Volume 03 Issue 09-2023
150
International Journal of Advance Scientific Research
(ISSN
–
2750-1396)
VOLUME
03
ISSUE
09
Pages:
150-158
SJIF
I
MPACT
FACTOR
(2021:
5.478
)
(2022:
5.636
)
(2023:
6.741
)
OCLC
–
1368736135
A
BSTRACT
This article is aimed at identifying the pathology of the cervical epithelium in the early diagnosis of cervical
cancer using an express test. During the study 10716 women aged 25-65 years were examined (mean age
43.28±3.82 years). To increase the specificity and sensitivity of screening, local express tests were used, in
particular, a modified CIN-Diag test. As a result, the use of the proposed algorithm for screening CC made
it possible to detect metaplasia of the CC epithelium in the early stages (precancer) and reduce the need
for colposcopy by 4.65 times.
K
EYWORDS
Cervical cancer, screening, CIN-DIAG test.
I
NTRODUCTION
Journal
Website:
http://sciencebring.co
m/index.php/ijasr
Copyright:
Original
content from this work
may be used under the
terms of the creative
commons
attributes
4.0 licence.
Research Article
THE ROLE OF CIN-DIAG RAPID TEST IN SCREENING FOR
CERVICAL EPITHELIUM PATHOLOGY
Submission Date:
September 17, 2023,
Accepted Date:
September 22, 2023,
Published Date:
September 27, 2023
Crossref doi:
https://doi.org/10.37547/ijasr-03-09-25
Dilfuzahon Zakirjanovna Mamarasulova
Dsc, Docent, Head Of The Department Of Oncology, Andijan State Medical Institute, Andiijan, Uzbekistan
Dilbarkhon Abdulkosimovna Urmanbaeva
Phd, Docent At The Department Of Oncology, Andijan State Medical Institute, Andiijan, Uzbekistan
Doniyorbek Shukhratbekovich Khasanov
Phd, Docent At The Department Of Oncology, Andijan State Medical Institute, Andiijan, Uzbekistan
Sherzodjon Takhirovich Abdukodirov
Assistant Of The Department Of Infectious Diseases, Andijan State Medical Institute, Andiijan, Uzbekistan
Volume 03 Issue 09-2023
151
International Journal of Advance Scientific Research
(ISSN
–
2750-1396)
VOLUME
03
ISSUE
09
Pages:
150-158
SJIF
I
MPACT
FACTOR
(2021:
5.478
)
(2022:
5.636
)
(2023:
6.741
)
OCLC
–
1368736135
Cervical cancer (CC) is a pathology for which the
possibility of effective prevention has been
proven. Preventive topical treatment of
preinvasive cervical lesions (so-called high-grade
cervical intraepithelial neoplasia, HG CIN) is an
established strategy that has proven its clinical
relevance [3,6]. Progression from human
papillomavirus infection (HPVI) to CC can take
15
–
20 years [13]. Such a long precancerous phase
provides opportunities for early diagnosis and
timely therapy, and also makes it possible to
express the imperative about the advisability of
population screening. Despite the introduction of
population screening, invasive cervical cancer
remains one of the most common malignant
diseases - the fourth most common among
malignant neoplasms in women, according to
world statistics [14].In 2018, cervical cancer was
diagnosed in 570,000 women and caused death in
311,000. At the same time, 84% of cases and 88%
of deaths from cervical cancer occur in
developing countries [4].
To increase the specificity and sensitivity of
screening, it is possible to use local express tests,
in particular, a modified CIN-Diag test (Anhui
Deepblue Medical Technology Co., LTD., China).
The test, being local, is not cytological. It is based
on determining the concentration of active
oxygen radicals in epithelial cells. Active oxygen
ions stain the colorless dye contained in the swab
in a dark color. The color intensity correlates with
the severity of the lesion. In the affected cells, a
large amount of active oxygen ions accumulates,
which is accompanied by an increase in the
expression of folic acid receptors on the cell
membrane. Folic acid contained on the surface of
the test swab penetrates into the cytoplasm of the
cell along with the dye and the buffer solution of
glacial acetic acid. According to the manufacturer,
the sensitivity of the test for the detection of HSIL
is 98%, the specificity is 95%. The test allows you
to detect inflammatory changes (light green or
green indicator, CIN 1 (dark green), CIN 2 (blue
green or emerald), CIN 3 (blue), cervical cancer
(dark gray or black).
This technology is based on the detection of
changes in cell biochemistry and is not
pathogenetically associated with oncogenesis, so
its place in the cervical cancer screening program
remains uncertain.However, the ability to detect
lesions of the CMM epithelium in the early stages
and calibrate the degree of damage sets the
direction for trail studies [3,7].
