Siemens IMMULITE 2000 AntiCPP IgG Mode D'emploi page 6

Total Tested
Disease State (n)
SLE 5
Sjogren's
5
Syndrome
Lyme Disease 5
Osteoarthritis 5
Scleroderma 5
Polymyositis
5
Thyroiditis 5
Mononucleosis 5
Three out of 40 samples (1 Sjogren's
syndrome; 1 Lyme Disease, and
1 Polymyositis) yielded positive results. All
samples were also evaluated on a
commercially available FDA-cleared
predicate testing device for Anti-CCP. The
three positive samples were confirmed
positive by the predicate testing device.
Bilirubin: Presence of conjugated and
unconjugated bilirubin in concentrations
up to 20 mg/dL has no effect on results,
within the precision of the assay.
Biotin: Specimens that contain biotin at a
concentration of 3500 ng/mL demonstrate
a less than or equal to 10% change in
results. Biotin concentrations greater than
this may lead to incorrect results for
patient samples.
Hemolysis: Presence of hemoglobin in
concentrations up to 500 mg/dL has no
effect on results, within the precision of the
assay.
Lipemia: Presence of triglycerides in
concentrations up to 1500 mg/dL has no
effect on results, within the precision of the
assay.
Rheumatoid Factor: Evaluation of high
levels of endogenous rheumatoid factor
(RF) was achieved by screening RF
positive samples and diluting them to
200 IU/mL. No clinically significant
changes were observed.
6
Alternate Sample Type: To assess the
Positive
effect of alternate sample types, 39
(n)
matched sets of apparently healthy donors
0
were drawn into, heparinized (Li Heparin),
EDTA, and BD SST Vacutainer
1
Twenty percent of these samples were
spiked to achieve anti-CCP levels across
1
the reportable range. All samples were
0
analyzed by the IMMULITE 2000
0
Anti-CCP IgG assay, with the following
results:
1
0 (Li Heparin) = 1.02 (Serum) – 0.46 U/mL
r = 1.000
0
(SST) = 1.02 (Serum) – 0.52 U/mL
r = 1.000
(EDTA) = 1.01 (Serum) – 0.31 U/mL
r = 1.000
Means:
52.3 U/mL (Serum)
52.9 U/mL (Li Heparin)
53.0 U/mL (SST)
52.2 U/mL (EDTA)
This study showed 100% positive and
negative agreements between all samples
collected in Serum, SST, EDTA and
Lithium Heparin.
Method Comparison : The IMMULITE
2000 Anti-CCP IgG assay was compared
to a commercially available Axis-Shield
DIASTAT Anti-CCP IgG assay on 457
patient samples.
DIASTAT
Positive
Negative
Total Agreement: 94.1%
Clinical Performance: The assay was
performed on the IMMULITE 2000 to
assess the clinical sensitivity and
specificity of well-characterized samples.
A total of 457 patient serum samples were
collected for the study. 257 samples were
rheumatoid arthritis (RA) positive
remaining 200 samples were from
apparently healthy donors (non-RA). RA
positive patients were classified according
to the ACR criteria.
IMMULITE 2000 Anti-CCP IgG (PIL2KPI-15, 2022-02)
®
tubes.
IMMULITE 2000 Anti-CCP IgG
Non- % Positive % Negative
Reac Reac Agreement Agreement
187 13
93.5%
14 243
12
12
94.6%
and the