Infectious disease test kit cobas® BV/CV

diagnosticfor bacterial vaginosisobstetrical/gynecological

Overview
cobas® BV/CV is a qualitative multiplex real-time PCR in vitro diagnostic assay for the direct detection of bacterial and Candida targets associated with bacterial vaginosis (BV) and candida vaginitis (CV). The assay runs on cobas® 5800, cobas® 6800 and cobas® 8800 systems and is supplied as kits providing 192 tests.

Intended use
For in vitro diagnostic use. Intended as an aid in the diagnosis of BV and/or CV in symptomatic individuals presenting with signs consistent with vaginitis, vaginosis, or both.

Key features

• Fully automated workflow: nucleic acid extraction, purification, PCR amplification and real-time detection.
• Simultaneous extraction of sample nucleic acid and internal control DNA (DNA‑IC).
• Multiplex real-time PCR with target‑specific primers and probes across multiple fluorescent channels.
• dUTP/AmpErase enzymatic contamination control to reduce carry‑over amplicon contamination.
• System software assigns results as positive, negative or invalid; results can be reviewed, exported or printed.

Detected organism targets (assay does not differentiate which specific organism(s) is present)
BV-associated (bacterial vaginosis):

• Gardnerella vaginalis (G. vaginalis)
• Lactobacillus species (examples detected: L. crispatus, L. gasseri, L. jensenii)
• Atopobium vaginae (A. vaginae)

CV-associated (candida vaginitis):

• Candida albicans (C. albicans)
• Candida dubliniensis (C. dubliniensis)
• Candida glabrata (C. glabrata)
• Candida krusei (C. krusei)
• Candida tropicalis (C. tropicalis)
• Candida parapsilosis (C. parapsilosis)

Sample types

• Clinician‑instructed self‑collected vaginal swab specimens (collected in cobas® PCR Media)
• Clinician‑collected vaginal swab specimens (collected in cobas® PCR Media)

Workflow / Principle
Samples are lysed, nucleic acids bind to silica-coated magnetic glass particles, impurities and inhibitors are removed by wash steps, and purified nucleic acid is eluted. Target‑specific primers and probes enable selective amplification and real‑time fluorescent detection across target channels.

System compatibility and automation

• Compatible with cobas® 5800 (single integrated instrument).
• Compatible with cobas® 6800 and cobas® 8800 (modular systems for sample supply, transfer, processing and analysis).
• Automated data management and result assignment performed by system software.

Kit configuration and packaging

• Kit reference: KIT COBAS 5800/6800/8800 BV/CV 192T IVD (192 tests per kit).
• Product type: Reagents, kits; 1 kit = 192 tests.

Regulatory / Quality
For in vitro diagnostic (IVD) use. Product information indicates an ACT Ecolabel assessment displayed on the product site.

Applications
Qualitative detection of organisms associated with BV and CV to support diagnostic evaluation of symptomatic patients.

Technical specifications

• Brand: cobas®
• Model/Commercial name: cobas® BV/CV
• Product ID: PID00001231
• Intended use: Qualitative in vitro nucleic acid test to aid diagnosis of BV and/or CV in symptomatic individuals
• Assay type: Qualitative real‑time PCR assay
• Technology: Automated nucleic acid extraction (magnetic glass particles) and probe‑based real‑time PCR
• Sample types: Clinician‑instructed self‑collected vaginal swab; clinician‑collected vaginal swab (collected in cobas® PCR Media)
• Targets: Multiple bacterial and Candida species associated with BV and CV
• Kit size: 192 tests per kit
• EAN: 00875197007497
• Regulatory status: IVD
• Compatible systems: cobas® 5800, cobas® 6800, cobas® 8800
• Result output: Positive, negative or invalid (assigned by system software)