scholarly journals Patterns of point-of-care test use among obstetricians and gynaecologists in the US

Sexual Health ◽  
2018 ◽  
Vol 15 (4) ◽  
pp. 318 ◽  
Author(s):  
Anne M. Rompalo ◽  
Neko Castleberry ◽  
Lea Widdice ◽  
Jay Schulkin ◽  
Charlotte A. Gaydos
Keyword(s):  
Test Performance ◽  
Point Of Care ◽  
Research Network ◽  
Becton Dickinson ◽  
Point Of Care Test ◽  
Hiv Test ◽  
Laboratory Test Results ◽  
Rapid Hiv Test ◽  
Sexually Transmissible Infections ◽  
Test Use

Background Point-of-care tests (POCTs) for reproductive health conditions have existed for decades. Newer POCTs for syphilis, HIV and trichomonas are currently available and easy to use. We surveyed practicing obstetricians and gynaecologists to determine current POCT use and perceived obstacles to use. Methods: Between June and August 2016, 1000 members of the American College of Obstetricians and Gynecologists were randomly selected and invited to complete a Qualtrics (222 West river Park Drive, Provo, Utah 84604, USA) survey; 600 of these were members of the Collaborative Ambulatory Research Network. Respondents who completed at least 60% of the survey were included in the analysis. Results: Of the 1000 selected members, 749 had valid emails and 288 (38%) of these participated in and completed the survey. Of the respondents, 70% were male with a mean of 18 years in practice. Detection of sexually transmissible infections (STIs) once or twice a week was reported by 30%, whereas 45% reported detecting STIs once or twice a month. POCTs used included pregnancy tests (83%), urine dipstick (83%), wet mount tests (79%) and the vagina pH test (54.8%). Few used Gram stain (5%) and stat rapid plasma regain tests (4%). Relatively newer US Food and Drug Administration-approved POCTs were used less frequently, with 25% of respondents reporting using the Affirm VPIII (Becton, Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ 07471, USA) test use and only 10% using a rapid HIV test. The most common perceived barriers to testing were the amount of reimbursement received for performing the test (61.9%) and the payment coverage from the patient (61.3%). Conclusions: US obstetricians and gynaecologists rely on laboratory test results and traditional POCTs to diagnosis STIs. Future development and marketing of POCTs should consider not only ease and time of test performance, but also the cost of the tests to the practice and the patient, as well as reimbursement.

scholarly journals A rapid and affordable point of care test for antibodies against SARS-CoV-2 based on hemagglutination and artificial intelligence interpretation

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Vanessa Redecke ◽  
Kazuki Tawaratsumida ◽  
Erin T. Larragoite ◽  
Elizabeth S. C. P. Williams ◽  
Vicente Planelles ◽  
...  
Keyword(s):  
Test Performance ◽  
Learning Algorithm ◽  
Point Of Care ◽  
Method Comparison ◽  
High Specificity ◽  
Turnaround Time ◽  
Analysis Tool ◽  
Point Of Care Test ◽  
Specificity And Sensitivity ◽  
A Cell

AbstractDiagnostic tests that detect antibodies (AB) against SARS-CoV-2 for evaluation of seroprevalence and guidance of health care measures are important tools for managing the COVID-19 pandemic. Current tests have certain limitations with regard to turnaround time, costs and availability, particularly in point-of-care (POC) settings. We established a hemagglutination-based AB test that is based on bi-specific proteins which contain a dromedary-derived antibody (nanobody) binding red blood cells (RBD) and a SARS-CoV-2-derived antigen, such as the receptor-binding domain of the Spike protein (Spike-RBD). While the nanobody mediates swift binding to RBC, the antigen moiety directs instantaneous, visually apparent hemagglutination in the presence of SARS-CoV-2-specific AB generated in COVID-19 patients or vaccinated individuals. Method comparison studies with assays cleared by emergency use authorization demonstrate high specificity and sensitivity. To further increase objectivity of test interpretation, we developed an image analysis tool based on digital image acquisition (via a cell phone) and a machine learning algorithm based on defined sample-training and -validation datasets. Preliminary data, including a small clinical study, provides proof of principle for test performance in a POC setting. Together, the data support the interpretation that this AB test format, which we refer to as ‘NanoSpot.ai’, is suitable for POC testing, can be manufactured at very low costs and, based on its generic mode of action, can likely be adapted to a variety of other pathogens.

scholarly journals Clinical evaluation of BD Veritor SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS Antigen point-of-care test.

