Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing Kit

The SteriSEQ Rapid Sterility Testing Kit is a TaqMan-based quantitative PCR (qPCR) kit for the detection of bacteria and fungi in complex bioproduction samples. Designed and tested using criteria for rapid bacteria and fungi detection in biotherapeutic manufacturing cell culture lots, the kit meets or exceeds sensitivity and specificity guidance provided in European Pharmacopoeia (E.P 2.6.27) and U.S. Pharmacopoeia (USP1071). The kit can detect 5–25 genome copies per reaction or the equivalent of 5–25 CFU per reaction.

Features of the SteriSEQ Rapid Sterility Testing Kit include:

• Fast—sample-to-answer turnaround time of less than a day; delivers results in <5 hours
• Specific—primers/probes designed specifically for bacteria (16S rRNA) and fungi (18S rRNA)
• Sensitive—detects bacterial and fungal species at 5–25 genome copies per reaction
• Efficient—minimizes use of sample material by simultaneously testing for bacteria and fungi, preserving precious cells for final product
• Accurate—discriminatory positive control helps eliminate false positives and an internal positive control helps ensure PCR reaction consistency in the samples

The SteriSEQ Rapid Sterility Testing Kit uses predefined experiment templates that are included with the following versions of AccuSEQ Real‐Time PCR Software for PCR set up, operation, and post-run analysis:

• AccuSEQ Real‐Time PCR Software 3.2.1 or later (used with the QuantStudio 5 Real‐Time PCR System)
• AccuSEQ Real‐Time PCR Software 2.2.1 or later (used with the 7500 Fast Real‐Time PCR Instrument)