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Perera et al. BMC Infectious Diseases (2024) 24:1249
https://doi.org/10.1186/s12879-024-10150-4 BMC Infectious Diseases
*Correspondence:
KCM Perera
chithranganieperera@yahoo.com
Full list of author information is available at the end of the article
Abstract
Background Cervical cancer is the 2nd most common female cancer among Sri Lankan females and is almost
associated with sexually transmitted cervicovaginal human papillomavirus (HPV) infection. The study objectives were
to determine the prevalence of vaginal and cervical HPV infection among 35year old ever-married women and assess
the validity of primary healthcare provider-collected vaginal HPV/DNA specimens as a cervical cancer screening tool
to improve the coverage of the programme.
Method A descriptive cross-sectional study was carried out from the 1st of September 2018 to the 31st of January
2019. Ever-married women 35 years of age in Kalutara district were the study population. Two women from each
Public Health Midwife area (n = 413) were selected randomly from the relevant area eligible families register/s. HPV/
DNA cervical specimen and vaginal specimen collection (n = 621) were carried out. Specimens were screened by the
Cobas 4800 HPV/DNA automated Polymerase Chain Reaction (PCR) machine. Participants’ proles were recorded by
the research assistants using an interviewer-administered questionnaire.
Results The overall prevalence of vaginal and cervical HPV infection was 7.08% (95% CI; 5.2-9.4%) and 6.12% (95%
CI; 4.26-8.3%) respectively. Sensitivity, specicity, positive predictive value (PPV), negative predictive value (NPV),
diagnostic accuracy, and the kappa coecient of the vaginal HPV/DNA screening method vs. cervical HPV/DNA
screening method were 100%, 98.9%, 86.4%, 100%, 99% and 0.92 respectively.
Conclusions Vaginal HPV/DNA specimen screening method can be used as a cervical cancer screening tool due to
its high validity. Pilots of the feasibility should be set up before the regional or national rollout of vaginal sampling
strategies.
Prevalence of vaginal and cervical HPV
infection among 35-year age cohort ever-
married women in Kalutara district of Sri
Lanka and the validity of vaginal HPV/DNA
specimen as a cervical cancer screening tool:
a cross-sectional study
KCMPerera1*, KNMapitigama2 and HTCSAbeysena3
Page 2 of 7Perera et al. BMC Infectious Diseases (2024) 24:1249
Background
According to the cancer incidence rates cervical cancer
is the 2nd leading cause of female cancers in Sri Lanka
and women at risk for cervical cancer are more than
8.4million [1]. In Sri Lanka, annually 1721 new cases of
cervical cancer are diagnosed and 690 women die from
the disease [1]. Cervical cancer has a well-known associa-
tion with HPV infection. Persistent infection with carci-
nogenic HPV types is the cause of most cervical cancer
incidents [2]. As in some other cancers, cervical cancer
is also preceded by precursor stages called cervical pre-
cancers. According to the histology used for the diagno-
sis, there are 3 types of pre-cancer stages before invasive
cervical carcinoma; Cervical Intraepithelial Neoplasia
(CIN) stages 1, II, and III [3].
In cervical pre-cancers, an abnormality occurs in epi-
thelial cells of the squamous-columnar junction (SCJ)
due to persistent Human papillomavirus (HPV) infection.
Cervical cancer is one of the few cancers, where a precur-
sor stage (pre-cancer) lasts decades before becoming an
invasive cancer giving ample opportunity for early detec-
tion and timely treatment. Since these lesions precede
cancer for decades, cervical cancer is highly preventable.
Moreover, if cervical cancer is detected early and treated
appropriately, it can still be cured [2].
More than one hundred and fty HPV genotypes have
been identied to date and nearly 60 dierent types of
them are known to infect the human genital tract includ-
ing cervix uteri. ere are carcinogenic and non-carcino-
genic genotypes and 10–15 carcinogenic genotypes are
mainly associated with cervical cancer [4]. Some carci-
nogenic genotypes are classied as “high risk” (16,18,3
1,33,35,39,45,51,52,56,58 and 59) as there is evidence of
increased risk association between HPV infection with
these strains and cervical cancer [5].
