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.
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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.
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
Scanning
- 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
Loading
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.
Simplexa® GBS Direct Kit ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa® GBS Direct Kit |
24 |
IVD | MOL3550 |
|
Simplexa® GBS Positive Control Pack |
10 |
IVD | MOL3560 |