{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "LDH Bio", "DisclaimerGroup1": null, "ControlTissue": [ "" ], "BrandName": "LDH Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "For quality control/manufacturing of IVD/medical devices/pharmaceutical products only.", "ID": "3.8.10.2.4.4", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_06343767001_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": "06343767001", "MaterialDescription": "LDH Cedex Bio", "RegisteredProductName": "LDH Bio", "GTIN": "07613336133484", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "200 tests", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\". Will be supplied as \"LDH Cedex Bio\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.8.10.1.2.22", "BrandName": "Control B Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.20", "BrandName": "Control B Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.19", "BrandName": "Calibrator B Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.21", "BrandName": "Control B Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Store the reagent at +2 to +8°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 reagent cassette is stable for up to 4 weeks on board.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Kit for determination of lactate dehydrogenase activity.", "Name": "Product Description" }, { "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*

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Cedex Bio test definition:

• Measuring mode                 Absorbance
• Abs. calculation mode       Kinetic
• Reaction direction               Increase
• Wavelength A/B                   340/659 nm
• Calc. first/last                       25/35
• Unit                                        U/L
• Reaction mode                   R1-S-SR

Pipetting parameters:

• R1                                         100 μl
• Sample                                4 μl + 4 μl Diluent (H2O)
• SR                                         20 μl + 10 μl Diluent (H2O)
• Total volume                       138 μl

Calibration:

• Calibrator                            Calibrator B Bio (CAL B 541)
• Calibration mode               Linear regression
• Calibration interval            Each new lot, and if recalibration is required due to QC results

Quality control:

• Control B Level 1 Bio (CONB1, 401)
• Control B Level 2 Bio (CONB2, 402)
• Control B Level 3 Bio (CONB3, 403)

Use the recommended control material. Other suitable control material can be used in addition.
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": "Rising enzymatic activity of lactate dehydrogenase (LDH) in a cell culture supernatant is a distinct marker for increasing cell degradation, causing release of LDH from the cytosol into the medium. For monitoring in a culture process, LDH can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "

Vial	Cap	Content	Composition
1 LDH2B R1	white	4 vials, 50 tests each	Reagent 1 (R1): N-methyl-D-glucamine, 400 mmol/L; lithium lactate, 62 mmol/L; stabilizer; preservative.
2 LDH2B SR	black	4 vials, 50 tests each	Start Reagent (SR): Nicotinamide adenine dinucleotide, 62 mmol/L; stabilizer, preservative.

", "Name": "Content" }, { "Language": "en", "Value": "LDH activity can be determined in following range:

• LDH2B: 20 - 1,000 U/L (0.334 - 16.7 μkat/L)
• LDH2D: 0.2 - 10.0 kU/L (3.34 - 167.0 μkat/L),

up to 100 kU/L (1.670 mkat/L) with postdilution.

Conversion Factors
Conversion factors for LDH activity:

• 1 U/L = 0.0167 μkat/L
• 1 μkat/L = 59.9 U/L

Traceability
This method has been standardized against an IFCC standard formulation.

Precision
Representative performance data on Cedex Bio HT 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	97 U/L	162 U/L	372 U/L
CV in-run	1.3%	1.3%	1.0%
CV inter-run	1.5%	1.7%	2.1%

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Method: Enzymatic photometric assay using oxidation of lactate to pyruvate (acc. IFCC).
Recovery: ±10%", "Name": "Specification" } ] } } ] }