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Ease, Comfort, and Performance of the

HerSwab Vaginal Self-Sampling Device for
the Detection of Chlamydia trachomatis
and Neisseria gonorrhoeae
ARTICLE in SEXUALLY TRANSMITTED DISEASES JANUARY 2016
Impact Factor: 2.84 DOI: 10.1097/OLQ.0000000000000406

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ORIGINAL STUDY

Ease, Comfort, and Performance of the HerSwab

Vaginal Self-Sampling Device for the Detection of
Chlamydia trachomatis and Neisseria gonorrhoeae
Manuel Arias, BSc, Dan Jang, BSc, Jodi Gilchrist, MSc, Kathy Luinstra, BSc, Jenny Li, BSc,
Marek Smieja, MD, PhD, and Max A. Chernesky, PhD
Background: Many sexually transmitted diseases are asymptomatic in
the lower genital tract and can cause upper tract complications if left untreated. Self-collected vaginal (SCV) swabs enable the accurate detection of many sexually transmitted infections and give women the
option of collecting their own samples while providing them with privacy and convenience.
Methods: We compared SCV samples collected and transported dry
using the HerSwab device to physician-collected vaginal (PCV) Aptima
swabs for the detection of Chlamydia trachomatis (CT) and Neisseria
gonorrhoeae (NG), and measured patients' ease and comfort with selfcollection. A total of 189 women aged 16 to 41 years were consented into
the study and answered a standardized anonymized questionnaire regarding
self-collection with the HerSwab device.
Results: Women reported self-collection with HerSwab to be easy
(97.1%) and comfortable (88.3%). They preferred self-collection over physician collection (80.9%) and would consider using HerSwab for selfcollection at home (79.7%). Samples of SCV and PCV showed an overall
agreement of 94.7% ( = 0.64) for CT and of 98.4% ( = 0.56) for
NG, and HerSwab collection detected 7 more positive patients than
PCV collection. The overall prevalence of infection was 10.6% for CT
and 2.6% for NG.
Conclusion: HerSwab SCV samples are suitable for the diagnosis of CT
and NG.

any sexually transmitted infections (STIs) are asymptomatic

in the lower genital tract of women and, if undiagnosed and
untreated, may cause upper tract complications.1 Although control programs require screening to treat and detect asymptomatic
infections, commonly reported barriers to STI screening include
embarrassment, fear of pain, lack of comfort with pelvic examinations, the invasiveness of physician sampling, concerns about

confidentiality, and denial of STI risk.25 Self-collection with a

vaginal swab has been used in screening because it is less invasive
than cervical sampling and facilitates greater privacy and convenience, widening the scope of screening programs to include noncompliant, remote, and low-income populations.6,7 Self-collected
vaginal samples are more sensitive than urine for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae
(NG).8 Previous evaluations of vaginal self-collection have demonstrated a high prevalence of CT infection among young, sexually active women in both clinical and nontraditional settings.8,9
Studies assessing acceptability for vaginal self-sampling have previously demonstrated high agreement between self-collected vaginal (SCV) and physician-collected vaginal (PCV) samples for the
detection of CT and NG infections, with participants reporting
high levels of acceptability, ease, and comfort during the selfcollection process.1012
Despite widespread evidence on the diagnostic effectiveness of vaginal self-sampling for the detection of STI's using
nucleic acid amplification tests,1315 there is a growing need to
evaluate self-collection devices for ease and comfort, particularly
for home-based applications. Eve Medical Inc (Toronto, ON,
Canada) has developed a new device (the HerSwab) for selfcollection and dry transport of vaginal samples for STI screening.
The objectives of this study were to survey opinions on ease and
comfort from young sexually active women who SCV samples with
HerSwab, and to compare agreements between SCVand PCV samples for the detection of CT and NG with a transcription-mediated
amplification RNA-based assay, Aptima Combo 2 (AC2; Hologic,
Inc, San Diego, CA).

MATERIALS AND METHODS

Study Design

From the St Joseph's Healthcare Hamilton/McMaster University, Hamilton,

Ontario, Canada
Acknowledgments: The research team would like to thank the staff and clinicians at the Evergreen Center for Street Youth for their assistance in
study design and recruitment. We would also like to thank Hologic,
Inc, for providing the Aptima swabs and specimen transport media used
in this study. The HerSwab devices were kindly provided by Eve
Medical Inc.
Conflict of interest and sources of funding: Eve Medical Inc (Toronto, ON,
Canada) kindly provided the HerSwab devices for the study and the
Aptima specimen collection and transport kits were kindly provided
by Hologic, Inc (San Diego, CA). All authors have no conflict of
interests to declare. This study was funded by the Ontario Centres of
Excellence and Eve Medical Inc.
Correspondence: Max Chernesky, PhD, St Joseph's Healthcare, 50 Charlton
Ave E., Hamilton, ON, Canada L8N 4A6. E-mail: chernesk@mcmaster.ca.
Received for publication September 30, 2015, and accepted November
16, 2015.
DOI: 10.1097/OLQ.0000000000000406
Copyright 2016 American Sexually Transmitted Diseases Association
All rights reserved.

