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Vial / Bottle	Cap	Label	Function/Description	Content
1	white	Residual Protein Galactosyltransferase, Incubation Buffer	Ready-to-use solution For preparation of the Biotin DIG working Solution	1 bottle,100 ml
2	blue	Residual Protein Galactosyltransferase, Conjugate Buffer	Ready-to-use solution For preparation of the Anti-DIG POD Reagent, Vial 6	1 bottle,100 ml
3	yellow	Residual Protein Galactosyltransferase, BiotinConjugate	Biotin labeled for target capture Monoclonal anti-1,4-Galactosyltransferase antibody 20-fold stock solution	1 vial,0.75 ml
4	purple	Residual Protein Galactosyltransferase, DIG conjugate	Digoxigenin labeled for target marking Monoclonal anti-1,4-Galactosyltransferase antibody 20-fold stock solution	1 vial,0.75 ml
5	red	Residual Protein Galactosyltransferase, Wash Buffer	For washing steps 10-fold stock solution	1 bottle,100 ml
6	red	Residual Protein Galactosyltransferase, Anti-DIG PODReagent	Peroxidase conjugated to anti-DIG antibody Lyophilizate	1 bottle
7	black	Residual Protein Galactosyltransferase, Detection Substrate (TMB)	For color development nd detection Ready-to-use solution	1 bottle,15 ml
8	colorless	Residual Protein Galactosyltransferase, Stop Solution	For stopping the color development Ready-to-use solution	1 bottle,15 ml
9	light brown	Residual Protein Galactosyltransferase, Standard A	For calibration of the assay Lyophilizate 1,4-Galactosyltransferase free	1 bottle
10	light brown	Residual Protein Galactosyltransferase, Standard B	For calibration of the assay 1,4-Galactosyltransferase Lyophilizate	1 bottle
11	light brown	Residual Protein Galactosyltransferase, Standard C	For calibration of the assay 1,4-Galactosyltransferase Lyophilizate	1 bottle
12	light brown	Residual Protein Galactosyltransferase, Standard D	For calibration of the assay 1,4-Galactosyltransferase Lyophilizate	1 bottle
13	light brown	Residual Protein Galactosyltransferase, Standard E	For calibration of the assay 1,4-Galactosyltransferase Lyophilizate	1 bottle
14	light brown	Residual Protein Galactosyltransferase, Standard F	For calibration of the assay 1,4-Galactosyltransferase Lyophilizate	1 bottle
15	white	Residual Protein Galactosyltransferase, Control X	Positive control 1,4-Galactosyltransferase Lyophilizate	1 bottle
16	green	Residual Protein Galactosyltransferase, Control Y	Positive control 1,4-Galactosyltransferase Lyophilizate	1 bottle
17	-	Residual Protein Galactosyltransferase, Coated Micro Titer Plate	Target capture Streptavidin- coated multi-well plate Ready-to-use	12 strips in frame
18	-	Residual Protein Galactosyltransferase, Multi-well SealingFilm	Sealing MWP during incubations	10 pieces of self-adhesive film

", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "

• Polypropylene tubes for preparation of antibody reagents
• 1 liter bottle for wash buffer preparation
• Micropipettes
• Centrifuge
• Multi-well plate shaker
• Roller mixer
• ELISA reader
• Multi-well plate washer

", "Country": "XG", "Code": "Additional Equipment and Reagent Required", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "

• Incubation time: 1 hour 45 minutes.
• Total assay time: approximately 2 hours 30 minutes.

", "Country": "XG", "Code": "Assay Time", "Name": "Assay Time" }, { "Language": "en", "Value": "

• Aqueous buffer solutions from biotechnology processes.
• Cell culture supernatant

", "Country": "XG", "Code": "Sample Materials", "Name": "Sample Materials" }, { "Language": "en", "Value": "Control X and Y are positive controls and are provided with the kit. For preparation of the positive controls, see section Preparation of Working Solutions.Analyte-free matrix of your sample material, such as buffer or cell culture medium.", "Country": "XG", "Code": "Control Reactions", "Name": "Control Reactions" }, { "Language": "en", "Value": "A quantitative, functional assay is performed to assess background signal, and the lot-specific concentrations of Standards A to F and Controls X and Y.", "Country": "XG", "Code": "Quality Control", "Name": "Quality Control" }, { "Language": "en", "Value": "