M
ATERIALS AND METHODS
In the course of this study during 2020-2021
10,716 women aged 25-65 years (mean age -
43.28±3.82 years) were examined, who did not
present complaints, indicating gynecological
pathology and did not have a history of erosive
lesions of the cervix. All examined women
underwent a PCR test to detect HPV DTCs in the
cells of the cervical mucosa. Cells were obtained
by taking with a special brush. As a result, groups
of HPV-positive (HPV+) and HPV-negative (HPV-)
women were identified. Also, all the subjects
underwent an examination of the cervix in
gynecological mirrors to visually determine the
state of the mucosal epithelium and cytological
Volume 03 Issue 09-2023
152
International Journal of Advance Scientific Research
(ISSN
–
2750-1396)
VOLUME
03
ISSUE
09
Pages:
150-158
SJIF
I
MPACT
FACTOR
(2021:
5.478
)
(2022:
5.636
)
(2023:
6.741
)
OCLC
–
1368736135
examination by the Papanicolaou method. During
the examination, all examined women were
divided into a group with unchanged cervical
mucosa (PAP-) and a group with erosive changes
in the cervical mucosa.
All women of these groups underwent a rapid
CIN-DIAG test, in case of detection of LSIL,
electrocoagulation of the affected area of the
cervical mucosa was performed, HSIL -
electroconization, carcinomas - hysterectomy.
During the study, the number of women with
indications for various treatment options for
cervical pathology was recorded, depending on
the algorithm of diagnostic tactics.
At the first stage today is a cytological
examination of the cervix, thanks to which
malignant processes can be detected in the early
stages. According to the author E.G. Novikova
(2000), in her study, tumor changes on the cervix
were detected in 94.5% of cases. The cytological
sampling is taken from three sites, from the
vagina, at the site of the transition of the stratified
squamous epithelium to the glandular one, from
the cervical canal.
A disposable instrument is used to take the
material, which includes a spatula, brush and
glass slides. A fence is taken after the menstrual
cycle, after careful processing and cleaning of
cervical mucus, by lightly scraping with an Eyre
spatula. The brush is also carefully inserted and a
swab is taken from the canal in a clockwise
circular motion.
The CIN-DIAG test, a modified express test for the
detection of metaplastic epithelial cells of the
cervical mucosa, was performed during a
gynecological examination. The patient was
located on the gynecological chair. The test kit
(Anhui Deep blue Medical Technology Co., LTD.,
China) is a swab immersed in a special solution of
folic acid, dye and glacial acetic acid. The method
is based on changing the color of the indicator
upon contact with active oxygen ions that
accumulate in tumor cells. The number of active
oxygen ions and, accordingly, the color intensity
correlates with the severity of metaplasia.The
color change is assessed after 30 seconds: if the
tampon does not change color, this indicates the
absence of pathologies on the epithelial tissues;
light green or green color - inflammatory changes;
dark green color - CIN1; blue-green, dark emerald
colors - CIN2; blue color - CIN3; dark gray and
black colors - CIN3 or carcinoma.
R
ESULTS AND DISCUSSION
During the study, all women with a positive HPV
test and a positive cytology test underwent rapid
CIN-DIAG testing to detect epithelial metaplasia.
The test result implies 5 options: normal (no
staining), inflammatory changes - ACSUS
equivalent (light green or green), CIN-1 - LSIL
equivalent (blue-green or emerald color), CIN-2 -
HSIL equivalent (blue color). ), CIN-3
–
cancer
(dark blue and black).
During the test, more than half of the women
(54%) showed a normal functional state of
epitheliocytes, 25% - inflammatory changes in
Volume 03 Issue 09-2023
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International Journal of Advance Scientific Research
(ISSN
–
2750-1396)
VOLUME
03
ISSUE
09
Pages:
150-158
SJIF
I
MPACT
FACTOR
(2021:
5.478
)
(2022:
5.636
)
(2023:
6.741
)
OCLC
–
1368736135
the epithelium (light green staining of the swab),
the rest (21%) - manifestations of epithelial
metaplasia (Fig. 1).
During the study, the distribution of the
occurrence of various staining variants in the CIN-
DIAG test by age groups was analyzed (Fig. 2). A
visual image shows that in women over 50 years
of age, the frequency of normal test results
decreases, which is probably due to the
climacteric syndrome with corresponding
dishormonal conditions.
Fig. 1 Frequency of different staining patterns in the CIN-DIAG test in women with indications for
colposcopy
1676, 54%
764, 25%
464, 15%
148, 5%
47, 1%
9, 0%
no staining
light-green
green
Emerald
Blue
Black
Volume 03 Issue 09-2023
154
International Journal of Advance Scientific Research
(ISSN
–
2750-1396)
VOLUME
03
ISSUE
09
Pages:
150-158
SJIF
I
MPACT
FACTOR
(2021:
5.478
)
(2022:
5.636
)
(2023:
6.741
)
OCLC
–
1368736135
Fig. 2 Frequency of different CIN-DIAG swab staining patterns in women with indications for
colposcopy by age
An assessment of the distribution of various results by age decades found that with increasing age of the
examined women, the frequency of normal results decreases and the frequency of pathological -
inflammatory changes and epithelial metaplasia increases (χ2=42.70, p<0.001, Table 1).