2020 ◽  
Author(s):  
Stephen Young ◽  
Stephanie Taylor ◽  
Catherine Cammarata ◽  
Celine Roger-Dalbert ◽  
Amanda Montano ◽  
...  
Keyword(s):  
Test Performance ◽  
Rapid Detection ◽  
Clinical Performance ◽  
Point Of Care ◽  
Point Estimate ◽  
Pcr Assay ◽  
Point Of Care Test ◽  
Nasal Swabs ◽  
High Degree ◽  
Antigen Testing

Objectives The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 antigen (Veritor), a chromatographic immunoassay that detects the SARS-CoV-2 nucleocapsid antigen as a point-of-care test, was evaluated on nasal specimens from individuals with COVID-19 symptoms. Methods and Materials Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (<=7 days from symptom onset [DSO]), >=18 years of age, were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR Assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (<=5 DSO), >=18 years of age, were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). Positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. Results In study 1, PPA for Veritor, compared to Lyra, ranged from 81.8%-87.5% for 0-1 through 0-6 DSO ranges. In study 2, Veritor had a PPA, NPA, and OPA of 97.4%, 98.1%, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Conclusions Veritor met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing (>=80% PPA point estimate) for the 0-5 and 0-6 DSO ranges. Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test should facilitate rapid and reliable results for COVID-19 diagnosis utilizing easy-to-collect nasal swabs.

Chlamydia and gonorrhoea point-of-care testing in Australia: where should it be used?

Sexual Health ◽  
2015 ◽  
Vol 12 (1) ◽  
pp. 51 ◽  
Author(s):  
Lisa Natoli ◽  
Rebecca J. Guy ◽  
Mark Shephard ◽  
Basil Donovan ◽  
Christopher K. Fairley ◽  
...  
Keyword(s):  
Sex Workers ◽  
Test Performance ◽  
Aboriginal People ◽  
Point Of Care ◽  
Qualitative Interviews ◽  
Easy Access ◽  
Sex Industry ◽  
Consumer Experience ◽  
Point Of Care Testing ◽  
Sexually Transmissible Infections

Background Diagnoses of chlamydia and gonorrhoea have increased steadily in Australia over the past decade. Testing and treatment is central to prevention and control but in some settings treatment may be delayed. Testing at the point of care has the potential to reduce these delays. We explored the potential utility of newly available accurate point-of-care tests in various clinical settings in Australia. Methods: In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with sexual health, primary care, remote Aboriginal health and laboratory expertise. Results: Participants reported that point-of-care testing would have greatest benefit in remote Aboriginal communities where prevalence of sexually transmissible infections is high and treatment delays are common. Some suggested that point-of-care testing could be useful in juvenile justice services where young Aboriginal people are over-represented and detention periods may be brief. Other suggested settings included outreach (where populations may be homeless, mobile or hard to access, such as sex workers in the unregulated sex industry and services that see gay, bisexual and other men who have sex with men). Point-of-care testing could also improve the consumer experience and facilitate increased testing for sexually transmissible infections among people with HIV infection between routine HIV-management visits. Some participants disagreed with the idea of introducing point-of-care testing to urban services with easy access to pathology facilities. Conclusions: Participants felt that point-of-care testing may enhance pathology service delivery in priority populations and in particular service settings. Further research is needed to assess test performance, cost, acceptability and impact.

scholarly journals Clinical Evaluation of BD Veritor SARS-CoV-2 Point-of-Care Test Performance Compared to PCR-Based Testing and versus the Sofia 2 SARS Antigen Point-of-Care Test

2020 ◽  
Vol 59 (1) ◽  
pp. e02338-20 ◽  
Author(s):  
Stephen Young ◽  
Stephanie N. Taylor ◽  
Catherine L. Cammarata ◽  
Katey G. Varnado ◽  
Celine Roger-Dalbert ◽  
...  
Keyword(s):  
Test Performance ◽  
Rapid Detection ◽  
Clinical Performance ◽  
Point Of Care ◽  
Point Of Care Testing ◽  
Pcr Assay ◽  
Point Of Care Test ◽  
Nasal Swabs ◽  
High Degree ◽  
Antigen Testing

ABSTRACTThe clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO, ≥18 years of age) were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). The positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. In study 1, the PPA for Veritor, compared to Lyra, ranged from 81.8 to 87.5% across the 0 to 1 and 0 to 6 DSO ranges. In study 2, Veritor had PPA, NPA, and OPA values of 97.4, 98.1, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Veritor met FDA emergency use authorization (EUA) acceptance criteria for SARS-CoV-2 antigen testing for the 0 to 5 and 0 to 6 DSO ranges (PPA values of 83.9% and 82.4%, respectively). Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs but demonstrated <100% PPA compared to PCR.

scholarly journals Point-of-care tests for sexually transmissible infections: what do ‘end users' want?

