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

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.

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Investigations and microscopy

Oxford Handbook of Genitourinary Medicine, HIV, and Sexual Health ◽

10.1093/med/9780198783497.003.0005 ◽

2019 ◽

pp. 63-80

Keyword(s):

Nucleic Acid ◽

Laboratory Testing ◽

Trichomonas Vaginalis ◽

Point Of Care ◽

Rapid Test ◽

The Other ◽

Nucleic Acid Amplification ◽

Blood Samples ◽

Dark Ground ◽

Point Of Care Tests

This chapter covers investigations and tests commonly used in sexual health. Some investigations can be performed on-site as the patient waits, such as urinalysis, pregnancy tests, and increasingly available point of care tests for infections such as HIV and, less commonly, the other blood-borne viruses, syphilis, Trichomonas vaginalis. On-site microscopy helps with diagnosis of genital candidiasis, bacterial vaginosis, N. gonorrhoeae infection, and T. vaginalis. Other investigations require sending samples away for laboratory testing of genital or ulcer swab, urine, or blood samples for STI and blood-borne viruses. This chapter explains the use of light and dark ground microscopy, near patient rapid test technologies, molecular methods such as nucleic acid amplification, culture and serology. Sensitivities and specificities of commonly available test kits are included.

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SafeSwab, a sample collection and dispensing device for near-patient testing

10.1101/2021.08.20.21262386 ◽

2021 ◽

Author(s):

Thomas E Grys ◽

Kathrine McAulay ◽

Darrell Ingram ◽

Craig Duffy ◽

Ashley Williams ◽

...

Keyword(s):

Los Angeles ◽

Health Systems ◽

Point Of Care ◽

Digital Health ◽

Rapid Test ◽

Sample Collection ◽

Patient Instruction ◽

Self Testing ◽

Test Result ◽

Rapid Test Result

The COVID-19 pandemic has accelerated the pace of innovation around virtual care visits and testing technology. Here we present the SafeSwab (Safe Health Systems, Los Angeles, CA), an integrated, universal sample collection and dispensing device that is designed to minimize user error and enable rapid testing in a point of care or self-testing format. The SafeSwab was used with the Safe Health Systems HealthCheck digital health application to enable self-testing by patients using lateral flow tests for SARS-CoV-2 antigen or for antibodies against SARS-CoV-2. Patients (n=74) using the SafeSwab produced a valid rapid test result in 96% of attempts, and 96% of patients felt confident that they had collected a good sample. The Safe HealthCheck app has an integrated image analysis algorithm, AutoAdapt LFA, that interprets a picture of a rapid test result, and the algorithm interpreted the result correctly 100% of the time. The SafeSwab was found to be versatile and easy to use for both self-collected nasal sampling as well as fingerstick blood sampling. The use of Safe Health Systems HealthCheck app allows an integrated solution for patient instruction and test interpretation

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Performance of the OSOM Trichomonas Rapid Test for diagnosis of Trichomonas vaginalis infection among women in Mysore, India

Sexual Health ◽

10.1071/sh13015 ◽

2013 ◽

Vol 10 (4) ◽

pp. 320 ◽

Cited By ~ 6

Author(s):

Purnima Madhivanan ◽

Tan Li ◽

Stephanie Trammell ◽

Chirayu Desai ◽

Vijaya Srinivas ◽

...

Keyword(s):

