TGS TA EBV Control Set
Contents
1. code If the bar code is not readable the identification data may be entered manually After the first use if they are stored at 2 8 C the control sera remain stable for 60 days if they are not left in the analyser for more than 1 hour per session The values for the anti EBV antibody concentration in the controls are recorded in the DATA DISK and automatically transferred to the analyser If the data are not transferred they may be entered manually At the end of the session the control vials must be closed with the top caps red caps provided and stored at 2 8 C until they are used again The Data Disk supplied with the Control Set contains information related to all the TGS TA line products updated to the last production lot with the exclusion of products that are out of date when the new Data Disk was compiled Only the Data Disk with the highest lot number needs to be kept to maintain the information required for correct operation of the system up to date Controls must be tested singly once every 24 hours when the test is in use and during each calibration The values for the control sera must be within the acceptability range specific for the lot If a control serum is not within the required range the sample results associated with it cannot be considered to be valid In such cases a new calibration must be carried out TECHNOGENETICS S r l Via Vanvitelli 4 20129 Milano Italy Operating facilities Via della Filanda 22. 6 26900 Lodi Italy IFUO40TGS TA Version 02 25 September 2013 Page 4 di 4
3. TGS TA EBV Control Set REF YB500030 TGS TA EBV Control Set INSTRUCTIONS FOR USE 8 C 2 C YB500030 M4 TECHNO IK GENETIC INTENDED USE The TGS TA EBV Epstein Barr Virus Control Set is used to control the quality of the TGS TA EBV VCA IgG TGS TA EBV EBNA 1 IgG TGS TA EA IgG and TGS TA VCA IgM assays performed with the TGS TA Analyser q SUMMARY AND EXPLANATION Control samples containing at least two different concentrations of analyte must be used regularly to guarantee the validity of the results obtained each day The TGS TA EBV Control Set contains a human serum Anti EBNA 1 IgG Negative Anti VCA IgG Negative Anti EA IgG Negative Anti VCA IgM Negative and a human serum Anti EBNA 1 IgG Positive Anti VCA IgG Positive Anti EA IgG Positive Anti VCA IgM Positive concentration lower than 10 UA mL concentration lower than 10 UA mL concentration lower than 10 UA mL N N concentration lower than 15 UA mL concentration higher than 10 UA mL concentration higher than 10 UA mL concentration higher than 10 UA mL concentration higher than 15 UA mL The controls supplied in the Control Set are used to monitor the accuracy and precision of the assay of anti VCA anti EBNA and anti EA IgG antibodies and anti VCA IgM antibodies performed with the TGS TA Analyser WARNINGS AND PRECAUTIONS The reagents supplied in the TGS TA EBV Control Set a
4. o YB500026 TGS TA Top Cap Set Cod No YC500010 300 red top caps to close the control vials after first use REAGENT STORAGE AND STABILITY Store the reagents supplied in the kit at 2 8 C in a vertical position in a dark place In these conditions unopened control sera are stable until their expiry date After the first use the control sera remain stable for 60 days if they are stored at 2 8 C and if they are not left in the analyser for more than 1 hour per session Do not freeze the control sera OPERATING PROCEDURE Carefully follow the instructions given in the user manual of the analyser to obtain reliable analytical results Loading of controls TGS TA controls are ready for use Leave the controls at room temperature for 10 minutes and then gently shake the contents either manually or using a vortex avoiding the formation of foam Do not turn the vial upside down When using the controls for the first time remove the guarantee seal and the white sealing cap before placing them in the analyser IFUO40TGS TA Version 02 25 September 2013 Page 3 di 4 TGS TA EBV Control Set YB500030 If the controls have already been used the container will have a top cap red cap with no guarantee seal Remove the red closing cap before placing them in the analyser Place the controls in the samples area of the analyser Please see the user manual for the analyser for identification of the controls by means of the test tube bar
5. re only for in vitro diagnostic use and not for in vivo use in humans or animals This product must be used by professional users in strict compliance with the instructions given in this document IFUO40TGS TA Version 02 25 September 2013 Page 1 di 4 TGS TA EBV Control Set YB500030 The control sera supplied in the Control Set are not specific for each lot of kits but can be used with kits from different lots Technogenetics cannot be held responsible for any losses or damages caused by use not in conformity with the instructions supplied Safety precautions This product contains material of human origin All units of serum or plasma used to produce the Control Set components have been analysed with FDA approved methods and found not to be reactive due to presence of HBsAg anti HCV anti HIV1 and anti HIV2 However since no analysis method is able to guarantee the absence of pathogenic agents all material of human origin must be considered to be potentially infected and handled as such In the event of damaged packaging or accidental leakage decontaminate the area concerned with a diluted solution of sodium hypochlorite after putting on suitable personal protective equipment overall gloves goggles Dispose of the material use for the clean up and of the packaging involved in the leakage according to national regulations for disposal of potentially infected waste The control sera contain sodium azide as a preser
6. vative Since sodium azide may react with lead copper and leaded brass forming explosive azides in piping it is recommended that reagents or waste are not poured down drains but are disposed of in compliance with the national regulations on disposal of potentially hazardous waste Operating precautions Reliable results can only be obtained by strictly complying with these instructions and carefully following what Is written in the user manual for the analyser Do not use the control sera after their expiry date MATERIALS AND REAGENTS Materials and reagents supplied CONTROL EE 3X 1 5 mL Human serum Negative for anti VCA IgG anti EBNA 1 IgG and anti EA IgG antibodies and for anti VCA IgM antibodies containing Sodium Azide lt 0 1 as preservative 3 vials each containing 1 5 mL of serum IFUO40TGS TA Version 02 25 September 2013 Page 2 di 4 TGS TA EBV Control Set YB500030 CONTROL 3X 1 5 mL Human serum Positive for anti VCA IgG anti EBNA 1 IgG and anti EA IgG antibodies and for anti VCA IgM antibodies containing Sodium Azide lt 0 1 as preservative 3 vials each containing 1 5 mL of serum DATA DISK Mini CD containing all the information and data related to the products in the TGS TA Line Materials and reagents required but not supplied in the kit TGS TA EBV EBNA 1 IgG Cod No YB500023 TGS TA EBV VCA IgG Cod No YB500024 TGS TA EBV EA IgG Cod No YB500025 TGS TA EBV VCA IgM Cod N
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