Performance evaluation and acceptability of point-of-care Trichomonas vaginalis testing in adult female emergency department patients

Abstract

We evaluated the accuracy and perception of a patient self-administered, tablet-facilitated rapid Trichomonas vaginalis (TV) point-of-care (POC) test in adult female emergency department (ED) patients.

ED patients undergoing gynecologic examination were eligible. Each consented participant self-collected a vaginal swab, performed a tablet-facilitated TV rapid test using the OSOM® Trichomonas Rapid Test, and completed pre- and post-test self-surveys. After the self-test, the clinician collected one standard-of-care (SOC) vaginal swab for wet-mount testing and two for research. The research coordinator performed the TV rapid test using the clinician-collected swab, and reported the results to the clinician and patient. If the self- and coordinator-performed results were discordant, a TV nucleic acid amplification test (NAAT) was performed in a clinical laboratory. A survey was later administered to providers to assess their perceptions of the utility of the POC TV test.

Of the 136 participants, 134 (98.5%) completed self-testing; two had invalid results. Comparing coordinator-performed TV rapid test adjudicated with NAAT, the sensitivity and specificity of self-administered test was 96.0% and 100%, respectively. The wet mount had a sensitivity of 52.0% and specificity of 100%. TV detection increased from 9.6% with wet mount to 18.4% with the TV rapid test. Most women (82.0%) stated self-testing was “not at all hard” (versus 66.2% before testing, p < 0.001). Clinicians indicated the TV rapid test affected their clinical management in 48.5% of cases, including 82.6% of positive cases and 41.6% of negative cases.

ED patients were able to reliably collect, perform, and interpret their own POC TV test using tablet instructions. Both participants and providers reported high levels of acceptability of POC TV testing, which nearly doubled rates of TV detection.

Keywords

self-collection self-testing point-of-care test emergency departments

Introduction

A lack of access to primary care as well as financial barriers, among other reasons, contributes to the relatively high use of emergency department (ED) services by patients with sexually transmitted infection (STI)-related chief complaints.^1–4 EDs are widely recognized as the primary sites of care for the treatment of patients with STIs, with an average of 1.36 million STI-related ED visits in the United States annually.⁵ One of the most common of these STIs is Trichomonas vaginalis (TV), of which there are estimated 3.7 million cases each year in the U.S.^6,7

Frequent under-treatment of patients with STIs might contribute to increasing rates of disease in ED populations. A one-year prospective study in an inner-city ED of 426 female patients receiving a pelvic examination demonstrated that nearly 40% of patients who tested positive for STIs did not receive antibiotic treatment during their initial ED visits. In addition, 65% never returned for treatment, despite receiving detailed follow-up instructions which recommended a follow-up visit for those with positive test results.⁸ The fast-paced ED environment and the heightened demands on staff for rapid patient throughput creates the need for developing a more streamlined approach for the diagnosis and management of patients with suspected STIs, which could offer equal or greater accuracy.

Development of point-of-care (POC) testing approaches for STIs holds promise and is well-suited for the high-demand, time-sensitive ED environment, given fast turnaround times. The OSOM Trichomonas Rapid Test, [also referred to as the TV Rapid Test (Sekisui Diagnostics, San Diego, CA)], is the only Clinical Laboratory Improvement Amendments-waived test approved by the Food and Drug Administration (FDA) for TV diagnosis.⁹ This 10-minute test is a lateral flow immunoassay to detect the presence of trichomonal membrane proteins in the specimen. Previous studies using this TV Rapid Test with provider collection demonstrated a sensitivity of 83–86% and a specificity of 99.4%.^10,11 These performance characteristics provide marked improvement over the traditionally-used wet mount microscopy, for which sensitivity of 38–59% and specificity of 99.3–100% have been reported, when compared to culture or a composite reference standard.^12,13 Self-collected POC testing has been proposed as a viable tool for alleviating wait-times and expediting diagnosis in varied clinical settings.¹⁴

