GBS Test: Advanced Molecular Diagnostic Product Profile

The GBS Test represents a significant leap forward in the realm of molecular diagnostics, providing an advanced nucleic acid microarray-qPCR test for the qualitative detection of Group B Streptococcus (GBS). This sophisticated test is suitable for use in a clinical setting to analyze samples from patients irrespective of symptomatic presentation.

Clinical Utility: This in vitro diagnostic assay facilitates the qualitative detection of GBS bacterial DNA, with applications in a variety of clinical scenarios. Intended for use with the FlashDx-1000-E system or analogous platforms, the GBS Test plays a crucial role in the clinical decision-making process, augmenting patient history and other diagnostic evaluations. It is essential to note that while the presence of GBS DNA can be determined, these results should be interpreted in the context of broader clinical findings.

Operational Principle: The GBS Test utilizes an in vitro diagnostic approach with a disposable cartridge designed for single use, containing reagents prepped for the entire workflow—from sample introduction to DNA amplification and final detection. The test’s design minimizes cross-contamination risk, thereby maintaining sample integrity throughout the process. The methodology employs a microarray with specific probes that bind to targeted GBS DNA sequences, allowing for accurate detection through amplification patterns akin to those observed in real-time qPCR assays.

Genetic Detection Focus: Focusing on the cfb and sip gene sequences of Streptococcus agalactiae, the GBS Test is engineered with precision to ensure specificity. The inclusion of human RNase P gene components serves as an internal procedural control, underpinning the assay’s reliability from sample processing to signal detection.

User Guidelines: The design of the GBS Test emphasizes operational ease. The user transfers the sample into the cartridge and initiates the automated process. The system seamlessly conducts sample processing, DNA amplification, and signal detection, concluding with an auto-generated analysis of the fluorescence signals corresponding to the DNA amplification events.

Storage and Maintenance: The cartridges are to be stored within a temperature range of 2-8°C to preserve reagent efficacy. The integrity of the cartridge’s pouch is paramount; once opened, the cartridge should be used within a specified time frame to guarantee optimal performance.

Conclusion: The GBS Test encapsulates the precision and efficiency demanded in modern molecular diagnostics. It is a cornerstone in the rapid detection of GBS, bolstering clinical workflows and enhancing patient care through timely and accurate diagnostics.