In 1998, conventional papaniculaou smear screening
was introduced in Sri Lanka as a cervical cancer screen-
ing method through the Well Woman programme. How-
ever, after 20 years of existence of the programme, there
has been no marked reduction in the incidence, morbid-
ity, and mortality of cervical cancer in Sri Lanka due to
poor sensitivity of the test (53%) [6] and the low coverage
of the programme (only 61.6%- in 2018) [7]. erefore,
the cervical cancer prevention programme needs to be
reviewed with special attention.
Cervical cancer screening is a secondary preventive
strategy with early detection of abnormal tissues from
the cervix before the development of cervical cancer.
HPV/DNA test also is used to detect cervicovaginal HPV
infection in women. erefore, the objectives of the study
were to determine the prevalence of vaginal and cervical
HPV infection among ever-married women and assess
the validity of primary healthcare provider-collected vag-
inal HPV/DNA specimens as a cervical cancer screening
tool among 35-year age cohort of ever-married women
in a district of Sri Lanka, with the ultimate aim of to
improving the quality and coverage of the cervical cancer
screening programme.
Methods
A descriptive cross-sectional study was conducted in
Medical Ocers of Health (MOOH) areas of Kalutara
district from September/2018 to January/2019 to deter-
mine the prevalence of vaginal and cervical HPV and to
assess the validity of primary healthcare provider-col-
lected vaginal HPV/DNA test to be used as a cervical
cancer screening tool in Sri Lanka among ever-married
women of 35 years of age, in Kalutara district. Women
with diagnosed invasive cervical cancer, women with
vaginal bleeding and active infection at the time of exam-
ination with evidence of medical records or by visual
inspection, women currently on treatment for HPV
infection, pregnant women and women ≤ 3 months in the
postpartum period, women who had undergone hyster-
ectomy, women with diagnosed physical or mental retar-
dation or bedridden due to disease status and women
who have not residing within the district continuously
for ≥ three months before the date of the survey were
excluded from the study.
e prevalence of cervical HPV in the target population
was 3.3% [8]. In the case of preliminary studies, if there is
a resource limitation, investigators may use a larger pre-
cision of > 10% [9], according to the assumptions of nor-
mal approximations-NP and N(1-P) > 5 [10]. erefore,
we needed 386 women. Further adjustment to the sample
size was made by considering the previous year’s WWC
non-response rate (42.4%) in the Kalutara district [7] and
the nal required sample size for diagnostic accuracy
was 671. e sensitivity of vaginal specimen vs. cervical
specimen for CIN II or worse in the Polymerase Chain
Reaction (PCR) based screening method was considered
99% [11].
e total number of Public Health Midwife (PHM)
areas was 413 in all 15 MOH areas in Kalutara dis-
trict. Two women from each PHM area eligible families
register/s were randomly selected for the study. If any
randomly selected women, were not recruited for the
study after applying exclusion criteria at the eld setting,
then the Principal Investigator (PI) checked the recruited
status of the other women selected for the study from
Keywords Prevalence, HPV infection, Cervical, Vaginal, HPV/DNA test, Vaginal HPV/DNA specimens, Cervical cancer,
Screening tool
Page 3 of 7Perera et al. BMC Infectious Diseases (2024) 24:1249
the same PHM area. In the case that none of the women
from a PHM area were recruited to the study, another
woman from that PHM area eligible families register/s
were randomly selected to the study to ensure the rep-
resentation of participants to the study from all PHM
areas in the district. A total number of 682 ever-married
women 35 years old that represented the whole Kalutara
district were recruited to the study after applying exclu-
sion criteria in the eld setting and invited to the eld
Well Woman Clinics (WWC) in Kalutara district (89).
Information regarding socio-demographic characteristics
was gathered by using an interviewer-administered ques-
tionnaire (Additional File).
Sta training for PHMM to collect upper vaginal HPV/
DNA specimens and MOOH or Public Health Nursing
Sisters (PHNSS) to collect cervical HPV/DNA specimens
were done by the PI at each MOH oce level in Kalu-
tara district. Fifteen such sta trainings were conducted
on monthly PHMM in-service training days for MOOH/
PHNSS and PHMM at each MOH oce. Videos created
for sta training by the Cobas 4800 HPV/DNA screening
machine manufacturers (Hologic company for women’s
health) were used in sta training. Instruction regarding
accurate numbering of specimens, completion of speci-
men request forms, and preparation for transport were
also included in the training sessions. Cyto-screeners
were uniformly trained for specimen barcoding, handling
the machine, and report writing to ensure the quality of
performance by a team of experts. Colposcopists were
uniformly trained to ensure the quality of performance.