Previous studies with adolescent female ED and teen clinic patients demonstrated the POC TV tests have equal accuracy when self-collected versus clinician-collected testing is performed; 99% of patients correctly performed and interpreted the test, with high rates of patient-reported acceptability and trust.^15,16 However, it is not known whether the acceptance of the POC TV test remains high in adult female ED patients, given a higher prevalence of TV in women aged 25–59 years (versus 18–24 years).¹⁷ The implementation of self-testing in EDs could remove the requirement for speculum examination, a factor that can deter women from accepting and clinicians from offering STI testing in EDs.¹⁸ This can be especially true for TV, an infection for which 85% of patients do not experience symptoms, and might not have clinical indications to undergo a pelvic exam.¹⁹ Another knowledge gap is that the potential clinical utility of the use of FDA-approved TV Rapid Test in the ED setting is with regard to the ED clinician’s management of female patients with suspected TV.

An additional tool that has been shown to improve the patient experience is the use of a tablet-based kiosk. Kiosks have been used with success and have previously been shown to advance acceptability of patient self-testing [for human immunodeficiency virus (HIV)], and ease of sharing of discharge instructions with patients.^20,21

This study aimed, first, to evaluate the accuracy of provider-collected, research coordinator-performed versus participant-collected, participant-performed POC TV testing facilitated by touch-screen kiosk tablet in adult female ED participants; and second, to determine acceptability of patient-collected vaginal swabs for POC TV testing from both the patient and provider perspective.

Materials and methods

This prospective non-randomized pilot study was conducted from July 2014 to May 2015 in an academic, urban hospital in Baltimore City, Maryland that serves a primarily socioeconomic unprivileged patient population. The Johns Hopkins School of Medicine Institutional Review Board approved this study application number NA_00093663, and 150 participants provided written informed consent prior to any study-related procedures.

Screening and eligibility

Eligibility was defined as any adult female patient between the ages of 18–50 years old undergoing a gynecological examination and the standard-of-care (SOC) testing for a suspected STI during her visit to the Johns Hopkins Hospital ED. In coordination with the IT department, a pager system was built in the electronic medical record system, EPIC, to notify the research coordinator of eligible patients when the ED triage physician electronically flagged an eligible patient. In addition, the research coordinator also screened the ED Trackboard for eligible patients by chart review of female patients with ‘suspected STI’ which was operationally defined as any patient undergoing a gynecologic examination, for whom a provider ordered STI testing (including a wet mount for TV). Patients who met the eligibility criteria were approached by the clinician for interest in participation. When patient interest was established, the research coordinator then explained the study and sought for written informed consent.

Patient self-testing and patient surveys

Consented participants first completed a survey that captured basic demographics, sexual health and history, and the baseline acceptability of self-testing for TV and other STIs on a Likert scale. After completing the survey, in a private room, the participant used a touch-screen tablet kiosk with step-by-step instructions, including diagrams (Figure 1(a) and (b)), to self-collect a vaginal swab, performed the TV Rapid Test (Sekisui Diagnostics, San Diego, CA), and interpreted the result.

Figure 1.

(a) Collecting the vaginal swab. (b) OSOM ® Trichomonas Rapid Test procedure.

After performing the self-collection, participants read and interpreted their self-testing results. Then, their interpretation of results were compared and verified with that of the research coordinator’s interpretation. After the participant completed self-collection, and performed the TV Rapid Test, the participant would receive an SOC pelvic examination performed by a clinician. During the SOC pelvic examination, providers collected two additional research-use-only vaginal swabs [one for “TV Rapid Test” and the other for “Gold Standard: Tie-Breaker” nucleic acid amplification test (NAAT)] after collection of a vaginal swab for a TV SOC test (wet mount microscopy testing).

The research coordinator performed the TV Rapid Test using the provider-collected swab, and results were entered into the electronic medical record. The results were also given to participants for comparison. The second clinician-collected swab was transported and stored in a CAP-certified laboratory for a TV NAAT assay in case of discordant results between participant’s self-testing and the research coordinator-performed TV Rapid Test and wet mount testing.

To conclude the research encounter, participants completed a second Likert-scale type survey again to assess the acceptability of the self-testing experience, after receiving the wet mount SOC and the coordinator-performed TV Rapid Test results. Survey items assessed the following domains: participant confidence in the self-test result, ease of sample collection and processing, health benefits of POC STI testing, a higher likelihood of recommendation of the test to others, acceptability of self-testing at home, and a comparison of self-test result to provider-collected TV Rapid Test.

