Sentosa® SA HSV-1/2 PCR Test

Qualitative assay for the detection of HSV-1 and HSV-2

RELEVANCE

Herpes simplex virus (HSV) is a human pathogen causing lesions of the skin or mucosa. There are two types of HSV: HSV-1 and HSV-2. HSV-1 most commonly causes lesions in the mouth, tongue, lips, pharynx, eyes and other parts of the face. Transmission generally occurs through skin / mucosal contact; it can also be sexually transmitted. In most cases, HSV-2 is the cause of genital herpes and sexual contact is the common route of infection. HSV-2 is also associated with neonate infection.1 In immunocompromised patients such as organ transplant recipients, HSV infection may cause severe mucocutaneous disease or central nervous system infections.2

 

References:

1) Warren T. The Updated Herpes Handbook. Portland, OR: The Portland Press; 2010.
2) Jenkins FJ, et al. Herpesvirus infections in organ transplant recipients. Clin Diagn Lab Immunol. 2003;10(19):1–7.

INTENDED USE

The Sentosa SA HSV1/2 PCR test is a multiplex, real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for use in the detection and differentiation of HSV-1 and HSV-2 DNA in genital or oral swabs in UTMi, EDTA plasma, serum and cerebrospinal fluid (CSF) from patients with signs and symptoms of HSV infections.

This in vitro diagnostic test is validated to be performed on the automated Sentosa SX101 instrument, using the Sentosa SX Virus Total Nucleic Acid Kit v2.0, in conjunction with the Rotor-Gene Q MDx 5plex HRM instrument.

i UTM: Copan Universal Transport Medium System

 

FEATURES AND BENEFITS

  • Combination of various sample materials in one run (EDTA Plasma, Serum, CSF, Swabs, Urine)
    Increases efficiency when detecting different conditions
  • Fast turn-around time and minimal hands-on time
    Reduces human error
  • Broad linear range and low limit of detection
    Aids decision making

PRODUCT FLYERS

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SA HSV-1/2 PCR Test (4x24) CE-IVD 4x24 300064
Sentosa SA HSV-1/2 PCR Test (4x24) RUO 4x24 300066
Sentosa SA HSV-1/2 Qualitative Controls Set (8x3) CE-IVD 8x3 300684
Sentosa SA HSV-1/2 Qualitative Controls Set (RUO) 8x3 300685
Sentosa SA HSV-1/2 Qualitative PCR Test (4x48) RUO 4x48 300670
Sentosa SA HSV1/2 Qualitative PCR Test (4x48) CE-IVD 4x48 300669
Rotor-Gene Q 1 400046
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) CE-IVD 4x24 300042
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) RUO 4x24 300044

DOWNLOADS

For availability in your country, please contact your Vela Diagnostics sales representative.

DOWNLOADS



User Manual
300064 Sentosa SA HSV1/2 PCR Test (4x24) (CE-IVD) V3.0
300042 Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) (CE-IVD) V3.0
400046 Rotor-Gene Q V1.0
400046 Rotor-Gene Q (Supplementary) V1.0
400046 Rotor-Gene Q Installation Guide V1.0
300066 Sentosa SA HSV1/2 PCR Test (4x24) (RUO) V3.0
300043 / 300044 Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x8)/(4x24) (RUO) V2.0
400046 Rotor-Gene Q (Supplementary) V1.0
400046 Rotor-Gene Q V1.0
300064 Sentosa SA HSV1/2 PCR Test (4x24) (CE-IVD) V3.0
400046 Rotor-Gene Q V1.0
400046 Rotor-Gene Q (Supplementary) V1.0
400046 Rotor-Gene Q (Supplementary) V1.0


MSDS
300064 Sentosa SA HSV1/2 PCR Test (4x24) (CE-IVD) V2.1
300042 Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) (CE-IVD) V3.0
300044 Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) (RUO) V2.1
300669 Sentosa SA HSV1/2 Qual PCR Test (4x48) (CE-IVD) V1.0
300670 Sentosa SA HSV1/2 Qual PCR Test (4x48) (RUO) V1.0
300684 Sentosa SA HSV1/2 Qual Controls Set (8x3) (CE-IVD) V1.0
300685 Sentosa SA HSV1/2 Qual Controls Set (8x3) (RUO) V1.0


Product Info
300064 Sentosa SA HSV 1/2 PCR Test (4x24) (CE-IVD) V2.4
300042 Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) (CE-IVD) V3.0
300066 Sentosa SA HSV1/2 PCR Test (4x24) (RUO) V2.3
300044 Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) (RUO) V2.1
300669 Sentosa SA HSV1/2 Qual PCR Test (4x48) (CE-IVD) V1.1
300670 Sentosa SA HSV1/2 Qual PCR Test (4x48) (RUO) V1.1
300684 Sentosa SA HSV1/2 Qual Controls Set (8x3) (CE-IVD) V1.0
300685 Sentosa SA HSV1/2 Qual Controls Set (8x3) (RUO) V1.0
300042 Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) (CE-IVD) V2.1
300064 Sentosa SA HSV 1/2 PCR Test (4x24) (CE-IVD) V2.4
300684 Sentosa SA HSV1/2 Qual Controls Set (8x3) (CE-IVD) V1.0