Products
Features
- Streamlines digene HC2 High-Risk HPV and other HC2 DNA tests
- Significant increase in labor savings
- Decreases turn-around time for delivering results to physicians
- Enables the laboratory to increase testing capacity
Product Details
The Rapid Capture System is a semi-automated pipetting and microplate handling system for high-volume sample-throughput testing. This system handles up to 352 specimens and 1 to 4 plates in a single 8 hour shift (competitive productivity comparison of 352 specimens, CT results only; data collected by third party consultants — on file). The Rapid Capture System fits on a standard bench top and is compatible with software that provides LIS interface connectivity.
Performance
The Rapid Capture System (RCS) is CE-IVD marked (see " IVD mark") for use with the digene HC2 High-Risk HPV DNA Test, digene HC2 HPV 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, as well as ThinPrep PreservCyt Solution (Hologic) and BD SurePath Preservative Fluid. 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).
| Overall agreement | Positive agreement | Negative agreement | R2 | Slope | Intercept | Kappa |
|---|---|---|---|---|---|---|
| 100% 96/97 (97.97–100) | 100% 64/64 (97.97–100) | 100% 32/32 (97.97–100) | 0.9936 | 0.97 | 0.47 | 1.0 |
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).
| Cyt. class. | HPV preval. % | Overall + agreement % (n/N) | Strong + region (>2.5) | Overall – agreement % (n/N) | Strong – region (<0.8) |
|---|---|---|---|---|---|
| WNL <30 years | 21% | 99.3% (139/140) 96.1, 100 | 99.1% (112/113) 95.2, 100 | 99.3% (538/542) 98.1, 99.8 | 100% (531/531) 99.3, 100 |
| WNL 30+ years | 15% | 92.0% (23/25)96.1, 100 | 93.8% (15/16)69.8, 99.8 | 100% (143/143) 97.5, 100 | 100% (142/142) 97.4, 100 |
| ASC-US | 65% | 98.1% (51/52)89.7, 100 | 100% (47/47)92.4, 100 | 96.4% (27/28) 81.7, 99.9 | 100% (26/26) 86.8, 100 |
| LSIL+ | 96% | 100% (65/65) 94.5, 100 | 100%(62/62) 94.2, 100 | 66.7% (2/3) 9.4, 99.2 | 66.7% (2/3) 9.4, 99.2 |
| Other | 33% | 100% (1/1) 2.5, 100 | 100% (1/1) 2.5, 100 | 100% (2/2) 15.8, 100 | 100% (2/2) 15.8. 100 |
| All STM | 28% | 98.6% (279, 283) 96.4, 99.6 | 99.2 (237/239) 97.0, 99.9 | 99.2 (712/718) 98.2, 99.7 | 99.9 (703/704) 99.2, 100 |
| Cyt. class | HPV preval. % | Overall + agreement % (n/N) | Strong + region (>2.5) | Overall – agreement % (n/N) | Strong – region (<0.8) |
|---|---|---|---|---|---|
| WNL <30 years | 20% | 96.2% (75/78) 89.2, 99.2 | 100% (64/64) 94.4, 100 | 98.4% (301/306) 96.2, 99.5 | 99.0% (293/296) 97.1, 99.8 |
| WNL 30+ years | 8% | 88.7 (47/53) 77.0, 95.7 | 92.1% (35/38) 78.6, 98.3 | 99.1% (578/583) 98.0, 99.7 | 99.5% (571/574) 98.5, 99.9 |
| ASC-US | 36% | 100% (48/48) 92.6, 100 | 100% (46/46) 92.3, 100 | 96.6% (84/87) 90.3, 99.3 | 96.5% (83/86) 90.1, 99.3 |
| LSIL+ | 77% | 100% (64/64) 94.4, 100 | 100% (62/62) 94.2, 100 | 89.5% (17/19) 66.9, 98.7 | 88.9% (16/18) 65.3, 98.6 |
| Other | 11% | 100% (3/3) 29.2, 100 | 100% (3/3) 29.2, 100 | 100% (24/24) 85.6, 100 | 100% (24/24) 85.8, 100 |
| All PreservCyt Clinical | 20% | 96.4% (238/247) 93.2, 98.3 | 98.6% (211/214) 96.0, 99.7 | 98.5% (1007/1022) 97.6, 99.2 | 98.9% (990/1001) 98.0, 99.4 |
| Positive agreement % (n/N) | Negative agreement % (n/N) | ||
|---|---|---|---|
| All + | High + subset | All – | Low – subset |
| 99.0% (417/421)97.6, 99.7 | 100% (375/375)99.0, 100 | 97.7% (1075/1079) 96.9, 98.7 | 98.7% (1050/1064) 97.8, 99.28 |
See figures
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 pipet 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 handling, precision reagent pipetting with liquid level-sensing tips, incubation at ambient and 65°C temperatures, and washing.
Procedure
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 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, PreservCyt solution, and SurePath Preservative Fluid.
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:
- Specimen pipetting
- Regent dispensing
- Microplate handling
- Microplate mixing
- Microplate incubation
- Microplate washing
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
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:
- High-risk human papillomavirus (HPV) infection
- High-risk and low-risk HPV infections
- Chlamydia trachomatis (CT) infections
- Neisseria gonorrhoeae (GC) infections
Software
The HC2 System Software reports qualitative assay results with a user-friendly interface. Software supports customizable report formats — sorted by plate or specimen, with summary or detailed outputs. All results are tracked by the user ID for auditing and QA. The Rapid Capture System ScriptSelect Software allows users to choose the appropriate protocol and number of tests being run.
The HC2 System Software is compatible with multiple types of bar codes, which saves time and reduces manual entry errors. The software fully interfaces with Laboratory Information Systems (LIS), through which designated users can send patient and QC data to the laboratory network.
Supporting data and figures
In vitro diagnostic device.
Resources
Instrument User Manuals (6)
Software User Guides (1)
Safety Data Sheets (1)