Sexually Transmitted Diseases

A total of 189 participants aged 16 to 41 years were enrolled in the study: 110 women from a street youth clinic and
79 women from a therapeutic abortion clinic. Women signed a
consent form for the collection of a PCV sample using an Aptima
swab and an SCV sample using HerSwab, as outlined on the consent form approved by the Hamilton Integrated Research Ethics
Board in Hamilton, Ontario, Canada. The order of physician collection and self-collection was computer randomized. After explanation of the study, the research coordinator demonstrated steps
for proper self-collection using HerSwab, provided participants
with written and visual instructions (Fig. 1), clarified any outstanding questions, and recorded STI history and symptoms.
Participants were classified as symptomatic if they reported symptoms such as discharge, dysuria, and pelvic pain. Each participant
then collected an SCV sample using HerSwab, and a physician
collected a PCV sample using an Aptima vaginal swab. After collection with HerSwab, women turned the handle of the device to
fully retract the brush tip back into the shaft and placed the device
back in its original packaging.

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Arias et al.

Figure 1. Procedure for vaginal self-sampling using the HerSwab device.

Questionnaire
Each participant was asked to anonymously complete a
2-page written questionnaire after collection. The first section
consisted of a 5-point Likert scale questionnaire where participants indicated ease (for steps 27) and comfort (for steps 36)
of self-collection (Fig. 1) using HerSwab. Additional open-ended
items on the questionnaire included the following: whether the instructions were easy to follow, whether participants preferred physician or self-collection, participants' reasons for preferring selfcollection or physician collection, whether participants would
consider self-sampling at home, and whether there was anything
that participants would change about the device to facilitate ease
and/or comfort.

Laboratory Testing
Samples of SCV and PCV were transported to the Infections Research Laboratory at St Joseph's Healthcare Hamilton on
the day of collection. Self-collected vaginal samples were transported dry in their original packaging, whereas PCV samples were
transported in 2.9 mL of Aptima Specimen Transport Media
(STM). Upon arrival in the laboratory, within 24 hours of collection, the HerSwab device handle was turned to expose the brush,
and the plastic brush tip was snapped off into an Aptima tube containing 2.9 mL of STM. The brush tip remained in the Aptima
STM tube for 48 hours and was subsequently removed from the
STM tube using a sterile swab or pipette tip, before testing to prevent interference with the probe of the automated instrument. All
samples in STM were inverted and tested for CT and NG using
the AC2 assay on the Panther automated system within 72 hours
of collection, as per the manufacturer's instructions. After testing
all SCV and PCV samples on AC2, a subset of 6 discordant and
6 concordant specimen pairs were further tested for -actin
DNA as a quantitative internal control for the amount of specimen collected in each sample type. DNA from 250 L of samples preserved in Aptima STM was extracted with Qiagen
MinElute spin columns and was based on the AmpliLute Liquid
Media Extraction Kit (Roche, Pleasanton, CA), followed by

126

quantitative polymerase chain reaction using previously published -actin primers.16

Statistical Analysis
Means and SDs were calculated to express results from
Likert items on patient questionnaires. Questionnaire responses
were recorded such that 45 meant easy/comfortable-very easy/
comfortable, 3 meant neutral, and 12 meant very difficult/
uncomfortable-difficult/uncomfortable. Descriptive statistics were
performed on patient demographics and open-ended questionnaire
items. Unpaired Student t test was used to test for significance of
(a) presence or absence of symptoms, (b) history of an STI, (c)
swab order randomization, and (d) preference for self-collection
or physician collection on mean questionnaire responses for ease
and comfort for each step of self-collection. An unpaired Student
t test was also used to determine significance of age on preference
for self-collection and on whether participants would consider
self-collection at home. 2 Tests of independence were performed
to test pairs of nominal variables, namely, the presence/absence of
symptoms and presence/absence of a history of an STI versus a
preference for self-collection and whether participants would
consider self-collection at home. Results of AC2 testing were
collated in a secure database, and agreement between sample
types was assessed as raw overall agreement and as agreement
beyond chance () along with 95% confidence intervals. A
paired t test was performed to determine significant differences
in quantity of -actin in CT-concordant versus CT-discordant
SCV/PCV pairs.

