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VERSANT HCV Genotype 2.0 Products (LiPA)

VERSANT HCV Genotype 2.0 Products (LiPA)Designed to identify and correctly detect multiple genotypes and subtypes

VERSANT^® HCV Genotype 2.0 Products (LiPA) provide improved accuracy in identification of HCV genotype and subtype data for optimal patient therapy. Improve your efficiency with fully automated strip processing and an integrated system from amplification to interpretation.

Improved efficiency—scalable strip processing automation: up to 48 tests with the Auto-LiPA 48; up to 10 tests with the Tendigo
Ease of use—fully automated strip processing requiring minimal hands-on time
Convenient Line Probe Assay (LiPA)* format—standardized, globally recognized LiPA format
Enhanced confidence in results—updated interpretation chart includes decreased number of undetermined subtypes and rare genotype/subtype patterns

Auto-LiPA 48 Instrument - High Volume

Features & Benefits

VERSANT^® HCV Genotype 2.0 Products – a simple and standardized method for HCV genotype and subtype detection. Learn more about how your lab can benefit from VERSANT HCV Genotype 2.0 Products.

Line Probe Assay (LiPA) Automation
Multiple throughput options to fit needs and volume requirements of small to large labs.

Improved Genotype/Subtype Performance
Overall performance data is comparable to NS5b sequencing. Identifies all 6 genotypes and more than 19 different subtypes. It is the only commercially available assay able to detect 6 (c-l). The addition of HCV Core region data to the assay allows more accurate differentiation of subtypes 1a and 1b, and more accurate identification of Genotype 6 (subtypes c-l).

LiPA Scan HCV Interpretation Software
Provides automation of strip interpretation and thus reduces the chance of operator error.

One Step RT-PCR
Easy-to-use for increased laboratory efficiency with a simple, complete, 1-step RT-PCR kit that can be used on commonly available thermocyclers.

Reduces hands-on labor and accelerates test reporting with complete walk-away processing of VERSANT® LiPA strips.

Assay Performance Data***
Characteristic	Result after initial testing	Result after repeat testing
Amplification (% of samples successfully amplified)	97.80%	99.70%
Accuracy (% of samples with correct genotype)	99.30%

*** Internal Evaluation Studies: 325 HCV-positive samples (Genotypes 1-6, Viral Loads – 2,173 IU/mL – 8,700,000 IU/mL versus reference method of NS5b Sequencing)

Assays

Technical Specifications

Hardware:
Auto-LiPA 48 Genotyping Instrument (Strip Processor)
Tendigo Genotyping Instrument (Strip Processor)

Reagents:
VERSANT^® HCV Genotype 2.0 Assay (LiPA)
VERSANT^® HCV Amplification 2.0 Kit (LiPA)
VERSANT^® HCV Control 2.0 Kit (LiPA)

Software:
LiPA Scan HCV Interpretation Software

Auto-LiPA 48 instrument

Specification	Description
General
Display unit	Liquid Crystal Display with 2 rows of 16 digits
Keyboard	4-key membrane keyboard
Number of dispensing channels	6 (7^th optional)
Capacity of reagent bottles	4 x 250 mL 2 x 500 mL 1 x 1000 mL 1 x 2000 mL 1 x 2500 mL 1 x 3000 mL
Computer Interface	Serial RS 232 C, 9600 Baud, USB
Incubation temperature	Adjustable between 35°C and 65°C
Volume of reagent dispensed	250 - 3000 µL steps
Dispensing accuracy	Less than or equal to 10%
Cooling	Temperature < 30°C within 6 min
Power
Supply	Auto-sensing for settings 100 - 120 Volt and 220 - 240 Volt 50 or 60 Hz
Main fuses	2 x T 8A / 250V (Slow Blow)
Consumption	Max. 900 VA
Physical
External dimensions	Closed Width: 804 mm/31" Height: 460 mm/18" Depth: 459 mm/18" Open: Width: 804.0 mm/31" Height: 671.4 mm/26" Depth: 510.6 mm/20"
Weight	47 kg

Services & Support

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* CE-marked in the EU. FDA-approved in the U.S.

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.