CerTest Turbilatex®. Application Note PDF

FOB Turbilatex Cobas c111

https://www.certest.es/wp-content/uploads/2020/05/Application-Note-AN-Fb-Cobas-c111.EN-rev2020.04.01.pdf

Host Interface Manual Version 2.1 October 2012

cobas c 111 and the. ® logo are registered trademarks of F. Hoffmann- La Roche Ltd. Canada: The above trademarks are owned by Roche Diagnostic Systems a

REVIEW MEMORANDUM

CRP: In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on the cobas c 111 system. ISE-Cl: The chloride electrode

Standard Operating Procedure References Applicable To Detail

13 May 2019 Employees of Gundersen Health System clinical laboratories. ... Refer to the Cobas c111 User Manual located in the chemistry department.

Standard Operating Procedure References Applicable To Detail

26 Aug 2019 The Cobas c 111 Urea/BUN (UREAL) bottle contains an in vitro diagnostic reagent system intended for use on Cobas systems for the quantitative ...

CerTest Turbilatex®. Application Note

31 Jul 2020 c111 (Roche) analyzer. For instructions consult analyzer manual. Calibration stability: Calibrate the system at least once a month is ...

Standard Operating Procedure References Applicable To Detail

21 Aug 2018 The cassette Cobas c111 alanine aminotransferase/ALT (ALTL) contains an in vitro diagnostic reagent system intended for use on Cobas systems ...

cobas c 111 analyzer - Small box. Big performance

The cobas c 111 analyzer is the smallest member of. Roche's cobas platform family. The system is designed to ... reduce manual entering errors.

Standard Operating Procedure References Applicable To Detail

16 Apr 2019 and neonates on the cobas c 111 system. PRINCIPLE: ... Refer to the Cobas c 111 User Manual located in the chemistry department.

Pancreatic Elastase Turbilatex, Cobas c111, Roche

(AN-EL-Cobas c111. EN rev 2020.07.31)

F-549 rev00 Page 1 of 3

CerTest Turbilatex®. Application Note

General Information

Intended use:

Pancreatic Elastase Turbilatex is a latex turbidimetric assay only for the quantitative detection of Pancreatic elastase

E1 in human stool samples.

This assay is simple and widely applicable. This product is optimized for several automated analyser. Test results should exclusively be used to evaluate exocrine pancreatic function in stool samples.

For professional in vitro diagnostic use only.

Pancreatic Elastase 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,

instructions on operating and programming user defined test.

Reagents:

Materials provided by CerTest BIOTEC:

Reagents Quantity Code

Turbidimetric

reagents (R1 & R2)

200 Det/kit

R1: 2 vials, 2x17 mL

R2: 1 vial, 1x32 mL

TL-022EL01

TL-022EL02

Auxiliary Reagents

Calibration kit

Calibrator: 6 vials,

6x1 mL.

TL-022EL70,

TL-022EL71

TL-022EL72

TL-022EL73

TL-022EL74

TL-022EL75

Controls kit

Control C1,

2 vials, 2x1 mL/vial.

Control C2,

2 vials, 2x 1 mL/vial.

TL-022EL08

TL-022EL09

Sample diluent kit 4 vials,

4x125 mL/vial TL-022EL03E

Sample dilutions

vials

1x2.4 mL/vial

1x2 mL/vial

MST-0021E

MST-0022ME

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. For longer storage, maximum 6 months, the specimen must be kept frozen at -20ºC. In this case, the sample will be totally thawed, and brought to room temperature (15-

30ºC) before testing. Freezing and thawing cycles are not

recommended. Homogenise stool samples as thoroughly as possible prior to preparation. Use Pancreatic Elastase Turbilatex sample collection vials for sample collections described the instructions for use.

Assay procedure

Application parameter set up:

Specific analyzers settings for Pancreatic Elastase Turbilatex must be programmed onto the analyzer, see below. For instructions, consult the Cobas c111 (Roche) analyzer manual and instructions for use provided with the kit.

Loading of reagents:

Load reagents according to the Cobas c111 (Roche) analyzer manual.

Calibration curve establishment:

A 6 point calibration curve can be established in Cobas c111 (Roche) 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 label and CoA.

QC controls:

Pancreatic Elastase Turbilatex controls C1 and C2 must be assayed each day before running patient fecal 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 fecal 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

Ǎ hEL/g of stool.

Pancreatic Elastase Turbilatex, Cobas c111, Roche

(AN-EL-Cobas c111. EN rev 2020.07.31)

F-549 rev00 Page 2 of 3

CerTest Turbilatex®. Application Note

Performance characteristics

The following results have been obtained during the validation of Pancreatic Elastase Turbilatex on the Cobas c111 (Roche) analyzer.

Linearity:

Pancreatic Elastase Turbilatex on Cobas c111 (Roche) analyzer using calibrator kit is linear in the calibration range of 0-400 Ǎg hEL/g of stool.

Measuring range:

Pancreatic Elastase Turbilatex assay measuring range is

3.2-125 Ǎ hEL/g of stool on Cobas c111 (Roche)

analyzer. Samples higher concentrated than 400 Ǎ hEL/g of stool must be diluted for proper quantification by the user, using additional sample buffer.

