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UC-TIB-AdV

Real time PCR kit for quantification of human Adenovirus.
For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.
IVD For in vitro diagnostic use.
UC-TIB-AdV

Aiding to reduce the risk of severe disease in transplant and immunocompromised patients

Adenoviruses are important causes of infections in both immunocompetent and immunocompromised individuals. With immunocompromised patients, viral disease arising from adenovirus is associated with a high degree of morbidity and mortality.1

Quantitative detection of human adenovirus with polymerase chain reaction (PCR) can be used as a predictor tool in the decision to initiate or assess response to therapy in symptomatic transplant patients.2

The UC-TIB-AdV test is a real-time PCR test for the detection and quantification of human adenovirus in EDTA plasma to aid in the diagnosis of AdV infections and monitoring of AdV DNA levels. The test has been designed to work in conjunction with the cobas® omni utility channel for use on the cobas® 6800/8800 Systems available in countries accepting CE-IVD.

Benefits of the UC-TIB-AdV (Quantitative Adenovirus Test)

test tube

Standardisation

Results are traceable to the World Health Organization international standard for Adenovirus (NIBSC code: 16/324) reporting in IU/mL for improved result harmonisation across different laboratories and hospital institutions.

erlenmeyer flask

Automation

Specifically designed and optimized for use on the cobas® 6800/8800 Systems, enabling menu testing consolidation and sample to result automation.

Settings

Simplicity & efficiency

The test minimizes variability and complexity in testing, offering an alternative to lab-developed tests (LDTs), reducing workload and alleviating risk of error for laboratories.

Performance summary

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Performance summary

Parameter Performance
Conserved assay target Hexon region 
Sample type EDTA plasma
Minimum amount of sample required 350 uL
Sample processing volume 200 μL
Analytical sensitivity 39.5 IU/mL
Linear range 1E+02 IU/mL to 1E+08 IU/mL
Specificity 100%
Species groups detected ADV (A to G)
Overall Precision  SD 0.06 - 0.16 log10
Kit stability 90 days with 35 re-uses* 
*While the cobas® omni utility channel cassette allows 40 runs, the positive controls provided in the UC-TIB-AdV kit are sufficient for 35 runs only

References

  1. Florescu et al. Adenovirus in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. The J of Clinical and Translational Research. 2019. https://doi.org/10.1111/ctr.13527

  2. Lion T. Adenovirus infections in immunocompetent and immunocompromised patients. Clin Microbiol Rev. 2014;27(3):441–462. doi:10.1128/CMR.00116-13

Overview

Detailed Specifications

Ordering Information

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