Analytical performance and user-friendliness of five novel point-of-care D-dimer assays

Heerink, Jorn; Gemen, Eugenie F.A.; Oudega, Ruud; Hopstaken, Rogier; Geersing, Geert‐Jan; Kusters, Ron

doi:10.1080/00365513.2020.1768586

Cited by 10 publications

(9 citation statements)

References 33 publications

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“…Data from the latest quantitative POCT devices was used in this study. These test systems are considered to be patient and user-friendly as they only require a capillary finger prick of blood, facilitating the application of these devices in settings outside the laboratory [ 16 ]. More studies on this topic have been performed on past-generation POCT devices, but none, to our knowledge, have incorporated productivity losses per health state or fully considered production costs and complication losses as detailed as in our study.…”

Section: Discussionmentioning

confidence: 99%

“…The probabilities of a positive or negative D-dimer test or CUS result were obtained from multiple studies [ 8 , 14 , 19 , 20 , 25 – 27 ]. A weighted estimate of sensitivity and specificity was obtained from a series of POCT and laboratory D-dimer assays in order to get a representative performance estimate of these two D-dimer assays [ 16 , 25 , 28 – 31 ]. The impact of a false negative test result, in terms of complications (PE and PTS), as well as accompanying costs and health impacts were included in the model, as were complications due to incorrectly treating patients with false positive D-dimer test results (major bleeding).…”

Section: Methodsmentioning

confidence: 99%

“…Patients with positive (elevated) D-dimer results are directly referred to undergo a CUS, while patients with a low CDR and negative POCT D-dimer test are discharged without further involving the GP. As an upcoming alternative, novel quantitative capillary (whole-blood) POCT D-dimer assays could be positioned in the GP practice instead of the traditional phlebotomy service, requiring only a finger-prick instead of a venipuncture, providing results in less than 15 minutes [ 16 ]. To our knowledge, the impact of both POCT strategies on health outcomes and costs, remains unknown.…”

Section: Introductionmentioning

confidence: 99%

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Two point-of-care test-based approaches for the exclusion of deep vein thrombosis in general practice: a cost-effectiveness analysis

et al. 2023

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Background In the diagnostic work-up of deep vein thrombosis (DVT), the use of point-of-care-test (POCT) D-dimer assays is emerging as a promising patient-friendly alternative to regular D-dimer assays, but their cost-effectiveness is unknown. We compared the cost-effectiveness of two POCT-based approaches to the most common, laboratory-based, situation. Methods A patient-level simulation model was developed to simulate the diagnostic trajectory of patients presenting with symptoms of DVT at the general practitioner (GP). Three strategies were defined for further diagnostic work-up: one based on current guidelines (‘regular strategy’) and two alternative approaches where a POCT for D-dimer is implemented at the 1) phlebotomy service (‘DVT care pathway’) and 2) GP practice (‘fast-POCT strategy’). Probabilities, costs and health outcomes were obtained from the literature. Costs and effects were determined from a societal perspective over a time horizon of 6 months. Uncertainty in model outcomes was assessed with a one-way sensitivity analysis. Results The Quality-Adjusted Life Years (QALYs) scores for the three DVT diagnostic work-up strategies were all around 0.43 across a 6 month-time horizon. Cost-savings of the two POCT-based strategies compared to the regular strategy were €103/patient for the DVT care pathway (95% CI: -€117–89), and €87/patient for the fast-POCT strategy (95% CI: -€113–67). Conclusions Point-of-care-based approaches result in similar health outcomes compared with regular strategy. Given their expected cost-savings and patient-friendly nature, we recommend implementing a D-dimer POCT device in the diagnostic DVT work-up.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Two point-of-care test-based approaches for the exclusion of deep vein thrombosis in general practice: a cost-effectiveness analysis

et al. 2023

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“…Recently, a comparison of the analytical performance of five quantitative POCT assays with a hospital reference test showed that four performed analytically well with a set of 238 plasma samples from patients clinically suspected of VTE in general practice. Most devices were considered easy to use in a primary care setting [ 51 ]. In addition to the potentially superior diagnostic performance offered by the quantitative POCT assays enabling closer harmonisation with the local laboratory D-dimer assay, such tests would allow the use of age-related cut-off values for the older population.…”

Section: Discussionmentioning

confidence: 99%

Point-of-Care Testing for D-Dimer in the Diagnosis of Venous Thromboembolism in Primary Care: A Narrative Review

2020

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Venous thromboembolism (VTE) is regarded as a significant cause of mortality and disability, affecting 1–2 per 1000 people annually, presenting with a relatively wide range of symptoms, which can pose a diagnostic challenge. Historically, people in whom VTE is suspected will have been taken to hospital for diagnosis and treatment; however, a high proportion of patients are found not to have VTE. Concerns have been expressed about potential delays in treatment, with the risk of additional morbidity and disability, and death. Diagnostic strategies are typically based on the use of a clinical prediction rule to determine the pre-test probability, complemented with a measurement of D-dimer, with confirmation by imaging assessment. This narrative review explores the literature on the use of point-of-care testing (POCT) for the measurement of D-dimer, as part of a clinical decision rule, for the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the primary care setting. In the two main prospective management (validation) studies that included D-dimer POCT or similar technologies, with a total cohort of 1600 participants, DVT was ruled out in 49% of patients, with a false negative rate of 1.4%, whereas PE was ruled out in 45% of patients, with a false negative rate of 1.5%. This suggests that uptake of POCT D-dimer in primary care has the potential to reduce the number of referrals to hospitals for imaging confirmatory investigation, with consequent cost savings. Thus, adopting POCT for D-dimer in primary care can offer clinical and cost benefits, particularly when quantitative POCT assays are being used. Furthermore, POCT should be undertaken in collaboration with the local laboratories to ensure the harmonisation of D-dimer methods and quality assurance to improve the diagnosis of VTE.

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“…However, many of the patients assessed in the hospital do not have VTE [2]. In fact, the typical ratio of imaging-confirmed VTE versus a negative diagnosis is 1:6 [3]. Conversely, there are patients who require further diagnostic tests but are not referred because they present with non-specific symptoms; such patients are at risk of receiving a delayed diagnosis, which could consequently lead to adverse outcomes [4,5].…”

Section: Introductionmentioning

confidence: 99%

Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test

et al. 2021

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Introduction: Fibrin degradation product Ddimer can be a valuable indicator for venous thromboembolism (VTE). The use of D-dimer testing in primary care settings can be limited by restricted access to laboratory services. This performance evaluation compares a quantitative, point-of-care (POC) D-dimer assay (Lumi-raDx D-Dimer Test) with a reference laboratorybased D-dimer assay. Methods: Plasma samples from patients presenting to secondary care in the UK, USA, and Germany were analyzed centrally using the LumiraDx D-Dimer Test and the reference test (bioMe ´rieux VIDAS D-Dimer Exclusion II immunoassay). Method comparison used Passing-Bablok regression analysis with pre-specified equivalence criteria of r C 0.9 and slope of

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Analytical performance and user-friendliness of five novel point-of-care D-dimer assays

Cited by 10 publications

References 33 publications

Two point-of-care test-based approaches for the exclusion of deep vein thrombosis in general practice: a cost-effectiveness analysis

Two point-of-care test-based approaches for the exclusion of deep vein thrombosis in general practice: a cost-effectiveness analysis

Point-of-Care Testing for D-Dimer in the Diagnosis of Venous Thromboembolism in Primary Care: A Narrative Review

Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test

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