First HPV/DNA vaginal specimen collection was car-
ried out by a well-trained PHM and then cervical speci-
men collection from the same client by MOH/PHNS
at the same clinic session in a separate place. Cusco’s
speculum was inserted to visualize the cervix before
obtaining an HPV/DNA cervical specimen. HPV/DNA
specimens obtained from the cervix and vagina using
special broom-like devices were separately placed into
HPV/DNA specimen collection containers. Cervical and
vaginal specimens from the same client were separately
packed with the same identication number. In vaginal
specimens, the letter “V” was written after the identica-
tion number for identication purposes.
Prepared guidelines were strictly adhered to during
data collection, barcoding, and preparation of specimens
for transport. Monitoring and supervision of the ongo-
ing eld activities and specimen collection were carried
out by the PI. Specimen identication numbers were
closely supervised by the PI at the community clinic level
for vaginal and cervical specimens including in request
forms. Specimen screening was done at the laboratory,
District General Hospital, Kalutara. Barcoding of speci-
mens at the laboratory before entering the specimens
into the Cobas 4800 machine was done under the PI’s
close monitoring and supervision. Result reports written
by Cyto-screeners at the laboratory were also randomly
checked by the PI.
Vaginal and cervical specimens were screened at the
laboratory by well-trained Cyto-screeners with a Cobas
4800 HPV/DNA automated PCR machine, which con-
sists of a Cobas 4800x instrument and a Cobas analyzer.
Cobas 4800 HPV/DNA screening machine included sev-
eral quality control mechanisms such as internal quality
control, external quality control, and contamination con-
trol. e test sensitivity and specicity to detect ≥ CIN II
are 92.9% and 71% respectively [12]. It detects 14 high-
risk carcinogenic HPV genotypes, such as; 16, 18, and 12
pooled high-risk (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66,
and 68) genotypes.
Data were analyzed by using SPSS version 20. Overall
vaginal and cervical HPV prevalence and subgroup anal-
ysis (genotype 16 & 18) of the vaginal and cervical speci-
mens and 95% CI were calculated. Sensitivity, specicity,
positive predictive value (PPV), negative predictive value,
(NPV), and diagnostic accuracy of vaginal specimen
vs. cervical specimen (gold standard) and 95% CI were
calculated. e likelihood ratios of vaginal HPV/DNA
specimens were calculated. e Kappa coecient of the
vaginal HPV/DNA specimen screening method vs. the
cervical HPV/DNA specimen screening method for the
Cobas 4800 test was calculated.
Results
Six hundred eighty-two women were recruited to the
study and only 631 of them attended community WWCs,
therefore the response rate was 92.5%. Of them, only 621
were subjected to vaginal and cervical specimen collec-
tion after applying exclusion criteria at the clinic set-
ting, therefore, the HPV/DNA coverage of the study was
91%. One recruit was excluded at the clinic setting from
the study, as she was pregnant (n = 1), while others were
excluded due to cervical erosion (n = 3), vaginal discharge
(n = 3), cervicitis (n = 2) and fungal infection (n = 1).
e majority of respondents were Sinhala (94.5%) and
Buddhists (94.4%). Out of the total study participants,
9% had not completed years of school education beyond
the 5th grade and another 12.9% of the study participants
had remained at the 6-11th grade level education. e
majority were educated only up to the O/L passed level of
education (58.9%) (Table1).
Prevalence of cervicovaginal HPV infection among the
35-year age cohort of ever-married women in Kalutara
district, according to the cervical specimen screening
method by Cobas 4800 was 6.12% (95% CI; 4.26-8.3%),
while the prevalence of HPV infection, according to the
vaginal specimen screening method by Cobas 4800 test
was 7.08% (95% CI; 5.2-9.4%).
