Rapid Capture System

For high-throughput Hybrid Capture 2 (HC2) assays

Products

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

RCS, Premium Agreement

Cat. No. / ID: 9243588

On-site Rapid Capture System instrument repair, including travel, labor and parts, for a period of one year. Response time of next business day. Includes one Preventive Maintenance or Inspection Service during the Premium Agreement period.

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RCS, Full Agreement

Cat. No. / ID: 9243231

On-site QIAsymphony RGQ instrument repair, including travel, labor and parts, for a period of one year. Response time of two business days. Includes one Preventive Maintenance or Inspection Service during the Full Agreement period.

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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, C_T 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).

Agreement of calibrator and control results of fresh vs. aged reagents
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

The assay performance of reagents was evaluated using freshly prepared reagents vs. reagents that were aged onboard the Rapid Capture System platform at room temperature for a period of 16 hours to simulate 2 work shifts in a laboratory setting. Simulated clinical specimens were tested using 2 Rapid Capture Systems each on 2 days (RCS 1: aged reagents on day 1 and fresh reagents on day 2; RCS 2: fresh reagents on day 1 and aged reagents on day 2). Results were comparable for fresh vs. aged reagents (CI: 95%), indicating that reagents are sufficiently stable when placed onboard the instrument for a period of up to 16 hours.

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).

RCS vs. manual HPV test method: STM patient specimen data (n=1001)
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

Clinical results using the Rapid Capture System were compared with results obtained using the manual method in a multicenter study (N=2270 patients). Patient specimens were collected from 5 collection sites and testing was performed at 3 external sites. The data set consisted of cervical specimens collected in ThinPrep PreservCyt Solution (1269) and Specimen Transport Medium (1001). Confidence interval=95%. LSIL+: low-grade squamous intraepithelial lesion or greater; +: positive; –: negative; ASC-US: atypical squamous cells of undetermined significance; STM: Specimen Transport Medium; WNL: within normal limits.

RCS vs. manual HPV test method: ThinPrep PreservCyt clinical specimen data (n=1269)
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

Clinical results using the Rapid Capture System were compared with those obtained with the manual method in a multicenter study (N=2270 patients). Patient specimens were collected from 5 collection sites, with testing performed at 3 external sites. The data set consisted of cervical specimens collected in ThinPrep PreservCyt Solution (1269) and Specimen Transport Medium (1001). In the results for the ThinPrep PreservCyt Solution, cytology data was unavailable from 4 patients. Confidence interval = 95%. LSIL+: low-grade squamous intraepithelial lesion or greater; +: positive; –: negative; ASC-US: atypical squamous cells of undetermined significance; WNL: within normal limits.

Rapid Capture System vs. manual HPV test method: SurePath specimen data
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

Two comparative tests were performed on separate aliquots of the same processed specimen (within-specimen SurePath result agreement with Rapid Capture System). Specimens were tested using the Rapid Capture System vs. the manual HPV test methods. High positive subset had an RLU/CO of 2.5 or higher. The low negative subset had an RLU/CO of <0.80. Confidence interval = 95%.

See figures

In vitro diagnostic device.

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.