INOGENGenetics Redefined

Antenatal screening

Inogen I-GBS Real-time PCR Kit

Antenatal screening for Group B Streptococcus, helping protect newborns from early infection.

gene target
cfb
limit of detection
100 CFU/mL
GBS variants in silico
11
PCR run time
~2 h

Request a quoteInstructions for use

  • Specific target

    Targets a specific sequence of the GBS cfb gene; in silico analysis covers 11 GBS variants (Ia, Ib, Ic, II to VIII, ND).

  • Sensitive

    Limit of detection of 100 CFU/mL.

  • No cross-reactivity found

    No cross-reactivity with 12 other species tested, including S. aureus, E. faecalis, E. coli and C. albicans.

  • Ready-mixed and stable

    The combined master mix and Taq polymerase can be aliquoted and stored at −20 °C for up to one month.

Targets

  • Group B Streptococcus (Streptococcus agalactiae), cfb gene
  • Internal control (beta-actin gene)

Intended use

  • Antenatal GBS screening of vaginal-rectal swabs between 36 0/7 and 37 6/7 weeks of pregnancy, as recommended in the instructions for use

02Specifications

Specifications

Regulatory status (IFU)
IVD
Intended user
Professional use in laboratories with trained staff
Type of analysis
Qualitative
Target
cfb gene of Group B Streptococcus
Validated specimen
Vaginal-rectal swab
Extraction
PCG® MagBead DNA Extraction Kit
Instruments
QuantStudio 5 and 7 Real-time PCR Systems; CFX96 Real-time PCR Detection System
Detection channels
FAM (GBS), HEX/VIC (internal control)
Precision
Repeatability and intermediate precision CV ≤ 5%
Storage
−20 °C (±5 °C), 12 months; up to 3 freeze-thaw cycles

03Workflow

Workflow

  1. 01

    DNA extraction

    Extract DNA from an enriched vaginal-rectal swab.

  2. 02

    Master mix preparation

    Combine the master mix and Taq polymerase and dispense 20 µL per tube.

  3. 03

    Real-time PCR

    Add 10 µL of DNA or control and run, about two hours.

04Ordering

Ordering

Kit contents

  • PCR Master Mix (1 × 1040 µL)
  • Taq DNA Polymerase (1 × 8 µL)
  • Positive control (1 × 200 µL)
Catalogue no.KitTestsInstrument
PI2600050Inogen I-GBS Real-time PCR Kit50QuantStudio 5/7, CFX96

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