Page 4 of 7Perera et al. BMC Infectious Diseases (2024) 24:1249
Prevalence of HR-HPV 16 & 18 genotype infection
among the 35-year age cohort ever-married women in
Kalutara district according to the cervical specimen col-
lection method by Cobas 4800 was 1.9% (95% CI; 1.89-
1.91%) (Table2), while the prevalence of HPV 16 and 18
genotypes infection according to the vaginal specimen
collection screening method was 2.1% (95% CI; 2.09-
2.11%) (Table3).
Sensitivity, specicity, PPV, and NPV, of the vaginal
vs. cervical HPV/DNA specimen collection screening
method, were 100% (95%CI: 90.7-100%), 98.9% (95%
CI: 97.8-99.6%) 86.4% (95% CI: 74.1-93.3%) and 100%
(95%CI: 90.7-100%) respectively (Table4).
Diagnostic agreement between vaginal vs. cervical
HPV/DNA specimen collection screening method was
99.0% (95% CI; 97.9-99.6%). Positive Likelihood Ratio (LR
+) and Negative likelihood ratio (LR-) for vaginal HPV/
Table 1 Distribution of participants according to ethnicity, religion, educational level, and occupational status
Characteristics Number of women (N = 621) Percentage %
1. Nationality
Sinhala
Tamil
Muslim
587
13
21
94.5
2.1
3.4
2. Religion
Buddhism
Catholic
Hindu
Islam
586
3
11
21
94.4
0.4
1.8
3.4
3. Education level
No schooling
Grade 1-5th
Grade 6-11th
O/L passed
A/L passed
Degree& above
2
54
80
230
164
91
0.3
8.7
12.9
37.0
26.4
14.7
4. Occupational status
Working women
Non-working women
184
437
29.6
70.4
Table 2 Distribution of participants according to cervical HPV/DNA specimen screening result for HR-HPV genotypes
Cervical HPV/DNA specimen results for HR-HPV genotype Number of women Percentage % 95% CI for percentages %
Negative 583 93.9
12 pooled positive 26 4.2 4.18–4.22
16-positive 10 1.6 1.59–1.61
18-positive 02 0.3 0.29–0.31
Total 621 100.0
Table 3 Distribution of participants according to vaginal specimen screening result for HR-HPV genotypes
Vaginal HPV/DNA specimen results for HR-HPV genotypes Number of women Percentage % 95% CI for percentage%
Negative 577 92.9 92.88–92.92
12 pooled positive 31 5.0 5.28–5.32
16-positive 11 1.8 1.79–1.81
18-positive 02 0.3 0.29–0.31
Total 621 100.0
Table 4 HPV/DNA vaginal specimen collection screening method vs. cervical HPV/DNA specimen collection screening method (as a
gold standard) by using Cobas 4800 HPV/DNA screening test
Screening test + ve/-ve
Vaginal vs. Cervical
Cervical HPV/DNA specimen + ve for HR-HPV Cervical HPV/DNA specimen –ve for HR-HPV
Vaginal HPV/DNA* specimen + ve for HPV 38 06
Vaginal HPV/DNA specimen –ve for HPV 0 577
Total 38 583
*HPV/DNA- Human papillomavirus/DNA
Page 5 of 7Perera et al. BMC Infectious Diseases (2024) 24:1249
DNA specimen screening were 97.2 (95% CI; 43.8-215.4),
and 0.0 respectively. e kappa coecient between vagi-
nal HPV/DNA specimen vs. cervical HPV/DNA speci-
men screening method by Cobas 4800 HPV/DNA test
was 0.92 (95% CI; 0.86–0.98%).
Discussion
Cervical cancer has a well-known association with HPV
infection. Persistent infection with carcinogenic HPV
types is the cause of most cervical cancer [2]. e HPV/
DNA test is used to detect cervicovaginal HPV infection
in women. In the present study, the prevalence of vagi-
nal HPV infection was 7.08% (95% CI; 5.2-9.4%) and the
prevalence of cervical HPV infection was 6.12% (95% CI;
4.26-8.3%) by Cobas 4800 PCR-based HPV/DNA test.
HPV/DNA screening methods are based on the detec-
tion of high-risk HPV/DNA in vaginal or cervical smears
[3]. e specimen can be collected from the SCJ of the
cervix or upper vagina using a swab or small brush and
placed in a small container with a preservative solution
(i.e. thin prep) [3, 13].
