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Simplexa® GBS Direct Kit

Detecting Group B Strep directly in Lim Broth enriched vaginal/rectal swab cultures

Enabling the clinical sensitivity and specificity needed to effectively detect GBS in determining the colonization status of antepartum women and enable antibiotic prophylaxis to decrease risk of GBS transmission to their newborn during birth.

Tecnologia Simplexa® per il rilevamento di Streptococco del gruppo B - Diasorin

Disease state

The CDC estimates that 25% of pregnant women are asymptomatically colonized with GBS in the genital and rectal mucous membrane sites. Vertical transmission of GBS to the newborn can result in an invasive infection known as early-onset disease (EOD).

The World Health Organization estimates that GBS causes an estimated 150,000 preventable stillbirths and infant deaths every year.

Group B Streptococcus (GBS) infection is a leading cause of sepsis and meningitis among newborns

The value of Simplexa® GBS Direct Kit

Enabling detection of GBS colonization in women and protecting newborns

Simplifying the screening process

Eliminate conventional labor-intensive and time-consuming means for identifying GBS through culture on blood agar plates and confirmation tests.

Delivering clinical confidence

Excellent clinical sensitivity (97%) in vaginal/rectal swab specimens enriched in Lim Broth compared to traditional culture methods.

How the Simplexa® GBS Direct Kit works

Simplexa® GBS Direct is an in-vitro qualitative real-time PCR assay with a simple workflow, enabling unextracted Lim broth enriched vaginal/rectal swabs and ready-to-use PCR reagent loading on a re-usable Direct Amplification Disc on the compact LIAISON® MDX system designed for operational simplicity, flexibility, and quality assurance for utility across any clinical lab.


Sample-to-answer workflow

Scan 1-8 unextracted Lim Broth enriched vaginal or rectal swab specimens per run, ready-to-use single-use reaction mix vials, and the 8-well Direct Amplification Disc. Simply load samples and reagents directly onto the disc, place the disc on the LIAISON® MDX Instrument, and press run for results in 60 minutes. 


Intiutive LIAISON® MDX Studio Software

Integrated QC checks and reporting for individual assays or use the multi-assay suite feature for compatible assays- Simplexa® GBS Direct is compatible with the Simplexa® GAS Direct assays in the same run: view PCR curves and QC Charts, interface with LIS, and even during run access software.

Indications for Simplexa® GBS Direct use

Assay and system

A real-time PCR assay run on LIAISON® MDX to detect GBS colonization

Patient types

Antepartum women

Diagnostic lab

Hospital (OBG), Commercial, Reference

Simplexa® GBS Direct workflow

 Scan, load and go

Ready to use

  • No prep & No waste
  • Single use reagents (24 reactions)
  • No mixing, pouring or rehydrating

Simple & easy workflow

  • No extraction needed, direct sample input
  • Liquid sensor to ensure adequate sample volume metered: No precise pipetting required
  • CLIA Moderate Complexity


  • Scan the assay definition QR code (upon first use only)
  • Scan the lot-specific QR code on a vial or card
  • Scan the disc barcode
  • Scan the sample barcode


In each Disc Wedge:

  • Load 50 µl of sample
  • Load 50 µl of reaction mix (= 1 vial content)
  • Close the foil and remove the tab
  • Disc may be re-used up to 8 times (until all Wedges are utilized)
  • Close the foil and remove the tab

Load and run

Load the disc onto the LIAISON® MDX and start the  run. The results and a final report are automatically generated by the software.

To be used on the LIAISON® MDX Instrument

The LIAISON® MDX is an innovative and powerful real-time PCR instrument with two consumable disc options: the 8-well Direct Amplification Disc and the 96-well Universal Disc for higher volume testing.

Supported by an expanding menu of molecular assays, the system provides easy-to-understand results with the ability to check amplification curves after a run. All of this in a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.

Molecular Diagnostic Tool LIAISON® MDX - Diasorin


One instrument.
Multiple discs.
Ultimate Flexibility.

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Simplexa® GBS Direct Kit ordering info

Part Name
Kit Size
Registration Status
Part Number

Simplexa® GBS Direct Kit




Simplexa® GBS Positive Control Pack





Diasorin document repository


Luminex document repository

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More details about Simplexa® GBS Direct Kit

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