Comparative Study of Rapid Urease Test and Histopathological Examination For Detection of H. Pylori Infection

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International Surgery Journal

Athavale VS et al. Int Surg J. 2017 Dec;4(12):4071-4075


http://www.ijsurgery.com pISSN 2349-3305 | eISSN 2349-2902

DOI: http://dx.doi.org/10.18203/2349-2902.isj20175413
Original Research Article

Comparative study of rapid urease test and histopathological


examination for detection of H. pylori infection
Virendra S. Athavale, Vinit Singh, Shivmurti N. Khandalkar*, Dakshayani S. Nirhale,
Aditya Lad, Iresh Shetty

Department of General Surgery, Dr. D. Y. Patil Medical College, Hospital and Research Centre, DPU University,
Pimpri, Pune, Maharashtra, India

Received: 17 September 2017


Accepted: 28 October 2017

*Correspondence:
Dr. Shivmurti N. Khandalkar,
E-mail: drshiva.khandalkar@gmail.com

Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background: Aims and objectives of the study was to study the incidence of H. pylori infection in our Hospital. To
find out the sensitivity and specificity of rapid urease test (RUT) and histopathological examination for the detection
of H. pylori on gastric biopsy. To study the effect of anti H. pylori drugs by performing follow-up endoscopy in terms
of positive or negative Rapid Urease Test and Histopathological Examination report.
Methods: The study was conducted at Dr. D. Y. Patil Medical College and Hospital, DPU University, for a period of
2 years (from July 2012-September 2014) and is a prospective and comparative randomized type of study using 100
patients. The study was approved by the Institute’s Ethics Committee.
Results: Data analysis showed that: In our study 84 patients (84%) were detected positive by RUT method. In our
study 83 patients (83 %) were detected positive by HPE method. There was an association between RUT and HPE
finding in study group with the sensitivity being 96.38 % and specificity being 74.47 %, PPV was 95.24% and NPV
was 81.25%. At the time of follow up after taking anti H pylori treatment, 79 patients were RUT negative and 8 were
RUT positive who were defaulters (not taken complete dose) and again started on treatment with the accuracy of the
drug being 98.85 %. At the time of follow up after taking anti H pylori treatment 78 patients were HPE negative and 9
were HPE positive who were defaulters (not taken complete dose) and again started on treatment. There was an
association between RUT and HPE finding at follow up with the sensitivity being 88.89 % and specificity being
100%, PPV was 100% and NPV was 98.73%.
Conclusions: Our study reveals that RUT is accurate for the diagnosis of H. pylori infection and its use will serve as a
good alternative to histology in management of patients with dyspepsia in resource poor environments, except in
patients who need histology for reasons other than H. pylori diagnosis.

Keywords: Anti H. Pylori treatment, H. Pylori, RUT

INTRODUCTION H. pylori by Marshall and Warren in 1983, overwhelming


evidence has accumulated to confirm that H. pylori
Helicobacter pylori (H. pylori) infection is very common infection plays a significant role in the development of
throughout the world, occurring in 40-50% of the chronic active gastritis and peptic ulcer.1 H. pylori is the
population in developed countries and 80-90 % of etiologic agent of acute and chronic gastritis, peptic ulcer
population in developing regions. Since the discovery of disease and two forms of gastric cancer.2

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Athavale VS et al. Int Surg J. 2017 Dec;4(12):4071-4075

