International definition of a point-of-care test in family practice: a modified e-Delphi procedure

Schols, Angel M R; Dinant, Geert-Jan; Hopstaken, Rogier; Price, Christopher P.; Kusters, Ron; Cals, Jochen

doi:10.1093/fampra/cmx134

Cited by 30 publications

(30 citation statements)

References 9 publications

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“…For example the AQT90 FLEX immunoassay analyser can perform six tests (D‐dimer, Procalcitonin, CRP, NT‐proBNP, Troponin T and Troponin I), yet only one evaluation, in this case of its D‐Dimer test, was identified in the review. However, since this instrument requires a large volume of blood, and therefore a venipuncture instead of a fingerpick, it may not be considered as a POCT . Therefore, studies investigating this multiple‐test device (or similar devices) without using POCT terminology may have been missed.…”

Section: Discussionmentioning

confidence: 99%

Point‐of‐care testing in primary care: A systematic review on implementation aspects addressed in test evaluations

et al. 2019

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Objectives There are numerous point‐of‐care tests (POCTs) available on the market, but many of these are not used. This study reviewed literature pertaining to the evaluation/usage of POCTs in primary care, to investigate whether outcomes being reported reflect aspects previously demonstrated to be important for general practitioners (GPs) in the decision to implement a POCT in practice. Methods Scopus and Medline were searched to identify studies that evaluated a POCT in primary care. We identified abstracts and full‐texts consisting of applied studies (eg trials, simulations, observational studies) and qualitative studies (eg interviews, surveys). Data were extracted from the included studies, such as the type of study, the extent to which manufacturers were involved in the study, and the biomarker/assay measured by the test(s). Studies were evaluated to summarise the extent to which they reported on, amongst others, clinical utility, user‐friendliness, turnaround‐time and technical performance (aspects previously identified as important). Results The initial search resulted in 1398 publications, of which 125 met the inclusion criteria. From these studies, 83 POCTs across several disease areas (including cardiovascular disease, venous thromboembolism and respiratory‐tract‐infections) were identified. There was an inconsistency between what is reported in the studies and what GPs consider important. GPs perceive clinical utility as the most important aspect, yet this was rarely included explicitly in test evaluations in the literature, with only 8% of evaluations incorporating it in their analysis/discussion. Conclusions This review showed that, despite the growing market and development of new POCTs, studies evaluating such tests fail to report on aspects that GPs find important. To ensure that an evaluation of a POCT is useful to primary care clinicians, future evaluations should not only focus on the technical performance aspects of a test, but also report on the aspects relating to the clinical utility and risks.

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Section: Discussionmentioning

confidence: 99%

Point‐of‐care testing in primary care: A systematic review on implementation aspects addressed in test evaluations

et al. 2019

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“…At enrolment, a nurse with experience in sexual health collected two vaginal swabs for POC testing on the Xpert CT/NG and the OSOM TV assays, and one Eswab (Copan, Brescia, Italy) specimen, which was sent to the regional National Health Laboratory Services reference laboratory for DNA extraction and parallel testing on the Anyplex II STI-7 Detection assay (Seegene, Seoul, Korea) within 24 hours of sample collection, according to Clinical and Laboratory Standards Institute requirements. Considering that all participants received their results during the same visit and the tests were performed in the clinic, we used the term ‘point-of-care’ for both assays, in line with the following consensus definition: ‘a point-of-care test…is a test to support clinical decision making, which is performed by a qualified…staff nearby the patient…during or very close to the time of consultation, to help the patient and physician to decide upon the best suited approach, and of which the results should be known at the time of the clinical decision making’ 15. All POC tests were processed according to manufacturers’ specification (www.sekisuidiagnostics.com/products/130-osom-trichomonas-test and www.cepheid.com/us/cepheid-solutions/clinical-ivd-tests/sexual-health/xpert-ct-ng) by laboratory technologists with experience using the GeneXpert platform at the clinic laboratory, but no access to participant clinical data.…”

Section: Methodsmentioning

confidence: 99%

Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study

et al. 2019

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ObjectivesSyndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- and middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the XpertChlamydia trachomatis/Neisseria gonorrhoeae(CT/NG) and OSOMTrichomonas vaginalis(TV) Test as part of a STI care model for young women in South Africa.DesignDiagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017.SettingOne large public healthcare facility in central Durban, KwaZulu-Natal, South AfricaParticipants247 women, aged 18–40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded.OutcomesDiagnostic performance of the Xpert CT/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay.ResultsWe obtained vaginal swabs from 247 women and found 96.8% (239/247) concordance between Xpert and Anyplex for CT and 100% (247/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0% (95% CI 10.5 to 19.4), NG 4.9% (2.2–7.5) and TV 3.2% (1.0–5.4). Sensitivity and specificity of Xpert CT/NG were 100% (100-100) and 97.6% (95.6–99.7) for CT and 100% (100-100) and 100% (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0% (45.0–100) and 100% (100-100).ConclusionThe Xpert CT/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs.Trial registration numberNCT03407586; Pre-results.

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“…POC tests for SARS-CoV-2 can help provide real-time and on-site detection of SARS-CoV-2 infection without the need for specialised laboratory equipment (12,13). Primary care physicians (PCPs) can increase the volume of face-to-face clinical encounters and use POC tests during (or very close to) the time of consultation to detect and prevent contagion within the clinic (14). Additionally, POC tests can act as a safety measures to control and contain risk in view of the uncertainties concerning the real-world e cacy of different vaccines (15), new variants of concern (16,17), complexities of vaccine hesitancy (18,19).…”

Section: Introductionmentioning

confidence: 99%

Strategies to implement SARS-CoV-2 point-of-care testing into primary care settings: A qualitative secondary analysis guided by the Behaviour Change Wheel

Kierkegaard¹,

Hicks²,

Aj³

et al. 2021

Preprint

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Background There is little empirical evidence to inform implementation strategies for introducing SARS-CoV-2 point of care (POC) testing into primary care settings. The purpose of this study is to develop a theory-driven understanding of the behavioural determinants underpinning the implementation of SARS-CoV-2 POC testing in primary care. This will allow identification of potential intervention strategies that could encourage successful implementation of testing into routine practice and facilitate face-to-face consultations. Methods We used a secondary qualitative analysis approach to re-analyse data from a qualitative study that involved interviewing 22 primary care physicians from 21 primary care practices across three regions in England. We followed the three-step method based on the Behaviour Change Wheel to identify barriers/enablers to the implementation of SARS-CoV-2 POC testing and identified behaviour change techniques to inform intervention strategies that targeted the barriers/enablers. Results We identified 10 barriers and enablers to POC implementation under eight Theoretical Domains Framework (TDF): (1) knowledge; (2) behavioural regulation; (3) reinforcement; (4) skills; (5) environmental context and resources; (6) social influence; (7) professional role and identity; and (8) belief about consequences. Linkages with the Behaviour Change Techniques (BCT) taxonomy enabled the identification of intervention strategies to address the social and contextual factors influencing primary care physician’s willingness and capacity to adopt POC testing. Conclusions A theory-informed approach identified barriers to the adoption of POC tests in primary care as well as guiding implementation strategies to address these challenges.

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International definition of a point-of-care test in family practice: a modified e-Delphi procedure

Cited by 30 publications

References 9 publications

Point‐of‐care testing in primary care: A systematic review on implementation aspects addressed in test evaluations

Point‐of‐care testing in primary care: A systematic review on implementation aspects addressed in test evaluations

Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study

Strategies to implement SARS-CoV-2 point-of-care testing into primary care settings: A qualitative secondary analysis guided by the Behaviour Change Wheel

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