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Quantitative immunoturbidimetric
test on IgM
Cat. No
824 001
824 002 (Hit I)
Package Size
5 x 20 ml / 1 x 20 ml
4 x 20 ml / 2 x 8 ml
Method
Assay Procedure
Wavelength
Optical path
Temperature
Measurement
Immunoturbidimetric test
Principle
Endpoint determination of human IgM through
photometric measurement of antigen-antibody-reaction
between goat antibodies to human IgM , and the
IgM present in the sample.
Blank
Sample/calibrator
Sample / calibrator
3 l
Reagent 1
350 l
350 l
Mix, incubate for 3 min., read absorbance (A1), then
add:
Reagent 2
70 l
70 l
Mix, incubate for 3 min., read absorbance (A2).
A = [(A2 A1)sample or calibrator] - [(A2 A1)blank]
Reagents
Components (Concentrations in the test mixture)
R1:
R2:
Phosphate buffer
pH 7.4
NaCl
Polyethylenglycol (PEG)
detergents, stabilizers
Phosphate buffer
pH 7.4
NaCl
Anti-human IgM antibody (goat)
100 mmol/l
160 mmol/l
100 mmol/l
160 mmol/l
Calculation
The concentration of IgM in unknown samples is derived
from a calibration curve using an appropriate
mathematical model such as logit/log. The calibration
curve is obtained with 5 calibrators at different levels
and NaCl solution (9 g/l) for determination of the zero
value.
Stability of calibration: 4 weeks
Preparation
Reagents R1 and R2 are ready-to-use.
Samples
Serum/ plasma (heparin or EDTA )
Stability*: 7 days
at
3 months
at
6 months
at
15 25 C
2 8 C
- 20 C
07/2014
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Performance Characteristics
Literature
Range
The
test
has
been
developed
to
determine
concentrations of IgM within a range from 3 800 mg/dl. When values exceed the range, samples
should be diluted 1 + 1 with NaCl solution (9 g/l) ,
result multiplied by 2.
Prozone Limit
No prozone effect was observed up to an IgM value of
8000 mg/dl.
Specificity / Interferences
Greiner Immunoglobulin M is a specific immunoassay
for human IgM. No interference was observed by
conjugated and unconjugated bilirubin up to 60 mg/dl,
hemoglobin up to 1000 mg/dl, lipemia up to 2000 mg/dl
triglycerides and RF up to 1700 IU/ml
No cross reaction with IgA or IgG was observed under
test conditions.
Sensitivity /Limit of Detection
The lower limit of detection is 3 mg/dl.
SYMBOLS USED
Batch Code
Use by
Temperature limitation
07/2014
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