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Sacace™ HHV6 Real-TM Quant ver. 05.05.2022 IVD For in Vitro Diagnostic Use HHV6 Real-TM Quant Handbook Real Time PCR kit for quantitative detection of Human Herpes Virus 6 REF V10-100FRT 100 Sacace™ HHV6 Real-TM Quant ver. 05.05.2022 NAME HHV6 Real-TM Quant INTENDED USE kit HHV6 Real-TM Quant is an in vitro Real Time amplification test for quantitative detection of Human Herpes Virus 6 in the biological materials. DNA is extracted from samples, amplified using real time amplification with fluorescent reporter dye probes specific for pol-gene of HHV6 and Internal Control (IC). Test contains an IC (-globine gene) which serves as an amplification control for each individually processed specimen and to identify possible reaction inhibition. PRINCIPLE OF ASSAY kit HHV6 Real-TM Quant is based on two major processes: isolation of DNA from specimens and Real Time amplification. Amplification results of HHV6 DNA are detected on the Joe/HEX/Yellow and -globine gene used as Internal Control is detected on the Fam/Green channel. If the sample is not correctly prepared or well stored (insufficient quantity 36), the result of analysis of such samples is considered equivocal. Repeat analysis of such samples in duplicate. If a positive result is obtained in both replicates, the result of analysis is considered as positive. If the results in two replicates are discrepant, the result of analysis of such samples is considered equivocal. 6. If the number of copies per reaction in DNA calibrators in quantitative tests exceeds the specified value by more than 30%, check the order of placing the tubes in the rotor (DNA calibrators should be inserted into the cells named “Standard” in the table of samples and cell no. 1 in rotor-type instruments should not be empty (fill it with any test tube). 7. If the correlation coefficient R in the Standard Curve window in quantitative tests is less than 0.9, this indicates error in calibration. Check whether the settings for DNA calibrators are correct and change them, if necessary. If this does not help, run PCR for all samples and calibrators. Sacace™ HHV6 Real-TM Quant ver. 05.05.2022 KEY TO SYMBOLS USED * SaCycler™ is a registered trademark of Sacace Biotechnologies * CFX™ and iQ5™ are registered trademarks of Bio-Rad Laboratories * Rotor-Gene™ is a registered trademark of Qiagen * MX3005P® is a registered trademark of Agilent Technologies * ABI® is a registered trademark of Applied Biosystems * LineGeneK® is a registered trademark of Bioer * SmartCycler® is a registered trademark of Cepheid Sacace Biotechnologies Srl via Scalabrini, 44 – 22100 – Como – Italy Tel +390314892927 Fax +390314892926 mail: info@sacace.com web: www.sacace.com List Number Caution! Lot Number Contains sufficient for tests For in Vitro Diagnostic Use Version Store at NCA Negative Control of Amplification Manufacturer NCE Negative control of Extraction Consult instructions for use C+ Positive Control of Amplification Expiration Date IC Internal Control
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