商品编号


M210



品牌


Quidel



公司


Quidel,inc.



公司分类


AmpliVue



Size

16 tests

商品信息

Description:
Assay Kit
Features & Benefits:






The AmpliVue HSV 1+2 Assay is an
in vitro
diagnostic test for the qualitative detection and differentiation of Herpes simplex virus type 1 (HSV-1) and Herpes simplex virus type 2 (HSV-2) nucleic acids isolated from cutaneous and mucocutaneous lesions of symptomatic patients.

The assay consists of three major steps: (1) specimen preparation (one-step dilution), (2) isothermal Helicase-Dependent Amplification (HDA) of target amplicons specific to HSV-1 and HSV-2, and (3) detection of the amplified DNA by target-specific hybridization probes via a colorimetric reaction on a lateral-flow strip which is embedded in a self-contained disposable cassette to prevent amplicon contamination.

Specimen preparation involves a simple one step dilution in which specimens in viral transport medium are added to a dilution tube.?The diluted sample is transferred into Reaction Tube containing lyophilized mix of HDA reagents including primers specific for the amplification of HSV-1 and HSV-2. Competitive amplification of the process control DNA takes place unless amplification inhibitory substances are present or the sample processing fails.

After completion of the HDA reaction, the Reaction Tube is transferred to a Cassette for rapid detection with the test result displayed as test and/or control lines in the window of the Cassette. The dual-labeled probe-amplicon hybrid is then detected by the lateral flow strip within the Cassette. The HSV-1 amplicon is captured at the T1-Line and HSV-2 amplicon is captured at the T2-Line, while the process control amplicon is captured at the C-Line.?The Biotin in the amplicon-probe complexes captures the streptavidin-conjugated color particles for visualization and the molecular test result is shown as colored lines that are visually read.










Feature
Benefit



Small, self-contained hand-held cassette
No isolation room needed

Convenient, easy-to-use, disposable device



HDA technology
Rapid method of nucleic acid amplification that does not require thermal cycler



Lyophilized Master Mix reagent
Easy-to-use format, just rehydrate with diluted sample.



Small easy-to-use heat blocks
Eliminates need for dedicated molecular space and costly capital equipment. Allows for testing in smaller labs.



CLIA moderately complex
Requires minimal training



Refrigerated storage
No freezer needed. 2°C to 8°C storage.



Long shelf life
24 months from date of manufacture



Room temperature set up
No ice or cooling block required












Product Specifications:




Product Spec Name
Product Spec Data



Sample Type
Cutaneous and mucocutaneous lesion specimens from symptomatic patients



Time to results
Approximately 60 minutes



Reagent storage conditions
2°C to 8°C Dilution and Reaction Tubes; 2°C to 30°C Amplicon Cartridge and Detection Cassette



Controls storage conditions
2°C to 8°C



Sample preparation storage conditions
20°C to 25°C for 1 hour prior to testing; 2°C to 8°C for 8 hours; and 1 month at –20°C to –70°C



HSV-1 Sensitivity*
Cutaneous Lesions – 100% (95% CI 88.6% to 100%); Mucocutaneous Lesions – 94.9% (95% CI 90.3% to 97.4%)



HSV-1 Specificity*
Cutaneous Lesions – 97.1% (95% CI 94.6% to 98.5%); Mucocutaneous Lesions – 96.5% (95% CI 94.8% to 97.7%)



HSV-2 Sensitivity*
Cutaneous Lesions - 98.3% (95% CI 91.0% to 99.7%); Mucocutaneous Lesions - 97.4% (93.4% to 99.0%)



HSV-2 Specificity*
Cutaneous Lesions: 95.6% (95% CI 92.8% to 97.3%); Mucocutaneous Lesions: 95.8% (94.2% to 97.0%)



LOD*
HSV-1: 1.1 x 10
5
TCID
50
/mL; HSV-2: 1.1 x 10
4
TCID
50
/mL








*Refer to Package Insert for additional performance claims.