SimpliRed and diagnosis of deep venous thrombosis
Report by Steve Jones, Clinical Research Fellow Search checked by Magnus Harrison, Clinical Research Fellow
Clinical scenario
A patient attends the emergency department with signs and symptoms consistent with a deep venous thrombosis. Somebody suggests
that there is a new bedside blood test, called SimpliRed, that may help to rule out the diagnosis in your patient. You know
that ruling out a diagnosis is possible by having a test with a high sensitivity or negative predictive value. You wonder
what evidence there is to suggest that SimpliRed fulfils these criteria?
Three part question
In a [patient with a suspected DVT] does the [SimpliRed test] reliably [rule out the diagnosis]?
Search strategy
Medline 1966–11/00 using the OVID interface. [(exp thrombosis or exp venous thrombosis or thrombosis.mp OR venous thrombosis.mp deep venous thrombosis.mp) AND (exp fibrin fibrinogen degradation products or simplired.mp OR d-dimer$.mp)] LIMIT to human and english language OR Medline 1966–11/00 using the OVID interface. simplired.mp.
Search outcome
Altogether 741 and 37 papers found of which 13 were relevant and of sufficient quality. These 13 remaining papers are shown
in table 6.
Comments
The “gold standard” investigation for DVT is contrast venography. This has now been replaced in many centres with a strategy of single or serial compression ultrasound, hence the use of different reference standard tests.
If an investigation is to be used in order to rule out a diagnosis, then it must have a sensitivity of 95% or above. In some
of the studies mentioned this is the case, however such is the variability of the results obtained in the other studies the
safety of SimpliRed as a lone exclusionary test must be in question. The reasons for this variability may include the operators
of the assay or the various techniques used. Many of the results however are still inadequate.
Clinical bottom line
It is not safe to use SimpliRed as a lone exclusionary test for a patient presenting to the emergency department with a possible
DVT.
Report by Steve Jones, Clinical Research Fellow Search checked by Magnus Harrison, Clinical Research Fellow
References
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Wells PS, Brill-Edwards P, Stevens P, et al. A novel and rapid whole-blood assay for D-dimer in patients with clinically suspected deep vein thrombosis. Circulation1995;91:2184–7.
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Brenner B, Pery M, Lanir N, et al. Application of a bedside whole blood D-dimer assay in the diagnosis of deep vein thrombosis. Blood Coagul Fibrinolysis1995;6:219–22.
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Turkstra F, van Beek EJ, ten Cate JW, et al. Reliable rapid blood test for the exclusion of venous thromboembolism in symptomatic outpatients. Thromb Haemost1996;76:9–11.
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Janssen MC, Heebels AE, de Metz M, et al. Reliability of five rapid D-dimer assays compared to ELISA in the exclusion of deep venous thrombosis. Thromb Haemost1997;77:262–6.
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Ginsberg JS, Kearon C, Douketis J, et al. The use of D-dimer testing and impedance plethysmographic examination in patients with clinical indications of deep vein
thrombosis. Arch Intern Med1997;157:1077–81.
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Mayer W, Hirschwehr R, Hippmann G, et al. Whole-blood immunoassay (SimpliRED) versus plasma immunoassay (NycoCard) for the diagnosis of clinically suspected deep
vein thrombosis. Vasa1997;26:97–101.
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Wildberger JE, Vorwerk D, Kilbinger M, et al. Bedside testing (SimpliRED) in the diagnosis of deep vein thrombosis. Evaluation of 250 patients. Invest Radiol1998;33:232–5.
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Wells PS, Anderson DR, Bormanis J, et al. SimpliRED D-dimer can reduce the diagnostic tests in suspected deep vein thrombosis. [Letter]. Lancet1998;351:1405–6.
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Mauron T, Baumgartner I, Z'Brun A, et al. SimpliRED D-dimer assay: comparability of capillary and citrated venous whole blood, between-assay variability, and performance
of the test for exclusion of deep vein thrombosis in symptomatic outpatients. Thromb Haemost1998;79:1217–19.
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Carter CJ, Serrano K, Breen DJ, et al. Rapid fibrin D-dimer testsfor deep venous thrombosis: factors affecting diagnostic utility. J Emerg Med1999;17:605–10.
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Lennox AF, Delis KT, Serunkuma S, et al. Combination of a clinical risk assessment score and rapid whole blood D-dimer testing in the diagnosis of deep vein thrombosis
in symptomatic patients. J Vasc Surg1999;30:794–803.
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Farrell S, Hayes T, Shaw M. A negative SimpliRed D-dimer assay result does exclude the diagnosis of deep venous thrombosis
or pulmonary embolus in emergency department patients. Ann Emerg Med2000;35:121–5.
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van der Graaf F, van den Borne H, van der Kolk, et al. Exclusion of deep venous thrombosis with D-dimer testing—comparison of 13 D-dimer methods in 99 outpatients suspected of deep venous thrombosis using venography as reference standard. Thromb Haemost2000;83:191–8.
