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

Abstract

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.

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

“…The latest NICE guidance already recommends using quantitative POC testing within such settings, as part of a defined diagnostic pathway, which limits unnecessary referrals [8]. Previous studies using qualitative POC D-dimer assays have demonstrated substantial benefits in terms of reducing unnecessary referrals for imaging without increasing the number of patients with undiagnosed VTE [12]. A greater disparity between D-dimer measurements at concentrations [ 1000 lg/l were observed between the LumiraDx D-Dimer Test and the bioMe ´rieux VIDAS D-Dimer Exclusion II immunoassay (Fig.…”

“…The NICE recommendation for POC testing for D-dimer in the primary care setting has the potential to reduce the number of unnecessary hospital referrals, thereby improving patient experience on the diagnosis pathway and relieving pressure on healthcare resources [12,13]. Indeed, prospective management studies have shown that even qualitative POC Ddimer tests can rule out a large proportion of patients who do not need a referral (up to 49%) [12,14,15], with low false-negative rates (1.4-2%) [12]. Moreover, the sensitivity and specificity of a combined clinical score and qualitative POC D-dimer test were comparable to the laboratory-based quantitative test [15].…”

“…The limited evidence available to date suggests that POC D-dimer assays can improve the effectiveness of the diagnosis pathway of VTE. An advantage of a quantitative POC assay over laboratory testing is that ageadjusted cut-off values can be implemented [12].…”

Revolutionizing Healthcare Finances: Navigating the Impact of Innovative Technologies on Medical Claims Cost Containment in the MENA Region

“…According to Price et al, (2021), there has been a substantial decrease in health care expenses implemented by hospitals. It has facilitated the establishment of a long-term relationship with patients and hospital administration in Middle Eastern countries.…”

Clinical decision rules in primary care: necessary investments for sustainable healthcare

“…Lastly, promising new diagnostic opportunities are emerging, such as easy-to-use point-of-care (POC) D-dimer tests, which enable performing a D-dimer test, preceded or not by a CDR, in a one-stop visit at the GP’s office (Ellis et al., 2021 ; Heerink et al., 2020 ; Price et al., 2021 ). In this way, the time delay that comes with referring the patient to the laboratory for a D-dimer test can be eliminated, potentially lowering the threshold for using a CDR.…”