TruLab N is a lyophilized quality control material made from human serum and other biological materials that monitors the performance of quantitative in vitro assays. It contains specified levels of various analytes like enzymes and proteins. The material should be reconstituted with distilled water and allowed to stand for 30 minutes before following the manufacturer's instructions. The document provides information on ordering, storage, stability and safety precautions for the control material.
TruLab N is a lyophilized quality control material made from human serum and other biological materials that monitors the performance of quantitative in vitro assays. It contains specified levels of various analytes like enzymes and proteins. The material should be reconstituted with distilled water and allowed to stand for 30 minutes before following the manufacturer's instructions. The document provides information on ordering, storage, stability and safety precautions for the control material.
TruLab N is a lyophilized quality control material made from human serum and other biological materials that monitors the performance of quantitative in vitro assays. It contains specified levels of various analytes like enzymes and proteins. The material should be reconstituted with distilled water and allowed to stand for 30 minutes before following the manufacturer's instructions. The document provides information on ordering, storage, stability and safety precautions for the control material.
TruLab N is a lyophilized quality control material made from human serum and other biological materials that monitors the performance of quantitative in vitro assays. It contains specified levels of various analytes like enzymes and proteins. The material should be reconstituted with distilled water and allowed to stand for 30 minutes before following the manufacturer's instructions. The document provides information on ordering, storage, stability and safety precautions for the control material.
Assayed quality control material for monitoring assay performance of quantitative in vitro determination of various analytes
Order Information Preparation
5 9000 99 10 061 6 x 5 mL The lyophilisate is vacuum sealed; therefore the vial should be 5 9000 99 10 062 20 x 5 mL opened very carefully to avoid loss of dried material. For reconstitution add exactly 5 mL of distilled water. Close the vial Description carefully and allow the control to stand for 30 minutes swirling TruLab N is a lyophilized control based on human blood occasionally. Avoid foaming! Do not shake! material (serum) and contains drugs, organic and non-organic chemicals and biological material of specified origin. The Procedure concentrations are either at normal or at borderline Please refer to the reagent package insert for instructions for pathological levels. use. Analyte Origin Alkaline Phosphatase Calf (intestine) Assay Values and Ranges Alanine Aminotransferase Porcine (heart) The analyte concentrations contained in TruLab N are specific Aspartate Aminotransferase Porcine (heart) and only valid for the corresponding lot and thus stated in the α-Amylase Porcine (pancreas) value sheet of the lot involved. All assay values have been established within standardized conditions with the method Bilirubin Porcine/Bovine stated in the value sheet by using the reagents specified via Creatine kinase Human, recombinant the product code. Glutamate dehydrogenase Bovine (liver) Ranges of acceptance were calculated as assigned value γ-Glutamyltransferase Porcine (kidney) ± the maximum tolerable deviation of a single value according Lactate dehydrogenase Porcine (heart) to the Guidelines of the German Federal Medical Council Lipase Human, recombinant (Rilibaek) from 2003 [3]. For analytes not listed in the Total bile acids Bovine (serum) Guidelines of the German Federal Medical Council (Rilibaek) The concentration of the biological material does not exceed ranges are indicated with a deviation of ± 20% from the given the maximum, lot specific target value concentration of the mean value. analyte. Each laboratory should establish corrective action in case of deviations in control recovery. Storage The unopened bottles of TruLab N must be stored at 2 – 8°C. Literature 1. Röhle G, Siekmann L. Quality assurance of quantitative Stability determination. In: Thomas L, editor. Clinical laboratory Unopened until the end of the indicated month of expiry. diagnostics. 1st ed. Frankfurt: TH-Books Verlags- Once reconstituted, TruLab N can be used within the period gesellschaft; 1998. p. 1393–1401. reported in the table below if stored tightly closed at the 2. Biosafety in Microbiological and Biomedical Laboratories. indicated temperature. U.S. Department of Health and Human Services, Washington 1993 (HHS Publication No. [CDC] 93-8395). + 4°C 3. Richtlinie der Bundesärztekammer zur Qualitätssicherung Bilirubin (in the dark), ALAT, ASAT 2 days quantitativer laboratoriumsmedizinischer Unter- Other analytes 7 days suchungen. Deutsches Ärzteblatt 2003;100:A 3335-38.
+ 25°C Waste management
ALAT 2 hours Please refer to local legal requirements. CK-NAC, CK-MB 4 hours Other analytes 8 hours Manufacturer DiaSys Diagnostic Systems GmbH - 20°C * Alte Strasse 9 Bilirubin 14 days IVD 65558 Holzheim Germany Other analytes 30 days * Only freeze once.
Warnings and Precautions
1. Each individual blood donation used for production of TruLab 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. TruLab N contains biological material of specified origin. The controls should be handled as potentially infectious and with the same precautions used for patient specimens. 3. Please refer to the safety data sheets and take the necessary precautions for the use of calibrators and controls. 4. For professional use only!
