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The Xpert® Xpress GBS test, performed on the GeneXpert® Instrument Systems, is an automated, real-time PCR test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients for intrapartum testing at term (e.g., >37 weeks) who have unknown or unavailable antepartum GBS screening test results and no additional risk factors that would warrant empiric antibiotic prophylaxis. The Xpert Xpress GBS test performed during intrapartum is intended to aid in the detection of GBS colonization in patients presenting in labor who may be candidates for antibiotic prophylaxis. The Xpert Xpress GBS test does not provide antimicrobial susceptibility test results. Culture is necessary to obtain isolates to perform susceptibility testing as recommended for penicillin-allergic patients. This test is conducted using direct specimen without enrichment is recommended to enhance detection of GBS colonization). In contrast to a positive test result, which can indicate colonization, a presumptive negative result cannot exclude the possibility of GBS colonization. A false negative test result at intrapartum carries a potential harm to the infant if it is used in making decisions regarding empiric antibiotic prophylaxis. Providers must use caution and default to known patient risk factors and clinical guidance regarding a role for intrapartum prophylaxis.

The Xpert® Xpress GBS test is an automated in vitro diagnostic test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients at intrapartum. The Xpert Xpress GBS test is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx. GeneXpert Infinity-48s and GeneXpert Infinity-80 systems), which consist of an instrument, computer and preloaded software for running tests and viewing the results. The GeneXpert Instrument Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and real-time detection. Depending on the instrument, the GeneXpert Instrument Systems can have from 1 and up to 80 randomly accessible modules, each capable of performing separate sample preparation and real-time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR as well as detection. The systems require the use of single-use disposable cartridges that hold the PCR reagents and host sample purification, nucleic acid amplification, and detection of the target sequences. Because the cartridges are self- contained, cross-contamination between cartridges during the testing process is minimized. The Xpert Xpress GBS test includes reagents for the simultaneous detection of target GBS DNA from vaginal/rectal swab specimens. The primers and probes in the Xpert Xpress GBS test are designed to amplify and detect unique sequence in two conserved chromosomal targets in S. agalactiae: a) a member of the glycosysl transferase gene family, and b) a LysR transcriptional regulator. A Sample Adequacy Control (SAC), Sample Processing Control (SPC) and a Probe Check Control (PCC) are also included in the cartridge utilized by the GeneXpert instrument. The SAC is a non-target sequence naturally present in the specimen. which is amplified along with the assay target. In the Xpert Xpress GBS test, the SAC detects the presence of the human hydroxymethylbilane synthase (HMBS) gene to ensure that the sample is properly collected and contains adequate human cells from the vaginal/rectal flora. The SPC is present to control for adequate processing of the sample and to monitor for the presence of potential inhibitor(s) in the PCR reaction. The SPC also ensures that the PCR reaction conditions (temperature and time) are appropriate for the amplification reaction and that the PCR reagents are functional. The PCC verifies reagent rehydration. PCR tube filling, and confirms that all reaction components are present in the cartridge including monitoring for probe integrity and dye stability. The Xpert Xpress GBS test is designed for use with vaginal/rectal swab specimens collected from pregnant patients at intrapartum and placed into a collection device. The ancillary specimen collection kit validated for use with the Xpert Xpress GBS test is the Cepheid Collection Device (Catalog 900-0370). The sample collection device allows dual vaginal/rectal swab specimens from patients to be collected and transported to laboratory prior to analysis with the Xpert Xpress GBS test.

The Xpert GBS LB XC test, performed on the GeneXpert® Instrument Systems, is an automated qualitative in vitro diagnostic test for the detection of Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens, using real- time polymerase chain reaction (PCR). Xpert GBS LB XC testing is indicated as an aid in determining the GBS colonization status of antepartum women. · The Xpert GBS LB XC test is intended for antepartum testing on enriched Lim broth cultures of vaginal/rectal swabs after 18-24 hours of incubation · The Xpert GBS LB XC test does not provide antimicrobial susceptibility test results. Culture is necessary to obtain isolates to perform susceptibility testing as recommended for penicillin-allergic women