HPV/DNA test by cervical specimens is highly sensitive
(92.9%) [12] for CIN II viral load, and it gives the oppor-
tunity for a visual examination of the cervix and cervi-
cal cytology as well, therefore the quality of the National
Cervical Cancer Screening programme can be improved
with the cervical HPV/DNA test. However, HPV/DNA
cervical specimen collection required vaginal Cusco’s
speculum insertion. erefore, only highly skilled health-
care workers (i.e. MOOH, MO, and PHNSS) can perform
the test in the WWC setting. erefore, the requirement
for a solution to improve the coverage of the National
Cervical Cancer Screening programme in Sri Lanka was
felt like a vital matter of concern.
A non-cytological screening method, which doesn’t
require vaginal speculum examination (i.e. HPV/DNA
vaginal specimen) may improve the quality and support
in improving the coverage of the cervical cancer screen-
ing programme in women who have access to health care.
Primary healthcare providers (PHMM) can perform vagi-
nal HPV/DNA test either at clinic setting or while during
their home visits for clinic non-attendees. Further, it is
reported vaginal specimens tested with aordable HPV/
DNA tests can increase the rate of screening in resource
constraint settings [14] and that women preferred vagi-
nal specimens to cervical HPV/DNA specimens as it was
private, comfortable, less painful, and less embarrassing
[15]. erefore, assessing the validation of HPV/DNA
vaginal specimens collected by PHMM against cervical
specimens collected by MOOH/PHNSS (gold standard)
is very important.
Sensitivity, specicity, PPV, and NPV values of the
vaginal HPV/DNA specimen screening vs. cervical HPV/
DNA specimen screening were 100%, 98.9%, 86.4%, and
100% respectively. In comparison, the false-positive
rate was high in vaginal HPV/DNA specimen screening
(1.1%). is over-reporting rate of the vaginal HPV/DNA
specimen screening method due to the lower specicity
rate, might lead to over-treatment and unnecessary anxi-
ety due to the fear of disease. However, considering the
cervical cancer morbidity and mortality rates, this over-
diagnosis rate can be negotiated by improving the qual-
ity and coverage of the existing cervical cancer screening
programme.
As a screening method, the most précised value of the
primary healthcare provider collected vaginal HPV/DNA
specimen screening was zero reporting of the false nega-
tives vs. the gold standard screening which would not let
missing and under-reporting cases. Similar patterns of
results were observed in the world by using dierent PCR
tests in comparison studies of vaginal HPV/DNA speci-
men screening vs. cervical HPV/DNA specimen screen-
ing [11, 16, 17].
e agreement between the vaginal HPV/DNA speci-
men screening method vs. cervical HPV/DNA screening
was 0.99, while the kappa coecient between the two
tests was 0.92. A similar agreement was shown in the
world by using dierent PCR tests in comparison stud-
ies of vaginal HPV/DNA specimen screening vs. cervical
HPV/DNA specimen screening [11, 16–18].
In this study, specimens were transferred to the labo-
ratory at room temperature. In delay of transport,
specimens were to be stored at the bottom level of a
refrigerator (2c°-8c°). Vaginal HPV/DNA specimens can
be obtained with a cotton swab combined with a glass
slide and successfully attempted in some other countries
[13], which can be a suitable measure to overcome the
associated challenge with specimen storage and trans-
portation in “‘thin prep cell collection media’” like in this
study.
Public health infrastructure is well developed in Sri
Lanka and each MOH area is sub-divided in to PHM
areas. For each PHM area, usually, one primary health
care worker (PHM) is assigned and she conducts rou-
tine home visits in the relevant PHM area, therefore, the
primary healthcare provider collected vaginal samples
can be collected while during their home visits for clinic
non-attendees and it will improve the coverage of the
programme. Usually, in a given setting WWCs are con-
ducted fortnightly and they provide many other services
(i.e. general examination, breast examination, health
education, family planning counseling…etc.) along with
cervical cancer screening opportunities. Also, in a clinic
setting providers have an unique opportunity to pre-
pare women for the test. Primary health care providers
are not trained for Cusco’s speculum insertion there-
fore they could not perform HPV/DNA cervical test at
WWC clinic setting. As a result, clients have to wait for a
Page 6 of 7Perera et al. BMC Infectious Diseases (2024) 24:1249
long waiting period for highly skilled healthcare workers
(MOH, MO, and PHNS), and only a limited number of
women can be screened per day, which may also lead to
high clinic non-attendants [7].
