This document provides instructions for using DUMOCON N, a lyophilized universal control serum for quantitative in vitro testing of various analytes in human samples. It contains specified concentrations of analytes at normal or borderline pathological levels from porcine, bovine, human, and calf sources. The control must be reconstituted with distilled water and can be stored refrigerated or frozen for various periods of time depending on the analyte and storage temperature. Proper precautions should be taken since the control contains biological material and is potentially infectious.
This document provides instructions for using DUMOCON N, a lyophilized universal control serum for quantitative in vitro testing of various analytes in human samples. It contains specified concentrations of analytes at normal or borderline pathological levels from porcine, bovine, human, and calf sources. The control must be reconstituted with distilled water and can be stored refrigerated or frozen for various periods of time depending on the analyte and storage temperature. Proper precautions should be taken since the control contains biological material and is potentially infectious.
This document provides instructions for using DUMOCON N, a lyophilized universal control serum for quantitative in vitro testing of various analytes in human samples. It contains specified concentrations of analytes at normal or borderline pathological levels from porcine, bovine, human, and calf sources. The control must be reconstituted with distilled water and can be stored refrigerated or frozen for various periods of time depending on the analyte and storage temperature. Proper precautions should be taken since the control contains biological material and is potentially infectious.
This document provides instructions for using DUMOCON N, a lyophilized universal control serum for quantitative in vitro testing of various analytes in human samples. It contains specified concentrations of analytes at normal or borderline pathological levels from porcine, bovine, human, and calf sources. The control must be reconstituted with distilled water and can be stored refrigerated or frozen for various periods of time depending on the analyte and storage temperature. Proper precautions should be taken since the control contains biological material and is potentially infectious.
Please refer to the safety data sheets and take the necessary precautions for the use DUMOCON N of calibrators and controls. 4. For professional use only! (Assayed Universal Control Serum Normal) Lyophilized universal control serum for the use in tests for the quantitative in vitro TEST PROCEDURE determination of various analytes in human samples on photometric systems. Please refer to the reagent package insert for instructions for use.
LOT SPECIFIC ASSAY VALUES AND RANGES
Content The analyte concentrations contained in Dumocon N are specific and only valid for the D98481 12 x 5 mL Kit corresponding lot and thus stated in the value sheet of the lot involved. All assay values D14481 5 x 5 mL Kit have been established within standardized conditions with the method stated in the value D98481SV 1 x 5 mL Single Vial sheet. Please refer to table with Lot specific assay values.
For professional in vitro diagnostic use only. Ranges of acceptance were calculated as assigned value ± the maximum tolerable deviation of a single value according to the Guidelines of the German Federal Medical Council GENERAL INFORMATION (Rilibaek) from 2003 [3]. For analytes not listed in the Guidelines of the German Federal Shelf Life 36 months from production date Medical Council (Rilibaek) ranges are indicated with a deviation of ± 20% from the given Storage 2 – 8 oC mean value.
INTENDED USE Each laboratory should establish corrective action in case of deviations in control recovery. Lyophilized universal control serum for the use in tests for the quantitative in vitro determination of various analytes in human samples on photometric systems. WASTE MANAGEMENT Please refer to local legal requirements. REAGENT COMPOSITION Dumocon N is a lyophilized control based on human blood material (serum) and contains LITERATURE drugs, organic and non-organic chemicals and biological material of specified origin. 1. Rohle G, Siekmann L. Quality assurance of quantitative determination. In: Thomas L, The concentrations are either at normal or at borderline pathological levels. editor. Clinical laboratory diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 1393-1401. Analyte Origin 2. Biosafety in Microbiological and Biomedical Laboratories. U.S. Department of Health Alkaline phosphatase Calf (Intestine) and Human Services, Washington 1993 (HHS Publication No. [CDC] 93¬8395). Alanine Aminotransferase Porcine (heart) 3. Richtlinie der Bundesarztekammer zur Qualitatssicherung quantitativer Aspartate Aminotransferase Porcine (heart) laboratoriumsmedizinischer Untersuchungen. Deutsches Arzteblatt 2003; 100:A 3335- α-Amylase Porcine (pancreas) 38. Bilirubin Porcine/Bovine Creatine kinase Human, recombinant Glutamate dehydrogenase Bovine (liver) γ-Glutamyltransferase Porcine (kidney) Lactate dehydrogenase Porcine (heart) Lipase Human, recombinant
The concentration of the biological material does not exceed the maximum, lot specific target value concentration of the analyte.
MATERIAL REQUIRED BUT NOT PROVIDED
Clinical chemistry analyser.
REAGENT PREPARATION 1. The lyophilisate is vacuum sealed, therefore the vial should be opened very carefully to avoid loss of dried material. 2. Add exactly 5 ml of distilled water (inaccurate reconstitution of the control can cause erroneous results.) 3. Close the vial carefully and let the control stand for 30 min. 4. Dissolve contents completely by swirling gently, avoiding the formation of foam. Do not shake!
STORAGE AND STABILITY
Storage: Unopened bottles must be stored at 2 - 8 °C.
Stability:
Unopened: Until the end of the indicated month of expiry.
Once reconstituted, Dumocon N can be used within the period reported in the table below if stored tightly closed at the indicated temperature.
Stability after reconstitution:
+ 4 ºC Bilirubin (in the dark), GOT, GPT 2 days Other analytes 7days
1. Each individual blood donation used for production of Dumocon N was found to be non- reactive when tested with approved methods for HbsAg, anti-HIV 1+2 and anti-HCV. As there is no possibility to exclude definitely that products derived from human blood transmit infectious agents, it is recommended to handle the control with the same precautions used for patient specimens. 2. Dumocon N contains biological material of specified origin. The controls should be handled as potentially infectious and with the same precatuions used for patient specimens.
