{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "DisclaimerGroup2": null, "ProductNameGlobal": "Ala-Gln Bio", "DisclaimerGroup1": null, "ControlTissue": [ "" ], "BrandName": "Ala-Gln Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "For quality control/manufacturing of IVD/medical devices/pharmaceutical products only.", "ID": "3.8.10.2.4.27", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductSpec": { "ProductSpecVariant": { "Chapters": [ { "Language": "English", "Value": "Onboard stability: After first use on the instrument, the reagents are stable for 4 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "English", "Value": "Store the reagent at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "English", "Value": "The L-alanyl-L-glutamine dipeptide (Ala-Gln) is hydrolyzed by amino acid arylamidase (AAA) to L-glutamine and L-alanine. L-glutamine is deaminated by glutaminase (GLNase) to L-glutamate. L-glutamate is oxidized in the presence of L-glutamate oxidase (GOD) to α-ketoglutarate, ammonia, and hydrogen peroxide, which generates a colored quinone dye in the presence of peroxidase (POD). The formation of the dye is measured photometrically and is directly proportional to the concentration of Ala-Gln.In order to prevent any influence on the result by L-glutamate in the sample, L-glutamate oxidase and catalase are added in a prior step to degrade L-glutamate and H₂O₂ without dye formation.", "Name": "Principle" }, { "Language": "English", "Value": "

Vial	Cap	Content	Composition
1 AQB R1	white	4 vials, 50 tests each	Reagent 1 (R1): Amino acid arylamidase, 2.1 kU/L; glutamate oxidase, 200 U/L; catalase, 600 kU/L; 4-aminoantipyrine (AAP), 0.4 mmol/L; TOOS, 2 mmol/L; preservative; HEPES buffer, pH 7.0.
2 AQB SR	black	4 vials, 500 tests each	Start Reagent (SR): Glutaminase, 2.5 kU/L; peroxidase, 8.6 kU/L; TOOS, 2 mmol/L; preservative; HEPES buffer, pH 7.0.

", "Name": "Content" }, { "Language": "English", "Value": "Applications AQB (075), AQD (076)
AQB is the standard protocol for the determination of Ala-Gln. If the Ala-Gln concentration of a sample is higher than 1.5 g/L (10 mmol/L), then protocol AQD should be used (same protocol with preset 1:10 sample predilution).
Results higher than the valid measuring range will be flagged, and a rerun with an automatic 1:10 predilution will be recommended by the software.

Cedex Bio test definition:
Measuring mode             Absorbance
Abs. calculation mode    Endpoint
Reaction mode                R1-S-SR
Reaction direction           Increase
Wavelength                       552 nm
Calc. first/last                    28/40
Unit                                     mmol/L, mg/L

Pipetting parameters:
R1                140 μl
Sample           4 μl
SR                  42 μl
Total volume 186 μl

Calibration:
Calibrator                   Calibrator D Bio (CAL D, 794)
Calibration mode      Linear regression
Calibration interval   84 days, and if recalibration is required due to QC results.

Quality control:
Controls    Control D Level 1 Bio (COND1, 307)
                    Control D Level 2 Bio (COND2; 308)
                    Control D Level 3 Bio (COND3, 309)

Use the recommended control material. Other suitable control material can be used in addition.

Intervals / limits         
Control intervals and acceptance limits should be adapted to each laboratory's individual requirements.

If values do not fall within the defined limits, corrective measures and recalibration are required", "Name": "Protocols - Help Corner" }, { "Language": "English", "Value": "Measuring Range
Ala-Gln concentration can be determined in following ranges: up to maximal solubility with automatic predilution.

Conversion Factors
Conversion factors for Ala-Gln concentration: Traceability
This method has been standardized against Ala-Gln net weight.

Precision
Representative performance data on Cedex Bio Analyzers are shown. Results obtained in individual laboratories may differ.
Precision was determined in samples of three concentration levels. Coefficients of variation (CV) were calculated for in-run precision (n=21) and inter-run precision (on 10 days).

