Fact Sheet

Prime Fungi Testing

Interest Group

Research and Development.

Description

State of the art Nucleic acid based (NAT) fungi sterility testing, from submission to result in 24-48 hours. Simple test service for rapid testing of samples for fungi contamination. Delivers fast and reliable results.

Recommended Sample Material

Cells, cell culture supernatant, cryo stocks.

Method

Qualitative Real-Time PCR.

Applied PCR System

Microsart ATMP Fungi (Sartorius Biotech GmbH).

Applied Extraction

Microsart Sterile Extraction (Sartorius Biotech GmbH).

Process Control

Extraction and Amplification.

Sample Volume / PCR

10 µl.

Average Turnaround Time

24 to 48 hours after sample receipt, express testing scheme* possible.

Sensitivity of Method

< 99 to <999 CFU / PCR depending on sample volume.

Regulatory Compliance

Not EP 2.6.7 compliant, if this is required please request SteriEP testing.

Sample Requirements

Minimum: 600 up to 6000 µl depending on required sensitivity and sensitivity.
Optimum: 2 units of 600 µl (2 x 6000 µl) each, label as sample A and sample B (backup, please mark in accession form.

Order No.

Fungi Testing ‘FungiPrime’      41-1004

Volume Discount Available

Yes, on request.

Additional Information

Please note: repetitions which are not caused by our laboratory and *express testing schemes are subject to additonal charges. Please contact us for further information.