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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": "Keep at +2 to +15°C for on-board use.
After first use on the instrument, the reagents are stable for up to 12 weeks.

", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Store the reagent cassette at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "NH3 concentration can be determined in following range:
  • NH3LB: 0.0278 - 1.389 mmol/L (0.4734 - 23.66 mg/L)
  • NH3B: 0.278 - 13.89 mmol/L (4.734 - 236.6 mg/L)
  • NH3D: 5.56 - 278 mmol/L (94.7 - 4734.0 mg/L)
     up to 1.39 mol/L (23.7 g/L) with automatic predilution.

Conversion Factors
Conversion factors for ammonia/ammonium concentration:
  • 1 mmol/L NH3 = 17.03 mg/L NH3
  • 1 mg/L NH3 = 58.72 μmol/ NH3
  • 1 mmol/L NH4+ = 18.04 mg/L NH4+
  • 1 mg/L NH4+ = 55.43 μmol/L NH4+

Traceability
This method has been standardized against a standard reference material (SRM 194).

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

 Level 1Level 2
Mean0.602 mmol/L (10.3 mg/L)2.31 mmol/L (39.3 mg/L)
CV in-run2.2%0.9%
CV inter-run3.6%1.8%
", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "
Analyzer and accessories
  • Cedex Bio HT Analyzer*, including accessories and disposables
  • Standard laboratory equipment
Calibrators and Controls
  • Calibrator B Bio*
  • Control B Level 1 Bio*
  • Control B Level 2 Bio*
  • Control B Level 3 Bio*
", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Kit for determination of ammonia.", "Name": "Product Description" }, { "Language": "en", "Value": "
VialContentComposition
NH3BReagent cassette,
150 tests
Reagent 1 (R1): BICINE, 330 mmol/L; glutamate dehydrogenase (microbial), ≥234 μkat/L; 2-oxoglutarate, 50 mmol/L; preservative; stabilizer; pH 8.3.
Reagent 2 (R2): NADPH, ≥1.0 mmol/L; buffer; preservative.
", "Name": "Content" }, { "Language": "en", "Value": "Cedex Bio HT test definiton:
  • Measuring mode\t\t\t\t   Absorbance
  • Abs. calculation mode\t\t  Endpoint
  • Reaction mode\t\t\t\t\t  R1-R2-S
  • Reaction direction\t\t\t\t Decrease
  • Wavelength A/B\t\t\t\t\t 340/629 nm
  • Calc. first/last\t\t\t\t\t\t 1/58
  • Unit\t\t\t\t\t\t\t\t\t\t  mmol/L

Pipetting parameters:
  • R1\t\t\t\t\t\t\t\t\t\t\t40 μL + 30 μL Diluent (H2O)
  • R2\t\t\t\t\t\t\t\t\t\t\t20 μL + 30 μL Diluent (H2O)
  • Sample\t\t\t\t\t\t\t\t   2 μL + 10 μL Diluent (H2O)
  • Total volume\t\t\t\t\t\t 132 μL

Calibration:
  • Calibrator\t\t\t\t\t\t\t   Calibrator B Bio (CAL B, 07-1105-5)
  • Calibration mode\t\t\t\t Linear regression
  • Calibration interval\t\t\t   Each new lot, and if recalibration is required due to QC results

Quality control:
  • Control B Level 1 Bio (CONB1, 07-1106-3)
  • Control B Level 2 Bio (CONB2, 07-1107-1)
  • Control B Level 3 Bio (CONB3, 07-1109-8)

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

For quality control in the low range of test protocol NH3LB, prepare an appropriate control by diluting \"Control B Level 1 Bio\" 1:5 using water as the diluent. Divide the NH3 concentration and the \"1s\" value of the original control by 5 for entering the lot-specific NH3 values.

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": "en", "Value": "Ammonia is produced in cell cultures or in microbial fermentation as a waste product, and accumulation of ammonia can suppress cell growth and product formation. For monitoring in a culture process, ammonia can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "en", "Value": "Method: Enzymatic photometric assay using glutamate dehydrogenase.
Recovery: ±10%", "Name": "Specification" } ] } } ] }

NH3 Bio HT

Test kit for the Cedex Bio HT Analyzer

Cedex NH3

Overview

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