CDIA™ HSV 1/2 (Mucocutaneous Lesions Swab) Rapid Test - Creative Diagnostics

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Infectious Disease Tests | HSV (herpesvirus) |

CDIATM HSV 1/2 (Mucocutaneous lesions swab) Rapid test (DTSXYZ14)

Intended Use

The HSV 1/2 (Mucocutaneous lesions swab) Rapid test Device is a rapid visual immunoassay for the qualitative presumptive detection of HSV 1 and 2 antigen in cutaneous specimens. This kit is intended to be used as an aid in the diagnosis of HSV infection.
  • Mucocutaneous lesions swab
  • Kit
  • 89.1%
  • 95.9%

Product Introduction

General Description

HSV is an envelop, DNA-containing virus morphologically similar to the other members of the genus Herpesviridae. Two antigenically distinct types are recognized, designated type 1 and type 2. HSV type 1 and 2 are frequently implicated in superficial infections of the oral cavity, the skin, the eye and the genitalia. After the primary infection been resolved, the virus may exist in a latent form in nervous tissue, from where it may re-emerge, under certain conditions, to cause a recurrence of the symptoms. This novel antigen test can differentiate other genital ulcer diseases with genital herpes, such as syphilis and chancroid, to help the early diagnosis and therapy of HSV infection.


The HSV 1/2 (Mucocutaneous lesions swab) Rapid test Device has been designed to detect HSV antigen through visual interpretation of color development in the internal strip. The membrane was immobilized with anti Herpes simplex virus monoclonal antibody on the test region. During the test, the specimen is allowed to react with colored monoclonal anti-HSV antibody colored particles conjugates, which were pre-coated on the sample pad of the test. The mixture then moves on the membrane by capillary action, and interacts with reagents on the membrane. If there were enough HSV antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. 

Reagents And Materials Provided

1. 20 Individually packed test devices: Each device contains a strip with colored conjugates and reactive reagents pre-coated at the corresponding regions.

2. 2 bottle of Extraction Buffer-10 ml: 0.1 M Phosphate buffered saline (PBS) and 0.02% sodium azide. 

3. 20 Extraction tubes: For specimens preparation use. 

4. 2 Workstation: Place for holding buffer vials and tubes.

5. 1 Package insert: For operation instruction. 

6. 1 Positive control swab (on request only): Contain inactived HSV type II and sodium azide. For external control. 

7. 1 Negative control swab (on request only): Not contain HSV type I&II. For external control.

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