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Study Protocol

Protocol for the study of bedside CSF analysis by urinary reagent strips and comparison with traditional laboratory measurements in a tertiary care centre in rural India

[version 1; peer review: 1 approved with reservations]
Dr. Shahzad Ahmad
https://orcid.org/0009-0004-8732-3941
1, Dr. Sham Lohiya1
Dr. Shahzad Ahmad
https://orcid.org/0009-0004-8732-3941
1, Dr. Sham Lohiya1
PUBLISHED 17 May 2024
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Abstract*

Background

Meningitis is an infection of leptomeninges. It is an emergency life-threatening condition that requires prompt treatment initiation. Diagnosis is the rate-limiting step because cerebrospinal fluid (CSF) analysis requires experienced personnel. Therefore, this study was conducted to assess the utility of urinary reagent strips for the rapid bedside diagnosis of CSF glucose, proteins, and leukocytes.

Objective

To determine the efficacy of a urinary reagent strip for bedside analysis of cerebrospinal fluid (CSF) samples.

Methods

This prospective comparative study will be conducted in the Department of Neonatology and Pediatrics, Jawaharlal Nehru Medical College, Sawangi, Wardha. CSF samples from patients suspected of infection of the central nervous system (CNS) and awaiting diagnosis will be subjected to semi-quantitative analysis using a urinary reagent strip (for glucose, proteins, and leukocytes). The results were compared with the laboratory results of the individual samples.

Result

After completing the study, we determined the efficacy of the urinary reagent strips in bedside estimation of CSF glucose, protein, and leukocyte levels in terms of sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy.

Conclusion

This study provides insight into the utility of urinary reagent strips for rapid bedside diagnosis of CSF samples from patients suspected of having an infection.

Keywords

Central nervous system infection, cerebrospinal fluid, meningitis, urinary reagent strips

Corresponding author: Dr. Shahzad Ahmad
Competing interests: No competing interests were disclosed.
Grant information: The author(s) declared that no grants were involved in supporting this work.
Copyright:  © 2024 Ahmad DS and Lohiya DS. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Ahmad DS and Lohiya DS. Protocol for the study of bedside CSF analysis by urinary reagent strips and comparison with traditional laboratory measurements in a tertiary care centre in rural India [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:482 (https://doi.org/10.12688/f1000research.145065.1) First published: 17 May 2024, 13:482 (https://doi.org/10.12688/f1000research.145065.1) Latest published: 17 May 2024, 13:482 (https://doi.org/10.12688/f1000research.145065.1)

Introduction

Meningitis is an infection and inflammation of the leptomeninges.1–3 Meningitis is associated with high mortality and morbidity in children.4 Delayed treatment of meningitis in infants and young children can cause serious developmental deficits, including speech, motor skills, cognition, vision, hearing, and even behavioral problems.5–8 Although meningitis is associated with classic symptoms of headache, stiff neck, and fever,9,10 diagnosis based on symptoms is difficult in the pediatric age group because of their inability to communicate and the informant being the mother or caregiver. Therefore, diagnosis is dependent on cerebrospinal fluid (CSF) microscopy, CSF chemistry, and microbiological studies. These laboratory tests often require an experienced microscopist to estimate cerebrospinal fluid cell counts and appropriate tests to estimate sugar and protein levels. In a developing country, such as ours, the universal availability of qualified and experienced personnel is a challenge, particularly in resource-poor settings. This may lead to long turnaround times and substantial delays in the initiation of definitive treatment.

As meningitis is a serious life-threatening infection, early diagnosis and prompt initiation of treatment are crucial for preventing complications. However, there are currently no bedside rapid diagnostic tests for the estimation of CSF parameters, although there are tests available for the estimation of CSF parameters in other body fluids. One such example is urinary reagent strips. CSF glucose, protein, and leukocyte counts are essential in differentiating infections from other conditions such as non-infectious epilepsy and febrile seizures, which commonly occur in the pediatric population. These parameters may also be used to differentiate between different types of meningitis, viz., bacterial, fungal, and viral.11–13 Therefore, in the present study, we included the semi-quantitative estimation of these three parameters of CSF using urinary reagent strips and compared them with the traditional laboratory tests to estimate their utility.

Protocol

Study design

The present study is a prospective, comparative study that will be conducted on patients admitted to the Neonatology and Pediatrics Department of Acharya Vinoba Bhave Rural Hospital, a tertiary care hospital located at Sawangi (Meghe), Wardha, Maharashtra, from February 2023 to January 2025.

