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.:
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.