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"Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Store the reagent at +2 to +8°C.", "Country": "XG", "Code": "Storage Conditions (Product)", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "Keep at +2 to +10°C for on board use. After first use on the analyzer, the reagent is stable for up to 4 weeks.", "Country": "XG", "Code": "Storage Conditions (Working Solution)", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "

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

• Calibrator B Bio*
• Control B Level 1 Bio*
• Control B Level 2 Bio*
• Control B Level 3 Bio*

", "Country": "XG", "Code": "Additional Equipment and Reagent Required", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Applications GLN2B (015), GLN2D (016)
\n
\nGLN2B is the standard protocol for glutamine determination. If the glutamine concentration of samples is expected to be higher than 1.5 g/L (10 mmol/L), then protocol GLN2D should be used (same protocol with preset 1:5 sample predilution).
\nResults higher than the valid measuring range will be flagged and a rerun with an automatic 1:5 predilution will be recommended by the software.
\n
\nCedex Bio test definition:
\nMeasuring mode              Absorbance
\nAbs. calculation mode     Endpoint
\nReaction direction            Increase
\nWavelength                      552 nm
\nCalc. first/last                    28/40
\nUnit                                    mmol/L, mg/L
\nReaction mode                 R1-S-SR
\n
\nPipetting parameters:
\nR1                                       140 μL
\nSample                                  2 μL
\nSR                                        42 μL
\nTotal volumen                  184 μL
\n
\nCalibration:
\nCalibrator                          Calibrator B Bio (CAL B, 541)
\nCalibration mode             Linear regression
\nCalibration interval          84 days, and if recalibration is required due to QC results
\n
\nQuality control:
\nControls
\nControl B Level 1 Bio (CONB1, 401)
\nControl B Level 2 Bio (CONB2, 402)
\nControl B Level 3 Bio (CONB3, 403)
\nUse the recommended control material. Other suitable control material can be used in addition.
\nControl intervals and acceptance limits should be adapted to each laboratory's individual requirements.
\nIf values do not fall within the defined limits, corrective measures and recalibration are required", "Country": "XG", "Code": "Protocols - Help Corner", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Measuring Range
\nGlutamine concentration can be determined in following ranges:\n

\n\t
• GLN2B: 15 to 1500 mg/L (0.1 to 10 mmol/L)
\n\t
• GLN2D: 75 to 7500 mg/L (0.5 to 50 mmol/L), up to maximal solubility with postdilution
\n

\n 
\nConversion Factors
\nConversion factors for glutamine concentration:\n

\n\t
• 1 g/L = 6.842 mmol/L
\n\t
• 1 mmol/L = 146.2 mg/L
\n

\n
\nTraceability
\nThis method has been standardized against Glutamine net weight.
\n
\nPrecision
\nRepresentative performance data on Cedex Bio Analyzers are shown. Results obtained in individual laboratories may differ.
\nPrecision 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).
\n \n\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\n

	Level 1	Level 2	Level 3
Mean	1.75 mmol/L \n\t\t\t(0.25 g/L)	3.77 mmol/L \n\t\t\t(0.55 g/L)	7.79 mmol/L \n\t\t\t(1.14 g/L)
CV in-run	0.9%	1.1%	0.9%
CV inter-run	1.3%	2.2%	1.4%

\n", "Country": "XG", "Code": "Background Information - Help Corner", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "This product is intended for quantitative determination of glutamine in aqueous solutions using the Cedex Bio Analyzer.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "

Vial	Cap	Content	Composition
1 GLN2B R1	white	4 vials, 50 tests each	Reagent 1 (R1): Glutamate oxidase, 200 U/L; catalase, 600 kU/L; 4-aminoantipyrine, 0.4 mmol/L; TOOS, 2 mmol/L; preservative; HEPES buffer, pH 7.0.
2 GLN2B SR	black	4 vials, 50 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.

", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "Glutamine is an essential nutrient required in cell cultures and microbial fermentation. For optimal cell growth and product formation the glutamine concentration has to be kept whithin an appropriate concentration range, providing sufficient nutrition and avoiding toxical accumulation of ammonia by degradation of an excess of glutamine. Due to the spontaneous degradation, additional glutamine should be added during the cultivation, according to the actual consumption. For control of culture media and for monitoring in a culture process, the glutamine concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "Method: Enzymatic photometric assay using glutaminase.
Recovery: ±15%", "Country": "XG", "Code": "Specification", "Name": "Specification" }, { "Language": "en", "Value": "

• 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 protection, when handling samples and kit reagents.
• Wash hands thoroughly after handling samples and reagents.

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

", "Country": "XG", "Code": "Safety Information", "Name": "Safety Information" } ] } } ] }