False Positive ◽

Trichomonas Vaginalis ◽

Rapid Test ◽

Health Clinic ◽

Resource Constrained ◽

Short Supply ◽

Predictive Values ◽

Wet Mount ◽

Kappa Agreement ◽

Culture Positive

Background Trichomonas vaginalis is the world’s most common treatable sexually transmissible infection. Currently, wet mount microscopy and syndromic management based on vaginal discharge are the most widely used methods for diagnosing and treating trichomoniasis in resource-constrained settings. Wet mount microscopy requires equipment and trained technicians, who are in short supply. We examined the diagnostic accuracy of the OSOM Trichomonas Rapid Test for detecting T. vaginalis vaginal infection among women in Mysore, India. Methods: During July 2009–August 2010, 450 sexually active women over 18 years seeking care at an urban reproductive health clinic were enrolled in the study. Clinician-collected vaginal swabs were evaluated for trichomonads using wet mount microscopy, InPouch culture and the OSOM test. Results: Of the 418 samples included in the analyses, culture detected 68 (16.3%) positive samples, wet mount microscopy detected 56 of the culture-positive samples and four false positive samples. The OSOM test detected 60 of the culture-positive samples plus two false positive cases. Using the composite reference standard (CRS), defined as wet mount- or culture-positive, the sensitivities of wet mount, the OSOM test and culture were 83.3%, 86.1% and 94.4%, respectively. The positive and negative predictive values of the OSOM test were 100% and 97.1% respectively. The Cohen’s kappa agreement between the OSOM test and the CRS was excellent (κ = 0.94). Conclusion: The OSOM test has high sensitivity, excellent specificity, and excellent positive and negative predictive value compared to a CRS. This simple test can improve screening and diagnosis of T. vaginalis infection in resource-constrained settings where microscopy and culture are unavailable.

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P3-S7.01 Evaluation of a simple point-of-care rapid test for detecting Trichomonas vaginalis among women in Mysore, India

Sexually Transmitted Infections ◽

10.1136/sextrans-2011-050108.484 ◽

2011 ◽

Vol 87 (Suppl 1) ◽

pp. A299-A299

Author(s):

K. Rao ◽

P. Madhivanan ◽

J. Klausner ◽

S. Trammell ◽

S. Kotian ◽

...

Keyword(s):

Trichomonas Vaginalis ◽

Point Of Care ◽

Rapid Test ◽

Simple Point

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The Evolution of Ultrasound in Medicine: A Case Report of Point-of-care Ultrasound in the Self-diagnosis of Acute Appendicitis

Clinical Practice and Cases in Emergency Medicine ◽

10.5811/cpcem.2020.7.48158 ◽

2020 ◽

Vol 4 (4) ◽

pp. 527-529

Author(s):

Barry Knapp ◽

Kean Feyzeau ◽

Austin Smith ◽

Donald Byars ◽

Craig Goodmurphy ◽

...

Keyword(s):

Emergency Department ◽

Medical Education ◽

Case Report ◽

Medical Student ◽

Point Of Care ◽

Rapid Evolution ◽

Lower Abdominal Pain ◽

The Self ◽

First Year ◽

Point Of Care Ultrasound

Introduction: Point-of-care ultrasound (POCUS) education during medical school develops physicians who are properly prepared for the next generation of medicine. The authors present the case of a first-year medical student who self-diagnosed appendicitis using POCUS. Case Report: A 25-year-old, first-year medical student presented to the emergency department with lower abdominal pain. What seemed like a straightforward appendicitis presentation came with a twist; the student brought self-performed ultrasound imaging of his appendix. Conclusion: The student’s ultrasound skill set reflects favorably on the rapid evolution of ultrasound teaching in medical education.

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Acceptability and Feasibility of Integrating Point-of-Care Diagnostic Testing of Sexually Transmitted Infections into a South African Antenatal Care Program for HIV-Infected Pregnant Women

Infectious Diseases in Obstetrics and Gynecology ◽

10.1155/2018/3946862 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 9

Author(s):

E. Morikawa ◽

M. Mudau ◽

D. Olivier ◽

L. de Vos ◽

D. Joseph Davey ◽

...

Keyword(s):

Antenatal Care ◽

Pregnant Women ◽

Sexually Transmitted Infections ◽

South African ◽

Trichomonas Vaginalis ◽

Point Of Care ◽

Diagnostic Testing ◽

Nucleic Acid Amplification ◽

National Guidelines ◽

Sexually Transmitted

Background. Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) infections may increase the risk of vertical transmission of the human immunodeficiency virus (HIV). In resource-limited settings, symptomatic screening, and syndromic management of sexually transmitted infections (STIs) during pregnancy continue to be the standard of care. In the absence of diagnostic testing, asymptomatic infections in pregnant women go untreated. Objective. To describe the acceptability and feasibility of integrating diagnostic STI screening into first antenatal care visits for HIV-infected pregnant women. Methods. HIV-infected pregnant women were recruited during their first antenatal care visit from three antenatal care clinics in Tshwane District, South Africa, between June 2016 and October 2017. Self-collected vaginal swabs were used to screen for CT, NG, and TV with a diagnostic point-of-care (POC) nucleic acid amplification test. Those with STIs were provided treatment per South African national guidelines. Results. Of 442 eligible women, 430 (97.3%) agreed to participate and were tested. Of those with a positive STI test result (n = 173; 40.2%), 159 (91.9%) received same-day results and treatment; 100% of STI-infected women were treated within seven days. Conclusions. Integration of POC diagnostic STI screening into first-visit antenatal care services was feasible and highly acceptable for HIV-infected pregnant women.