By promoting self-collected vaginal samples at home
setting women will miss, all other services provided by
the WWC. Also, it may lead to many issues related to
sample storage and transportation. Primary healthcare
providers will collect vaginal specimens during their
home visits only for eligible clinic non-attendees follow-
ing a repeated WWC invitation, therefore the opportu-
nity for WWC visit is always promoted. In addition, due
to the variety of literacy levels, primary healthcare pro-
viders collected HPV/DNA vaginal samples during their
home visits for clinic non-attendees would be a more
suitable option for the Sri Lankan setting than the self-
collected vaginal specimen at home setting.
In addition, all the primary health care workers (PHM),
who collected vaginal specimens are females. So, the
non-response due to cultural issues is minimized. Also,
the accuracy of the provider-collected sample would be
high according to some literature [19, 20]. erefore, we
preferred to assess the validity of the primary healthcare
provider collected vaginal specimens rst instead of self-
collection at the clinic setting. Validating self-collected
vaginal samples in clinic settings is yet to be carried out
to make recommendations on it.
Limitations of the study
is study was restricted to one district out of 25 districts
in Sri Lanka due to logistic constraints.
Conclusion
e present study revealed that the primary healthcare
provider collected vaginal HPV/DNA specimens have
a high validity against the gold standard. erefore, in
addition to the cervical HPV/DNA tests, primary health-
care provider-collected vaginal HPV/DNA tests can be
considered for routine screening, especially for clinic
non-attendees to improve the coverage of the National
Cervical Cancer Screening programme after careful
assessment of its feasibility.
Abbreviations
HPV Human Papilloma Virus
SCJ Squamous-columnar junction
MOH Medical Ocer of Health
PCR Polymerase Chain Reaction
PI Principal Investigator
MO Medical Ocer
PHNSS Public Health Nursing Sisters
PHMM Public Health Midwives
RA Research Assistant
WWC Well Woman Clinic
ASCUS Atypical Squamous Cells of Undetermined Signicance
PPV Positive predictive value
NPV Negative predictive value
HR-HPV High-Risk Human Papilloma Virus
Supplementary Information
The online version contains supplementary material available at h t t p s : / / d o i . o r
g / 1 0 . 1 1 8 6 / s 1 2 8 7 9 - 0 2 4 - 1 0 1 5 0 - 4 .
Supplementary Material 1
Acknowledgements
We are grateful to the study participants, research assistants, and the Post
Graduate Institute of Medicine, University of Colombo.
Author contributions
KCMP was the principal investigator of the study and participated in the
design of study, coordinated data collection, performed the statistical analysis,
and drafted the version of the manuscript. HTCSA and KNM participated in
the design of the study. HTCSA has performed the statistical analysis and
interpreted data. Both HTCSA and KNM helped to draft the manuscript. All
three authors read and approved the nal manuscript.
Funding
We hereby declare that the cost for specimen collection instruments and
reagents (test kits) was funded by the Family Health Bureau, Colombo, Sri
Lanka. There was no inuence from the above-mentioned institute during the
process of conducting or report writing of this research.
Data availability
The datasets used to analyze this study are available at the corresponding
author upon reasonable request.
Declarations
Ethical approval and consent to participate
Ethical clearance was obtained from the Ethics Review Committee (ERC),
National Institute of Health Science (NIHS), Kalutara Sri Lanka (ref. number
NIHS/ERC/18/06R). Informed written consent was obtained from each of
the selected participants in the eld during the study. Condentiality was
highly maintained while handing over individual HPV/DNA result reports.
Administrative clearance to conduct the study was obtained from the
Provincial Director of Health Services/Western Province, Regional Director of
Health Services/Kalutara district, Director/ District General Hospital K alutara,
and Director /NIHS, Kalutara.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Author details
1Consultant Community Physician, Nutrition Division, Ministry of Health,
Colombo, Sri Lanka
2Consultant Community Physician, Family Health Bureau, Colombo, Sri
Lanka
3Senior Professor in Community Medicine, University of Kelaniya, Kelaniya,
Sri Lanka
Received: 12 April 2024 / Accepted: 29 October 2024
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