Performance Data - Siemens IMMULITE 2000 HCG Bedienungsanleitung

Performance Data

See tables and graphs for data
representative of the assay's performance.
Results are expressed as mIU/mL.
(Unless otherwise noted, all were
generated on serum samples collected in
tubes without gel barriers or clot-
promoting additives.)
Reportable Range: Up to 5,000 mIU/mL,
in terms of the WHO 3rd IS 75/537 for
quantitative determinations in serum.
Analytical Sensitivity:
0.4 mIU/mL.
High-Dose Hook Effect: None up to
2,000,000 mIU/mL.
Precision: Samples were assayed in
duplicate over the course of 20 days, two
runs per day, for a total of 40 runs and 80
replicates. (See "Precision" table.)
Linearity: Samples were assayed under
various dilutions. (See "Linearity" table for
representative data.)
Recovery: Samples spiked 1 to 19 with
three solutions (1,313, 5,720 and
30,340 mIU/mL) were assayed. (See
"Recovery" table for representative data.)
Specificity: The assay is highly specific
for HCG, with low crossreactivity to other
glycoprotein hormones present in patient
samples. (See "Specificity" table.)
For concentrations as high as
10,000 ng/mL, the HCG α-subunit (WHO
75/569) showed less than 1%
crossreactivity. HCG β-subunit (WHO
75/551), spiked into HCG Sample Diluent,
yielded the tabulated results. (See
"Specificity" table.)
Bilirubin: Presence of bilirubin in
concentrations up to 200 mg/L has no
effect on results, within the precision of the
assay.
Hemolysis: Presence of hemoglobin in
concentrations up to 384 mg/dL has no
effect on results, within the precision of the
assay.
Lipemia: Presence of lipemia in
concentrations up to 3,000 mg/dL has no
effect on results, within the precision of the
assay.
Alternate Sample Type: To assess the
effect of alternate sample types, blood
was collected from 14 volunteers into
IMMULITE 2000 HCG (PIL2KCG-26, 2009-04-17)
plain, heparinized, EDTA vacutainer
tubes, and SST. Equal volumes of the
matched samples were spiked with
various concentrations of HCG, to obtain
values throughout the calibration range of
the assay, and then assayed by the
IMMULITE 2000 HCG procedure.
(Heparin) = 1.06 (Serum) – 7.06 mIU/mL
r = 0.99
(EDTA) = 1.08 (Serum) – 6.7 mIU/mL
r = 0.99
(SST) = 0.98 (PlainTubes) – 3.25 mIU/mL
r = 0.99
Means:
204 mIU/mL (Serum)
211 mIU/mL (Heparin)
197 mIU/mL (EDTA)
214 mIU/mL (SST)
Method Comparison (Serum): The
assay was compared to IMMULITE HCG
on 115 patient samples. (Concentration
range: approximately 1 to over
3,000 mIU/mL. See graph.) By linear
regression:
(IML 2000) = 1.0 (IML) – 21 mIU/mL
r = 0.994
Means:
668 mIU/mL (IMMULITE 2000)
689 mIU/mL (IMMULITE)
For the 63 data pairs (out of 116) with
results by both methods from 1 to
500 mIU/mL:
(IML 2000) = 0.91 (IML) + 0.9 mIU/mL
r = 0.987
For the 22 data pairs (out of 116) with
results by both methods from 1 to
50 mIU/mL:
(IML 2000) = 0.96 (IML) + 0.3 mIU/mL
r = 0.953
Method Comparison (Urine): A total of
123 urine samples from pregnant women
were processed by the IMMULITE 2000
HCG assay and by Double Antibody HCG.
The samples, some of which were diluted,
had HCG values ranging up to
approximately 300 mIU/mL. By linear
regression:
IML 2000 = 1.04 (DAb) – 10 mIU/mL
r = 0.988
In another study with the IMMULITE 2000
HCG assay, as a check on the
appropriateness of the 30 mIU/mL cutoff
used in the qualitative procedure, urinary
results for nonpregnant women showed a
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