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REPLY
Clinical Assessment and D-dimer Testing in Deep Venous Thrombosis
Clive Kearon, MB, PhD, and
Jeffrey S. Ginsberg, MD
3 September 2002 | Volume 137 Issue 5 Part 1 | Pages 371-372
IN RESPONSE:
Dr. Wakai is concerned that other clinical centers, and particularly emergency departments, may have difficulty replicating the results of our study. We believe that the two limitations he discusses, which are common to most diagnostic tests, are interrelated and can be readily overcome. In contrast to other D-dimer assays, the assay we used in our study, SimpliRED (AGEN Biomedical, Ltd., Brisbane, Australia), can be performed at the bedside on a fingerstick sample and yields a result within minutes. At our institution, a nurse or a technician with previous training performs the test; we estimate that it takes about 2 hours of training to learn how to perform and interpret it. Alternatively, the SimpliRED assay can be performed in the laboratory on an anticoagulated venous blood sample (1). Regardless of where and on what type of sample the test is performed, the interpretation of presence (positive result) or absence (negative result) of red cell agglutination is subjective. Although interobserver agreement has been reported to be excellent (2), this may not always be the case; subjective errors of interpretation are probably responsible for the high false-negative rate of this test for venous thromboembolism reported by some investigators (3).
Provided that diagnostic accuracy is not sacrificed and that there is a short "turnaround time," we agree with Dr. Wakai about the advantage of an objective D-dimer test. Rapid enzyme-linked immunosorbent assays (4) and novel microparticle latex-based tests (5) seem to satisfy these requirements. However, compared with SimpliRED, the equipment required to perform these assays is substantial. Regardless of the type of D-dimer assay used, staff training and ongoing quality control of test performance will be required.
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Author and Article Information
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McMaster University; Hamilton, Ontario L8V 1C3, Canada
1. Chunilal SD, Brill-Edwards PA, Stevens PB, Joval JP, McGinnis JA, Rupwate M, et al. The sensitivity and specificity of a red blood cell agglutination D-dimer assay for venous thromboembolism when performed on venous blood Arch Intern Med. 2002;162:217-20. [PMID: 11802756].
2. Turkstra F, van Beek EJ, Büller HR. Observer and biological variation of a rapid whole blood D-dimer test Thromb Haemost. 1998;79:91-3. [PMID: 9459330].
3. Farrell S, Hayes T, Shaw M. A negative SimpliREDD-dimer assay result does not exclude the diagnosis of deep vein thrombosis or pulmonary embolus in emergency department patients Ann Emerg Med. 2000;35:121-5. [PMID: 10650228].
4. Perrier A, Desmarais S, Miron MJ, de Moerloose P, Lepage R, Slosman D, et al. Non-invasive diagnosis of venous thromboembolism in outpatients Lancet. 1999;353:190-5. [PMID: 9923874].
5. Bates SM, Grand'Maison A, Johnston M, Naguit I, Kovacs MJ, Ginsberg JS. A latex D-dimer reliably excludes venous thromboembolism Arch Intern Med. 2001;161:447-53. [PMID: 11176771].
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Brief Communications
Management of Suspected Deep Venous Thrombosis in Outpatients by Using Clinical Assessment and D-dimer Testing
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- Annals 2001 135: 108-111.
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