Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay

The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in
vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim
Broth enriched vaginalrectal specimen swabs obtained from pregnant women.

The objective of this study is to establish the diagnostic accuracy of ARIES GBS Assay
through a multi-site, method comparison on prospectively collected, left-over enriched Lim
broth specimens.

Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity.

Inclusion Criteria:

- The specimen is from a female patient who is at 35-37 weeks gestation.

- The specimen was collected in unexpired liquid Transport Media (e.g. Liquid Stuart or
liquid Amies).

Exclusion Criteria:

- The specimen was not properly collected, transported, processed or stored according
to the instructions provided by the sponsor.