Qiagen, 9001932, HC2 RCS Upgrade Instrument Package

Upgrade package for existing HC2 customers, including: installation of Rapid Capture System and HC2 System on existing validated hardware

Features

- Streamlines digene HC2 High-Risk HPV and HC2 CT/GC DNA tests
- Significant increase in labor savings
- Decreases turn-around time for delivering results to physicians
- Enables the laboratory to increase testing capacity

Performance

Overall agreement: Positive agreement
100% 96/97 (97.97–100): 100% 64/64 (97.97–100)

Cyt. class.: HPV preval. %
WNL <30 years: 21%
WNL 30+ years: 15%
ASC-US: 65%
LSIL+: 96%
Other: 33%
All STM: 28%

Cyt. class: HPV preval. %
WNL <30 years: 20%
WNL 30+ years: 8%
ASC-US: 36%
LSIL+: 77%
Other: 11%
All PreservCyt Clinical: 20%

The Rapid Capture System (RCS) is FDA-approved (see IVD mark ) for use with the digene HC2 High-Risk HPV DNA Test, digene HC2 CT/GC DNA Test, digene HC2 CT-ID DNA Test, and the digene HC2 GC-ID DNA Test. The system processes cervical samples collected in Specimen Transport Medium (STM), which is part of the digene Cervical Sampler. Other digene tests or sample types may be available for use on the RCS, depending on country regulations.

Onboard reagent stability

The RCS provides reagent stability of 16 hours for those reagents most likely to be subject to extended onboard placement — Probe Mix, Detection Reagent 1, Detection Reagent 2, and the Capture Plates (see table).

Agreement of Rapid Capture System vs. manual HPV test methods

The Rapid Capture System HPV application results show agreement with the manual method in clinical specimens. Statistical agreement was shown for cervical specimens collected in ThinPrep PreservCyt solution and STM (see tables).

Principle

The Rapid Capture System reduces repetitive manual steps, with technology that performs semi-automated assays. The system is designed to work with the Hybrid Capture 2 screening technology, and it is the only high-throughput system for testing cervical samples with the FDA-approved digene HC2 High-Risk HPV DNA Test. The Rapid Capture system provides the flexibility of multiple software scripts, allowing laboratories to adjust their schedules to improve workflow.

Specimen contamination or carryover of residual alkaline phophotase is minimized through the use of disposable pipette tips for reagent and specimen aspiration. The system automates sample transfers (from sample tubes to hybridization plate, then from hybridization plate to Capture Plate), plate handline, precision reagent pipetting with liquid level-sensing tips, incubation at ambient and 65°C temperatures, and washing.

Procedure

- Specimen pipetting
- Regent dispensing
- Microplate handling
- Microplate mixing
- Microplate incubation
- Microplate washing

Multiple assays for flexible workflows

The Rapid Capture System (RCS) accommodates multiple assays or sample types during a single run — enabling scheduling flexibility. For instance, when running a single run of the digene HC2 High-Risk HPV DNA Test on the RCS, separate plates can handle both liquid based cytology (LBC) samples and digene cervical samples.

The Rapid Capture System can be used with the digene HC2 High-Risk HPV DNA Test, digene HC2 CT-ID DNA test, and digene HC2 GC-ID DNA Test. Depending on the test, the specimens can be collected using the digene Cervical Sampler, Specimen Transport Medium (STM), digene Female Swab Specimen Collection Kit, and PreservCyt solution.

High-throughput design for optimized workflow

The Rapid Capture System performs up to 352 tests/8 hours, automating 6 procedural steps of the manual method:

User intervention is limited to specimen preparation, loading of specimen racks onto the deck, deck setup, chemiluminescent signal detection, and result reporting. Denaturation of the specimens in preparation for testing with the digene HC2 DNA Tests is performed independently of the Rapid Capture System. In addition, amplified chemiluminescent signal detection and result reporting are performed using the offline DML 2000/3000 Instrument and using the digene Hybrid Capture System Version 2 (DHCS v.2) Software.

The Rapid Capture System is intended to be used only in combination with QIAGEN kits indicated for use with the Rapid Capture System for applications described in the kit handbooks.

Applications

- High-risk human papillomavirus (HPV) infection
- Chlamydia trachomatis (CT) infections
- Neisseria gonorrhoeae (GC) infections

A range of digene HC2 DNA Tests enable high-throughput detection of pathogens using the Rapid Capture System. Using kits for Hybrid Capture applications, the Rapid Capture System automates detection of: