Background
Molecular vaginitis testing may involve the simultaneous detection of microorganisms associated with bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. These conditions can present with overlapping symptoms and may also occur as co-infections or polymicrobial imbalances, adding complexity to analytical interpretation.
In this context, independent assay performance verification is particularly relevant. Manufacturer internal controls or previously characterized positive specimens may be limited, insufficiently standardized, or unable to reflect the complexity of vaginal microbiota profiles. An external panel with different microbiological configurations helps laboratories assess whether the molecular workflow can detect clinically relevant target combinations.
Product information
AMPLIRUN® TOTAL Vaginal Panel Control is a multi-panel control set designed to simulate different vaginal microbiota profiles, ranging from normal flora dominated by Lactobacillus crispatus to mixed clinical scenarios including Candida, Trichomonas vaginalis, Atopobium vaginae, and bacterial vaginosis-associated microorganisms.
The product includes 2 x 5 lyophilized vials. Each panel represents a different microbiological condition:
- Vial 1: normal flora with Lactobacillus crispatus
- Vial 2: normal flora with Candida albicans
- Vial 3: normal flora with Atopobium vaginae
- Vial 4: bacterial vaginosis profile with Lactobacillus crispatus, Trichomonas vaginalis, Gardnerella vaginalis, and Atopobium vaginae
- Vial 5: bacterial vaginosis plus Candida profile with Candida krusei, Gardnerella vaginalis, and Atopobium vaginae
The complete inactivated microorganisms are provided in a matrix that mimics a human vaginal swab sample and includes human epithelial cells for a more representative extraction process. The material is quantified at a low positive concentration, with lot-specific concentrations provided in the Certificate of Analysis. Its design makes it suitable for assay verification, performance assessment, lot-to-lot comparison, and evaluation of molecular workflows challenged by polymicrobial profiles.
PRODUCTS
AMPLIRUN TOTAL VAGINAL PANEL CONTROL (SWAB)
HOW IT WORKS
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