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

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Dr Mohan Z Mani

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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."



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Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
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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.
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Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




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"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




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" 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 : 2021 | Month : August | Volume : 15 | Issue : 8 | Page : OC01 - OC05 Full Version

Efficacy of Ascitic Fluid Dipstick Leukocyte Esterase Activity in Early Diagnosis of Spontaneous Bacterial Peritonitis


Published: August 1, 2021 | DOI: https://doi.org/10.7860/JCDR/2021/48466.15176
Sanjay Gupta, Heerak Singh

1. Associate Professor, Department of Gastroenterology, SGRR Institute of Medical and Health Sciences, Dehradun, Uttarakhand, India. 2. Senior Resident, Department of Medicine, SGRR Institute of Medical and Health Sciences, Dehradun, Uttarakhand, India.

Correspondence Address :
Dr. Sanjay Gupta,
Associate Professor, Department of Gastroenterology, SGRR Institute of Medical and Health Sciences, Patel Nagar, Dehradun-248001, Uttarakhand, India.
E-mail: gastrogupta@gmail.com

Abstract

Introduction: Spontaneously occurring ascitic fluid infections {Spontaneous Bacterial Peritonitis (SBP)} are the most common and recurring complications in patients with decompensated cirrhosis with ascitis. Unlike other infections, ascitic fluid infections usually present with non specific symptoms and may be asymptomatic in a large number of patients. They not only accelerate hepatic decompensation, but may also lead to, or exacerbate other complications like hepatic encephalopathy, hematemesis, renal failure and death. The existing protocol of diagnosis of SBP includes ascitic fluid total and differential leukocyte counts, and ascitic fluid cultures, by inoculating the ascitic fluid in blood culture vials, which are not only cumbersome, but also costly, time consuming and cannot be followed in all patients presenting for outpatient treatment for therapeutic peracentesis.

Aim: To evaluate the efficacy of testing ascitic fluid pH, protein and Leucocyte Esterase (LERS) activity, by using Siemens Multistix 10SG Reagent Strips (SMRS) for early screening of patients for SBP.

Materials and Methods: The observational study was conducted at SGRR Institute of Medical and Health Sciences Dehradun, Uttarakhand, India, from January 2018 to March 2019. The study included 329 patients with cirrhosis and ascites presenting in either the Outpatient Department (OPD) or Emergency Room for therapeutic paracentesis or with cirrhotic complications were evaluated for SBP using SMRS for ascitic fluid pH, Leukocyte Esterase (LERS) activity and ascitic fluid protein, for early detection of SBP. The standard diagnostic criteria i.e., ascitic fluid Polymorphonuclear Counts (PNM) more than 250 cells/mm3, by Chamber Counting Method or positive ascitic fluid culture after 48 hours incubation were used as gold standard for diagnosis of SBP. Chi-square test was applied to find out significant association between independent and dependent variables. A p-value of <0.05 was considered significant.

Results: Among total 329 patients with cirrhotic ascitic, 81 were diagnosed to have SBP. At a cut-off of 2+, SMRS correctly detected SBP in 77/81 patients, was negative in 4/81 patients and falsely positive in 7/248 NSBP patients, thereby having a sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of 95%, 97.33%, 98.96% and 96.69%. At a cut-off of 3+, SMRS was able to detect SBP in 53/81 patients, and was falsely positive in 1/248 patients, thereby, although decreasing the sensitivity to 64%, but improving the specificity and PPV to 99.6% and 98.11%, respectively.

Conclusion: During diagnostic paracentesis, ascitic fluid LERS activity using SMRS are highly sensitive markers for early detection of SBP, especially in the presence of fever, vomiting and shock.

Keywords

Ascites, Cirrhosis, Polymorphonuclear, SIEMENS Multistix 10SG reagent strips

The development of ascites is an important landmark in the natural history of cirrhosis (1),(2). Ascites is invariably the first complication to occur and mark decompensation of liver cirrhosis (2),(3). Bacterial infections are common and recurring complication of cirrhosis, and associate with poor outcome (3). The most common infection in cirrhotic patients is SBP (25%), followed by urinary tract infection (20%), Pneumonia (15%), bacteremia (12%) and cellulitis (2-11%) (4).

SBP patients usually present to the clinician with non specific features like abdominal pain, fever, diarrhoea, paralytic ileus, vomiting, altered sensorium, upper gastrointestinal bleed, hypotension, hypothermia, respiratory distress, coma or sudden worsening of ongoing features of advanced cirrhosis (5). However, in upto 10% to 30% patients with SBP remain asymptomatic, and hence diagnosis of SBP without evaluation of the ascitic fluid is inadequate.