The Xpert GBS LB XC test is an automated in vitro diagnostic test for qualitative detection of DNA from Group B Streptococcus (GBS) from vaginal-rectal swab specimens obtained from pregnant women that are transported to the laboratory following enrichment in Lim broth. The primers and probes in the Xpert GBS LB XC test are designed to simultaneously amplify and detect two unique GBS chromosomal targets: the first is a target within a coding region for a glycosyl transferase family protein and the second is within a coding region for a LysR family transcriptional regulator of Streptococcus agalactiae DNA. The Xpert GBS LB XC test includes reagents for the detection of DNA from GBS in Lim broth-enriched vaginal/rectal swabs. A Sample Processing Control (SPC) and a Probe Check Control (PCC) are also included in the cartridge. The SPC is present to control for adequate extraction and processing of the target sequences and to monitor for the presence of inhibitors in the PCR reaction. The PCC verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dve stability. The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of GBS genomic DNA in as little as 27 minutes with high titer specimens; GBS negative specimens generate results in approximated 43 minutes. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems and the GeneXpert Infinity Systems, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR and RT-PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and RT-PCR and detection. The Xpert GBS LB XC test is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System platform automates sample preparation, amplification and real-time detection. The GeneXpert systems consist of an instrument, computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument Systems require the use of single-use, disposable cartridges (the Xpert GBS LB XC cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized.

The DiaSorin Molecular Simplexa™ GBS Direct assay is a real-time polymerase chain reaction (PCR) assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of Group B Streptococcus (GBS) nucleic acid from 18 to 24 hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Assay results can be used as an aid in determining the colonization status of antepartum women, but are not intended to diagnose or monitor treatment of a GBS infection. The Simplexa™ GBS Direct assay does not provide susceptibility results. Culture isolates are needed to perform susceptibility testing as recommended for penicillin-allergic women. Simplexa™ GBS Positive Control Pack The Simplexa™ GBS Positive Control Pack is intended to be used as a control with the Simplexa™ GBS Direct kit. This control is not intended for use with other assays or systems.

The Simplexa™ GBS Direct assay system is a real-time PCR system that enables the direct amplification and qualitative detection of Group B Strep bacterial DNA from vaginal swabs enriched in Lim Broth for eighteen to twenty-four (18 to 24) hours that have not undergone a nucleic acid extraction. The system consists of the Simplexa™ GBS Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc (DAD) and associated accessories. In the Simplexa™ GBS Direct assay, primers and fluorescent probes are used together to amplify Group B Streptococcus bacterial DNA and the Internal Control (DNA IC). The assay targets a conserved region of the cfb gene to identify Group B Streptococus in the specimen. The DNA IC is used to detect PCR failure and/or inhibition.

The Panther Fusion GBS assay is an automated qualitative in vitro diagnostic test utilizing real-time PCR for detection of Group B Streptococcus DNA from either Lim or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18-24 hours incubation. This test is performed on the Hologic Panther Fusion system and is intended to aid in determining the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The Panther Fusion GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The Panther Fusion GBS assay involves the following steps: Sample lysis, nucleic acid capture and elution, and multiplex RT-PCR where analytes (when present) are simultaneously amplified, detected and differentiated. Nucleic acid capture and elution takes place in a single tube on the Panther Fusion system. The eluate is transferred to the Panther Fusion system reaction tube containing the assay reagents. RT-PCR is then performed for the eluted nucleic acid on the Panther Fusion system. Sample Collection and Enrichment: After collecting and transporting a swab sample to the laboratory, the swab is placed in Lim Broth or Carrot Broth for 18 to 24 hours of enrichment. Prior to testing on the Panther Fusion system, enriched specimens are then transferred to a tube containing specimen transport media (STM) that lyses the cells, releases target nucleic acid and protects them from degradation during storage. Nucleic Acid Capture and Elution: Specimens are then first incubated in an alkaline reagent (FER-X) to enable cell lysis. The Internal Control (IC-X) is added to each test specimen and controls via the working Panther Fusion capture Reagent-X (wFCR-X). The IC-X monitors specimen processing, amplification and detection. Magnetic particles with covalently bound oligonucleotides, contained in Panther Fusion capture Reagent-X (FCR-X), mediate the nucleic acid capture by hybridizing to total nucleic acid in the test specimen. The capture nucleic acids are then separated from residual specimen matrix in a magnetic field by a series of wash steps with a mild detergent. The captured nucleic acid is then eluted from the magnetic particles with a reagent of low ionic strength (Panther Fusion Elution Buffer). Elution transfer and PCR: During the elution transfer step, eluted nucleic acid is transferred to a Panther Fusion Reaction tube already containing oil and reconstituted mastermix. PCRbased target amplification subsequently occurs with target-specific forward and reverse primers, generating a fluorescence signal. The Panther Fusion GBS Software computes a cycle threshold result (Ct) to qualitatively determine the presence of the analyte targets and corresponding fluorescent channels used in the Panther Fusion GBS Assay are summarized in the Table 1 below.

