nal von minden NADAL D-Dimer Test Instructions D'utilisation page 8

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observed when testing a specimen containing a D-Dimer
concentration as high as 50 µg/mL.
Diagnostic sensitivity and specificity
A clinical study was performed on 149 negative plasma
specimens (EIA confirmed, Roche Cobas c701) and 153
positive plasma specimens (EIA confirmed). The results are
presented in the following table:
NADAL®
+
D-Dimer
̶
Test
Total
Relative sensitivity: 151/(151+2) = 98.7% (96.91% - 100%)*
Relative specificity: 133/(133+16) = 89.3% (84.34% - 94.26%)*
Overall agreement: (151+133)/(151+2+133+16) = 94.0%
(91.36% - 96.72%)*
*95% Confidence interval
Cross-reactivity
1 mg/mL fibrinogen, 25 µg/mL fragment D and 25 µg/mL
fragment E do not cross-react with the NADAL® D-Dimer Test.
Elevated levels of rheumatoid factors (RF) or heterophile
antibodies might interfere with test results.
Interfering substances
Negative and positive specimens spiked with the following
potentially interfering substances were evaluated in triplicates
using the NADAL® D-Dimer Test.
Concentra-
Analyte
tion
Human albumin 110 mg/mL
Acetaminophen 50 µg/mL
Acetylsalicylic acid 50 µg/mL
Ascorbic acid 50 µg/mL
Atenolol 50 µg/mL
Atorvastatin
calcium 50 µg/mL
Anisodamine 50 µg/mL
Bilirubin 6 mg/mL
Chloramphenicol 50 µg/mL
Chlordiazepoxide 50 µg/mL
Cholesterol 5 mg/mL
Caffeine 50 µg/mL
Captopril 50 µg/mL
Cilazapril 50 µg/mL
Diclofenac 50 µg/mL
Digoxin 50 µg/mL
Erythromycin 50 µg/mL
Isosorbide
mononitrate 50 µg/mL
Furosemide 50 µg/mL
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® D-Dimer Test
EIA
+ ̶
151 16
2 133
153 149
Concentra-
Analyte
tion
Hydrochlo-
rothiazide 50 µg/mL
D,L-Tyrosine 50 µg/mL
Labetalol 50 µg/mL
Oxazepam 50 µg/mL
Phenobarbital 50 µg/mL
Quinine 50 µg/mL
Triglycerides 15 mg/mL
Trimethoprim 50 µg/mL
Verapamil 50 µg/mL
Felodipine 50 µg/mL
Nifedipine 50 µg/mL
Bisoprolol
fumarate 50 µg/mL
Ramipril 50 µg/mL
Metoprolol
tartrate 50 µg/mL
Moricizine
hydrochloride 50 µg/mL
Pentoxifylline 50 µg/mL
Flunarizine
hydrochloride 50 µg/mL
Haemoglobin 10 mg/mL
(Ref. 351006N-05/351006N-10/351006N-25)
None of the substances interfered with the assay at the
concentrations tested.
Precision
Repeatability and reproducibility
Repeatability was established by testing 10 replicates of 3
specimens (0 ng/mL, 500 ng/mL and 2000 ng/mL D-Dimer)
with each of 3 independent NADAL® D-Dimer test lots.
Reproducibility was established by testing triplicates of 3
Total
specimens (0 ng/mL, 500 ng/mL and 2000 ng/mL D-Dimer)
with 3 independent NADAL® D-Dimer test lots.
167
135 The NADAL®
repeatability and reproducibility. The negative and positive
302
values were correctly identified >99% of the time.
15. References
1. Gaffney, P.J. D-dimer History of Discovery, Characterisation and Utility of this and
other Fibrin Fragments. Fibrinolysis 7 Suppl 2:2-8; 1993
2. Lane, D.A. et al. Characterisation of Serum Fibrinogen and Fibrin Fragments
Produced During Disseminated Intravascular Coagulation. Haematology. 40: 609-
615; 1978.
3. Keeling, D.M. et al. The Haemostasis and Thrombosis Task Force of the British
Committee for Standards in Haematology. The diagnosis of deep vein thrombosis in
symptomatic outpatients and the potential for clinical assessment and D-dimer
assays to reduce the need for diagnostic imaging. Br. J. Haematol. 124(1): 15-
25;2004.
4. Bick, R.L. et al. Diagnostic Efficacy of the D-dimer assay in Disseminated
Intravascular Coagulation (DIC) Thromb. Res. 65:785-790; 1992.
5. Bick, R.L. et al. Disseminated Intravascular Coagulation: Objective Clinical and
Laboratory Diagnosis, Treatment, and Assessment of Therapeutic Response. Semin.
Thromb. Hemost. 22(1): 69-88; 1996.
6. Scarvelis, D and Wells, P.S. Diagnosis and Treatment of Deep Vein Thrombosis. Can.
Med. Assoc. J. 175 (9):1087-92; 2006
7. Subramanian, R.M. et. al. Does an Immunochromatographic D-dimer exclude acute
lower limb deep venous thrombosis? Emer. Med. Austral. 18: 457-463; 2006.
8. Runyon, M.S. et. al. Comparison of the Simplify D-dimer assay performed at the
bedside with a laboratory based quantitative D-dimer assay for the diagnosis of
pulmonary embolism in a low prevalence emergency department population.
Emerg. Med. J. 25:70-75; 2008.
9. Ginsburg, J.S. et. al. Sensitivity and specificity of a rapid whole-blood assay for D-
dimer in the diagnosis of pulmonary embolism. Ann. Intern. Med. 129(12), 1006-11;
1998.
10. Hunt, F.A. et al. Serum Cross-Linked Fibrin (XDP) and Fibrinogen/Fibrin Degradation
Products (FDP) in Disorders Associated with Activation of the Coagulation or
Fibrinolytic Systems. Br. J. Haematol. 60: 715-722; 1985.
11. Smith, R.T. et al. Fibrin Degradation Products in the Post-Operative Period-
Evaluation of a New Latex Agglutination Method. AJCP. 60: 644-647; 1973.
12. Nolan, T.E. et al. Maternal Plasma D-dimer Levels in Normal and Complicated
Pregnancies. Obstetrics & Gynecology. 81(2): 235-238, 1993.
D-Dimer Test demonstrated
Rev. 1, 2021-04-08 FS/SS
acceptable
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