDR/2022/58347.17424

Date of Submission: Jun 09, 2022
Date of Peer Review: Aug 20, 2022
Date of Acceptance: Nov 01, 2022
Date of Publishing: Feb 01, 2023

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

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jun 24, 2022
• Manual Googling: Sep 28, 2022
• iThenticate Software: Oct 31, 2022 (4%)

ETYMOLOGY: Author Origin

JCDR is now Monthly and more widely Indexed .
  • Emerging Sources Citation Index (Web of Science, thomsonreuters)
  • Index Copernicus ICV 2017: 134.54
  • Academic Search Complete Database
  • Directory of Open Access Journals (DOAJ)
  • Embase
  • EBSCOhost
  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com