{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "OD Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "OD Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.23", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07705620001_im_en.png", "ImageType": "Image main" }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Solutions", "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "OWP Product Types", "NodeName": "Assays Reagents and Strips", "NodeID": "20-000-00" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Cedex Bio Analyzer Products", "NodeID": "02-0009" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Family", "NodeName": "Cedex", "NodeID": "490" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07705620001", "MaterialDescription": "OD Bio", "RegisteredProductName": "OD Bio", "GTIN": "07613336102657", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "400 tests", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.8.10.1.2.32", "BrandName": "Control OD Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.33", "BrandName": "Control OD Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.34", "BrandName": "Control OD Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Store the reagent at +15 to +25°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "Keep at +2 to +10°C for on-board use. After first use on the instrument, the reagents are stable for up to 4 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Applications ODB (ACN 026), ODD (ACN027)

Test Protocol
ODB is the sensitive protocol for determination of low optical density up to OD 10 in the starting phase of a fermentation.
If the optical density is expected to be higher than OD 10, then protocol ODD should be used (same protocol with preset 1:30 predilution step).

Cedex Bio test definition:
Measuring mode                          Absorbance
Abs. calculation mode                 Endpoint
Reaction direction                        Increase
Wavelength A/B                            583 nm
Calc. first/last                                6/8
Unit                                                 StdUni
Reaction mode                             R1-S

Pipetting parameters:
R1                                                   18 μl + 142 μl Diluent (H2O)
Sample                                          20 μl + 20 μl Diluent (H2O)
Total volume                               200 μl

Calibration:
No test specific calibration is required for the OD test. The factory-made calibration of the photometer unit of Cedex Bio Instruments is stable and highly equivalent between the instruments.

Quality control:
Control OD Level 1 Bio (CONO1, 114)
Control OD Level 2 Bio (CONO2, 115)
Control OD Level 3 Bio (CONO3, 116)

Use the recommended control material. Other suitable control material can be used in addition.
Intervals / limitsControl intervals and acceptance limits should be adapted to each laboratory's individual requirements.", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "The optical absorbance at 583 nm is measured photometrically using the Cedex Bio Analyzer. The absorbance value (OD) is proportional to the amount of biomass in the sample.", "Name": "Principle" }, { "Language": "en", "Value": "

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

• Control OD Level 1 Bio*
• Control OD Level 2 Bio*
• Control OD Level 3 Bio*

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Measuring Range
The optical density of microbial suspensions can be determined in following ranges:

• ODB: 0.1 to 10 OD
• ODD: 3 to 360 OD

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 OD	2	20	150
CV in-run	0.7%	1.0%	1.0%
CV inter-run	1.2%	1.2%	1.4%

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

Vial	Cap	Content	Composition
1 ODB R1	white	4 vials, 100 tests each	Reagent 1 (R1): Phosphate buffered saline, stabilizer; pH 7.0.

", "Name": "Content" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "This product is intended for determination of optical density using the Cedex Bio Analyzer for biomass measurements during microbial fermentation.", "Name": "Product Description" }, { "Language": "en", "Value": "The most common method to monitor the growth in bacterial and yeast cultures is the determination of the optical density of the culture suspension, which relates to the number of cells per culture volume. The manual procedure to prepare the required diutions and to perform the measurements on a photometer is usually very imprecise, error-prone and laborious. The automated testing using a Cedex Bio or Cedex Bio HT Analyzer, offers a standardized OD determination with high precison, reliability and convenience.", "Name": "Applications" }, { "Language": "en", "Value": "Method: Automated sample dilution and photometric determination at 583 nm.
Recovery: ±15%", "Name": "Specification" } ] } } ] }