Bilirubin (DIRECT) - Spectrum Diagnostics

1 Bilirubin ( direct )ColorimetricREF: 224 001 120 TestR1 direct Bilirubin 2 x 90 mlR2 Nitrite 1 x 7 mlIntended UseSpectrum Diagnostics Bilirubin reagent is intended for the in-vitroquantitative, diagnostic determination of Bilirubin in human serum on both automated and manual average level of the Bilirubin produced in humans from differentsources ranges between 250 to 300 mg/day, of which 85% is derivedfrom the heme moiety of the haemoglobin released from senescenterythrocytes that are destroyed in the reticuloendothelial remaining 15 % is produced from erythrocytes destroyed in thebone marrow and from catabolism of other heme containing proteinssuch as cytochromes and it is produced in the peripheral tissues, Bilirubin is transportedto the liver in association with albumin. In the liver, Bilirubin isconjugated with glucuronic acid for solubilization and subsequenttransport through the bile duct and elimination via the digestive or conditions which, through hemolytic processes, produce Bilirubin faster than the liver can metabolize it, cause thelevels of unconjugated (indirect) Bilirubin to increase in the duct obstruction or damage to hepatocellular structure causesincreases in the levels of both conjugated ( direct ) and unconjugated(indirect) Bilirubin in the PrincipleBilirubin is converted to colored diazotized sulfanilic acid andmeasured photometrically.

2 Of the two fractions presents in serum, Bilirubin glucuromide and free Bilirubin loosely bound to the former reacts directly in aqueous solution ( Bilirubin direct ),ReagentsReagent 1 (R1) D- BilirubinSulfanilic acid 30 mmol/lHCL 150 mmol/lReagent 2 (R2)Sodium Nitrite 29 mmol/lDeteriorationDo not use the Spectrum Bilirubin reagents if precipitate to recover control values within the assigned range may bean indication of reagent Collection and PreservationAvoide exposure of the specimen to light. If plasma is used, onlyheparin and oxalate plasma are suitable. Other anticoagulants shouldnot be used. The average half-life of total Bilirubin and direct bilirubinin serum is 17 days and few hours : -20 oC 4 8 oC 20 25 oCDirect 6 months 7 days 2 daysProcedureDirect Bilirubin Sample blank SampleReagent 1 (D) mlReagent 2 ----- 50 lSample100 l100 lMix and incubate for 5 minutes at 20 25 oC.

3 Measure absorbanceof sample (Asample) against sample blank at 546 nm(530 - 580 nm)Calculation{(A)Sample - (A) Sample blank} x Factor* = mg/dl*Theoritical FactorDirect Bilirubin = 14 Conversion Factor = mg/dl x = mol/lNoteFor Bilirubin determination in newborns, pippete 50 l of the result by ControlNormal & abnormal commercial control serum of known concentrationsshould be analyzed with each REPSYMBOLS IN PRODUCT LABELLINGA uthorised RepresentativeFor in-vitro diagnostic useBatch Code/Lot numberCatalogue NumberConsult instructions for useTemperature LimitationUse by/Expiration DateCAUTION. Consult instructionsfor useManufactured byThe Creative Approach to BiosciencePrecautions and WarningsS28 After contact with skin, wash immediately with plenty of soapand not ingest or inhalate. In case of contact with eyes or skin; rinseimmediately with plenty of soap and water. In case of severe injuries;seek medical advice Preparation, Storage and StabilitySpectrum Bilirubin reagents are supplied ready-to-use and stable upto the expiry date labeled on the bottles when stored at 2 - 8 oCPerformance CharacteristicsPrecisionWithin run (Repeatiblity)Run to run (Reproducibility)Methods ComparisonA comparison between Spectrum Diagnostics Bilirubin and acommercial reagent of the same methodology was performed on 20human sera.

4 A correlation of was run as recommended, the sensitivity of this assay is mg/dL( mol/L) for total and mg/dL ( mol/L) for direct reaction is linear up to a direct Bilirubin concentration of 18mg/dL(308 mol/L). Specimens showing higher concentration shouldbe diluted 1+4 with physiological saline and repeat the assay(result 5).Interfering substancesSerum, plasmaHaemolysisAvoid haemolysis since it interferes with the specimens interfere with the and propranolol may cause artificially low total ValuesDirect Bilirubin 0 mg/dL (0 51 mol/L)MDSS GmbHSchiffgraben 4130175 Hannover, GermanyEC REPE gyptian Company for Biotechnology ( )Obour city industrial area. block 20008 piece 19 A. Cairo. : +202 4665 1848 - Fax: +202 4665 Diagnostics does not interpret the results of a clinicallaboratory procedure; interpretation of the results is consideredthe responsibility of qualified medical personnel.

5 All indicationsof clinical significance are supported by literature RangeDirect Bilirubin : 18 mg/dL ( 308 mol/L)Waste DisposalThis product is made to be used in professional consult local regulations for a correct waste :dispose of this material and its container at hazardous or special waste collection :use appropriate container to avoid environmental :avoid release in environment. refer to special instructions/safetydata Balistreri WF, Shaw LM. Liver function. In: Tietz NW, ed. Fundamentals of clinical rd ed. Philadelphia:WBSaunders: 1987 Malloy HT, Evelyn KA. The determination of Bilirubin with the photoelectric colorimetric method. J Biol :119 Tietz NW, ed. Clinical guide to laboratory tests. 3rd : WB saunders; 1995:268-273. ORDERING INFORMATIONCATALOG NO. QUANTITY 224 001 120 testLevel (mg/dL)SDCV%DirectLevel (mg/dL)SDCV%DirectIFUFCC65 Rev.

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