Provider testing and survey

Treating clinicians were given the results of the TV Rapid Test performed by the research coordinator, which was validated by the Department of Pathology POC Department for clinical decision-making. Providers made treatment decisions based on their clinical judgment and were surveyed to assess the potential impact of the TV Rapid Test on clinical decision making.

Discordant results procedure

The tie-breaker swab collected by the provider served as the gold standard for use in discordant results only. These were defined as non-unanimous results (i.e. no cross-board same negative or positive results) among the wet mount microscopy, the participant-performed TV Rapid Test interpreted by participant, the participant-performed TV Rapid Test interpreted by coordinator, and the coordinator-performed TV Rapid Test. In these circumstances, a NAAT assay for TV, the Aptima Trichomonas Vaginalis Assay (Hologic, San Diego, CA), was performed using the extra swab.²²

Data analysis

Descriptive data analyses were performed to provide summarized statistics. The performance of participant’s self-testing TV Rapid Test was first evaluated by their interpretation of testing results as compared to that by the research coordinator. Then, the self-testing results were compared to the results of the provider-collected, coordinator-performed TV Rapid Test. Sensitivity and specificity of the participants’ self-testing as well as the SOC wet mount microscopy were determined by comparing the NAAT-adjudicated results of the coordinator-performed TV Rapid Test. Changes in attitudes of the TV Rapid Test before and after the participant’s self-testing were compared using the McNemar test. The clinical impact of the TV Rapid Test on the ED provider’s management, as well as “plan to treat” after receiving the result of TV Rapid Test, were analyzed by the positivity of the rapid test.

Results

One hundred and fifty women were consented and enrolled. Of them, 136 patients who had self-performed the TV Rapid Test, the clinician-performed TV Rapid Test, and the SOC wet mount microscopy, were included for data analysis. Fourteen women were excluded from data analysis, including 8 who withdrew after enrollment, 4 who did not have the coordinator-performed TV Rapid Testing, 1 who did not perform self-testing due to the need to move to a different room for routine ED procedures/testing, and 1 who did not complete self-testing. The average age of those 136 participants was 27.8 ± 8.4 years and the socio-demographics of participants are described in Table 1. Regarding participants' sexual histories, 82.4% of participants reported that they had sex with men only, 2.2% with women only, 8.1% with both sexes, and 7.4% had missing information. Participants reported a history of the following STIs and vaginal infections being diagnosed: yeast infection (52.9%), bacterial vaginosis (45.6%), Trichomonas vaginalis (23.5%), Chlamydia trachomatis (29.4%), Neisseria gonorrhoeae (17.6%), genital herpes (4.4%), pubic lice or crabs (2.9%), genital warts (2.2%), and HIV (1.5%); 22.3% reported no STIs having been diagnosed. Condom use during the most recent vaginal sexual encounter was reported by 15.4% of participants (Table 1).

Table 1.

Characteristics of 136 female urban emergency department patient participants.

N = 136	n	(%)
Age (years)
18 – 24	62	45.6
25 – 34	47	34.6
35 – 50	27	19.8
Race
African American or Black	121	89.0
White	15	11.0
Ethnicity
Hispanic	3	2.2
Non-Hispanic	133	97.8
Partner preference
Male	112	82.4
Female	3	2.2
Both sexes	11	8.1
Missing	10	7.4
Health insurance
Medicaid	85	62.5
Private	21	15.4
Self-Pay	13	12.5
Don’t know/Missing	17	9.6
History of STI and Vaginal Infections
Yeast infection	72	52.9
Bacterial vaginosis	62	45.6
Trichomonas vaginalis	32	23.5
Neisseria gonorrhoeae	24	17.6
Chlamydia trachomatis	40	29.4
Genital herpes	6	4.4
Genital warts	3	2.2
HIV	2	1.5
Pubic lice/crabs	4	2.9
None	29	21.3
Missing	6	4.4
Condom use with last vaginal sex
Yes	21	15.2
No	101	74.3
Missing	14	10.3
Urogenital symptoms
Vaginal discharge	73	53.7
Vaginal itching or pain	40	29.4
Pain or burning during urination	17	9.6
Lower abdominal pain	86	63.2