Observation	Possible cause	Recommendation
Absorbance of samples too low  \t\t\t\t\t	Insufficient TMB reaction	Increase the incubation time with the Detection Substrate (TMB) for color development (Step 12). The incubation time can be increased until the wells with the higher concentrated standards show a clearly observable blue color, up to 30 minutes.
POD conjugate has a reduced enzymatic activity.	Use freshly prepared POD conjugate.
Low concentration after dilution of highly concentrated samples\t\t\t\t\t\t\t\t\t\t\t	Reduce dilution factor for highly concentrated samples.
Absorbance ofsamples too high	Concentration exceeds measuring range.	Dilute samples to ensure that they are within the specified detection range.
Background of sample matrix.	Check analyte-free sample matrix for background absorbance value. Correct sample values for background absorbance of matrix.
Contamination of samples with 1,4-Galactosyltransferase from lab workspace.	Check absorbance values of Standard A and negative control. If the absorbance values of Standard A and the negative control are significantly increased, repeat the experiment in a different workspace using a new kit. Be careful when reconstituting lyophilizates. Thoroughly clean contaminated workspace.
Absorbance ofnegative controltoo high	Contamination of matrix used as negative control with 1,4-Galactosyltransferase from lab workspace.	Check for potential contamination with 1,4-Galactosyltransferase in the analyte-free matrix. Use a matrix sample from an independent batch or another 1,4-Galactosyltransferase-free solution (e.g. water) for comparison.
Absorbance of the background too high	Substrate shows color development without enzymatic activity.	Use a newly opened vial of Detection Substrate (TMB).
Variations toohigh	Insufficient mixing of sample and incubation mix.	Ensure mixing on the multi-well plate mixer is done with 300 rpm.
Residual buffer after washing	Check performance of multi-well plate washer. Wells should not contain residual buffer after washing. Try tapping the Multi-well Plate on an absorbent paper towel to remove traces of Wash Buffer.
Sample matrix difficult to pipette due to viscosity or composition.	Carefully pipette samples without droplets on outside of tip. Avoid high aspiration or ejection velocity when pipetting the samples.
Precision of micropipettes	Check the precision of the micropipettes.
Multi-well plate washer not washing correctly.	Check the multi-well plate washer for tip blockage or salt crystallization, which may affect the evenness and effectiveness of the washing steps.

", "Country": "XG", "Code": "Troubleshooting", "Name": "Troubleshooting" }, { "Language": "en", "Value": "In addition to the ready-to-use solutions supplied with this kit, you will need to prepare the following working solutions:

Solution	Content	Reconstitution/Preparation of Working Solution	Storage and Stability	For use in...
9 to 14	Standards A to F (Bottles 9 to 14)	Add 500 μl of double-distilled water to each of the vials and mix thoroughly for 30 minutes to completely dissolve the lyophilizate.	Store 4 weeks at +2 to +8°C	Calibration of the assay
15 and 16	Controls X and Y (Bottles 15 and 16)	Add 500 μl of double-distilled water to each of the vials and mix thoroughly for 30 minutes to completely dissolve the lyophilizate. The controls supplied with the kit are ready to use once reconstituted. Do not further dilute the Positive Controls X and Y.	Store 4 weeks at +2 to +8°C	Positive controls
5	Wash Buffer (Bottle 5)	Dilute the entire contents of the bottle (100 ml) with 900 ml water and mix thoroughly.	Store 4 weeks at +2 to +8°C	Washing steps
3	Biotin Conjugate (Vial 3)	Dilute the appropriate volume 1:10 with Incubation Buffer from Bottle 1. For a 96-well plate, prepare 500 μl of Biotin Conjugate stock solution + 4.5 ml of Incubation Buffer. If using only a part of the 96 wells, then prepare a proportionally reduced volume of this working solution.	Store 4 weeks at +2 to +8°C	Preparation of Biotin DIG Working SolutionTarget capture
4	DIG Conjugate (Vial 4)	Dilute the appropriate volume 1:10 with Incubation Buffer from Bottle 1. For a 96-well plate, prepare 500 μl of DIG Conjugate stock solution + 4.5 ml of Incubation Buffer. If using only a part of the 96 wells, then prepare a proportionally reduced volume of this working solution.	Store 4 weeks at +2 to +8°C	Preparation of Biotin DIG Working SolutionTarget marking
6	Anti-DIG POD Reagent (Bottle 6)	Add 500 μl double-distilled water to the vial and mix thoroughly for 30 minutes to completely dissolve the lyophilizate. The concentration of the reconstituted solution is 4 U/ml. Dilute the 4 U/ml solution with Conjugate Buffer (Bottle 2) to achieve a working concentration of 10 mU/ml, as follows: 25 μl Anti-DIG POD Solution (4 U/ml) + 9.975 ml Conjugate Buffer.	Store 4 weeks at +2 to +8°C	Detection
-	Biotin DIG Working Solution	Combine equal volumes of the prepared working solutions: Biotin Conjugate (Solution 3) and DIG Conjugate (Solution 4).Mix thoroughly, for example, using a roller mixer for 10 minutes. Always prepare the Biotin DIG Working Solution just before use, and use the solution within 30 minutes after preparation.	Use within 30 minutes after preparation.	ELISA Step 6

", "Country": "XG", "Code": "Working Solution", "Name": "Working Solution" }, { "Language": "en", "Value": "The Roche Residual Protein Galactosyltransferase kit, based on an immuno assay with tailor-made monoclonal antibodies against β-1,4-Galactosyltransferase makes testing for residual β-1,4-Galactosyltransferase, rec. sensitive and reliable. The assay is suited for process development, in-process control and final quality control.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "Immunologic assay for sensitive detection of β-1,4-Galactosyltransferase.", "Country": "XG", "Code": "Positioning", "Name": "Positioning" }, { "Language": "en", "Value": "

• Fast: Total assay time of 2 - 2.5 hours
• High sensitivity: Detection limit ≤ 0.25 ng/mL, measuring range 0.25 - 25 ng/mL
• High specificity: Specific detection of β-1,4-Galactosyltransferase by use of monoclonal antibodies

", "Country": "XG", "Code": "Benefits", "Name": "Benefits" }, { "Language": "en", "Value": "The kit is designed for sensitive detection of residual β-1,4-Galactosyltransferase in in-process control and release testing.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "Performance: Corresponds to specification
Stability: At +2 to 8°C within specification for 12 months.", "Country": "XG", "Code": "Specification", "Name": "Specification" } ] } } ] }