Present day diagnosis of SBP is made by diagnostic paracentesis, where a positive ascitic fluid culture with an elevated ascitic fluid absolute Polymorphonuclear leukocyte (PMN) cell count (atleast 250 cells/mm3) with no evidence of an intra-abdominal surgically treatable source of infections (1). Reported incidence of SBP in ascitic patients is upto 30% (1). Altered host immune system and translocation of the bacteria from the gut into the ascitic fluid is thought to be the mode of infection, and the most common organisms are enteric pathogens, most common being Escherichia coli, which is present in about 70% of SBP patients (1).

The probability of developing SBP in decompensated cirrhotics is approximately 10% per year. However, recurrence of SBP after the 1st episode is as high as 70% every year (2),(3). Earlier literature describes high rates of mortality in SBP. However early diagnosis and aggressive management, have results in declining mortality. Currently the rate of in hospital mortality has been describes as 30% to 50% (1).

Even though, early diagnosis is the key to successful management of SBP, the existing protocol of diagnosis of SBP includes ascitic fluid total and differential leukocyte counts, and ascitic fluid cultures, by inoculating the ascitic fluid in blood culture vials. Although, automated counters are now being used in many laboratories, manual counting method (Improved Neubauer Chamber and light microscopy), is still the most prevalent method in most hospitals and laboratories. The transportation of fluid, processing and reporting is time consuming, technically challenging, and reports are often available after several hours. The culture reports are invariably availably only after 48 hours only. Automated cell counters although have shown promising results, but their availability and cost are the major limitations (6).

Efforts are being made in recent years to develop tests for a rapid and accurate diagnosis of SBP, a test that can be performed bedside at the time of paracentesis and has a high sensitivity and low false positive rates. Earlier studies, focusing on the use of various ascitic fluid and serum biomarkers for rapid diagnosis of SBP have their own limitations like cost, availability, interpretation, technical challenges etc., (7). Reagent strips have gained importance, as they have been proposed to achieve a “rapid” bedside diagnosis of SBP with good accuracy and are reasonably cost effective. Several studies have evaluated the utility of reagent strips activity for the screening and diagnosis of SBP (8),(9),(10),(11). Although, they have shown promising results, but these studies are few and needs to be performed in large groups of patients to validate their usefulness. The present study was performed to evaluate the usefulness of ascitic fluid pH, protein and leukocyte esterase activity, by using reagent strips for screening of SBP in cirrhotics with ascites.

Material and Methods

The observational study was conducted at SGRR Institute of Medical and Health Sciences Dehradun, Uttarakhand, India, from January 2018 to March 2019. The study was previously approved by the Institutional Ethics Committee vide letter No. SGRR/IEC/26/18 on 28th May 2018. An informed consent was taken from all the patients included in the study after explaining them the whole procedure.

The study population included all patients who were either newly diagnosed with liver cirrhosis and ascites or had previously been diagnosed to have cirrhosis and ascites, and on treatment and presented in the Outpatient Department (OPD) or Emergency Room for therapeutic paracentesis or any complication of liver cirrhosis, and fulfilled inclusion criteria.

A total of 483 patients with ascites were analysed, of which 349 patients were diagnosed to have cirrhotic ascites. A total of 134 patients having other causes for ascites, like tuberculous ascetis, malignancy related ascitic etc., were excluded. Of these 349 patients, with liver cirrhosis and ascetis, 20 patients were excluded from the final analysis, as 17 had haemorrhagic ascites, two patients presenting with hematemesis in ER and died within two hours after presentation and one patient was later noted to have obstructed inguinal hernia. Thus, 329 patients were finally analysed.

Inclusion criteria: a) SBP Group: Liver cirrhosis, diagnosed either by clinical, biochemical, radiological or histo-pathological evidence. Presence of high Serum Ascitic Albumin Gradient (SAAG) ascites and ascitic fluid PMN >=250 cells/mm3, by Chamber Counting Method or positive ascitic fluid culture within 48 hours incubation, were included in SBP group.

b) 2.2 Non-SBP group: Liver cirrhosis, diagnosed either by clinical, biochemical, radiological or histopathological evidence with presence of high SAAG ascites but ascitic fluid PMN less than 250 cells/mm3, by ‘Chamber Counting Method’ and a negative ascitic fluid culture after 48 hours incubation.