Eligibility criteria

All patients (aged less than 14 years) admitted to the Neonatology and Pediatrics Department with suspected central nervous system (CNS) infection and undergoing CSF examination for diagnosis were included in the study. All cases where parents/legal guardians refused to consent to participate in the study and any case where the sample was hemorrhagic or those received after a long duration of the tap (after more than 1 h) will be excluded.

Ethical considerations

Prior to the initiation of the study, approval was obtained from the Institutional Ethics Committee. After obtaining approval, recruitment of patients will begin. The parents/legal guardians of all patients will be briefed about the study procedure and plans for the publication and dissemination of the study results. They will be given sufficient time and any queries raised will be answered by the research team. Thereafter, they were required to sign an informed consent form. After obtaining voluntary written informed consent, the patients were included in the study.

Sample size and sampling procedure

All consecutive patients meeting the inclusion criteria were included in the study until the desired sample size was met (Table 1).

Table 1. Sample size.

Prevalence of Meningitis (p)0.10
Precision (± expected)0.10
Confidence level 100 (1-α)95%
Expected dropout rate10%
Sample size112
Final sample size (including dropout rate)125

Methodology

After inclusion, detailed demographic information was recorded for each patient. A CSF tap will be performed by lumbar puncture using all aseptic precautions as per the standard guidelines, and CSF samples will be collected. Urinary reagent strips with an analysis of 10 parameters were used in the study. Upon receipt of the sample, 2 to 3 drops of CSF will be added using a pipette on the urinary reagent strip on the patches for glucose, protein, and leukocytes. The strips will be observed for changes in color, and the interpretation for semi-quantitative analysis of the parameters will be done for the levels of glucose, proteins, and leukocytes.

  • 1. Glucose: Normal CSF glucose levels are approximately two-thirds of the plasma levels. Glucose levels will be interpreted using manufacturer-provided grading as follows:

    • a. No color for levels upto 50 mg/dL

    • b. Change of color for levels more than 50 mg/dL

  • 2. Protein: The normal range of CSF proteins is 15–45 mg/dL. Protein levels will be interpreted using manufacturer-provided grading as follows:

    • a. No color for levels less than 30 mg/dL

    • b. 1+ for levels between 30 to 100 mg/dL

    • c. 2+ for levels between 100 to 500 mg/dL

    • d. 3+ for levels more than 500 mg/dL

  • 3. CSF leukocytes: The normal range of CSF leukocytes was <5 cells/mm3. The levels are interpreted using manufacturer-provided grading as follows:

    • a. No color for levels less than 10 cells/mm3

    • b. 1+ for levels between 10 to 75 cells/mm3

    • c. 2+ for levels between 75 to 500 cells/mm3

    • d. 3+ for levels more than 500 cells/mm3

The quantitative analysis of each sample will also be performed using standard laboratory tests for the estimation of glucose and proteins, and the leukocyte count will be assessed by microscopic examination. The laboratory results were compared with those obtained using the urinary reagent strip and analyzed.

Statistical analysis

Data will be entered into the latest version of the SPSS software and analyzed. Descriptive and analytical statistics were used for the statistical analysis. Continuous data are presented as the mean±standard deviation, and categorical data are presented as percentages. For analytical statistics, continuous data will be analyzed using the unpaired t-test, and categorical data will be analyzed using the chi-square test. The sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy were calculated. P was set at p < 0.05.

Conclusion

The results of this study will help us assess the efficacy of urinary reagent strips as a means for the semi-quantitative estimation of CSF glucose, proteins, and leukocytes. This will enable us to assess its utility as a rapid bedside test for the diagnosis of CSF infections.

Dissemination

The results of the study will be presented in conferences/scientific meetings and published in peer-reviewed journals.

Study status

Data collection ongoing, expected to be completed in January 2025.

Data availability

Underlying data

No data is associated with this article.