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Feasibility of large-scale population testing for SARS-CoV-2 detection by self-testing at home

Scientific Reports ◽

10.1038/s41598-021-89236-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Paula Iruzubieta ◽

Tatiana Fernández-Lanas ◽

Laura Rasines ◽

Lorena Cayon ◽

Ana Álvarez-Cancelo ◽

...

Keyword(s):

Large Scale ◽

Rapid Test ◽

The Self ◽

Healthcare Personnel ◽

Testing Strategy ◽

Self Testing ◽

Scale Population ◽

Self Test ◽

Test Result ◽

At Home

AbstractThe simplicity and low cost of rapid point-of-care tests greatly facilitate large-scale population testing, which can contribute to controlling the spread of the COVID-19 virus. We evaluated the applicability of a self-testing strategy for SARS-CoV2 in a population-based, cross-sectional study in Cantabria, Spain, between April and May 2020. For the self-testing strategy, participants received the necessary material for the self-collection of blood and performance of a rapid antibody test using lateral flow immunoassay at home without the supervision of healthcare personnel. A total of 1,022 participants were enrolled. Most participants correctly performed the COVID-19 self-test the first time (91.3% [95% CI 89.4–92.9]). Only a minority of the participants (0.7%) needed the help of healthcare personnel, while 6.9% required a second kit delivery, for a total valid test result in 96.9% of the participants. Incorrect use of the self-test was not associated with the educational level, age over 65, or housing area. Prevalence of IgG antibodies against SARS-CoV2 for subjects with a valid rapid test result was 3.1% (95% CI 2.2–4.4), similar to the seroprevalence result obtained using a conventional approach carried out by healthcare professionals. In conclusion, COVID-19 self-testing should be considered as a screening tool.

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Evaluation of the BD MAX™ Vaginal Panel for the detection of vaginal infections in a sexual health service in the UK

International Journal of STD & AIDS ◽

10.1177/0956462418815284 ◽

2019 ◽

Vol 30 (4) ◽

pp. 411-414 ◽

Cited By ~ 4

Author(s):

Jackie Sherrard

Keyword(s):

Health Service ◽

Sexual Health ◽

Trichomonas Vaginalis ◽

Vaginal Swab ◽

Nucleic Acid Amplification ◽

Current Standard ◽

Becton Dickinson ◽

Vaginal Infections ◽

Specificity And Sensitivity ◽

Sexual Health Service

The aim of this study is to compare the performance of the BD MAX™ Vaginal Panel (Becton, Dickinson and company, Franklin Lakes, NJ, USA) in the diagnosis of bacterial vaginosis (BV), candidiasis and trichomoniasis with current standard tests in a UK specialist sexual health service. Women with abnormal vaginal discharge attending the service who had not used douches or vaginal treatment in the preceding 48 hours had two vulvovaginal swabs taken: one for Chlamydia and gonorrhoea nucleic acid amplification test (NAAT) and one for testing on the BD MAX™ Vaginal Panel on the BD MAX System. Speculum examination was then performed and vaginal swabs taken for vaginal pH, and microscopy of vaginal secretions: Gram stain for Candida and BV using the Hay–Ison score and wet-mount for clue cells and Trichomonas vaginalis (TV). Forty-six (23.6%) women were negative for all three infections on the Vaginal Panel. Ninety-three were positive for BV (47.7%), 70 (35.9%) for Candida and 9 (4.6%) had TV detected. Thirty-six women tested positive for both BV and Candida on the BD MAX™. The investigational test sensitivity for all Candida species was 86.4% with a specificity of 86.0% and for BV the sensitivity was 94.4% with a specificity of 79%. The sensitivity for BV was good but specificity is lower than previously described and may reflect the high rates of sexually transmitted infections in this population which potentially altered the vaginal microbiome. The lower specificity and sensitivity for Candida is not unexpected as a high proportion of women are colonised with Candida, and in all cases other pathogens were found to account for their symptoms. NAATs do not provide the immediate results available from in-clinic microscopy but were easy to perform and process and offer benefits over the traditional “high vaginal swab” performed in primary care and other settings where immediate microscopy is unavailable.

