Tabla de contenido
Publicidad
Idiomas disponibles
Idiomas disponibles
9
Results' interpretation
CRP
Elevation of CRP value is unspecific and the results should be interpreted in the light of
other clinical findings.
CRP test result
< 10 mg/l
10–50 mg/l
> 50 mg/l
Hemoglobin
Hemoglobin results can only be obtained from whole blood samples.
Reference group
Women
Men
Children 1–12 years*
* Children's hemoglobin values increase progressively reaching gradually adult levels.
Result levels are affected by patients' diet and the elevation from sea level of their place of
residence, so it is recommended that each laboratory determines their own reference values
for hemoglobin. When diagnosing patients, the patient's overall clinical status should always
be taken into account.
10 Limitations of the procedure
Assay procedures other than those specified in these instructions may yield questionable
results. Some substances may interfere with the test results; please see Section 12.
"Performance Characteristics".
Test results should never be used alone, without a complete clinical evaluation, when making
a diagnosis. Intra-individual variations in CRP are significant and should be taken into account
– for example, by means of serial measurements – when interpreting the values.
11
Expected values
The assay reference range limit was determined by using 143 apparently healthy adults
(59 males and 84 females) with age 19–65 according to CLSI EP28-A3C guideline. Based
on the results the 95% reference limit was concluded to be ≤ 5 mg/l for each sample type.
Results are based on a non parametric approach.
However, each laboratory is recommended to establish a range of normal values for their
population in their
??
12 Performance characteristics
CRP
Method comparison
Patient plasma samples were measured using two clinical laboratory methods, and the
QuikRead go CRP method. Summary of correlation studies is presented in the table below.
Clinical laboratory method 1
y
=
r
=
n
=
Whole blood vs. plasma comparability
In a comparison of 104 clinical samples, whole blood (y) and plasma samples (x) yielded
comparable results. y = 1.03x – 0.3
Precision and reproducibility
A precision study was performed according to Clinical and Laboratory Standards Institute
(CLSI) guideline EP5-A2.
Sample
Sample
material
number
Sample 1
Whole
Sample 2
blood
Sample 3
Sample 1
Plasma
Sample 2
Sample 3
Control
Sample 1
Interference
Interfering substance
Bilirubin
Vitamin C
Triglycerides
Cholesterol
Rheumatoid factors (RF)
Leucocytes
Anticoagulants (Li-heparin or EDTA)
Most heterophilic or anti-sheep antibodies in the samples do not interfere with the test, as
the assay antibodies lack the Fc-part. In rare cases, interference by IgM myeloma protein
has been observed.
Antigen excess
CRP concetrations less than 1,000 mg/l do not give falsely low results.
Hemoglobin
Method comparison
Patient whole blood samples were analysed using a reference method
test and the QuikRead go CRP+Hb test. A summary of correlation studies is presented in
the table below.
Reference method
=
y
=
r
=
n
Precision and reproducibility
A precision study was performed according to Clinical and Laboratory Standards Institute
(CLSI) guideline EP5-A2.
Sample
Sample
material
number
Sample 1
Whole
Sample 2
blood
Sample 3
Level 1
Control
Interfering substances
Interfering substance
Bilirubin
Vitamin C
Triglycerides
Rheumatoid factors (RF)
Leucocytes
Thrombocytes
β-carotene
Ibuprofen
Salicylic acid / Acetylsalicylic acid
Tetracyclines
Urea
Anticoagulants (Li-heparin or EDTA)
Interpretation of result
Excludes many acute inflammatory diseases, but does not specifically
exclude inflammatory processes.
Elevated concentrations found in acute disease that occur in the
presence of a slight to moderate inflammatory process.
Indicates high and extensive inflammatory activity.
Reference values
120–150 g/l (12.0–15.0 g/dl, 7.4–9.3 mmol/l)
130–170 g/l (13.0–17.0 g/dl, 8.1–10.6 mmol/l)
110–155 g/l (11.0–15.5 g/dl, 6.8–9.6 mmol/l)
region.?
Passing-Bablok analysis
1.00x + 1.0
0.994
116
Within-run, between-day and total precision
Mean CRP
Number
(mg/l)
of days
20
20
20
20
20
20
20
Passing-Bablok analysis
8, 9
1.07x – 7.8
0.996
59
Within-run, between-day and total precision
Mean Hb (g/l)
Number
of days
20
20
20
7
7
10
Clinical laboratory method 2
Within-run
CV (%)
9
4.5
52
1.4
177
1.9
10
3.7
55
1.5
148
2.0
30
2.0
No interference found up to
concentration
400 µmol/l
200 µmol/l
11.5 mmol/l
9.0 mmol/l
525 IU/ml
145x10
cells
9
No interference
Point-of-care test
Within-run
CV (%)
96
1.7
134
1.7
164
1.5
126
1.6
No interference found up to
concentration
200 µmol/l
200 µmol/l
11.5 mmol/l
525 IU/ml
65 x 10
/l
9
/l
1000 x 10
9
3.7 µmol/l
500 mg/l
650 mg/l
200 mg/l
5000 mg/l
No interference
y
=
0.93x + 1.4
r
=
0.987
n
=
113
Between-day
CV (%)
4.3
2.4
2.8
0.1
0.4
1.0
3.1
, a point-of-care
8, 9
y
=
1.01x – 1.1
r
=
0.994
n
=
130
Between-day
CV (%)
1.2
1.3
0.9
2.1
Total
CV (%)
6.2
3.2
3.6
4.2
1.9
2.4
3.7
Total
CV (%)
2.2
2.1
2.2
3.0
Publicidad
Tabla de contenido
