Dengue fever test kit cobas® CHIKV/DENV

chikungunyaviruschikungunya

Overview cobas® CHIKV/DENV for use on the cobas® 6800/8800 Systems is a qualitative in vitro nucleic acid test for direct detection of chikungunya virus (CHIKV) RNA and dengue virus (DENV) serotypes 1–4 RNA in human plasma. The assay integrates automated sample preparation, PCR amplification and real-time detection on the cobas® 6800/8800 platforms. Results are reported by system software as non-reactive, reactive, or invalid.

Intended use Intended for screening donor plasma samples for CHIKV RNA and/or DENV RNA, including individual donor screening of whole blood and blood components, screening of organ and tissue donors when samples are obtained from living donors, and pooled testing of plasma aliquots. Not for use with cord blood samples and not intended as a diagnostic aid.

Key features

• Qualitative detection of CHIKV and DENV (serotypes 1–4) RNA in human plasma
• Optimized for fully automated workflow on cobas® 6800/8800 Systems (sample supply, transfer, processing and analytic modules)
• Automated data management and result assignment by cobas® 6800/8800 software
• Supports individual or pooled plasma testing; optional pre-analytical pooling with cobas p 680 instrument or cobas® Synergy Software with Hamilton MICROLAB® STAR IVD
• Includes armored RNA internal control (IC) and external positive/negative controls
• CE-IVD kit sized for 480 tests (KIT C68/88 CHIKV/DENV 480T)
• For in vitro diagnostic (IVD) use

Sample handling and controls The assay requires human plasma specimens. An armored RNA internal control is co-extracted to monitor extraction and amplification performance. Two external controls (positive and negative) are used to monitor run performance. The assay is not validated for cord blood samples.

Automated extraction and purification Viral nucleic acids are released by proteinase and lysis reagents, then captured on silica-coated magnetic glass particles. Wash steps remove unbound substances and inhibitors; purified nucleic acids are eluted at elevated temperature. Extraction and purification are fully automated on the cobas® 6800/8800 platforms.

Amplification and detection Target-specific primers amplify conserved regions of CHIKV and DENV genomes. A thermostable polymerase performs reverse transcription and PCR. The master mix incorporates dUTP and uracil-N-glycosylase (AmpErase) to reduce carry-over contamination. Three fluorescent probes detect CHIKV, DENV and the internal control simultaneously, with reporter signals measured at defined wavelengths.

Performance and result reporting cobas® 6800/8800 Systems automatically process, analyze and assign results as non-reactive, reactive, or invalid. Results are reviewable on the system interface and printable. The assay is intended for qualitative donor screening applications.

References and assay design notes Design and contamination-control practices follow standard molecular diagnostics approaches, including use of uracil-N-glycosylase and probe-based real-time PCR chemistries. Relevant literature and validation data are cited in product documentation.

Additional product identifiers and regulatory status CE-IVD; Product ID: RMD-6800-8800-CHIKV-001; Kit: KIT C68/88 CHIKV/DENV 480T (480 tests).

Technical specifications

• Intended analytes: CHIKV RNA; DENV serotypes 1–4 RNA
• Specimen type: Human plasma (individual or pooled aliquots)
• Not for use: Cord blood; not intended as a diagnostic aid
• Platform: cobas® 6800/8800 Systems (automated extraction, amplification, detection)
• Controls: Armored RNA internal control; external positive and negative controls
• Kit size: 480 tests (KIT C68/88 CHIKV/DENV 480T)
• Regulatory: CE‑IVD
• Product ID / model: RMD-6800-8800-CHIKV-001
• Methodology: Automated nucleic acid extraction (silica magnetic glass particles), RT‑PCR amplification, probe-based fluorescent detection with three reporter dyes
• Contamination control: dUTP incorporation and AmpErase (uracil‑N‑glycosylase)
• Result interpretation: System software assigns non‑reactive, reactive, or invalid