Up to 80% of gastric carcinomas and 92% of low grade endoscopy for examination, and other two biopsies were
gastric mucosa-associated lymphoid tissue lymphomas subjected to RUT and result was seen within 1-2 hrs.
are H. pylori associated.3 Every method for detection of H
Pylori has its own inherent advantages and disadvantages. Specific preparation
Rapid Urease Test (RUT), with its high sensitivity and
specificity, is considered to be a quick and reliable test Patients were instructed not to eat or drink for 4-6 hours
for the initial diagnosis of H. pylori infection and is before endoscopy. Patients with gastric outlet or
simple and inexpensive.4 oesophageal obstruction were kept NBM for a longer
period.
The present study is done for evidence of H. pylori
infection in our set up and detection of H. pylori from Pre-endoscopy preparation
Gastric biopsy specimen using Rapid Urease Test and
Histopathological examination and the efficacy of the IV access was obtained for giving IV fluids and SOS
anti H. pylori treatment by doing the follow up Injectable Antispasmodics.
endoscopy and diagnostic test.
Premedication
In this study, we aim: to study the incidence of H. pylori
infection in our Hospital. And to find out the Sensitivity Premedication consists of local oral anaesthesia by
and Specificity of Rapid Urease Test and lidocaine topical aerosol (LOX 10% oral spray).
Histopathological Examination for the detection of H.
pylori on gastric biopsy. Also, to study the effect of anti Examination
H. pylori drugs by performing follow-up Endoscopy in
terms of positive or negative Rapid Urease Test and All patients were kept NBM for 6 hrs prior to endoscopy
Histopathological Examination report. and after bringing the patient to endoscopy room LOX
10% spray was sprayed on the both tonsillar pillars,
METHODS posterior pharyngeal wall and after waiting for 5 minutes,
patient was kept in left lateral position with the head on a
The study was conducted at Dr. D. Y. Patil Medical small pillow flexed forward and mouth tilting downward
College and Hospital, DPU University, for a period of 2 to facilitate drainage of saliva and a pulse oximeter was
months (from July 2012-September 2014) and is a attached to the patient and endoscope was introduced
prospective and comparative randomized type of study after placing a mouth gag.
using 100 cases. The study was approved by the
Institute’s Ethics Committee. The scope was passed through the oropharynx and
nudged through cricopharynx under vision with the
Inclusion criteria voluntary swallowing movement of the patient. The
scope was rapidly passed through the esophagus doing a
• Age- 18-75 years rough scanning and leaving the detailed mucosal
• All patients with upper abdominal pain more than 6 examination to be done during withdrawal.
month.
As per the endoscopic finding a total of 4 biopsies were
Exclusion criteria taken. 2 of the biopsy samples were taken for the RUT
and rest for the Histopathological Examination. After
• Alcoholic Patients confirming haemostasis, the scope was removed after
• Patients taking NSAIDS5 deflating the stomach.
• Acute Abdominal pain
• Immunocompromised patient 2 biopsies were placed on yellow paper of RUT kit after
• Active TB. removing the plastic cover and a single drop of distilled
water was placed on yellow paper and then plastic cover
In our study, 100 patients with history of epigastric pain was again sealed with its own adhesive and results were
for more than 6 months, burning sensation in epigastric observed after 1- 2 hrs. Change of colour of yellow paper
region, were admitted and evaluated. Patients taking to pink indicates an H. pylori infection.
NSAIDS and PPIs were advised to stop taking the drugs
at least 5 days prior to endoscopy. HIV and HbSAg status 2 biopsies were sent for histopathological examination, in
was done. a plain bulb containing 1:10 of formalin and water
mixture to the pathology department, for Giemsa stain.
Patients were kept Nil by Mouth (NBM) 4-6 hrs. prior to
Endoscopy. Four biopsies were taken from different sites The patient was advised to start oral diet after 1 hour of
(Antrum and Pylorus). Two biopsies were sent to the procedure. Negative PPI Started immediately. The anti H.
Pathology department in plain bulb containing 1:10 pylori therapy included: a Lansoprazole (PPI) 30 mg,
mixture of distilled water and formalin after the

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Athavale VS et al. Int Surg J. 2017 Dec;4(12):4071-4075

clarithromycin 500 mg, and Tinidazole 500 mg for a duration of 14 days.

Table 1: Algorithm.

RUT Histopathological examination Remark


Positive Positive Anti H. Pylori therapy started Immediately
Positive Negative Anti H. Pylori therapy started Immediately
Negative Positive PPI Started immediately and Anti H. Pylori therapy after HPE report.
Negative Negative PPI Started immediately

Follow up negative is 4 and HPE positive and RUT negative is 3


and both negative is 13.
H. pylori positive patients were advised for follow up
endoscopy after 6 weeks of completion of the treatment. Table 5: Treatment wise distribution of cases in study
Patient was again assessed by doing follow up endoscopy group.
and taking biopsies for RUT and HPE.
Treatment No of cases Percentage
RESULTS Anti H pylori 87 87
PPI 13 13
The Table 2 showing that 84 patients out of 100 are RUT Total 100 100
positive and 16 patients are RUT negative.
The Table 5 showing that 87 patients were treated with
Table 2: RUT wise distribution of cases in study anti h pylori treatment and rest with PPI.
group.
Table 6: RUT at follow up wise distribution of cases in
RUT No of cases Percentage study group.
Positive 84 84
Negative 16 16 RUT No of cases Percentage
Total 100 100 Positive 8 9.20
Negative 79 90.80
The Table 3 showing that Total 83 patients shows Total 87 100
presence of H. pylori positive in HPE.
This Table 6 showing that 9.20% cases were positive
Table 3: HPE finding wise distribution of cases in RUT at the time of follow up after treatment and rest that
study group. is 90.80 % were RUT negative.

