H. pylori Turbilatex, AU480/680, Beckman Coulter
(AN-HP-AU480/680. EN rev 2022.07.26)
F-549 rev00 Page 1 of 3
CerTest Turbilatex®. Application Note
General Information
Intended use:
H. pylori Turbilatex is a latex turbidimetric assay only for
the quantitative detection of Helicobacter pylori antigen
in human stool samples (not to be used for body fluid as
blood, serum, plasma, urine, cerebrospinal fluid, oral fluid,
synovial fluid or empyema fluid). This assay is simple and
widely applicable.
For professional in vitro diagnostic use only.
H. pylori Turbilatex can be performed on every open
chemistry analyser. Please follow the subsequent
instructions in order to assure performance characteristics
as describes in the instructions for use. This instruction has
been validated by CerTest BIOTEC S.L. Laboratories.
Additionally, please read the “Instructions for use” for
instructions on operating and programming user defined
test.
Reagents:
Materials provided by CerTest BIOTEC S.L.:
Reagents
Quantity
Code
Turbidimetric
reagents (R1 & R2)
200 Det/kit
R1: 2 vials, 2x33 mL
R2: 1 vial, 1x7 mL
TL-022HP01
TL-022HP02
Auxiliary Reagents
Calibration kit
Calibrator: 6 vials,
6x1 mL.
TL-022HP70,
TL-022HP71
TL-022HP72
TL-022HP73
TL-022HP74
TL-022HP75
Controls kit
Control C1,
2 vials, 2x1 mL/vial.
Control C2,
2 vials, 2x 1 mL/vial.
TL-022HP08
TL-022HP09
Sample dilutions
vials
1x2 mL/vial
1x2.4 mL/vial
MST-0014MP
MST-0020P
Preparation of reagents:
R1 and R2 are ready to use.
Calibrators are ready to use
Controls are ready to use.
Storage and stability
Kit components must be stored at temperature indicated
on the label. Do not freeze.
Reagents are stable up to the expiration date printed on
the label, always considering that reagent containers
must be properly closed to avoid any contamination,
must be kept away from the sunlight and conserved at
temperature indicated on the label of each reagent.
Specimen:
Collect enough quantity of human stool samples. These
samples should be collected in clean and dry containers
(no preservatives or transport media). The samples can
be stored in the refrigerator (2-8ºC) for 7 days prior to
testing. Homogenise stool samples as thoroughly as
possible prior to preparation.
The sample dilution vial with diluted sample can be
stored for 7 days in the refrigerator (2-8ºC) prior to testing.
Use H.pylori Turbilatex stool collection tubes for sample
collections described the instructions for use.
Assay procedure
Application parameter set up:
Specific analyzers settings for H. pylori Turbilatex must be
programmed onto the analyzer, see below. For
instructions, consult the AU480/680 Beckman
Coulteranalyzer manual and instructions for use provided
with the kit.
Loading of reagents:
Load reagents according to the AU480/680 Beckman
Coulter analyzer manual.
Calibration curve establishment:
A 6 point calibration curve can be established in
AU480/680 Beckman Coulter analyzer. For instructions
consult analyzer manual.
Calibration stability:
Calibrate the system at least once a month is extremely
recommended. Recalibrate the system when reagent lot
is change or when the controls are out of the assigned
range given in the control labels and CoA.
QC controls:
H. pylori Turbilatex controls C1 and C2 must be assayed
each day before running patient faecal sample extract
to validate the calibration curve. The controls have
assigned value ranges indicated on the label and
certificate of analysis supplied. The control measurements
must be within the indicated value range to obtain valid
results for patient faecal extract. If the control values are
out of range, follow next procedures: 1) Repeat QC
control measurement, 2) Repeat calibration
measurement.
Results:
The results are evaluated automatically by the analyzer
and presented in ng H.pylori antigen/mL.
H. pylori Turbilatex, AU480/680, Beckman Coulter
(AN-HP-AU480/680. EN rev 2022.07.26)
F-549 rev00 Page 2 of 3
CerTest Turbilatex®. Application Note
Performance characteristics
The following results have been obtained during the
validation of H.pylori Turbilatex on the AU480/680
Beckman Coulter analyzer.