Exclusion criteria: Patients with age <18 years, history of any abdominal surgery within three months of study entry, antibiotic history within seven days of presentation, or hospitalisation within last 30 days, high SAAG ascites due to hepatic infiltration (liver metastasis/hepatocellular carcinoma), ascites due to other cause (gestrointestinal malignancy, congestive cardiac failure, chronic renal failure, pancreatic ascites or tuberculous ascites), patients with evidence of secondary bacterial peritonitis, total ascitic fluid drained less than 100 mL were excluded from the study.

Procedure

At the time of presentation, a detailed history and examination was taken as per the study protocol. Diagnostic paracentesis was performed bedside. Ultrasound probe was used for guidance, wherever necessary. The fluid was collected in two 100 mL sterile containers. At the same time bedside inoculation of blood culture bottle with 5 mL of ascitic fluid was done for culture and sensitivity.

Therapeutic/large volume peracentesis was performed, wherever required depending upon patients symptoms. The first container was used to determine the physical appearance of ascitic fluid and bedside examination of the ascitic fluid using SMRS. The reagent strip was immediately immersed in the container containing the ascitic fluid, and compared with the charts given on the container, as per manufacturer’s guidelines, for identification of ascitic fluid pH, protein and leukocyte esterase. The results were recorded in the data sheet immediately.

The second container was sent for laboratory evaluation of ascitic fluid parameters including Total Leukocyte Count (TLC), Polymorphonuclear leukocytes (PMNs) count, protein, albumin and glucose levels. Other blood investigations including complete blood counts, liver and renal function tests were also done at the time of parecentesis.

The strips are commercially available. The principal of each variable i.e., pH, protein estimation and leukocyte elastase activity is clearly mentioned and the procedure details are clearly mentioned in the package insert available with the container. The manufacturer’s guidelines were strictly followed during the study.

Statistical Analysis

Data entry was done using Microsoft Excel 2011 and analysis was carried out by using Statistical Package for the Social Sciences (SPSS) version 23.0. Chi-square test was applied to find out significant association between independent and dependent variables. A p-value of <0.05 was considered significant.

Results

Among these 329 patients with cirrhotic ascitic, 81 were diagnosed to have SBP as per the gold standard for diagnosis of SBP, i.e., ascitic fluid PNM more than 250 cells/mm3, by chamber counting method or positive ascitic fluid culture after 48 hours incubation. A total of 248 patients did not have SBP.

Of the 81 patients in SBP group, 53 were males and 28 were females. In the NSBP group, there were 159 males and 89 females (p-value=0.93). The mean age of patients in the SBP group and NSBP group were 49.49±15.88 years and 52.31±12.04 years, respectively. There was no significant difference in age among both the groups (p-value=0.87).

Patients with SBP were significantly more likely to present with fever, vomiting, and shock. However a large number of patients were asymptomatic (Table/Fig 1). In SBP patients, ascitic fluid was more likely to be turbid, had higher leucocyte count and higher neutrophil count. The ascitic fluid pH was significantly lower in the SBP group. (Table/Fig 2) shows all the evaluated parameters (laboratory and those using SMRS).

Using the bedside SMRS, 41/81 (50%) of SBP patients were noted to have pH ≤7 as compared with 15/248(6%) of Non SBP group (p-value <0.001). Using ascitic fluid pH ≤7.0 as cut-off, yielded a sensitivity of 51% and specificity of 94% compared to gold standard for diagnosing SBP. Analysis of blood pH using ABG analyser showed significantly lower blood pH in the SBP than in Non SBP group (p-value <0.003). Using blood pH ≤7.38, as cut-off, yielded a sensitivity of 68% and specificity of 56%.

Taking 2+ as the cut-off, the LERS was positive in 84/329 patients. The LERS strip could thus correctly diagnose SBP in 77/81 (95%) of patients with SBP. However it was negative in 4/81 (4.93%) patients with SBP and was positive in 7/248 (2.82%) patients in NSBP group (Table/Fig 3). Hence, the sensitivity, specificity, PPV and NPV for LERS, taking 2+ as cut-off were 95%, 97.33%, 98.96% and 96.69%, respectively.

Taking 3+ as the cut-off, the LERS was positive in 53/329 patients. The LERS strip could correctly diagnose SBP in 52/81 (64.1%) of patients in SBP group. However it was negative in 29/81 (35.8%) patients with SBP and was positive in 1/248 (0.4%) patients in NSBP group (Table/Fig 4). Hence the sensitivity, specificity, PPV and NPV for LERS, taking 3+ as cut-off were 64.20%, 99.6%, 98.11% and 89.49% respectively.