HPE finding No of cases Percentage Table 7: HPE finding at follow up wise distribution of
Positive 83 83 cases in study group.
Negative 17 17
Total 100 100 HPE finding No of cases Percentage
Positive 9 10.34
Table 4: Association between RUT and HPE finding Negative 78 89.66
in study group. Total 87 100

HPE This Table 7 shows that 10.34 % cases were positive in


RUT Total
Positive Negative HPE at the time of follow up and rest were negative.
Positive 80 4 84
Negative 3 13 16 This Table 8 showing total number of cases positive for
Total 83 17 100 both RUT and HPE were 8 and RUT positive and HPE
Chi-square=55.73, P<0.0001, Sensitivity=96.38%, negative were 0 and both RUT and HPE negative were 78
Specificity=74.47%, PPV=95.24%, NPV=81.25%, and HPE positive and RUT negative were 1.
Accuracy=93%.
It shows that RUT is 88.89 % sensitive and 100 %
This Table 4 showing total no. of cases positive for both specific and accuracy of treatment was 98.85 %.
RUT and HPE positive is 80 RUT positive and HPE

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Athavale VS et al. Int Surg J. 2017 Dec;4(12):4071-4075

Table 8: Association between RUT and HPE finding HPE results at the time of follow up
at follow up in study group.
At the time of follow up after taking anti H. pylori
RUT at HPE at follow up treatment, 78 patients are HPE negative and 9 are HPE
Total
follow up Positive Negative positive which are defaulters (not taken complete dose)
Positive 8 0 8 and again started on treatment.
Negative 1 78 79
Total 9 78 87 Association between RUT and HPE finding at follow up
Chi-square=66.08, P<0.0001, Sensitivity=88.89%,
Specificity=100%, PPV=100%, NPV=98.73%, The sensitivity was 88.89 % and specificity was 100%,
Accuracy=98.85%. PPV was 100% and NPV was 98.73%. This is
comparable with study conducted by Megraud F. found
DISCUSSION sensitivity, specificity, PPV and NPV was 93.33%, 100
%, 80.76 % and 91.17 % respectively.9 According to
RUT results at first presentation Islam MDU, Shamsuzzaman SHZ et al, a comparative
study among different invasive methods for the diagnosis
In our study 84 patients were detected positive by RUT of H. pylori was done and it was concluded that
method. This is comparable with study conducted by comparing among culture, rapid urease test, and
Jemilohun et al found RUT is accurate for the diagnosis histopathology methods all are highly sensitive and
of H. pylori infection. Its use will serve as a good specific to diagnose H. pylori infection.10
alternative to histology in management of patients with
dyspepsia in resource poor environments, except in CONCLUSION
patients who need histology for reasons other than H.
Pylori diagnosis.6 The results support the view that RUT is accurate for the
diagnosis of H. pylori infection as it is as sensitive to
HPE results at first presentation HPE examination. Main disadvantage of this procedure is
that it is an invasive procedure. In our population the
In our study 83 patients (83 %) were detected positive by OMA regimen shows 99 % sensitivity which was proven
HPE method. This is comparable with study conducted by follow up biopsy with RUT and HPE. To conclude,
by MDU Islam, SHZ Rahman et al found culture, RUT our study reveals that RUT is accurate for the diagnosis
and HPE all are high sensitive and specific to diagnose H. of H. pylori infection and its use will serve as a good
pylori infection.7 alternative to histology in management of patients with
dyspepsia in resource poor environments, except in
Association between RUT and HPE finding in study patients who need histology for reasons other than H.
group pylori diagnosis.

The sensitivity was 96.38 % and specificity was 74.47 %, Funding: No funding sources
PPV was 95.24% and NPV was 81.25%. This is Conflict of interest: None declared
comparable with study conducted by Jemilohun et al Ethical approval: The study was approved by the
found sensitivity, specificity, PPV and NPV was 93.33%, Institutional Ethics Committee
75.6 %, 80.76 % and 91.17 % respectively.6
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