RESULTS
Demographics
Participants from the street youth clinic ranged in age from
16 to 26 years (mean [SD], 23.5 [4.7] years), with 24.5% (27/110)
presenting with STI symptoms and 43.6% (48/110) having history
of an STI. Participants from the therapeutic abortion clinic ranged
in age from 16 to 41 years (mean [SD], 24.2 [5.3] years), with

Sexually Transmitted Diseases

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Sexually Transmitted Diseases

Volume 43, Number 2, February 2016

N/A
N/A
N/A
N/A
4.77 (0.689)

4.03 (1.146)
70.50% (122/173)
18.50% (32/173)
11.00% (19/173)
4.62 (0.795)
6.60% (12/183)

3.30% (6/184)

3.80% (7/183)

2.70% (5/184)

89.60% (164/183)

3.80 (1.165)
63.00% (109/173)
23.70% (41/173)
13.30% (23/173)
4.41 (0.953)
8.70% (16/183)
6.60% (12/183)

84.70% (155/183)

3.86 (1.138)
67.50% (112/166)
21.70% (36/166)
10.80% (18/166)
4.77 (0.575)
2.70% (5/184)

96.20% (177/184)

N/A
N/A
N/A

1.10% (2/184)

Mean (SD)
Response

4.83 (0.50)
97.30% (179/184)
2.20% (4/184)
0.50% (1/184)

Comfort

% Rating
Step as
Neutral (3)
% Rating Step as
UncomfortableVery
Uncomfortable (12)
% Rating Step
as EasyVery
Easy (45)

Ease

% Rating
Step as
Neutral (3)

94.00% (173/184)

N/A indicates not applicable.

Overall prevalence of infection was 10.6% (20/189) for

CT and 2.6% (5/189) for NG. Prevalence in the street youth clinic
was 12.7% for CT and 4.5% for NG, and 7.6% for CT and 0% for
NG in the therapeutic abortion clinic. Overall agreement between
PCV and SCV samples tested by AC2 was 94.7% (90.2%97.3%;
= 0.64 [0.430.85]) for CT and 98.4% (95.1-99.6; = 0.56
[0.13-1]) for NG (Table 2). HerSwab detected 4 more CT and
3 more NG infections than PCV samples collected with conventional Aptima vaginal swabs. Quantity of -actin DNA, measured
in number of log copies/mL (data not shown), was not significantly different between SCV and PCV samples (t = 0.105,
P = 0.918), or when comparing groups of CT-concordant and
CT-discordant specimen pairs (mean difference, 0.342 [0.516]

% Rating Step
as DifficultVery
Difficult (12)

Testing Comparison of Sample Types

TABLE 1. Summary of Ease and Comfort of Each Step of Vaginal Self-Collection Using the HerSwab Device

The questionnaire revealed that instructions were easy

to follow for 97.1% (169/175) of respondents; 80.9% (140/173)
preferred self-collection over physician collection; and 79.7%
(137/172) would consider self-collection at home (Table 1). In
answer to the ease related to self-collection of each step,
96.2% (177/184) found the insertion of the device into the vagina to be easy or very easy, and 93.4% (171/183) found the
turning of the device handle while inside the vagina to be easy,
very easy, or neither easy nor difficult. Withdrawing the device
from the vagina was easy or very easy for 89.6% (164/183) of
respondents. The presence of symptoms, history of an STI,
swab order randomization, and preference for self-collection
versus physician collection were not significantly related to
ease and comfort of collection with HerSwab, as determined
by Student t tests of mean questionnaire responses for each step
of self-collection. Age was not significantly related to preference for self-collection versus physician collection (t = 0.13,
P = 0.90) or to whether participants would consider selfcollection at home (t = 0.022, P = 0.98). 2 Tests of independence revealed that a history of an STI (2 = 1.489, P = 0.22)
or the presence of symptoms (2 = 0.519, P = 0.47) were not
significantly related to a preference for self-collection versus physician collection. Similarly, neither a history of STI nor the presence of symptoms was related to whether participants would
consider self-collection at home (2 = 0.807 [P = 0.37] and
2 = 0 [P = 1], respectively).
The questionnaire provided an opportunity for women to
answer why they preferred self-collection with the HerSwab. Of
the 123 women who preferred self-collection and stated a reason, increased comfort (n = 50), privacy (n = 38), and convenience (n = 21) were primarily cited. Additional reasons for
preferring self-collection included faster sampling, an opportunity for self-education on own body, lack of comfort with male
doctors, greater access to screening for people with disabilities,
and a reduction of physical and psychological stress. The 10.4%
(18/173) of respondents that preferred physician collection over
self-collection cited concerns about collecting an inadequate sample (n = 12) and that self-collection was not as comfortable as collection by a physician (n = 6). Feedback with the design of the
HerSwab device was generally positive. However, some suggestions to make self-sampling easier and more comfortable included making the brush bristles softer (n = 10) and including
arrows on the handle of the device to better indicate the direction
of turning (n = 3).