Overall results of TV rapid test [self-testing (self-read or coordinator-read) and coordinator-testing] and standard-of-care wet mount microscopy

Of all 136 participants who completed self-testing on their self-collected swab, 24 (17.7%) read their self-testing result as positive, 110 (80.9%) as negative, and 2 (1.5%) as invalid. The research coordinator interpreted that 26 (19.1%) patients’ self-testing results were positive, 107 (78.7%) were negative, and 3 (2.2%) were invalid. On the other hand, the SOC wet mount testing on the usual care swab identified 13 (9.6%) TV-positive patients and 113 (90.4%) negative patients while there were 23 (16.9%) positive and 113 (83.1%) negative by TV Rapid Test performed by the research coordinator on the research swab. Overall, 13 participants had positive test results and 106 negative test results in all 4 testing approaches discussed while 17 participants had discrepant results (Table 2).

Table 2.

Results of Trichomonas vaginalis (TV) nucleic acid amplification test (NAAT) of patients with discordant results by self-testing and research-coordinator testing.

Subject	Self-testing	RC-interpreted	Clinician-collected RC testing	Wet mount	NAAT
1	Negative	Positive	Positive	Negative	Positive
2	Negative	Invalid	Negative	Negative	Negative
3	Negative	Positive	Negative	Negative	Negative
4	Positive	Positive	Negative	Negative	Positive
5	Positive	Positive	Negative	Negative	Positive
6	Positive	Positive	Negative	Negative	Positive
7	Negative	Negative	Positive	Negative	Negative
8	Positive	Positive	Positive	Negative	Positive
9	Positive	Positive	Positive	Negative	Positive
10	Positive	Positive	Positive	Negative	Positive
11	Positive	Positive	Positive	Negative	Positive
12	Positive	Positive	Positive	Negative	Positive
13	Positive	Positive	Positive	Negative	Positive
14	Positive	Positive	Positive	Negative	Positive
15	Positive	Positive	Positive	Negative	Positive
16	Invalid	Invalid	Negative	Negative	Negative
17	Invalid	Invalid	Negative	Negative	N.P.

RC: Research Coordinator.

NP: Not Performed.

NAAT testing on samples with discrepant results

NAAT was performed on all but one participant with discrepant results (Table 2). NAAT was not performed on the participant who had an invalid result of self-testing (both self-read and coordinator-read) and a negative result for the wet mount testing and research coordinator-testing. Of these 16 participants, NAAT confirmed 12 were positive and 4 were negative. Together, a total of 25 (18.4%) TV-positive participants were diagnosed among 136 participants after NAAT adjudication.

Performance of patients’ self-testing of TV rapid tests

Patients’ Interpretation of Self-Testing Results: There were three discordant results between patients’ interpretation and the research coordinator’s read on self-test results with a kappa agreement of 0.933 [95% CI: (0.858, 1.000)]. Of these 3 discordant tests, NAAT demonstrated that 1 self-testing negative result, the research coordinator-read positive as NAAT positive; 1 self-testing negative result, the research coordinator-read positive as NAAT negative; and 1 self-testing negative, research coordinator-read invalid, which was NAAT negative (Table 2).

Patients’ Self-Testing VS Research Coordinator-Testing: When comparing the research coordinator-performed test, there were seven discordant results between the patient’s self-testing and the research coordinator’s testing with a kappa agreement of 0.827 [95% CI: (0.705, 0.950)]. Of these 6 discrepant tests with NAAT performed, NAAT found that 1 self-testing negative, the research coordinator-testing positive as NAAT negative, 1 self-testing negative, research coordinator-testing positive as NAAT positive, 1 self-testing invalid, research coordinator-testing negative as negative, and 3 self-testing positive research coordinator-read negative as NAAT positive (Table 2). Overall, compared to clinician-collected, research coordinator-performed TV Rapid Test adjudicated with NAAT, the sensitivity and specificity of patient self-collected, self-testing TV Rapid Test was 96.0% (24/25, 95% CI: 79.7%, 99.9%) and 100% (109/109, 95% CI: 96.7%, 100%), respectively, after excluding two invalid self-testing results (Table 3). The kappa was 0.929 (95% CI: 0.851, 1.000) or 0.975 (95% CI: 0.926, 1.000), if excluding 2 invalid self-testing tests.