The NeuMoDx™ GBS Assay as implemented on the NeuMoDx™ 288 Molecular System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour Lim broth enrichments of vaginal/rectal swabs from pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect an 88 bp region of the pcsB gene sequence in the Streptococcus agalactiae chromosome. Results from the NeuMoDx™ GBS Assay can be used as an aid in determining colonization status in antepartum women. The NeuMoDx™ GBS Assay does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The NeuMoDx™ GBS Assay (Subject Device) as implemented on the NeuMoDx™ 288 Molecular System is an automated, qualitative, in vitro diagnostic test for the detection of group B Streptococcus (GBS), also known as Streptococcus agalactiae from vaginal/rectal swabs collected from pregnant women at 35 - 37 weeks of gestation and enriched in a commercially available Lim broth medium. An aliquot of an overnight Lim broth culture added to the NeuMoDx™ GBS Assay is used for the testing. All further specimen handling is automated. The GBS Assay test strip, in combination with required NeuMoDx buffers, extraction reagents, wash and release solutions, as well as the microfluidic cartridge (non-active,) and the fully automated NeuMoDx™ 288 Molecular System (a real time nucleic acid amplification system), utilizes real-time polymerase chain reaction (PCR) for the amplification of GBS DNA and fluorogenic target-specific TaqMan® probes for the detection of the amplified GBS DNA. General use components and the System are packaged and provided separately by NeuMoDx. After the test is processed, a determination of the presence/absence of GBS DNA in the specimen is automatically made based on the amplification status of GBS and the Sample Process Control using preestablished decision criteria. The test results will be reported as Negative, Positive, Indeterminate or Unresolved based on the amplification status of the target and sample processing control. Results are reported based on the decision algorithm noted in Table 1.

The Solana® GBS assay is a qualitative in vitro diagnostic test for detection of Group B Streptococcus in either LIM or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation. The Solana® GBS Assay utilizes helicase-dependent amplification (HDA) of the Thiolase (atoB) gene sequence. The Solana® GBS Assay is intended for use only with the Solana® Instrument. The Solana® GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The Solana GBS Assay amplifies and detects GBS DNA isolated from enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation. The assay consists of two (2) major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to GBS using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe. Patient specimen is transferred to a Process Buffer tube, subjected to heat treatment at 95 ± 2°C for 5 minutes and mixed. The processed sample is transferred to a Reaction Tube and mixed. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the processed sample, the Reaction Tube is placed in Solana for amplification and detection of specific target sequences. In Solana, the GBS target sequence is amplified by GBS specific primers and detected by a GBS specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Process Tube to monitor sample processing, for the presence of inhibitory substances in clinical samples, reagent or device failure. The PRC target is amplified by specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore (FAM or ROX, respectively) on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to GBS or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana will then report the test results to the user on its display screen, and it can print out the results using the attached printer.

