IgE AU UDI: 4260481081240

EDMA: 12.02.01.02.00

Immunological and turbidimetric test for determination of human IgE in serum and plasma

For use with the chemistry analyzers

Beckman Coulter AU400/AU480/AU640/AU680/AU2700/AU5400/AU5800/DxC700 AU

PACKAGE INSERT

For In Vitro Diagnostic Use

eIFU Indicator

The IgE Product Documentation for other languages is available here:

https://www.biomed.de/en/ige-product-documentation/

To get access to this secured website-area, please enter the following password:

LSYNVabj7

Do not hesitate to contact info@biomed or 0049-89-3157000 if you have further questions.

!
BIOMED Labordiagnostik GmbH • Bruckmannring 32 • 85764 Oberschleissheim • Germany • +49 89 3157000 • www.biomed.de Version 2018-05

Intended Use:
The BIOMED IgE AU test is intended for the quantitative in
vitro determination of IgE in human serum and plasma with
clinical chemistry analyzers. Application only through
specifically trained medical-technical personnel, under
adherence to the working guidelines for medical
laboratories. The test procedure takes place according to
the approved instructions and technical applications from
BIOMED. Otherwise guarantee becomes invalid.
Background:
Immunoglobulins consist of two light (L-) and two heavy (H-)
chains. The IgE is predominately present as a monomer and is
also classified as a reagine. IgE-antibodies produce a Type-I-
Hypersensitivity reaction from the quick reaction type. Through
polyvalent antigens, such as Pollinis siccum extractum, house
dust mite, components from nutrition elements, parasites or insect
bites, the B-cells of the mucous membrane at the entry point
through intervention of the CD4+-cells are activated to produce
specific IgE. This bond through the Fc-Receptors to the mast
cells, which have now been sensitized. At next contact of the
Antigens with the mast cells they will be cross-linked to the bound
IgE-Antibodies, the cell degranulates and the mediator will be set
free. This causes the symptoms of hay fever, asthma and atopic
eczema.
IgE is not placenta activated and does not activate any
complement.
Principle of Method and Reaction Process:
The reagent is based on an immunological reaction with
anti-human-IgE antibodies (latex based) that bind the
serum/plasma IgE. The agglutination is proportional to the
IgE concentration in the sample. The resulting light
scattering is measured by turbidimetry at 570 nm.
Warnings and Precautions:
Each operator performing the test must be able to read.
Read the package insert and the SDS completely before
using the product. Follow the instructions carefully. Missing
that may lead to inaccurate test results.
The BIOMED IgE AU test has not been validated for uses
other than the chemistry analyzers Beckman Coulter
AU400/AU480/AU640/AU680/AU2700/AU5400/AU5800/
DxC700 AU.
These diagnostics are to be used only by laboratory
professionals in compliance to the standard precautionary
measures. Each operator performing the test must be
experienced in working with the chemistry analyzer.
For in vitro diagnostic use only.
Wear proper laboratory attire when handling this reagent.
Do not mix reagents with different lots or R1 and R2.
Do not use reagents after their stated expiration dates.
Do not use reagents if they have not been properly stored
at 2 - 8 °C, protected from light. It is not necessary to
equilibrate reagents to room temperature before use.
Do not use reagent if appearance (diffusion, color) or odor
have changed.
 IgE levels are calculated by the analyzer using the values
BIOMED Labordiagnostik GmbH • Bruckmannring 32 • 85764 Oberschleissheim • Germany •
2
Not to be used internally in humans or animals. Avoid
swallowing, skin contact and contamination, do not pipette
with the mouth and do not inhale.
Reagent components from human origin were found to be
non-reactive for HCV, HIV and HBsAg. However, as no
method can offer complete assurance as to the absence of
infective agents, this material and all patient samples
should be handled as though capable of transmitting
infectious disease.
Handling of whole blood samples and assay component
during use, storage and disposal should be in accordance
with procedures defined in the national biohazard safety
guidelines.
IgE AU is produced using only bovine serum albumin made
in a member country recognized as having a negligible
BSE risk in accordance with Chapter 11.4. of the Terrestrial
Code of the World Organisation for Animal Health (OIE).
The R1- and R2-solutions contain sodium azide. Sodium
azide may react with lead or copper from piping and form
explosive metal azides. All reagent components should be
disposed by flushing with lots amounts of water. For further
information, refer to "Decontamination of Laboratory Sink
Drains to Remove Azide Salts" in the Manual Guide-Safety
Management No. CDC-22 issued by the Centers for
Disease Control, Atlanta, Georgia.
Test Components and Active Contents:
R1-solution:
Glycine-buffer, Sodium Chloride, bovine serum albumin, EDTA,
preservative.
R2-solution:
Latex particle coated with 0.125% anti-human-IgE-antibodies
(mouse), Glycine-buffer, Sodium Chloride, preservative.
Preparation of the Reagents:
The reagents are ready to use. Mix by gently inverting
several times before use (avoid foaming). For optimal
homogeneity we recommend to mix the reagent weekly or
better daily. Place the R1 solution into the R1 reagent rack
and the R2 solution into the R2 reagent rack. Do not use
test component R1 and R2 with different LOTs or mix
reagents with different LOTs.
Calibration and Quality Control:
A multi point calibration should be performed using the
BIOMED Duocal IgE - Set or a compatible multi-calibrator.
Use physiological saline as S1-standard. A full calibration is
required with every LOT change or if required by the quality
control results. To prepare the calibration curve, the
standard solutions should be measured at least twice.
It is suggested to use at least two levels of control in each
assay run. We recommend Duotrol® CRM Liquid (available
in up to three levels) or other compatible control materials
with known concentrations of IgE for the accuracy and
precision control. Control the values according to the given
method or according to the manufacturers control
specifications.
derived by the multi point calibration.

