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IDI-Strep B™ assay is a qualitative in vitro diagnostic test for the rapid detection of Group B streptococcus (GBS) DNA in vaginal/rectal specimens from prepartum or intrapartum women. The test performed on the Smart Cycler® automated analyzer utilizes polymerase chain reaction (PCR) for the amplification of a cfb gene sequence of GBS recovered from clinical samples and fluorogenic target-specific hybridization for the detection of the amplified DNA. IDI-Strep B™ assay can be used to establish GBS colonisation status of prepartum and intrapartum women.

IDI-Strep B™ assay is a qualitative in vitro diagnostic test for the rapid detection of Group B streptococcus (GBS) in vaginal/rectal specimens from intrapartum maternity patients. The test performed on the Smart Cycler® automated analyzer utilizes polymerase chain reaction (PCR) for the amplification of GBS DNA recovered from clinical samples and fluorogenic target-specific hybridization for the detection of the amplified GBS DNA. IDI-Strep B™ assay can be used as the sole diagnostic information at the time of delivery for establishing GBS colonisation status of intrapartum maternity patients. Test Description: GBS collected from a vaginal/rectal swab is resuspended in sample preparation buffer. A sample is added to the lysing tube containing glass beads. The proprietary procedure is based on a combination of chemical and physical (glass beads) action and takes less than 10 minutes. A sample of the lysate solution is then added to the tube containing the PCR master mix which has the GBS-specific primers used to amplify the GBS ofb gene, if present, and the internal control (IC) template. Finally, 25 µi is transferred to the reaction tube which is placed in the Smart Cycler® assay. Amplified target DNA is detected with hybridization probes labeled with quenched fluorophores, i.e. molecular beacons. Different fluorophores are used for the GBS amplicon and for the detection of the IC amplicon. Their detection is independent of one another. Amplification of the internal control monitors for inhibitors potentially introduced with the clinical specimen and, in negative specimens, confirms the integrity of assay reagents. The interpretation of the data collected by the Smart Cycler® is made entirely by the diagnostic software of the Smart Cycler® instrument. The amount of fluorescence at any given cycle, or following cycling, depends on the amount of specific amplicon present at that time. The Smart Cvcler® instrument monitors simultaneously the fluorescence emitted by each beacon, interprets all data and at the end of the cycling program provides a final result. The operation of the Smart Cycler® instrument is based on the proprietary microprocessor-controlled I-CORE® (Intelligent Cooling/Heating Optical Reaction) module. Each Smart Cycler® processing block contains 16 independently controlled, programmable I-Core® modules, each with one reaction site. Thermally optimized proprietary reaction tubes combined with the design of the I-CORE® modules allow very rapid temperature cycling and rapid amplification. Up to 6 Smart Cycler® processing blocks can be daisy-chained together, allowing simultaneous analysis of 96 discrete samples.