Instructions

IVD CAPSULE D-Dimer - Instructions for Use (IFU)
REF P02.00050
IVD CAPSULE D-Dimer 2022_05_EN_V1.0
• Consistently high or low values from assay kits from the
same batch.
In such cases the kit should not be used.
Limitations
• Test results should be interpreted within the complete
clinical picture. Definitive diagnosis and/or clinical decision
should not be based solely on the results of any single
diagnostic test but made after all clinical and laboratory
findings are evaluated.
• Clinically elevated total protein level may interfere with test
results.
• Grossly haemolytic, icteric, or grossly lipemic specimen
may interfere with test results at clinically elevated
concentrations.
• All assay materials are single-use and cannot be re-used
or transferred to another kit.
The user shall report any serious incident that has occurred in
relation to the device to the manufacturer and the relevant
national competent authority.
Expected values
The mean D-Dimer concentration range in adults was
measured in 516 randomly selected normal subjects at 306 +/-
130 ng/ml FEU
7
.
It is recommended that each laboratory determine its own
reference values.
Measuring range: 212 - 1000 ng/ml FEU
The linear range of the assay was determined by diluting a pool
of samples with clinically elevated D-Dimer levels in a pool of
samples with low D-Dimer levels to obtain concentrations
spanning the entire assay range (212 to 1000 ng/ml FEU of D-
Dimer). Regression analysis demonstrated that the assay
response was linear with a slope of 0.97 and an intercept of
15.93 in this range. The analytical sensitivity study
demonstrated a limit of blank (LoB) of 77 ng/ml FEU, a limit of
detection (LoD) of 109 ng/ml FEU and a limit of quantification
(LoQ) of 212 ng/ml FEU.
D-Dimer concentrations below 212 ng/ml FEU are reported as
“< 212 ng/ml FEU”, and values above 1000 ng/ml FEU are
reported as “> 1000 ng/ml FEU”.
Linearity was established in accordance with the
recommendation of the CLSI document EP06, 2
nd
edition
8
, and
the LoB, LoD and LoQ with EP17-A2
9
.
The IVD CAPSULE D-Dimer showed no high-dose effect
(“prozone effect”, “Hook effect”) at concentrations below 43500
ng/ml FEU (this was the highest tested D-Dimer concentration)
for trisodium citrate anticoagulated whole blood.
Precision
The between-day precision was measured with 1 run of 4
replicates per day, for 20 days, on 3 samples covering the
assay reportable range of the IVD CAPSULE D-Dimer on the
abioSCOPE 2.0 (Table 3).
D-Dimer
level
Mean value [ng/ml
FEU]
Between-day CV
Level 1
319
6%
Level 2
603
0%
Level 3
1051
0%
Table 3| Summary of the 20 days precision study.
The between-lot precision was measured with 3 lots of IVD
CAPSULE D-Dimer, 5 replicates per day, for 5 days, on 3
samples covering the assay reportable range of the IVD
CAPSULE D-Dimer on the abioSCOPE 2.0 (Table 4).
D-Dimer
level
Mean value [ng/ml
FEU]
Between-lot CV
Level 1
220
5%
Level 2
382
1%
Level 3
671
2%
Table 4| Summary of the between-lot precision study.
The between-device precision was measured on 3 different
abioSCOPE with 1 lot of IVD CAPSULE D-Dimer, 5 replicates,
on 3 samples covering the assay reportable range of the IVD
CAPSULE D-Dimer on the abioSCOPE 2.0 (Table 5).
D-Dimer
level
Mean value [ng/ml
FEU]
Between-device
CV
Level 1
261
7%
Level 2
426
4%
Level 3
671
5%
Table 5| Summary of the between-device precision study.
For practical reasons, the precision studies mentioned above
were performed with trisodium citrate plasma samples. The
within device precision of trisodium citrate anticoagulated
whole blood and matching plasma has been verified and found
to be similar.
The repeatability of the IVD CAPSULE D-Dimer on the
abioSCOPE 2.0 has been evaluated with 10 sodium citrate
anticoagulated venous whole blood samples covering the
range of D-Dimer concentrations from 211 to 1046 ng/ml FEU.
All samples were measured 10 times in a row on 1 abioSCOPE
with 1 lot of IVD CAPSULE D-Dimer. Imprecision values
ranged from 10% to 20%.
All the precision studies were designed, executed, and
analysed in accordance with the recommendations of the CLSI
document EP05-A3, 3
rd
edition
10
.
Analytical selectivity
The substances listed below were tested for interference. Each
substance was tested at a clinically elevated concentration, on
three D-Dimer samples covering the low, intermediate (near the
medical decision point) and high range of the assay. Analytical