Prozone effect

Using the reported parameters, no hook effect was observed up to 1250 Ǎ hEL/g of stool. Samples with Pancreatic Elastase concentration of 1250 Ǎ hEL/g of stool give a typical positive result >400 Ǎg hEL/mL.

Detection limit

Limit of detection (LOD): 1.5 Ǎg hEL/g of stool (*). The lower limit of detection of Pancreatic Elastase Turbilatex was determined on 20 samples and 2 sample replicates as the mean value+2·SD. Limit of quantification (LOQ): 3.2 ǍEL/g of stool (*). 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 Cobas c111 (Roche) analyzer. (*) Data obtained by the analyser Biolis 24i (Tokyo Boeki)

Precision

Pancreatic Elastase Turbilatex was tested with three different controls levels. Low (25 µg/mg)

Medium

(100 µg/mg) High (200 µg/mg)

N 20 20 20

Mean (µg/g) 25.8 95.8 192.0

SD (µg/g) 2.4 3.0 1.6

CV (%) 9.3 3.1 0.8

Method comparison

Results obtained with Pancreatic Elastase Turbilatex on the Cobas c111 (Roche) analyzer were compared with a commercial immunoassay (Pancreatic Elastase 1 Quick®,

Schebo).

Sensitivityy Specificity

Pancreatic Elastase 1

Quick®

95% >99%

Shipping damage

Please notify your distributor, it this product was received damaged.

Symbols key

Manufacturer

CERTEST BIOTEC

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; Interpretation of results. 0 100
200
300
400

0100200300400

Theoretical Pancreatic Elastase (

µg/g)

Measured Pancreatic Elastase (µg/g)

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 test DIL Sample diluent

Keep out of the sunlight

Pancreatic Elastase Turbilatex, Cobas c111, Roche

(AN-EL-Cobas c111. EN rev 2020.07.31)

F-549 rev00 Page 3 of 3

CerTest Turbilatex®. Application Note

Cobas c111 (Roche)/Application parameters

ASSAY PARAMETERS

Std. No 6

R1 110 µL

Sample 4 µL

R2 110 µL

Others NA

Reaction mode End point

Primary wavelength 480 nm

Secondary wavelength None

Direction Increase

Reagent blank lecture (cycle) 12

Final lecture (cycle) 40

Reaction time 10 min

Linear range 0-400 µg/g

CALIBRATION

Linear

Calibration set 5 calibrators+Blank

Blank Calibrator 1 (0 µg/g)

Calibrator 1 Calibrator 2 (25 µg/g)

Calibrator 2 Calibrator 3 (50 µg/g)

Calibrator 3 Calibrator 4 (100 µg/g)

Calibrator 4 Calibrator 5 (200 µg/g)

Calibrator 5 Calibrator 6 (400 µg/g)

STEPS

Addition R1

Addition Sample

Incubation

Addition R2

Blank Lecture Cycle 12

Incubation

Final lecture Cycle 40

quotesdbs_dbs25.pdfusesText_31

[PDF] CerTest Turbilatex®. Application Note

Pancreatic Elastase Turbilatex, Cobas c111, Roche

CerTest Turbilatex®. Application Note

General Information

Intended use:

E1 in human stool samples.

For professional in vitro diagnostic use only.

Additionally,

Reagents:

Materials provided by CerTest BIOTEC:

Reagents Quantity Code

Turbidimetric

200 Det/kit

R1: 2 vials, 2x17 mL

R2: 1 vial, 1x32 mL

TL-022EL01

TL-022EL02

Auxiliary Reagents

Calibration kit

Calibrator: 6 vials,

6x1 mL.

TL-022EL70,

TL-022EL71

TL-022EL72

TL-022EL73

TL-022EL74

TL-022EL75

Controls kit

Control C1,

2 vials, 2x1 mL/vial.

Control C2,

2 vials, 2x 1 mL/vial.

TL-022EL08

TL-022EL09

Sample diluent kit 4 vials,

4x125 mL/vial TL-022EL03E

Sample dilutions

1x2.4 mL/vial

1x2 mL/vial

MST-0021E

MST-0022ME

Preparation of reagents:

R1 and R2 are ready to use.

Calibrators are ready to use.

Controls are ready to use

Storage and stability

Specimen:

30ºC) before testing. Freezing and thawing cycles are not

Assay procedure

Application parameter set up:

Loading of reagents:

Calibration curve establishment:

Calibration stability:

QC controls:

Results:

Ǎ hEL/g of stool.

Pancreatic Elastase Turbilatex, Cobas c111, Roche

CerTest Turbilatex®. Application Note

Performance characteristics

Linearity:

Measuring range:

3.2-125 Ǎ hEL/g of stool on Cobas c111 (Roche)

Prozone effect

Detection limit

Precision

Medium

N 20 20 20

Mean (µg/g) 25.8 95.8 192.0

SD (µg/g) 2.4 3.0 1.6

CV (%) 9.3 3.1 0.8

Method comparison

Schebo).

Sensitivityy Specificity

Pancreatic Elastase 1

Quick®

95% >99%

Shipping damage

Symbols key

Manufacturer

CERTEST BIOTEC