You are on page 1of 2

Immunoglobulin M (5+1)

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

340 nm Main / 800 nm Sub


1 cm
37 C
Against reagent blank

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

Storage and Stability


Reagents are stable up to the of expiry date printed on
the labels ,when stored at 2 8 C and contamination
is avoided. Do not freeze the reagents!
Warnings / Precautions
Reagents contain sodium azide (0.95 g/l) as
preservative. Do not swallow! Avoid contact with skin
and mucous membranes!
Waste
Refer to local legal requirements.

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

Calibrators and Controls


For the calibration of the test on analyzers Greiner
Unical Protein calibrator set is recommended.
For internal quality control use e.g. Greiner Protein
control.

Applications for automated systems are


available on request

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

*not valid in case of repeated freezing.

Discard contaminated specimens.

07/2014

Page 1/2

Greiner Diagnostic GmbH - Unter Gereuth 10 D-79353 Bahlingen Germany


www.greiner-diagnostic.com

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.

1. Thomas L. Clinical Laboratory Diagnostics. 1st ed.


Frankfurt: TH-Books Verlagsgesellschaft; 1998. p.
667-78.
2. Johnson AM, Rohlfs EM, Silverman LM. Proteins. In:
Burtis CA, Ashwood ER. editors. Tietz textbook of
clinical chemistry. 3rd ed. Philadelphia: W. B.
Saunders Company; 1999. p. 507-12.
3. Bartl R, Hoechtlen-Vollmar W, Thomas L. Monoclonal
immunoglobulins. In: Thomas L. Clinical Laboratory
Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 742-58.
4. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner
S, Bienvenu J et al. Consensus of a group of
professional societies and diagnostic companies on
guidelines for interim reference ranges for 14
proteins in serum based on the standardization
against the IFCC/BCR/CAP reference material (CRM
470). Eur J Clin Chem Clin Biochem 1996;34:51720.

SYMBOLS USED

Imprecision and Method Comparison


The experimental values have been measured and the
results were found good. At the moment these values
are being summarized and will be published soon.

Batch Code

Reference Range [4]


40 - 230 mg/dl

For in vitro diagnostic medical use

(0.40 2.30 g/l)

Use by
Temperature limitation

07/2014

Page 2/2

Greiner Diagnostic GmbH - Unter Gereuth 10 D-79353 Bahlingen Germany


www.greiner-diagnostic.com