+49 89 3157000 • www.biomed.de Version 2018-05
Storage and Shelf Life:
The reagents have a shelf life as indicated in the expiry
date when unopened and kept between 2 - 8 °C protected
from light. When opened, cooled and protected from light
in the device: 7 weeks shelf life.
Automated Analyzer Application:
Suitable for chemistry analyzers Beckman Coulter AU
400 / 480 / 640 / 680 / 2700 / 5400 / 5800 / DxC700.
Normal Values – Reference Values in Serum:
For adults, hypersensitivity is unlikely at 0-25 IU/mL,
possible at 26-100 IU/mL, likely at >115 IU/mL.
The reference values are dependent on age as well as on
other factors. Each laboratory should check and if
necessary determine the reference area validity for their
own patient groups.
Sensitivity: 12,11 IU/mL (analytical detection limit)

Please refer to the instrument manual from Beckman Corresponds to the lowest measurable activity, which can
Coulter, especially concerning: be differentiated from zero. The calculation is made of
three standard deviations (n=30) of the lowest standard
- Installing procedures and requirements (zero standard).
- Operating mode
- Function Antigen Surplus (High-Dose-Hook-Effect):
IgE-Concentrations higher than 60000 lU/mL.
- Performance, working instructions
- Calibration procedures For the avoidance of antigen excess, serums with unclear
clinical characteristics should first be tested by means of
- Operational precautions, risks and limitations
protein electrophoresis.
- Information about service and maintenance
Performance Data:
Sample Material:
Type of precision conc. IU/mL sample type %CV n d
Use serum or plasma (heparin, EDTA, sodium citrate) taken
with standard single-use sampling tubes. Samples Repeatibility (SD) 67 Serum L1 2,23 6 5
containing precipitates must be centrifuged before 409 Serum L2 0,99 6 5
determination. Within-laboratory 67 Serum L1 1,28 6 5
It is recommended that blood sampling is carried out
409 Serum L2 1,31 6 5
according to NCCLS document M29-A4 and NCCLS
guideline NCCLS H3-A6. Total 67 Serum L1 2,41 6 5

409 Serum L2 1,07 6 5

Shelf Life of Samples:

at 20 - 25 °C: 7 days
at 4 - 8 °C: 7 days Method Comparison:
at -20 °C: up to 6 months
Methode n r y

Measurement Range: Nephelometer

92 0,99 0,92x + 0,25
Behring (Siemens)
15 - 1000 IU/mL for normal sample volume Turbidimetrical
86 0,9932 1,01x + 3,47
(AU5800)
1200
EIA 55 0,9967 1,01x + 11,7
1000
measured values [IU/mL]

800 Interference, Procedure Boundaries:

600 No interference: recovery within +/-10%
Icterus: 60 mg/dL Bilirubin (conj. & unconj.)
400 Hemolysis: 1500 mg/dL Hb
Lipemia: 1200 mg/dL Triglyceride
200
RF: 100 lU/mL
IgA: 1400 mg/dL
0,00 0,25 0,50 0,75 1,00 IgG: 7600 mg/dL
IgM: 680 mg/dL
" Dilution series