% Rating Step as
ComfortableVery
Comfortable (45)

Questionnaire Results

Hold the applicator with your

fingers on the indents and the
white tip facing towards you.
Stand with your legs apart. Insert
the white tip into your vagina.
Slowly and gently turn the handle
left until it stops turning.
Remove the device from your
vagina. Do NOT turn the
handle backwards.
Turn the blue handle right to
retract the pink brush back
into the device fully.

Mean (SD)
Response

none experiencing STI symptoms and 31.6% (25/79) having history of an STI.

N/A

HerSwab Vaginal Self-Sampling Device

127

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Arias et al.

TABLE 2. Agreement of CT and NG Infections by Method of

Collection

PCV
Self-collected HerSwab

CT +
CT
Total

CT +

CT

Total

10
3
13
NG +
2
0
2

7
169
176
NG
3
184
187

17
172
189

NG +
5
NG
184
Total
189
CT positive agreement = 50.0%
Negative agreement = 94.4%
Overall agreement = 94.7% (90.2%97.3%); = 0.64 (0.430.85)
NG positive agreement = 40.0%
Negative agreement = 98.4%
Overall agreement = 98.4% (95.1%99.6%); = 0.56 (0.131.0)

in concordant pairs; mean difference, 0.265 [1.74] in discordant

pairs; data not shown).

DISCUSSION
As with previous studies of self-collection,1012 results
from the questionnaire in this study revealed that most women
found vaginal self-sampling with the HerSwab device to be easy
or very easy, and most found the process to be comfortable, very
comfortable, or neutral. Most participants would consider selfcollection at home using HerSwab. Reasons for preferring selfsampling in this study support findings from previous studies of
vaginal self-collection methods, which have cited primarily comfort, privacy, and convenience.1012,1719 Results of testing with
AC2 showed good overall agreement between SCVand PCV samples for the detection of CT and NG (Table 2). Similar agreement
has been previously observed in other studies comparing SCV
swabs against clinician-collected samples.11,20,21
The few extra positives by HerSwab (4 for CTand 3 for NG,
Table 2) may be due to random chance when dealing with a small
number of positives or due to differences in the collection devices.
There are distinct differences between the Dacron tip of an Aptima
vaginal swab and the soft plastic bristles on the end of the
HerSwab device. The HerSwab did not collect significantly more
cells compared with the Aptima vaginal swab, as determined
by the quantity of -actin DNA in concordant and discordant
pairs. Differences were not related to order of collection. One important limitation of this study is the sample size. However, the
HerSwab did identify as many or more positives than the traditional Aptima swab.
Vaginal self-collection kits that require the patient to insert
the swab into a transport media may discourage women from selfcollection for fear of spilling the fluid on themselves (unpublished
data). In a study among female soldiers, researchers found no statistical difference between swabs transported dry or transported in
liquid media, demonstrating that polymerase chain reaction testing
of vaginal swabs transported dry can be an accurate diagnostic
method for detecting CT and NG.22 Further studies have shown
that vaginal collection with a flocked swab, shipped in a dry state,
is a viable alternative to the collection of cervical swabs for identifying women infected with high-risk human papillomavirus
and CT.23 Furthermore, a recent evaluation of a brush-based selfcollection device transported dry demonstrated comparable specimen integrity and diagnostic concordance with clinician-collected
samples collected in liquid media for the detection of human

128

papillomavirus.24 Transport media is usually designed to preserve

analytes and to prevent the overgrowth of unwanted and inhibitory agents. We have found that samples transported dry are free
of these substances when processed within 7 days (unpublished
data). Collectively, these findings demonstrate the feasibility of
home-based vaginal self-collection using HerSwab.
In conclusion, the HerSwab was well accepted in terms
of ease and comfort for vaginal self-sampling in this population of young women avoiding pelvic examination, demonstrating good agreement compared with a PCV sample. Future
studies are warranted for the diagnosis of other STIs using this
collection device.
We would like to note that the HerSwab device is still investigational and not yet Food and Drug Administration approved.
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