AmpliVue HSV 1+2_微生物检测_药物检测仪器_仪器设备库_商城

货号：	QD-005
保存条件：	详见官方网站
供应商：	钰博生物
保质期：	详见说明书
英文名：	AmpliVue HSV 1+2
数量：	大量

AmpliVue HSV 1+2

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.

Features & Benefits

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

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 10⁵ TCID₅₀/mL; HSV-2: 1.1 x 10⁴ TCID₅₀/mL