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The BD MAX™ Vaginal Panel performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
The BD MAX™ CT/GC/TV assay, as performed using the BD MAX System, incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected female endocervical swab specimens and patient-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals.
The HSV-1, HSV-2, VZV, CMV assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), varicella-zoster virus (VZV), and cytomegalovirus (CMV). The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
This assay is intended to aid in the diagnosis of individuals with a clinical presentation consistent with HSV-1, HSV-2, VZV, and/or CMV.
The Vaginitis (VAG) Panel is a comprehensive laboratory-developed test designed for the semi-quantitative detection of a wide array of pathogens commonly responsible for vaginal infections. It assists in the detection of the following targets:
The HPV Genotyping Test targets the following HPV types:
• HPV16
• HPV18
• HPV45
• HPV31
• HPV33
• HPV51
• HPV39
• HPV35
• HPV52
• HPV68
• HPV59
• HPV56
• HPV66
• HPV58
Coming soon.