Panther Fusion® GBS Assay

Performance You Can Trust

The Panther Fusion GBS assay expands the molecular test menu on the Panther Fusion® system. This assay detects the gram-positive bacterium Streptococcus agalactiae (GBS) in pregnant women so providers can help prevent its transmission to their babies.1 GBS has serious long-term health consequences, including death, in newborns.

A Sensitive Assay for a Distinct Threat

This assay features world-class performance and sensitivity, answering a crucial need for GBS detection. GBS is a serious and sometimes fatal infection that is passed to infants during birth.2 GBS is a leading cause of early-onset neonatal sepsis in the United States, and it can cause sepsis, pneumonia, meningitis and death.2 Antibiotic prophylaxis during delivery can reduce transmission of GBS to babies when administered properly. The Panther Fusion GBS assay helps providers detect GBS in mothers so they can confidently determine if intrapartum prophylaxis is needed.

Intuitive Design for Real-World Need

The CDC states that accurate results are more important than rapid turnaround time for antenatal screening.2 When providers have diagnostic tools with excellent sensitivity and performance, they can deliver the highest level of care. The Panther Fusion GBS assay is a real-time PCR assay for antepartum testing with enriched vaginal and rectal swabs. It features dual-target detection of Cfb and SIP genes and 100% clinical sensitivity.1

True Flexibility and Full Automation

Run on the Panther Fusion system, this assay offers the benefits of Panther Fusion full automation, high-throughput flexibility and ease of use, allowing for high-volume GBS testing in reference laboratories and hospitals. The Panther Fusion GBS assay and utilizes ready-to-use reagents with 60-day on board stability, eliminating reagent prep and reducing reagent waste. It may be processed, without batching, on the Panther Fusion system with other Aptima® and Panther Fusion® assays for women’s health, virology, respiratory and sexually transmitted infections.

 


* The Panther Fusion SARS-CoV-2 assay has not been FDA cleared or approved: This test has been authorized by FDA under an EUA for use by authorized laboratories; The Panther Fusion SARS-CoV-2 assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Panther Fusion SARS-CoV-2 assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
References: 1. Panther Fusion GBS assay. US package insert AW-17997. Hologic, Inc.; 2018. 2. CDC. Prevention of Perinatal Group B Streptococcal Disease: Revised Guidelines from CDC, 2010. MMWR. 2010;59:RR-10.

Performance You Can Trust

The Panther Fusion GBS assay expands the molecular test menu on the Panther Fusion® system. This assay detects the gram-positive bacterium Streptococcus agalactiae (GBS) in pregnant women so providers can help prevent its transmission to their babies.1 GBS has serious long-term health consequences, including death, in newborns.

A Sensitive Assay for a Distinct Threat

This assay features world-class performance and sensitivity, answering a crucial need for GBS detection. GBS is a serious and sometimes fatal infection that is passed to infants during birth.2 GBS is a leading cause of early-onset neonatal sepsis in the United States, and it can cause sepsis, pneumonia, meningitis and death.2 Antibiotic prophylaxis during delivery can reduce transmission of GBS to babies when administered properly. The Panther Fusion GBS assay helps providers detect GBS in mothers so they can confidently determine if intrapartum prophylaxis is needed.

Intuitive Design for Real-World Need

The CDC states that accurate results are more important than rapid turnaround time for antenatal screening.2 When providers have diagnostic tools with excellent sensitivity and performance, they can deliver the highest level of care. The Panther Fusion GBS assay is a real-time PCR assay for antepartum testing with enriched vaginal and rectal swabs. It features dual-target detection of Cfb and SIP genes and 100% clinical sensitivity.1

True Flexibility and Full Automation

Run on the Panther Fusion system, this assay offers the benefits of Panther Fusion full automation, high-throughput flexibility and ease of use, allowing for high-volume GBS testing in reference laboratories and hospitals. The Panther Fusion GBS assay and utilizes ready-to-use reagents with 60-day on board stability, eliminating reagent prep and reducing reagent waste. It may be processed, without batching, on the Panther Fusion system with other Aptima® and Panther Fusion® assays for women’s health, virology, respiratory and sexually transmitted infections.

 


* The Panther Fusion SARS-CoV-2 assay has not been FDA cleared or approved: This test has been authorized by FDA under an EUA for use by authorized laboratories; The Panther Fusion SARS-CoV-2 assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Panther Fusion SARS-CoV-2 assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
References: 1. Panther Fusion GBS assay. OUS package insert AW-17997. Hologic, Inc.; 2018. 2. CDC. Prevention of Perinatal Group B Streptococcal Disease: Revised Guidelines from CDC, 2010. MMWR. 2010;59:RR-10.
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