During the study, a total of 108 asymptomatic patients were noted, of which 26 were in SBP group and 82 in NSBP group. Of these 31 were positive for LERS test using 2+ as cut-off. Sensitivity, specificity, PPV, NPV of LERS 2+ positive as 96.015%, 92.68%, 80.65%, 98.70% respectively compared to the gold standard. When authors considered LERS test 3+ as cut-off, out of 108 asymptomatic patients 19 were detected to have SBP with no false positive and 7 false negatives. The sensitivity, specificity, PPV, NPV of LERS 3+ positive was 73.08%, 100%, 100%, 92.13%. Considering both these results authors were able to safely conclude that leukocyte esterase reagent strip test can be efficiently used as bedside screening test in asymptomatic patients. Almost 75% of our asymptomatic SBP patients were later confirmed to have SBP by the gold standard.

Ascitic fluid pH and LERS activity could thus be used as the rapid and cheap bedside intervention for screening patients with SBP.

Discussion

Spontaneous Bacterial Peritonitis (SBP) is a life-threatening complication in patients with decompensated cirrhosis of liver and is defined as ascitic fluid infection in the absence of any identifiable intra-abdominal foci of infection (1). The prognosis greatly depends on its prompt diagnosis and early initiation of antibiotics, which is the most crucial step in management of SBP (3). The mortality in such patients is very high if not intervened timely. But diagnosis of SBP is presently based on ascitic fluid leukocyte count and ascitic fluid culture, which may delay the diagnosis. The initiation of antibiotics is thus delayed by atleast several hours if not days. It was shown by Karvellas CJ et al., that each hour of delay in treatment was associated with a 1.86 times increase in mortality (12). Avoiding this delay warrants a rapid diagnostic procedure which can be performed bedside with high sensitivity and specificity to facilitate rapid diagnosis and early treatment in such cases.

It is easy to suspect SPB in most patients with worsening hepatic functions, encephalopathy, fever, shock, respiratory distress, renal and respiratory failure etc. In the present study also, fever and shock were found to be significantly high in the SBP group. However, these symptoms themselves are late in clinical course of any infection, and are usually due to worsening sepsis, and Multiple Organ Dysfunction Syndrome (MODS). Abdominal pain has been noted as the most common presenting symptom in a number of studies and in a meta analysis also (7),(13),(14),(15). In the present study also, abdominal pain was one of the most common presenting symptoms. It is however a non specific symptom. Although it may aid in the diagnosis of SBP, along with other symptoms, alone may have poor diagnostic significance and may be due to other reasons, such as overstretching of the abdominal wall due to tense ascites, lurking abdominal wall hernias, sense of discomfort due to rapid filling of ascites or rarely due to diseases of other intra abdominal organs like gall bladder, pancreas and kidneys.

In the present study also, although, pain was the most common presenting symptom in the SBP group, in none of the cases it was not the sole presenting symptom. Moreover almost 57% patients in NSBP group had pain as the most prominent presenting symptom. It may also be noted that as many as 32% of patients in SBP group were asymptomatic. Asymptomatic SBP patients in various studies showed a wide variation, ranging from 10% to 40% (14). It is possible that in most patients, the infection in ascitic fluid may initially be asymptomatic, and later become symptomatic, once sepsis supervenes. Abdominal pain and tense ascites are the usual presenting symptoms in a large number of OPD patients, who are otherwise stable and presents for routine therapeutic paracentesis. A high degree of suspicion is usually required in this group of patients, to diagnose SBP early, thereby preventing further deterioration of hepatic functions and improve survival. It is therefore, a routine practice in many centers, to get ascitic fluid TLC and PMN counts done in all such cases during therapeutic paracentesis, to detect SBP in these asymptomatic patients.

The LERS activity by SMRS may prove as a useful armamentarium in the management of such patients. While all patients admitted to the Emergency Room are likely to have all the investigations like Renal Function Test (RFT), Complete Blood Count (CBC) and ascitic fluid analysis and culture done, same cannot be done for all OPD patients presenting for routine therapeutic paracentesis. In such case, screening with a test with reasonably high sensitivity and PPV is needed, for early detection of SBP. Multistix 10 SG Reagent Strip for LERS and ascitic fluid pH may be helpful in suspecting SBP. It is reasonable to start parenteral antibiotic therapy for all patients if the LERS test 3+ results are achieved. However as the PPV of LERS test 2+ results were slightly lower, starting antibiotic therapy with LERS test 2+ entails treating a few extra patients (approx. 20%) for suspected infection, and missing a few (approx. 3-4%)with definitive SBP. It is still heartening that almost 75% of the asymptomatic SBP patients are correctly picked up by LERS test results.

