For Research Use Only. Not for use in diagnostic procedures. Others UC-TIB-AdV RUO RUO UC-TIB-AdV (RUO) RMD-UC-003 10 336 510 001 10336510001 UC-TIB-AdV-RUO UC-TIB-AdV-RUO 04260159336092 Reagents, kits 1 kit Not Available false 09 838 899 001 9 838 899 001 09838899001 9838899001 09838899001 UC-TIB-AdV-RUO UC-TIB-AdV-RUO Reagents, kits 1 kit 192 tests false UC-TIB-AdV (RUO) is an automated in vitro nucleic acid amplification test for the detection and quantification of human Adenovirus (AdV) DNA. This test is intended to be used on the open channel functionality (cobas® omni utility channel) of the cobas® x800 Systems. This test can be used to quantify AdV DNA levels. en Viral DNA is analyzed by real-time PCR that amplifies a 74 bp long fragment of AdV hexon gene analyzed with FAM-labeled probes in channel 02. The quantification of AdV DNA is ensured by the four AdV standards (STD1, STD2, STD3 and STD4) provided in the UC-TIB-AdV (RUO) kit. For cobas® 6800/8800 systems software version 1.4 data management is performed by the cobas® omni utility channel Optimization Tool software used in combination with the UC-TIB-AdV Offline Quantification Tool which assigns test results for all tests as either target not detected, AdV DNA detected < LLoQ (lower limit of quantification), AdV DNA detected > ULoQ (upper limit of quantification), or a value in the linear range LLoQ < x < ULoQ. For cobas® 5800 and cobas® x800 system software version 2.1 or higher the generation of a quantitative UCAP is recommended as described in the cobas® omni utility channel for cobas® 5800/6800/8800 System User Assistance. The (+)_Ctrl comprise aplasmid with a 251 bp long synthetic fragment of AdV-2 hexon gene (Accession number: MT277585 position 18838 - 19088). en The limit of detection (LoD) of UC-TIB-AdV (RUO) was determined by analysis of serial dilutions of the WHO International Standard for AdV (1st WHO International Standard) obtained from NIBSC (Code 16/324), in AdV- negative human EDTA plasma (200 μL sample volume). The study demonstrates that the UC-TIB-AdV (RUO) detects at least 40 IU or less per mL, determined by LOGIT analysis with a hit rate of 95%. en

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