A rapid and quantitative D-Dimer assay in whole blood and plasma on the point-of-care PATHFAST analyzer

Fukuda, Teruko; Kasai, Hidetoshi; Kusano, Takeo; Shimazu, Chisato; Kawasugi, Kazuo; Miyazawa, Yukihisa

doi:10.1016/j.thromres.2006.12.021

Cited by 13 publications

(7 citation statements)

References 18 publications

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“…In particular, more studies are needed of the quantitative assays in the domain of primary care. A previous study of the diagnostic accuracy of the Pathfast assay showed a higher sensitivity (1.0 vs 0.98) and much higher specificity (0.63 vs 0.39) compared to our study (7 ). Many studies have evaluated the diagnostic accuracy of the Vidas D-dimer test, which showed, as did our study, high sensitivity and only moderate specificity for excluding DVT (4 ).…”

Section: User-friendlinesssupporting

confidence: 54%

“…Most patients with suspected DVT, however, are first seen in primary care settings, and for such cases referral to central laboratories for D-dimer testing is not always a practical solution. Therefore, to enable exclusion of DVT in the doctor's office, several point-of-care D-dimer tests have been developed (5)(6)(7)(8)(9)(10)(11)(12)(13)(14). These tests yield results within 10 -15 min and in many cases may eliminate the need for referrals to central laboratories or diagnostic services.…”

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confidence: 99%

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Diagnostic Accuracy and User-Friendliness of 5 Point-of-Care D-Dimer Tests for the Exclusion of Deep Vein Thrombosis

et al. 2010

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BACKGROUND Point-of-care D-dimer tests have recently been introduced to enable rapid exclusion of deep venous thrombosis (DVT) without the need to refer a patient for conventional laboratory-based D-dimer testing. Before implementation in practice, however, the diagnostic accuracy of each test should be validated. METHODS We analyzed data of 577 prospectively identified consecutive primary care patients suspected to have DVT, who underwent 5 point-of-care D-dimer tests—4 quantitative (Vidas®, Pathfast™, Cardiac®, and Triage®) and 1 qualitative (Clearview Simplify®)—and ultrasonography as the reference method. We evaluated the tests for the accuracy of their measurements and submitted a questionnaire to 20 users to assess the user-friendliness of each test. RESULTS All D-dimer tests showed negative predictive values higher than 98%. Sensitivity was high for all point-of-care tests, with a range of 0.91 (Clearview Simplify) to 0.99 (Vidas). Specificity varied between 0.39 (Pathfast) and 0.64 (Clearview Simplify). The quantitative point-of-care tests showed similar and high discriminative power for DVT, according to calculated areas under the ROC curves (range 0.88–0.89). The quantitative Vidas and Pathfast devices showed limited user-friendliness for primary care, owing to a laborious calibration process and long analyzer warm-up time compared to the Cardiac and Triage. For the qualitative Clearview Simplify assay, no analyzer or calibration was needed, but interpretation of a test result was sometimes difficult because of poor color contrast. CONCLUSIONS Point-of-care D-dimer assays show good and similar diagnostic accuracy. The quantitative Cardiac and Triage and the qualitative Clearview Simplify D-dimer seem most user-friendly for excluding DVT in the doctor's office.

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Section: User-friendlinesssupporting

confidence: 54%

mentioning

confidence: 99%

Diagnostic Accuracy and User-Friendliness of 5 Point-of-Care D-Dimer Tests for the Exclusion of Deep Vein Thrombosis

et al. 2010

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“…This corres ponds to previous findings, where Pathfast analytical characteristics were described as satisfactory, with sensitivity in diagnosis of DVT as high as 100% (25,26).…”

Section: D-dimer Poc Assayssupporting

confidence: 91%

»Point-of-Care« D-Dimer Testing

Antović¹

2010

Journal of Medical Biochemistry

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Kratak sadr`aj: Odre|ivanje D-dimera omogu}ava efikasno isklju~ivanje venskog tromboembolizima (VTE). Labo ratorijsko testiranje D-dimera prete`no se izvodi u centralizovanim laborato rijama u okviru bolnica, iako se ve}ina pacijenata kod kojih se sumnja na VTE javlja na pregled u ustanove primarne zdravstvene za{tite. Tako|e, skra}enje ukupnog trajanja laboratorijskog testiranja bi znatno pobolj{alo efikasnost u urgentnim centrima. Stoga bi uvo|e -nje brzog »Point of Care (POC)« D-dimer testa koji se lako izvodi, dovelo do pobolj{anja dijagnostike VTE u primarnoj zdravstvenoj za{titi kao i u urgentnim centrima, ali tako|e i u dijagnostici drugih te{kih klini~kih stanja (diseminovana intravaskularna koagulacija (DIK), aneurizma aorte) u kojima je D-dimer povi{en. Ve}ina dostupnih POC D-dimer testova ispunjava kriterijume za brzo i sigurno isklju~ivanje VTE-a. U na{em ispitivanju tri testa (Stratus, Pathfast i Cardiac) pokazala su karakteristike sli~ne D-dimer testu koji je u rutinskoj upotrebi u na{oj laboratoriji (Tinaquant).

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“…We, at the Clinical Chemistry Laboratory at Karolinska University Hospital, have validated some of those assays recently 45 . Our evaluation as well as data observed by others indicate that Pathfast Ddimer, Cardiac D-dimer and Stratus CS D-dimer may safely and adequately rule out VTE in out-patients [45][46][47][48][49][50][51][52][53] . The main potential problem with POC assays is inadequate quality control since assays are most commonly performed by personnel without laboratory training and knowledge of quality control procedures, while assays commonly use whole blood and such samples for quality control are not available.…”

Section: Point Of Care (Poc) D-dimer Testingsupporting

confidence: 77%

D-dimer: A laboratory point of view

Antović¹

2013

Srce i krvni sudovi

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A rapid and quantitative D-Dimer assay in whole blood and plasma on the point-of-care PATHFAST analyzer

Cited by 13 publications

References 18 publications

Diagnostic Accuracy and User-Friendliness of 5 Point-of-Care D-Dimer Tests for the Exclusion of Deep Vein Thrombosis

Diagnostic Accuracy and User-Friendliness of 5 Point-of-Care D-Dimer Tests for the Exclusion of Deep Vein Thrombosis

»Point-of-Care« D-Dimer Testing

D-dimer: A laboratory point of view

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