	Level 1	Level 2	Level 3
Mean	0.5 mmol/L (109 mg/L)	4.0 mmol/L (869 mg/L)	7.0 mmol/L (1520 mg/L)
CV in-run	0.7%	0.8%	1.1%
CV inter-run	1.2%	0.9%	1.2%

", "Name": "Background Information - Help Corner" }, { "Language": "English", "Value": "

• Cedex Bio Analyzer*, including accessories and disposables
• Standard laboratory equipment

• Calibrator D Bio*
• Control D Level 1 Bio*
• Control D Level 2 Bio*
• Control D Level 3 Bio*
• Glutamine V2 Bio* (only for correction of free glutamine background)
• Calibrator B Bio* (only for correction of free glutamine background)
• Control B Level 1 Bio* (only for correction of free glutamine background)
• Control B Level 2 Bio* (only for correction of free glutamine background)
• Control B Level 3 Bio* (only for correction of free glutamine background)

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "English", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "English", "Value": "Method: Enzymatic photometric assay using hydrolysis by peptidase and deamination of glutamine by glutaminase.
Recovery: ± 15%", "Name": "CB - Specification" }, { "Language": "English", "Value": "This product is intended for quantitative determination of the cell culture supplement alanyl-glutamine (GlutaMAX) in aqueous solutions using the Cedex Bio Analyzer.", "Name": "Product Description" }, { "Language": "English", "Value": "Glutamine is an essential nutrient required in cell cultures and microbial fermentation. Under culture conditions, glutamine has the disadvantage of fast degradation, producing cell-toxic ammonia. The dipeptide Ala-Gln is heat-stable and shows no spontaneous breakdown. Living cells in a culture are able to gradually release glutamine from the Ala-Gln dipeptide by secretion of peptidases. Depending on the number of cells and on the intensity of their metabolism, more dipeptide has to be fed over the culture time to achieve permanently an optimal supply. For control of culture media and for monitoring in a culture process, the Ala-Gln concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "English", "Value": "Method: Enzymatic photometric assay using hydrolysis by peptidase and deamination of glutamine by glutaminase.
Recovery: ± 15%", "Name": "Specification" }, { "Language": "English", "Value": "Precautions

• Handle all samples as if potentially infectious, using safe laboratory procedures. As the sensitivity and titer of potential pathogens in the sample material can vary, the operator must optimize pathogen inactivation and follow the appropriate measures according to local safety regulations.
• Do not eat, drink, or smoke in the laboratory work area.
• Do not pipette by mouth.
• Wear protective disposable gloves, laboratory coats, and eye pro\u00adtection, when handling samples and kit reagents.
• Wash hands thoroughly after handling samples and reagents.

Waste handling

• Discard unused reagents and waste in accordance with country, federal, state, and local regulations.
• Safety Data Sheets (SDS) are available online at dialog.roche.com, or upon request from the local Roche office.

", "Name": "Safety Information" } ] } }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "StructureSystemID": null, "NodeID": "520" }, { "StructureSystemName": "OWP Product Types", "NodeName": "Assays, Reagents and Strips", "StructureSystemID": null, "NodeID": "20-000-00" }, { "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureSystemID": null, "NodeID": "01-01-01-07-00" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Cedex Bio Analyzer Products", "StructureSystemID": null, "NodeID": "02-0009" }, { "StructureSystemName": "OWP Family", "NodeName": "Cedex", "StructureSystemID": null, "NodeID": "490" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "08056978001", "MaterialDescription": "Ala-Gln Bio", "RegisteredProductName": "", "GTIN": "00365702702455", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "200 tests", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.8.10.1.2.29", "BrandName": "Control D Level 1 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.28", "BrandName": "Calibrator D Bio", "ProductNameAddition": "Calibrator reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.30", "BrandName": "Control D Level 2 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.31", "BrandName": "Control D Level 3 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] } }