Infectious disease test kit MPX-E

hepatitis Bhepatitis Chepatitis E

Overview
The cobas® MPX‑E is a qualitative in vitro nucleic acid test for use on the cobas® 5800/6800/8800 systems for the direct detection of HIV‑1 group M RNA, HIV‑1 group O RNA, HIV‑2 RNA, HCV RNA, HBV DNA and HEV RNA in human plasma and serum. The test is intended for donor screening (individual or pooled plasma/serum depending on donation type) including whole blood, blood components, organ and tissue donors (individual samples required for cadaveric donors).

Intended use / Applications
The test is intended to screen donor samples for HIV‑1 group M, HIV‑1 group O, HIV‑2, HCV, HBV and HEV in plasma and serum from individual human donors. For whole blood and blood components donations, samples may be tested individually or pooled (aliquots). For cadaveric (non-heart beating) donors, only individual sample screening is permitted.

Key clinical roles
The cobas® MPX‑E can be used as a supplemental test to confirm HIV, HCV or HBV infection for samples repeatedly reactive on CE‑IVD antibody or antigen screening tests when the cobas® MPX‑E result is reactive for the respective pathogen.

Test principle and workflow
The cobas® MPX‑E test is based on automated sample preparation (nucleic acid extraction and purification) followed by real‑time PCR amplification and detection on the cobas® 5800/6800/8800 systems. Nucleic acid and an armored RNA internal control (IC) are simultaneously extracted to provide full process control from extraction through amplification/detection. The assay uses virus‑specific primers selected from highly conserved regions and detection probes labeled with distinct fluorescent reporter dyes to permit simultaneous detection and discrimination of HIV (including dual HIV‑1 group M targets), HCV, HBV, HEV, and the IC.

Automation and pooling
Fully automated on cobas® 5800/6800/8800 systems; results are assigned as non‑reactive, reactive or invalid by the system software and can be reviewed on the instrument, printed or transmitted to a LIMS/result management system. Samples can be tested individually or pooled; if pooling is performed, cobas® Synergy software combined with the Hamilton MICROLAB® STAR/STARlet IVD may be used in a pre‑analytical step (optional).

Controls and process monitoring
The assay includes an armored RNA internal control (IC) added to monitor the entire process and detect potential interference leading to false negatives. In addition, two external controls (positive and negative) are used. Potentially affected samples (e.g., IC failure) are invalidated.

Assay chemistry and contamination control
Reverse transcription and amplification use a thermostable DNA polymerase. The PCR master mix contains dUTP (instead of dTTP) and incorporates AmpErase enzyme (uracil‑N‑glycosylase) to eliminate contaminating amplicons from prior PCR runs during the first thermal step; AmpErase is inactivated above 55°C so newly formed amplicons are not eliminated. For HIV‑1 Group M, two genomic regions (dual target) are amplified.

Detection
Specific detection probes for HIV‑1 (Groups M and O), HIV‑2, HCV, HBV, HEV and IC are each labeled with unique fluorescent reporter dyes and a quencher dye. Cleavage of probes during amplification separates reporter and quencher, generating fluorescent signals measured at defined wavelengths to permit simultaneous detection and discrimination of targets.

Sample types
Human plasma and serum from donors. Pooling permitted for donations of whole blood/blood components where applicable; cadaveric donors only individual testing.

Regulatory / designation
For in vitro diagnostic use.

Ordering / kit variants (examples from product page)

• KIT COBAS 58/68/8800 MPX‑E 480T — Material number: 09917438190 — EAN: 00875197007237
• KIT COBAS 58/68/8800 MPX‑E 192T — Material number: 09917420190 — EAN: 00875197007220

Notes
When used on cobas® 5800/6800/8800 systems, automated data management assigns results and supports review, printing or electronic transfer. The assay is intended for qualitative detection and donor screening workflows.

Technical characteristics / specifications

• Brand: cobas®
• Model: MPX‑E
• Intended analytes: HIV‑1 group M RNA, HIV‑1 group O RNA, HIV‑2 RNA, HCV RNA, HBV DNA, HEV RNA
• Sample types: human plasma and serum
• Platform compatibility: cobas® 5800, cobas® 6800, cobas® 8800 systems
• Technology: fully automated nucleic acid extraction + real‑time PCR (qPCR) with fluorescent probe detection
• HIV‑1 Group M: dual target amplification
• Controls: armored RNA internal control (full process control), external positive and negative controls
• Contamination control: dUTP in master mix and AmpErase (uracil‑N‑glycosylase)
• Pooling: supported for plasma pools (individual testing required for cadaveric donors); optional cobas® Synergy + Hamilton MICROLAB® STAR/STARlet IVD pre‑analytical pooling support
• Kit packaging examples: 480T and 192T kits (see ordering variants)