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Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings

Clinical Infectious Diseases ◽

10.1093/cid/ciaa260 ◽

2020 ◽

Cited By ~ 3

Author(s):

Sharon L Hillier ◽

Michele Austin ◽

Ingrid Macio ◽

Leslie A Meyn ◽

David Badway ◽

...

Keyword(s):

Trichomonas Vaginalis ◽

Medical Center ◽

Point Of Care ◽

Nucleic Acid Amplification ◽

Yeast Culture ◽

Community Practice ◽

University Of Pittsburgh ◽

Inappropriate Treatment ◽

Common Diagnosis ◽

Point Of Care Tests

Abstract Background Although vaginal symptoms are common, diagnosis of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV) is not standardized. Diagnostic approaches and appropriateness of treatment were evaluated for women with symptoms of vaginitis who were seeking care at community practice sites. Methods Three hundred three symptomatic women, across 8 University of Pittsburgh Medical Center–affiliated clinics, were evaluated per standard office-based practice. Four of 5 vaginal swabs (1 cryopreserved) were collected for a US Food and Drug Administration–authorized nucleic acid amplification test (NAAT) for vaginitis/vaginosis diagnosis; Nugent scoring (BV); yeast culture (VVC); and a second NAAT (for TV). Two hundred ninety women had evaluable samples. Medical record extraction facilitated verification of treatments prescribed within 7 days of the index visit and return visit frequency within 90 days. Results Women had a mean age of 29.4 ± 6.5 years, 90% were not pregnant, 79% were of white race, and 38% reported vaginitis treatment within the past month. Point-of-care tests, including vaginal pH (15%), potassium hydroxide/whiff (21%), and wet mount microscopy (17%), were rarely performed. Of the 170 women having a laboratory-diagnosed cause of vaginitis, 81 (47%) received 1 or more inappropriate prescriptions. Of the 120 women without BV, TV, or VVC, 41 (34%) were prescribed antibiotics and/or antifungals. Among women without infectious vaginitis, return visits for vaginitis symptoms were more common among women treated empirically compared to those not receiving treatment (9/41 vs 5/79, P = .02). Conclusions Within a community practice setting, 42% of women having vaginitis symptoms received inappropriate treatment. Women without infections who received empiric treatment were more likely have recurrent visits within 90 days. Clinical Trials Registration NCT03151928.

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Point-of-Care Testing for the Emergency Department Patient: Quantity and Quality of the Available Evidence

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2020-0495-ra ◽

2021 ◽

Vol 145 (3) ◽

pp. 308-319

Author(s):

David N. Alter

Keyword(s):

Emergency Department ◽

English Language ◽

Drugs Of Abuse ◽

Point Of Care ◽

Rapid Test ◽

Emergency Department Patient ◽

Free Text ◽

Point Of Care Test ◽

Viral Influenza ◽

Pubmed Search

Context.— Point-of-care test (POCT) instruments produce lab results with rapid turnaround times. Based on that fact, emergency department (ED) POCT requests are predicated on the belief that rapid test turnaround times lead to improved care, typically a decreased ED length of stay (LOS). Objective.— To compile the available peer-reviewed data regarding use of POCT in the ED with an emphasis on ED-LOS. Data Sources.— An English-language PubMed search using the following free text terms: (“EMERGENCY” AND “POINT OF CARE”) NOT ULTRASOUND as well as “RAPID INFECTIOUS DISEASE TESTING.” In addition, the PubMed “similar articles” functionality was used to identify related articles that were not identified on the initial search. Conclusions.— Seventy-four references were identified that studied POCT ED use to determine if they resulted in significant changes in ED processes, especially ED-LOS. They were divided into 3 groups: viral-influenza (n = 24), viral-respiratory not otherwise specified (n = 8), and nonviral (n = 42). The nonviral group was further divided into the following groups: chemistry, cardiac, bacterial/strep, C-reactive protein, D-dimer, drugs of abuse, lactate, and pregnancy. Across all groups there was a trend toward a significantly decreased ED-LOS; however, a number of studies showed no change, and a third group was not assessed for ED-LOS. For POCT to improve ED-LOS it has to be integrated into existing ED processes such that a rapid test result will allow the patient to have a shorter LOS, whether it is to discharge or admission.

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