Accukit™ Adventitious Agents (AA20)

Quantitative Standards for Monitoring Biocontaminants by NGS

The problem:

Advances in biopharmaceutical manufacturing require faster and more sensitive biocontaminant testing to achieve safe biomedicines.  Traditional animal and cell-based methods can take up  to a month or more, lack sensitivity and create delays in production.

The product:

The Accukit™ Adventitious Agents (AA20) assay and standard system is an NGS-library prep workflow for 20 common adventitious agents found in Chinese hamster ovary cell bioproduction processes.  The Accukit contains all the necessary reagents for library preparation of cell lysate samples to target a panel of adventitious agents (Table 1) to achieve a sensitivity of 10 copies of target per ml of lysate.

Table 1: Adventitious Agents Targets in Accukit AA20

Bovine adenovirusEpizootic Haemorrhagic Disease virus
Bovine coronavirusHuman Adenovirus 2
Bovine enterovirusMinute virus of Mice
Bovine parvovirusPorcine Circovirus 2
Bovine Parainfluenzavirus 3Porcine Circovirus 1
Bovine polyoma virusPorcine Hemagglutinating Encephalomyelitis virus
Bovine respiratory syncytial virusPorcine transmissible gastroenteritis virus
Bluetongue virusRabies virus
Bovine viral diarrhoea virusSeneca Valley Virus (Senecavirus)
Cache Valley virusVesivirus 2117

Why it works:

The Accukit relies on matched DNA and RNA SNAQ™-SEQ spike-in standards that are added to the samples prior to extraction as a quantitative process control to ensure assay performance.  By adding the standards to the sample they can provide a quantitative measure of the sensitivity and limit of detection achieved by the assay for EACH sample. This is critically important to providing confidence in the negative result.

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