The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The GenePOC GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The GenePOC GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The GenePOC GBS LB assay is a single-use test for the qualitative detection of Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens using realtime Polymerase Chain Reaction (PCR) technology with fluorogenic detection of the amplified DNA. The GenePOC GBS LB assay utilizes the GBS LB microfluidic cartridge for the simultaneous detection of the target GBS DNA and the internal process control (PrC) DNA (to monitor processing, amplification, and the absence of reaction inhibitors). The GenePOC GBS LB assay is an automated assay performed on the revogene™ including sample processing. The GenePOC Group B Strep (GBS) LB is composed of a GBS specific disposable microfluidic cartridges, Sample Buffer Tube (SBT) and Disposable Transfer Tool (DTT). These components are used to lyse and dilute the sample, amplify, and detect GBS nucleic acid from vaginal/rectal swabs following LIM broth enrichment. User intervention is required for sample preparation, discharging the LIM broth enriched sample into the SBT, transferring the sample into the cartridge and loading/unloading the cartridge into the revogene instrument. Once the sample is added into the cartridge, the process is then fully automated. Each GenePOC GBS LB Test kit contains 24 individual pouches, and each pouch has components for 1 test including 1 cartridge, 1 SBT, and 1 DTT. The GBS LB Test is run on the revogene instrument which can process from one up to a maximum of 8 samples simultaneously in the same run. On completion of a run, the results are interpolated by the revogene™ from measured fluorescent signals and embedded calculation algorithms. For the GBS application, two spectral signals are processed: GBS target and Internal Process Control. The output results include positive, negative, indeterminate, and unresolved. On completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. Results may be viewed, printed, transferred, and/or stored by the user.

The ARIES GBS Assay, performed on ARIES Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test. The ARIES GBS Assay is designed to detect Group B Streptococcus (GBS) nucleic acid from 18-24 hour Lim broth enrichments of vaginal-rectal specimen swabs obtained from pregnant women. The ARIES GBS Assay is intended for use as a method for detection in antepartum women. It is not intended to diagnose or monitor treatment of a GBS infection. The ARIES GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

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The Great Basin Portrait™ GBS Assay, performed on the PA500 Portrait™ Analyzer System, is a qualitative in vitro diagnostic test (IVD) for the detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swabs from antepartum women, following enrichment in LIM Broth for 18 - 29 hours. The assay utilizes automated sample preparation and polymerase chain reaction (PCR) to amplify a cfb gene sequence specific to the Streptococcus agalactiae (GBS) genome which is detected by hybridization probes immobilized on a silica chip surface. Results from the Portrait™ GBS Assay can be used as an aid in determining colonization status in antepartum women. The Portrait™ GBS Assay does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. The Portrait™ GBS Assay is intended for use in clinical laboratory, and reference laboratory settings. The Portrait™ GBS Assay is not intended for point of care use.

The Great Basin PA500 Portrait Analyzer System is a fully automated system that includes the Portrait Analyzer, single-use Portrait GBS Assay Test Cartridges, and the Portrait data analysis software. The PA500 Portrait Analyzer System is designed to perform automated sample preparation, PCR, and optical chip-based detection with integrated data analysis in approximately 90 minutes. The Great Basin Portrait™ GBS Assay utilizes automated hot-start PCR technology to amplify target nucleic acid sequences that are detected using species-specific S. agalactiae DNA hybridization probes immobilized on a modified silicon chip surface.

The AmpliVue® GBS Assay is a qualitative in vitro diagnostic test for the rapid detection of Group B Streptococcus from vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation in an LIM enrichment broth culture. The AmpliVue" GBS Assay utilizes helicase-dependent amplification (HDA) of the thiolase (atoB) gene sequence and a self-contained disposable amplification detection device that allows for manual evaluation of assay results. Results can be used as an aid in determining the colonization status of antepartum women. The AmpliVue GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. The AmpliVue® GBS Assay is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

The AmpliVue® GBS Assay combines simple sample processing, an isothermal amplification technology named helicase-dependent amplification (HDA), and a selfcontained disposable amplicon detection device, for the detection of Group B Streptococcus from vaginal /rectal swabs following 18 to 24 hours incubation in Lim enrichment broth culture. A small amount of cultured specimen is transferred into a dilution tube. The diluted sample culture is then transferred into a lysis tube, and the cells are lysed by simple heat treatment. After heat treatment, an aliquot of the lysed sample is added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of the thiolase (atoB) gene. The rationale behind the selection of this particular target sequence were: 1) a BLAST search of this gene resulted in no thiolase with significant homology in species other than those belonging to S. agalactiae; 2) the gene is conserved in GBS based on the recent GBS Genome project. The assay also includes a process control that monitors sample processing, confirms the integrity of the assay reagents and cassette detection, and assays for HDA-inhibitors that may be present within a broth culture. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection with test result displayed as test and/or control lines in the window of the cassette.