Thus all patients who present in the OPDs for routine therapeutic paracentesis should be investigated with Multistix 10 SG Reagent Strip. Those patients, who have ascitic fluid pH of more than 7.0 or LERS test activity of less than 2+ should not be tested further and allowed to go home. Those with pH less than or equal to 7.0 or LERS test activity 2+ or 3+ should be further investigated with ascitic fluid total and differential leukocyte count and ascitic fluid culture, and be either admitted or closely monitored. In case they don’t want to get admitted, they may be atleast started on oral antibiotics, till laboratory results are available.

Because of wide variation in sensitivity and PPV between reported studies (Table/Fig 5) (16),(17),(20),(21), some authors have raised doubt over the use of LERS as a valid surrogate marker of SBP (11), but there has been reported heterogeneity in the number of patients included in each study, the ascitic fluid samples tested and SBP episodes observed, which may affect test results (10),(11),(12). Other potential cause of error may be the possibility of inter-observer variation in matching of colour. However, because of the consistently excellent NPV (>95% in the majority of the studies) for LERS, its place in the ascitic tap diagnostic algorithm, specially as a preliminary screening tool for SBP diagnosis can be strongly advocated. Apart from high diagnostic potential, the advantages of reagent strips include its easy availability, easy to use, low cost and rapid results. With use of bedside LERS test early antibiotic therapy can be started in a fair percentage of asymptomatic SBP patients. In the present study, authors could start early treatment in 16 out of 20 asymptomatic SBP patients, based upon LERS test results.

Limitation(s)

The present study although presented the largest experience with the Multistix 10 SG Reagent Strip for routine ascitic fluid analysis, was still a single centre study and non randomised. It is to be emphasised in this study reagent strips used were currently marketed only for urinary analysis.

Conclusion

High suspicion and early diagnosis of SBP is the most important factor in preventing rapid deterioration of hepatic functions and prolonging life in patients with decompensated chronic liver disease. ascitic fluid turbidity has low predictive value in diagnosing SBP. Routine screening of ascitic fluid with SMRS for leucocyte elastase activity and pH has high potential in early diagnosis of SBP, especially during routine therapeutic peracentesis in asymptomatic patients on outpatient basis.

