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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

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

*Refer to Package Insert for additional performance claims.

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
M210

Assay Kit

16 tests
M109

Quidel Molecular HSV 1+2 Control Set

1 mL

CLIA Status

Helicase Dependent Amplification Video