Table 3.

Performance evaluation of participant self-testing.

	Clinician-collected, coordinator-performed testing, adjudicated with NAAT
Self-testing		Positive	Negative	Total
	Positive	24	0	24
	Negative	1	109^a	110^a
	Total	25	109^a	134^a

Kappa = 0.975, 95% CI: 0.926, 1.000.

^aExcluding 2 patients with invalid self-testing results.

Performance of standard-of-care wet mount testing

The performance of the SOC at our institution, wet mount microscopy, was evaluated as compared to the research coordinator-performed TV Rapid Test adjudicated with NAAT. The wet mount had a sensitivity of 52.0% (13/25, 95% CI: 31.3%, 72.2%) and specificity of 100% (111/111, 95% CI: 96.7%, 100%) and kappa of 0.639 (95% CI: 0.457, 0.821) when compared to the TV Rapid Test (Table 4). Discrepant cases that accounted for 8.8% (12/136) of the total were all positive results undetected by the wet mount, as confirmed by the gold standard, NAAT (Table 2). With use of the TV Rapid Test, the TV detection rate increased from 9.6% (13/136, 95% CI: 5.2%, 15.8%) with wet mount to 18.4% (25/136, 95% CI: 12.3%, 25.9%) with the TV Rapid Test.

Table 4.

Performance evaluation of provider-collected standard-of-care wet mount microscopy testing.

	Clinician-collected, coordinator-performed testing, adjudicated with NAAT
Wet mount		Positive	Negative	Total
	Positive	13	0	13
	Negative	12	111	123
	Total	25	111	136

Kappa = 0.639, 95% CI: 0.457, 0.821.

ED patients’ acceptability of self-testing

Levels of acceptability for self-testing by participants were high at baseline before testing. The majority of participants reported that it would be not hard at all for them to correctly self-collect specimen, insert swab, or perform the test (64.0%, 71.3%, and 64.7%, respectively). 94.9% of participants believed that their self-testing results would be probably or definitely correct. Furthermore, acceptance for self-testing increased and strengthened with testing experience. After performing the self-testing, more participants reported that it was not hard at all for them to correctly self-collect specimen, insert swab, or perform the test (86.8%, 86.8%, and 81.6%, respectively). For 133 participants responding to both pre- and post-self-testing questions, in terms of perceived difficulty, 82.0% of women thought that testing themselves was “not at all hard” (compared with 66.2% before testing, p < 0.001). After comparing their own results to those of their clinician-collected test, 80.1% of women reported that self-testing was “just as good as” (63.2%) or “better than” (16.9%) clinician testing. The majority of women (80.5%) stated that they would “definitely” test themselves at home if this test were available over the counter (compared with 70.7% before testing, p = 0.007).

ED providers’ acceptability of TV rapid test

Providers, who completed a brief survey regarding their treatment plan for each participant, focusing on their intent to treat for TV, indicated that the TV Rapid Test affected their clinical management in 48.5% (66/136) of all cases. These included 41.6% (47/113) of negative cases and 82.6% (19/23) of positive cases by the TV Rapid Test. Providers stated they planned to treat all 23 patients with positive TV Rapid Test results with specific antimicrobials for TV and not to treat any patients with negative results for TV.

Discussion

In this prospective ED-based study, the feasibility and acceptability of POC testing for Trichomonas vaginalis, including participant self-testing, was assessed. With touch-screen kiosk tablet facilitation, we demonstrated that adult female ED patients were able to collect, perform, and interpret a POC test for TV with a high degree of accuracy. Furthermore, more than 80% of ED physicians reported that TV Rapid Test has affected their clinical management toward their patient with a positive test and all of them reported that they plan to treat their TV-positive patients with specific antimicrobials for TV.