Table 1
The frequency of detection of a normal result, inflammatory and metaplastic changes in the cervix
according to the results of the CIN-DIAG test in women with indications for colposcopy by age
decades.
Age Group
Regular
Inflammatory changes
in the epithelium
Epithelia
metaplasia
25-35
544
182
144
36-45
495
179
144
46-55
528
231
191
56-65
109
172
189
Total
1676
764
668
281
263
294
201
505
23
27
82
62
120
93
86
89
142
120
52
28
86
55
48
44
82
93
28
6
14
12
16
16
34
39
11
3
7
5
5
4
8
9
6
0
0
2
1
2
1
2
1
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
25-30
31-35
36-40
41-45
46-50
51-55
56-60
61-65
GROUP AGE
no staining
Light-green
Green
Blue-green
Blue
Black
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VOLUME
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Pages:
150-158
SJIF
I
MPACT
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(2021:
5.478
)
(2022:
5.636
)
(2023:
6.741
)
OCLC
–
1368736135
χ
2
42,70, p<0,001
The age distribution of various results of the CIN-DIAG test with signs of metaplasia found that with
increasing age, the proportion of blue and black staining of the swab increases, indicating CIN-3 metaplasia
and carcinoma (Table 2).
Table 2
The frequency of detection of various staining variants, indicating metaplastic changes in the
cervix, according to the results of the CIN-DIAG test in women with indications for colposcopy by
age decades.
Age Group
Green
Blue-green
Blue
Black
25-35
114
20
10
0
36-45
103
28
10
3
46-55
126
50
12
3
56-65
121
50
15
3
Total
464
148
47
9
χ
2
=14,12, p<0,01
The study examined the diagnostic significance of the CIN-DIAG test in terms of detecting the pathology of
the cervical epithelium in women with indications for colposcopy (Table 3).
Table 3
Sensitivity, specificity and diagnostic significance of the CIN-DIAG test in terms of detecting
inflammatory and metaplastic conditions of the cervical epithelium in women with indications for
colposcopy
Types of test
response
critical + critical -
Sensitivity
Specificity
Diagnostic
significance
All pathological
changes
1381
51
4
1672
99,71
97,04
98,23
Green, blue-green,
blue, black
661
7
41
2399
94,16
99,71
98,46
Volume 03 Issue 09-2023
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International Journal of Advance Scientific Research
(ISSN
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2750-1396)
VOLUME
03
ISSUE
09
Pages:
150-158
SJIF
I
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FACTOR
(2021:
5.478
)
(2022:
5.636
)
(2023:
6.741
)
OCLC
–
1368736135
Blue-green, blue
201
3
3
2901
98,53
99,90
99,81
Black color
7
2
0
2951
100,00
99,93
95,17
Note: (as a verification of the diagnosis, the results of colposcopy were used, the calculation method
is given in Table 3.3, in the numerator - pathology +, in the denominator - pathology -)
It has been established that the rapid test is highly
sensitive and specific, which allows it to be used
to narrow indications for colposcopy. That is, to
include in the screening scheme for women 25-65
years old with a positive HPV test and a
cytological examination of the CIN-DIAG test to
exclude women without pathological changes in
the cervical epithelium and with inflammatory
lesions of the epithelium. Thus, it is possible to
limit the need for colposcopy in women with
evidence of cervical epithelial metaplasia (all
stages of metaplasia). Such a modification of the
screening algorithm will reduce the financial,
labor and time costs of colposcopy, as well as
solve the problem of insufficient availability of the
method.
The present study showed that the CIN-DIAG
rapid test is a sensitive and specific method for
detecting the pathology of the cervical epithelium,
accessible, technically simple, and does not
require special equipment and personnel. The
test can be recommended for inclusion in the
screening algorithm for women aged 25-65.
C
ONCLUSION
The CIN-DIAG rapid test has high sensitivity,
specificity and diagnostic value in terms of
detecting high-grade epithelial metaplasia and
cervical cancer (98.53% and 100%, 99.90% and
99.93% and 99.81 and 95.17%, respectively). The
use of the proposed algorithm for screening
cervical cancer makes it possible to detect
metaplasia of the epithelium of the cervical
cancer at an early stage (precancer) and reduce
the need for colposcopy by 4.65 times (up to
6.33% of the entire target population).
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Pages:
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