RSS-Feed abonnieren
DOI: 10.1055/s-0038-1651178
Investigations into the Clinical Utility of Latex D-Dimer in the Diagnosis of Deep Venous Thrombosis
Publikationsverlauf
Received
26. Februar 1992
Accepted after revision
07. September 1992
Publikationsdatum:
24. Juli 2018 (online)
![](https://www.thieme-connect.de/media/10.1055-s-00035024/199301/lookinside/thumbnails/10-1055-s-0038-1651178-1.jpg)
Summary
The serial use of non-invasive tests has been shown to be a safe method of managing outpatients who are suspected of having lower limb deep venous thrombosis (DVT). Objective testing has shown that the majority of these outpatients do not have venous thrombosis. A rapid test to exclude DVT in these patients, without the need for expensive and inconvenient serial non-invasive vascular testing, would have practical and economic advantages.
Studies measuring the fibrin degradation product D-dimer using enzyme-linked immunoassays (EIA) in patients with veno-graphically proven DVT suggest that it should be possible to exclude this condition by the use of one of the rapid latex bead D-dimer tests.
We have examined 190 patients with suspected DVT using both a latex and an EIA D-dimer assay. The latex D-dimer test used in this study was negative in 7 of the 36 proven cases of DVT. This sensitivity of only 80% is not sufficient to allow this type of assay, in its current form, to be used as an exclusion test for DVT. The same plasma samples were tested with an EIA assay. This information was used to mathematically model the effects of selecting a range of D-dimer discriminant cut off points for the diagnosis of DVT. These results indicate that 62% of suspected clinically significant DVT could have this diagnosis excluded, with a 98% sensitivity, if the rapid latex or equivalent D-dimer test could be reformulated to measure less than 185 ng/ml of D-dimer.
-
References
- 1 Haeger K. Problems of acute venous thrombosis. 1. The misinterpretation of signs and symptoms. Angiology 1969; 20: 219-223
- 2 Cranley JJ, Canos AJ, Sull WJ. The diagnosis of deep vein thrombosis: Fallibility of clinical signs and symptoms. Arch Surg 1976; 111: 34-36
- 3 Hirsh J, Hull RD. Diagnosis of venous thrombosis. In: Venous Thrombosis, Natural History, Diagnosis, and Management. Hirsh J, Hull RD. (eds). CRC Press; Boca Raton, FL: 1987: 29-31
- 4 Zielinsky A, Hirsh J, Straumanis G, Carter CJ, Gent M, Sackett DL, Hull RD, Kelton JG, Powers P, Turpie AG. The diagnostic value of the fibrinogen/fibrin fragment E antigen assay in clinically suspected venous thrombosis. Blood 1982; 59: 346-350
- 5 Hull RD, Carter CJ, Jay RM, Ockelford PA, Hirsch J, Turpie AG, Zielinsky A, Gent M, Powers P. The diagnosis of acute recurrent, deep-vein thrombosis; a diagnostic challenge. Circulation 1983; 67: 901-907
- 6 Sigel B, Felix WR, Popky GL, Ipsen J. Diagnosis of lower limb venous thrombosis by Doppler ultrasound technique. Arch Surg 1972; 104: 174-179
- 7 Strandness DE, Sumner DS. Ultrasonic velocity detector in the diagnosis of thrombophlebitis. Arch Surg 1972; 104: 180-183
- 8 Hull RD, Hirsh J, Carter CJ, Jay RM, Ockelford PJ, Buller HR, Turpie AG, Powers P, Kinch D, Dodd PE, Gill GJ, Leclerc JR, Gent M. Diagnostic efficacy of impedance plethysmography for suspected venous thrombosis: a randomized trial. Ann Intern Med 1985; 102: 21-28
- 9 Huisman MW, Buller HR, ten Cate JW, Heijermans HSF, van der Laan J, van Maanen DJ. Management of clinically suspected acute venous thrombosis in out-patients with serial impedance plethysmography in a community setting . Arch Intern Med 1989; 149: 511-515
- 10 Lensing AW, Prandoni P, Brandjes D, Huisman PM, Vigo M, Tomasella G, Krekt J, ten Cate JW, Huisman MV, Büller HR. Detection of deep vein thrombosis by real-time B-mode ultrasound. N Engl J Med 1989; 320: 342-345
- 11 Tibbut DA, Chesterman CN, Allington MJ, Williams EW, Faulkner T. Measurement of fibrinogen-fibrin-related antigen in serum as an aid to diagnosis of venous thrombosis in outpatients. Br Med J 1975; 1: 367-369
- 12 Cooke ED, Gordon YB, Bowcock SA, Sola CM, Pilcher MF, Chard T, Ibbotson RM, Ainsworth ME. Serum fibrin(ogen) degradation products in the diagnosis of deep vein thrombosis and pulmonary embolism after hip surgery. Lancet 1975; ii: 51-54
- 13 Rylatt DB, Blake AS, Cottis LE, Massingham DA, Fletcher WA, Masci PP, Whitaker AN, Elms M, Bunce I, Webber AJ, Wyatt D, Bundesen PG. An immunoassay for human D-dimer using monoclonal antibodies. Thromb Res 1983; 31: 767-778
- 14 Elms MJ, Bunce IH, Bundersen PG, Rylatt DB, Webber AJ, Masci PP, Whitaker AN. Rapid detection of crosslinked fibrin degradation products in plasma using monoclonal antibody coated latex particles. Am J Clin Pathol 1986; 85: 360-364
- 15 Greenberg CS, Devine DV, McCrae KM. Measurement of plasma fibrin D-dimer levels with the use of a monoclonal antibodiy coupled to latex beads. Am J Clin Pathol 1987; 87: 94-100
- 16 Devine DV, Kinney TK, Thomas PF, Rosse WF, Greenberg CS. Fragment D-dimer levels: an objective marker of vaso-occlusive crisis and other complications of sickle cell disease. Blood 1986; 68: 317-319
- 17 Rowbotham BJ, Carroll P, Whitaker AN, Bunce IH, Cobcroft RG, Elms MJ, Masci PP, Bundesen PG, Rylatt DB, Webber AJ. Measurement of crosslinked fibrin derivatives in the diagnosis of venous thrombosis. Thromb Haemostas 1987; 57: 59-61
- 18 Barnes RW, Russel HE, Wu KK, Hoak JD. Accuracy of Doppler ultrasound in clinically suspected venous thrombosis. Surg Gynecol Obstet 1976; 143: 425-428
- 19 Hull RD, Delmore T, Genton E, Hirsh J, Gent M, Sackett DL, McLoughlin D, Armstrong P. Wafarin sodium versus low-dose heparin in the longterm management of venous thrombosis. N Engl J Med 1979; 301: 855-858
- 20 Speiser W, Mallek R, Kopperstein R, Stumpflen A, Kapiotis S, Minar E, Ehringer H, Lechner K. D-dimer and TAT measurements in patients with deep venous thrombosis: utility in diagnosis and judgement of anticoagulant treatment effectiveness. Thromb Haemostas 1990; 64: 196-201
- 21 John MA, Elms MJ, O’Reilly EJ, Rylatt DB, Bundesen PG, Hillyard CJ. The simpliRED D-dimer test: a novel assay for the detection of crosslinked fibrin degradation products in whole blood. Thromb Res 1990; 58: 273-281