Linearity:
H. pylori Turbilatex on AU480/680 Beckman Coulter
analyzer using calibrator kit is linear in the calibration
range of 0-40 ng H.pylori antigen/mL.
Measuring range:
H.pylori Turbilatex assay measuring range is 0.8-40 ng
H.pylori antigen/ml on the AU480/680 Beckman Coulter
analyser. Samples higher concentrated than 40 ng
H.pylori antigen/mL of stool must be diluted for proper
quantification by the user, using additional sample buffer.
Prozone effect
Using the reported parameters, no prozone effect (hook
effect) was observed up to 0.2 mg H. pylori antigen/mL of
stool. Samples with H. pylori antigen concentration of 0.2
mg H. pylori antigen/mL give a typical positive result >40
ng H.pylori antigen/mL.
Detection limit
Limit of detection (LOD): 0.8 ng H. pylori antigen/ml (*).
The lower limit of detection of H. pylori Turbilatex was
determined on 20 samples and 2 sample replicates as
the mean value + 2xSD.
Limit of quantification (LOQ): 1 ng H. pylori antigen/mL (*).
The lower limit of quantification is defined as the lowest
actual amount of analysis that can be reliably detected;
imprecision is < 20% as CV% on the Biolis i24, Tokio Boeki
analyzer.
(*) Data obtained by the analyzer Biolis i24 (Tokio Boeki).
Precision
H. pylori Turbilatex was tested with three different controls
levels.
Low
(1 ng/mL)
High
(40 ng/mL)
N
20
20
Mean (ng/mL)
1.08
39.76
SD (ng/mL)
0.12
2.01
CV (%)
11
5
Method comparison
Results obtained with H. pylori Turbilatex on the analyser
Biolis 24i (Tokyo Boeki) were compared with an
immunochromatographic test (CerTest H. pylori, CerTest).
The results were as follows:
Sensitivityy
Specificity
H. pylori Turbilatexvs
CerTest H. pylori
86.5%
>98%
Shipping damage
Please notify your distributor, it this product was received
damaged.
Symbols key
Manufacturer
CERTEST BIOTEC S.L.
Pol. Industrial Río Gállego II,Calle J, Nº 1, 50840,
San Mateo de Gállego, Zaragoza (SPAIN)
www.certest.es
NOTES
Please refer to the instruction for use for the detailed
information about the test on the following:
Synthesis; Principle; Precautions; Reagents; Specimen
collection and preparation; Interpretation of results and
limitations.
0
5
10
15
20
25
30
35
40
0 10 20 30 40
Measured H. pylori antigen concentration [ng/mL]
Theorical
H. pylori antigen concentration
[ng/ml]
For in vitro diagnostic use only
Keep dry
Consult instructions for use
Temperature limitation
Catalogue number
Lot number
Use by
Manufacturer
n
Contains sufficient for <n> test
DIL
Sample diluent
Keep out of the sunlight
H. pylori Turbilatex, AU480/680, Beckman Coulter
(AN-HP-AU480/680. EN rev 2022.07.26)
F-549 rev00 Page 3 of 3
CerTest Turbilatex®. Application Note
AU480/680 Beckman Coulter/Application parameters
ASSAY PARAMETERS
Std. No
6
R1
200 µL
Sample
10 µL
R2
17 µL
Others
NA
Reaction mode
Endpoint
Primary wavelength
450 nm
Secondary wavelength
800 nm
Direction
Increase
Reagent blank lecture
11 cycle
Final lecture
27 cycle
Reaction time
10 min
Linear range
0-40 ng/ml
CALIBRATION
Calibration Method
Linear
Calibration set
5 calibrators + Blank
Blank
Calibrator 1 (0 ng/ml)
Calibrator 1
Calibrator 2 (2.5 ng/ml)
Calibrator 2
Calibrator 3 (5 ng/ml)
Calibrator 3
Calibrator 4 (10 ng/ml)
Calibrator 4
Calibrator 5 (20 ng/ml)
Calibrator 5
Calibrator 6 (40 ng/ml)
STEPS
Addition R1
Addition Sample
Incubation
Addition R2
Blank Lecture
Cycle 11
Incubation
Final lecture
Cycle 27