Instructions

IVD CAPSULE D-Dimer - Instructions for Use (IFU)
REF P02.00050
IVD CAPSULE D-Dimer 2022_05_EN_V1.0
selectivity was established in accordance with the
recommendation of the CLSI document EP07, 3
rd
edition
11
and
its supplement EP37, 1
st
edition
12
.
No interference was observed on the three D-Dimer samples
at these concentrations (bias within +/- 10%) (Table 6).
Substance
Highest doses tested
Albumin
60 g/l
Hemoglobin
10 g/l
Free bilirubin
40 mg/dl
Conjugated bilirubin
40 mg/dl
D-Dimer
43500 ng/ml FEU (reported as ‘>
1000 ng/ml FEU’)
Rheumatoid factor
100 IU/ml
Heparin, lithium
3 U/ml
Heparin, sodium
3 U/ml
Acethylsalicylic acid
3 mg/dl
Warfarin
7.50 mg/dl
Dalteparin sodium (anti-
factor Xa)
5 IU/ml
Table 6| Test substances (endogenous and exogenous) and
their concentrations.
An underestimation of 12% of the D-Dimer concentration has
been observed on high level D-Dimer samples (> 800 ng/ml
FEU) containing fibrinogen above 10 g/l. No interference was
observed at this fibrinogen concentration for samples
containing low or intermediate D-Dimer levels.
A clinically elevated immunoglobulin G (IgG) concentration
(2000 mg/dl) might lead to an overestimation of the D-Dimer
concentration on samples containing low D-Dimer levels (250
ng/ml FEU). No significant bias was observed at this IgG
concentration for samples containing more than 400 ng/ml FEU
of D-Dimer.
The following substances were found to bias test results by
more than 10% (Table 7).
Substance
Concentration
Human anti-mouse antibodies
(HAMA)
490 ng/ml
Triglycerides
500 mg/dl
Table 7| Substances that showed a significant bias at the tested
concentration.
Although precautions have been taken to minimize interference
caused by endogenous and exogenous substances, erroneous
results caused by interferences can be observed. For
diagnostic purposes, the results should always be compared to
the patient's medical history, clinical signs, and other findings.
Method comparison
The IVD CAPSULE D-Dimer on the abioSCOPE 2.0
demonstrated a good comparability with the reference
laboratory method VIDAS® D-Dimer Exclusion
TM
II,
bioMérieux. 105 paired samples (sodium citrate venous whole
blood on abioSCOPE 2.0 and corresponding venous plasma
on reference method) were assessed on both methods in single
replicate according to recommendation of CLSI document
EP09-C, 3
rd
edition
13
.
The Table 8 summarizes the study results.
abioSCOPE 2.0 versus VIDAS®
Non-Weighted Deming linear regression
Slope (95% CI)
1.19 (0.99 to 1.39)
Intercept (95% CI)
-14 (-89 to 60)
Table 8 | Comparison of methods Linear regression statistics
were applied to the entire data set covering a range of value (on
the abioSCOPE 2.0) of 222 to 930 ng/ml FEU (n = 105).
References
1. CLSI. H59A: Quantitative D-dimer for Exclusion of Venous
Thromboembolic Disease. Approved Guideline. CLSI
document H59-A. (2011).
2. Adam, S. S., Key, N. S. & Greenberg, C. S. D-dimer antigen:
current concepts and future prospects. Blood 113, 2878–
2887 (2009).
3. Righini M et al., D-Dimer for venous thromboembolism
diagnosis: 20 years later. J Thromb Haemost. 2008;6:1059-
71.
4. Ten Cate-Hoek AJ et al., Management studies using a
combination of D-dimer test result and clinical probability to
rule out venous thromboembolism: a systematic review. J
Thromb Haemost. 2005;3:2465-70.
5. Carrier M. et al., VIDAS D-dimer in combination with clinical
pre-test probability to rule out pulmonary embolism. A
systematic review of management outcome studies. Thromb
Haemost. 2009;101:886-92.
6. Clinical and Laboratory Standards Institute (CLSI), M29-A4,
4
th
ed. 2014.
7. Giansante C. et al., Fibrinogen, D-dimer and thrombin-
antithrombin complexes in a random population sample:
relationships with other cardiovascular risk factors, Thromb
Haemost. 1994, 71:581-6.
8. Clinical and Laboratory Standards Institute (CLSI), EP06, 2
nd
ed. 2020.
9. Clinical and Laboratory Standards Institute (CLSI), EP17-A2,
2
nd
ed. 2012.
10. Clinical and Laboratory Standards Institute (CLSI), EP05-A3,
3
rd
ed. 2014.
11. Clinical and Laboratory Standards Institute (CLSI), EP07, 3
rd
ed. 2018
12. Clinical and Laboratory Standards Institute (CLSI), EP37, 1
st
ed. 2018.
13. Clinical and Laboratory Standards Institute (CLSI), EP09-C,
1
st
ed. 2018.
Date of issue of this document: May 25, 2022 (V1.0).
IVD CAPSULE, abioMIX and abioSCOPE are trademarks of
Abionic. © 2022, Abionic SA.
CE marking according to the Directive 98/79/EC
Abionic SA, Route de la Corniche 5,
CH-1066 Epalinges, Switzerland
e-mail:
[e-mail].
Near-patient testing.