References

1.
Cirera I, Bauer TM, Navasa M, Vila J, Grande L, Taurá P, et al. Bacterial translocation of enteric organisms in patients with cirrhosis. J Hepatol. 2001;34(1):32-37. [crossref]
2.
Ginés P, Rimola A, Planas R, Vargas V, Marco F, Almela M, et al. Norfloxacin prevents spontaneous bacterial peritonitis recurrence in cirrhosis: Results of a double-blind, placebo-controlled trial. Hepatology. 1990;12(4):716-24. [crossref] [PubMed]
3.
Ribeiro TC, Chebli JM, Kondo M, Gaburri PD, Chebli LA, Feldner AC. Spontaneous bacterial peritonitis: How to deal with this life-threatening cirrhosis complication? Ther Clin Risk Manag. 2008;4(5):919. [crossref] [PubMed]
4.
Taneja SK, Dhiman RK. Prevention and management of bacterial infections in cirrhosis. Int J Hepatol. 2011;2011:784540. [crossref] [PubMed]
5.
Amini M, Runyon BA. Alcoholic hepatitis 2010: A clinician's guide to diagnosis and therapy. World J Gastroenterol. 2010;16(39):4905-12. [crossref] [PubMed]
6.
Angeloni S, Nicolini G, Merli M, Nicolao F, Pinto G, Aronne T, et al. Validation of automated blood cell counter for the determination of polymorphonuclear cell count in the ascitic fluid of cirrhotic patients with or without spontaneous bacterial peritonitis. Am J Gastroenterol. 2003;98(8):1844-48. [crossref] [PubMed]
7.
Greenberger NJ. Ascites & spontaneous bacterial peritonitis. Current diagnosis & treatment: Gastroenterology, hepatology, & endoscopy, Second Edition, Norton J. Greenberger.(Ed), New York: McGraw-Hill; 2012:515.
8.
Torun S, Dolar E, Yilmaz Y, Keskin M, Kiyici M, Sinirtas M, et al. Evaluation of leukocyte esterase and nitrite strip tests to detect spontaneous bacterial peritonitis in cirrhotic patients. World J Gastroenterol. 2007;13(45):6027. [crossref] [PubMed]
9.
Nousbaum JB, Cadranel JF, Nahon P, Khac EN, Moreau R, Thévenot T, et al. Diagnostic accuracy of the Multistix 8 SG reagent strip in diagnosis of spontaneous bacterial peritonitis. Hepatology. 2007;45(5):1275-81. [crossref] [PubMed]
10.
Castellote J. Can leukocyte esterase reagent strips be used for the diagnosis of spontaneous bacterial peritonitis?. Nature Clinical Practice Gastroenterology & Hepatology. 2005;2(12):566-67. [crossref] [PubMed]
11.
Nousbaum JB, Cadranel JF. Are reagent strips useful for the diagnosis of spontaneous bacterial peritonitis? Gastroenterol Clin Biol. 2006;30(3):439-41. [crossref]
12.
Karvellas CJ, Abraldes JG, Arabi YM, Kumar A, Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Appropriate and timely antimicrobial therapy in cirrhotic patients with spontaneous bacterial peritonitis-associated septic shock: A retrospective cohort study. Aliment Pharmacol Ther. 2015;41(8):747-57. [crossref] [PubMed]
13.
Runyon BA, Montano AA, Akriviadis EA, Antillon MR, Irving MA, McHutchison JG. The serum-ascites albumin gradient is superior to the exudate-transudate concept in the differential diagnosis of ascites. Ann Intern Med. 1992;117(3):215-20 [crossref] [PubMed]
14.
Duah A, Nkrumah KN. Prevalence and predictors for spontaneous bacterial peritonitis in cirrhotic patients with ascites admitted at medical block in Korle-Bu Teaching Hospital, Ghana. Pan Afr Med J. 2019;16(33):35. [crossref] [PubMed]
15.
Puri AS, Puri J, Ghoshal UC, Sharma BC, Saraswat VA, Ayyagari A, et al. Frequency, microbial spectrum and outcome of spontaneous bacterial peritonitis in north India. Indian J Gastroenterol. 1996;15(3):86-89.
16.
Butani RC, Shaffer RT, Szyjkowski RD, Weeks BE, Speights LG, Kadakia SC. Use of Multistix® leukocyte esterase dipstick testing for ascitic fluid infection. Gastroenterology. 2000;118(4):A979. [crossref]
17.
Sapey T, Kabissa D, Fort E, Laurin C, Mendler MH. Instant diagnosis of spontaneous bacterial peritonitis using leukocyte esterase reagent strips: Nephur-Test® vs. MultistixSG®. Liver Int. 2005;25(2):343-48. [crossref] [PubMed]
18.
Kim DY, Kim JH, Chon CY, Han KH, Ahn SH, Kim JK, et al. Usefulness of urine strip test in the rapid diagnosis of spontaneous bacterial peritonitis. Liver Int. 2005;25(6):1197-201. [crossref] [PubMed]
19.
Li J, Pan Y, Bao WG, Niu JQ, Wang F. Multistix10SG urine test in diagnosing spontaneous bacterial peritonitis. Zhonghua Ganzangbing Zazhi. 2006;14:784-85.
20.
Ribeiro TC, Kondo M, Amaral AC, Parise ER, Bragagnolo Júnior MA, Souza AF. Evaluation of reagent strips for ascitic fluid leukocyte determination: Is it a possible alternative for spontaneous bacterial peritonitis rapid diagnosis? Braz J Infect Dis. 2007;11(1):70-4l. [crossref] [PubMed]
21.
De Araujo A, de Barros Lopes A, Trucollo Michalczuk M, Stifft J, Nardelli E, Escobar G, et al. Is there yet any place for reagent strips in diagnosing spontaneous bacterial peritonitis in cirrhotic patients? An accuracy and cost-effectiveness study in Brazil. Journal of Gastroenterology and Hepatology. 2008;23(12):1895-900. [crossref] [PubMed]

DOI and Others

10.7860/JCDR/2021/48466.15176

Date of Submission: Jan 09, 2021
Date of Peer Review: Feb 03, 2021
Date of Acceptance: Jul 09, 2021
Date of Publishing: Aug 01, 2021

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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