Sexual Health ◽  
2013 ◽  
Vol 10 (6) ◽  
pp. 541 ◽  
Author(s):  
Anne M. Rompalo ◽  
Yu-Hsiang Hsieh ◽  
Terry Hogan ◽  
Mathilda Barnes ◽  
Mary Jett-Goheen ◽  
...  
Keyword(s):  
Qualitative Content Analysis ◽  
Point Of Care ◽  
High Sensitivity ◽  
Advantages And Disadvantages ◽  
Point Of Care Test ◽  
Home Test ◽  
Sexually Transmissible Infections ◽  
Important Quality ◽  
Point Of Care Tests ◽  
At Home

Background Clinicians and developers identify sensitivity as an important quality in a point-of-care test (POCT) for sexually transmissible infections (STIs). Little information exists regarding what patients want for STI POCTs. Methods: A qualitative study, encompassing five focus groups among attendees of STI and adolescent health centres in Baltimore, Maryland, and Cincinnati, Ohio, were conducted between March 2008 and April 2009. Discussion topics included advantages and disadvantages of having a POCT, perceived barriers to using POCTs in the clinic setting and at home, priorities for the development of new POCTs for STIs, and envisioned characteristics of an ideal POCT. All discussions were recorded and transcribed. A qualitative content analysis was performed to examine frequencies or patterns of recurring codes, which were regrouped and indexed to identify salient themes. Results: Patients attending STI and adolescent outpatient clinics are in favour of diagnostic tests that are rapid, easy to read and simple to use. Home testing options for POCTs were acceptable and provided better confidentiality, privacy and convenience, but clinic-based POCTs were also acceptable because they offer definitive results and ensure immediate treatment. Barriers to home POCTs centred on cost and the ability to read and perform the test correctly at home. Opinions did not differ by patient ethnicity, except that Hispanic participants questioned the reliability of home test results, wanted high sensitivity and desired bilingual instructions. Conclusions: Patients attending STI and adolescent medical centres are in favour of STI POCTs if they are affordable, rapid, easy to read and simple to use.

scholarly journals P4.14 Patterns of point of care test use among obstetricians and gynaecologists(OB-GYNS) in the u.s

2017 ◽  
Author(s):  
Anne M Rompalo ◽  
Neko Castleberry ◽  
Lea Widdice ◽  
Charlotte Gaydos ◽  
Jay Schulkin
Keyword(s):  
Point Of Care ◽  
Point Of Care Test ◽  
Test Use ◽  
The U.S

scholarly journals Human anti-HIV IgM detection by the OraQuick ADVANCE® Rapid HIV 1/2 Antibody Test

PeerJ ◽  
2018 ◽  
Vol 6 ◽  
pp. e4430 ◽  
Author(s):  
Geraldine Guillon ◽  
Graham Yearwood ◽  
Casey Snipes ◽  
Daniel Boschi ◽  
Michael R. Reed
Keyword(s):  
Detection System ◽  
Point Of Care ◽  
Acute Infection ◽  
Protein A ◽  
Antibody Test ◽  
Hiv Test ◽  
Rapid Hiv Test ◽  
Gold Conjugate ◽  
Testing Environments ◽  
Hiv 1

The Centers for Disease Control and Prevention (CDC) and many public health jurisdictions continue to advocate for the most sensitive rapid HIV test that is available. Currently, the recommendation is to utilize tests that can detect HIV infection biomarkers within 30 days of infection, when initial immune responses are mounted. The infected patient’s IgM response is often used to detect acute infection within a 20–25 days window after infection. This requirement applies to lab-based testing with automated analyzers and rapid, point of care (POC) testing used for screening in a non-clinical setting. A recent study has demonstrated that POC tests using a Protein A-based detection system can detect samples with predominantly HIV-1 IgM reactivity (Moshgabadi et al., 2015). The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test (OraQuick ADVANCE®) also uses Protein A as the detection protein in the antibody-binding colloidal gold conjugate, so it is expected that the OraQuick ADVANCE® Test will also detect samples with predominantly IgM reactivity. This report definitively demonstrates that the OraQuick ADVANCE® Test can detect IgM antibodies during an acute infection window period of approximately 20–25 days after infection, and is therefore suitable for use in testing environments requiring adherence to current CDC recommendations.

Testing for resistance: Point-of-care testing as a communicational tool in antibiotic prescribing

2018 ◽  
Vol 14 (3) ◽  
pp. 229-240
Author(s):  
Johanna Lindell
Keyword(s):  
Point Of Care ◽  
Rapid Test ◽  
Antibiotic Use ◽  
Treatment Recommendation ◽  
Antibiotic Prescribing ◽  
Communicative Practices ◽  
Effective Strategies ◽  
Reactive Protein ◽  
Point Of Care Test ◽  
Test Result

As antibiotic resistance becomes a growing health emergency, effective strategies are needed to reduce inappropriate antibiotic use. In this article, one such strategy – communicative practices associated with the C-reactive protein point-of care test – is investigated. Building on a collection of 31 videorecorded consultations from Danish primary care, and using conversation analysis, this study finds that the rapid test can be used throughout the consultation to incrementally build the case for a nonantibiotic treatment recommendation, both when the test result is forecast and reported. The study also finds that the format of reports of elevated results differs from that of ‘normal’ results, resulting in a subtle shift of authority from doctor to test.

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