References

  • 1.  Lien CY, Lee JJ, Tsai WC, et al.: The clinical characteristics of spontaneous Gram-negative bacterial meningitis in adults: A hospital-based study. J. Clin. Neurosci. 2019 Jun; 64: 101–105. PubMed Abstract | Publisher Full Text
  • 2.  Fuentes-Antrás J, Ramírez-Torres M, Osorio-Martínez E, et al.: Acute Community-Acquired Bacterial Meningitis: Update on Clinical Presentation and Prognostic factors. New Microbiol. 2019 Apr; 41(4): 81–87. PubMed Abstract
  • 3.  Rohde S: Inflammatory Diseases of the Meninges. Inflammatory Diseases of the Brain. 2012 Jun 21; pp. 127–137. Publisher Full Text
  • 4.  Wright C, Blake N, Glennie L, et al.: The Global Burden of Meningitis in Children: Challenges with Interpreting Global Health Estimates. Microorganisms. 2021 Feb 13; 9(2): 377. PubMed Abstract | Publisher Full Text | Free Full Text
  • 5.  Cushing SL, Papsin BC, Rutka JA, et al.: Vestibular end-organ and balance deficits after meningitis and cochlear implantation in children correlate poorly with functional outcome. Otol. Neurotol. 2009 Jun; 30(4): 488–495. PubMed Abstract | Publisher Full Text
  • 6.  Chandran A, Herbert H, Misurski D, et al.: Long-term sequelae of childhood bacterial meningitis: an underappreciated problem. Pediatr. Infect. Dis. J. 2011 Jan; 30(1): 3–6. Publisher Full Text
  • 7.  Christie D, Rashid H, El-Bashir H, et al.: Impact of meningitis on intelligence and development: A systematic review and meta-analysis. PLoS One. 2017 Aug 24; 12(8): e0175024. PubMed Abstract | Publisher Full Text | Free Full Text
  • 8.  Zainel A, Mitchell H, Sadarangani M: Bacterial Meningitis in Children: Neurological Complications, Associated Risk Factors, and Prevention. Microorganisms. 2021 Mar 5; 9(3): 535. PubMed Abstract | Publisher Full Text | Free Full Text
  • 9.  van Ettekoven CN , van de Beek D , Brouwer MC: Update on community-acquired bacterial meningitis: guidance and challenges. Clin. Microbiol. Infect. 2017 Sep; 23(9): 601–606. PubMed Abstract | Publisher Full Text
  • 10.  Charalambous LT, Premji A, Tybout C, et al.: Prevalence, healthcare resource utilization and overall burden of fungal meningitis in the United States. J. Med. Microbiol. 2018 Feb; 67(2): 215–227. PubMed Abstract | Publisher Full Text | Free Full Text
  • 11.  Bahr NC, Boulware DR: Methods of rapid diagnosis for the etiology of meningitis in adults. Biomark. Med. 2014; 8(9): 1085–1103. PubMed Abstract | Publisher Full Text | Free Full Text
  • 12.  Richie MB, Josephson SA: A Practical Approach to Meningitis and Encephalitis. Semin. Neurol. 2015 Dec; 35(6): 611–620. PubMed Abstract | Publisher Full Text
  • 13.  Gomes HR: Cerebrospinal fluid analysis: Current diagnostic methods for central nervous system infectious diseases. Arq. Neuropsiquiatr. 2022 May; 80(5 Suppl 1): 290–295. PubMed Abstract | Publisher Full Text | Free Full Text

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Ahmad DS and Lohiya DS. Protocol for the study of bedside CSF analysis by urinary reagent strips and comparison with traditional laboratory measurements in a tertiary care centre in rural India [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:482 (https://doi.org/10.12688/f1000research.145065.1)
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
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Reviewer Report 23 Jul 2024
Davide Chiasserini, University of Perugia, Perugia, Italy 
Approved with Reservations
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https://doi.org/10.5256/f1000research.158952.r294842
The protocol by Shahzad Ahmad and Sham Lohiya is an interesting experimental plan to use urine strip for approximate measurements of CSF parameter for meningitis diagnosis in rural setting in India. The idea is interesting, I have minor comments: ... Continue reading
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Chiasserini D. Reviewer Report For: Protocol for the study of bedside CSF analysis by urinary reagent strips and comparison with traditional laboratory measurements in a tertiary care centre in rural India [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:482 (https://doi.org/10.5256/f1000research.158952.r294842)
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https://f1000research.com/articles/13-482/v1#referee-response-294842
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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The paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations
A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved
Fundamental flaws in the paper seriously undermine the findings and conclusions

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  1. Davide Chiasserini, University of Perugia, Perugia, Italy

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    Alongside their report, reviewers assign a status to the article:
    Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
    Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
    Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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