Disposal Note:
Dilute samples 1+1 with physiological saline solution when
results are above linearity area. Multiply results by 2. Please dispose the external packing and the completely
emptied and rinsed bottles according to the national
Calculation Factor: disposal guidelines.
ng/mL x 0.42 = IU/mL lU/mL x 2.4 = ng/mL

BIOMED Labordiagnostik GmbH • Bruckmannring 32 • 85764 Oberschleissheim • Germany • +49 89 3157000 • www.biomed.de Version 2018-05

3
Device setup:
Beckman Coulter AU 400 / 480 / 600 / 640 /
680 / 2700 / 5400 / 5800 / DxC 700:
Test Name: IgE Type: Serum Operation: Yes
Sample: Volume 2.5 µL Dilution Volume 0 µL
Reagent 1: Volume 100 µL Dilution Volume 0 µL
Reagent 2: Volume 53 µL Dilution Volume 0 µL µl
Wave length Pri. 570 Sec. -
Method: END
Reaction slope: +
Measuring Point 1: First 12 Last 19
Measuring Point 2: First - Last - Wayne, PA: Clinical and Laboratory Standards Institute
Linearity limit: - % No-Lag-Time: N
Min. OD: L -2.0000 Max. OD: H 2.5000
Reagent OD limit:
First: L -1.0000 First: H 2.5000
Last: L -1.0000 Last: H 2.5000
Dynamic range: L 10 H 1000.0
Correlation factor: A 1.0 B 0.0
Literature:
1. Thomas L, Labor und Diagnose,TH-Books Verlagsgesellschaft mbH,
2012, 8, 1231-1240.
2. Kjellman NIM, Johansson SGO, Roth A. Clinical Allergy 1976, 6, 51-59.
3. Ringel KP, Dati F, Buchholz E. IgE-Normalwerte bei Kindern.
Laboratoriumsblätter 1982, 32, 26-34
4. Tiller, F-W, Stein, B. Das klinische Labor. 2005 ecomed MEDIZIN,
Verlagsgruppe Hüthig Jehle Rehm GmbH
5. Guder WG, Narayanan S, Wisser H, Zawta B. List of Analytes;
Preanalytical Variables. Brochure in: Samples: From the Patient to the
Laboratory. Darmstadt: GIT-Verlag, 1996.
6. Passing H, Bablok W. A New Biometrical Procedure for Testing the
Equality of Measurements from Two Different Analytical Methods. J Clin
Chem Clin Biochem 1983, 21, 709-720.
7. Bablok W et al. A General Regression Procedure for Method
Transformation. J Clin Chem Clin Biochem 1988, 26, 783-790.
8. CLSI. Protection of Laboratory Workers From Occupationally Acquired
Infections: Approved Guideline-Fourth Edition. CLSI document M29-A4.
9. Simundic* A et al. Compliance of blood sampling procedures with the
CLSI H3-A6 guidelines: An observational study by the European
Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working
group for the preanalytical phase (WG-PRE). Clin Chem Lab Med 2015;
53(9): 1321–1331, NCCLS H3-A6
Number of Tests:
AU 400 / 480 / 640 / 680 / 2700 / 5400 / 5800 /
DxC700: 220-260 tests per kit

Onboard Stability Period: 7 weeks

Packaging:
Calibration Specific: Content:
Calibration Type: 6 AB Formula: Polygonal
Counts: 2* Process: Conc. 133 390: 2 x 15 mL R1 and 1 x 18 mL R2
Cal.No. OD CONC Factor/OD-L Factor/OD-H
Point1 phys. NaCl ( ) 0.00 105 390ST: 5 x 2 mL Duocal IgE Set
Point2 * *
Point3 * * Labeling Symbols:
Point4 * *
In vitro diagnostic medical device
Point5 * *
Point6 * * Catalogue number
Note: Reagent placement
The reagents are labelled with a system barcode. Please place Batch code
bottle in the required devices according to the application number
on the bottle label. Use-by date
* data input by user.
Temperature limit

Contains sufficient for <n> tests

Keep away from sunlight

Caution

Consult instructions for use

Manufacturer

Conformité Européenne

BIOMED Labordiagnostik GmbH • Bruckmannring 32 • 85764 Oberschleissheim • Germany • +49 89 3157000 • www.biomed.de Version 2018-05