Our results are consistent with the literature on self-collection and its acceptability among patients. In a similar study conducted with an adolescent population, more than 99% of participants correctly performed and interpreted their POC test for TV.¹⁵ Similar to the results in our study, acceptability of self-testing has been shown to increase with experience.¹⁶ High rates of acceptability were also found in male populations when using self-collected penile-meatal swabs to test for STIs, with 90.1% reporting that it was “easy” or “very easy” to collect.²³

Our results also demonstrate an extremely high agreement and accuracy between patient self-testing and the NAAT-adjudicated, coordinator-performed rapid TV test. There was only 1 discordant test, plus 2 additional invalid self-tests. Two of them were around 20 years old and the remaining one was in her late 30 s. Two of them had Medicaid and one reported that she did not have health insurance. Socio-demographic factors, including age and socioeconomic status, have been linked with the performance of POC self-test.^24,25 Performance likely improves with experience with self-testing,¹⁶ suggesting that this is a conservative estimate of self-test performance. Of note, four self-test results in five discordant results between self-test and coordinator-performed test were confirmed by a more sensitive NAAT. Three false negatives performed by the coordinator might be due to low TV load and the vaginal swab specimen order where self-collection swab was first one collected but the swab for the coordinator-performed test was the second or third one collected by the clinician. The impact of vaginal swab collection order on POC TV test remains unclear, even though studies did not find evidence in cervical swabs for the detection of genital chlamydial and gonococcal infections.^26,27

Growing evidence in the literature has proved the significant impact of POC and rapid diagnostic tests on clinical management of STIs in the ED. Two separate randomized clinical trials and one quasi-experimental study have demonstrated that the use of a rapid chlamydia and gonorrhea assay has reduced overtreatment and improved undertreatment of patients tested in the ED as well as their adherence to antibiotic treatment.^28–30 A retrospective chart review study also found that implementation of a POC TV antigen test in a pediatric ED improves clinical management ED physicians by reducing 43% of inaccurate treatment in adolescent patients as compared to pre-implementation of this POC assay.³¹ Yet, the maximal clinical utility and economic impact of the TV Rapid Test in the ED will not be realized until it has fully integrated with the clinical flow of each individual ED.³²

The results of this study should be interpreted with several limitations in mind. First, selection bias resulting from women who were willing to participate in our study and self-collect vaginal swabs could have influenced acceptability findings. Similarly, we recruited a convenience sample of primarily symptomatic female ED patients who were already undergoing pelvic examination and STI testing for clinical reasons, as the TV Rapid Test is not intended to screen asymptomatic women, although it performed well in asymptomatic women in other studies.^10,33 It would be interesting to see the acceptability and feasibility of use of this test for screening asymptomatic patients in the ED. The sensitivity of the coordinator-performed TV Rapid Test and wet mount testing might be lower since all of provider-collected vaginal swabs were obtained after SOC speculum insertion during the pelvic exam as well as serial swab collection.³⁴ A potential bias in asking about participants’ confidence on their self-testing results also likely existed since many of them found out that their result was concordant with research coordinator’s result. Finally, the wet mount was chosen as the SOC comparator and gold standard testing was conducted for discrepant results only. However, the sensitivity and specificity of the TV Rapid Test compared to NAAT has been extensively documented in the literature previously.^10,11,35,36

The results of our study have implications beyond the ED. TV testing via self-collection could extend into other settings, including STD clinics, pharmacies, or at home.^33,37 Improving the ease with which STI testing is performed could lead to increased rates of accurate diagnosis and appropriate treatment, with the potential for lowering rates of transmission. Further research is required to assess the accuracy and acceptability of expanding self-collected POC tests for STIs.

Footnotes

Declaration of conflicting interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: CAG received grants from Hologic Inc., Cepheid Inc., Binx Health, and Becton Dickinson and a speaking honorarium from Hologic Inc. All other authors declared no potential conflicts of interest.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Hsieh, Rothman, and Gaydos are supported by NIH NIBIB U54EB007958. Gaydos is also supported by NIH NIAID U01AI068613.

ORCID iD

Yu-Hsiang Hsieh

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