nal von minden NADAL D-Dimer Test Instructions D'utilisation page 35

NORSK
Relativ sensitivitet: 151/(151+2) = 98,7% (96,91% - 100%)*
Relativ specificitet: 133/(133+16) = 89,3% (84,34% - 94,26%)*
Total overensstemmelse: (151+133)/(151+2+133+16) = 94,0%
(91,36% - 96,72%)*
*95% Konfidensintervall
Kryssreaktivitet
1 mg/mL fibrinogen, 25 µg/mL fragment D og 25 µg/mL
fragment E kryssreagerer ikke med NADAL® D-Dimer test.
Forhøyede nivåer av revmatoidefaktorer (RF) eller heterfile
antistoffer kan forstyrre testresultatene.
Substanser som kan påvirke
Negative og positive prøver tilsatt følgende potensielt
forstyrrende stoffer ble evaluert i triplikater ved bruk av
NADAL® D-Dimer Test.
Konsentra-
Analys
sjon
Menneskelig
albumin 110 mg/mL
Paracetamol 50 µg/mL
Acetylsalicylic acid 50 µg/mL
Askorbinsyre 50 µg/mL
Atenolol 50 µg/mL
Atorvastatin
kalsium 50 µg/mL
Anisodamine 50 µg/mL
Bilirubin 6 mg/mL
Kloramfenikol 50 µg/mL
Chlordiazepoxide 50 µg/mL
Kolesterol 5 mg/mL
Koffein 50 µg/mL
Captopril 50 µg/mL
Cilazapril 50 µg/mL
Diklofenak 50 µg/mL
Digoksin 50 µg/mL
Erythomycin 50 µg/mL
Isosorbide
mononitrat 50 µg/mL
Furosemid 50 µg/mL
Ingen av stoffene forstyrret analysen ved konsentrerte tester.
Presisjon
Repeterbarhet og reproduserbarhet
Repeterbarhet ble etablert ved å teste 10 replikater av 3
prøver (0 ng/mL, 500 ng/mL og 2000 ng/mL D-Dimer) med
hver av 3 uavhengige NADAL® D-Dimer testpartier.
Reproduserbarhet ble etablert ved å teste triplikater av 3
prøver (0 ng/mL, 500 ng/mL og 2000 ng/mL D-Dimer) med 3
uavhengige NADAL® D-Dimer testpartier.
NADAL® D-Dimer Test viste akseptabel repeterbarhet og
reproduserbarhet. De negative og positive verdiene ble
korrekt identifisert >99% av tiden.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® D-Dimer Test
Konsentra-
Analys
sjon
hydroklortiazid
D,L-Tyrosin
Labetalol
Oxazepam
Fenobarbital
kinin
Triglyserider
Trimetoprim
Verapamil
Felodipin
Nifedipin
Bisoprolol
fumarat
Ramipril
Metoprolol
tartrat
Moricizine
hydrochloride
Pentoxifylline
Flunarizin
hydrochlorid
Hemoglobin
(Ref. 351006N-05/351006N-10/351006N-25)
15. Referanser
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;
50 µg/mL
1998.
10. Hunt, F.A. et al. Serum Cross-Linked Fibrin (XDP) and Fibrinogen/Fibrin Degradation
50 µg/mL
Products (FDP) in Disorders Associated with Activation of the Coagulation or
50 µg/mL
Fibrinolytic Systems. Br. J. Haematol. 60: 715-722; 1985.
11. Smith, R.T. et al. Fibrin Degradation Products in the Post-Operative Period-
50 µg/mL
Evaluation of a New Latex Agglutination Method. AJCP. 60: 644-647; 1973.
50 µg/mL 12. Nolan, T.E. et al. Maternal Plasma D-dimer Levels in Normal and Complicated
Pregnancies. Obstetrics & Gynecology. 81(2): 235-238, 1993.
50 µg/mL
15 mg/mL
50 µg/mL
50 µg/mL
50 µg/mL
50 µg/mL
50 µg/mL
50 µg/mL
50 µg/mL
50 µg/mL
50 µg/mL
50 µg/mL
10 mg/mL
Rev. 1, 2021-04-08 KD
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