MultiCode®-RTx HSV 1&2 Kit

Real-Time PCR Qualitative Detection and Typing of HSV-1 or HSV-2

Overview

HSV is a common human pathogen found worldwide which produces a wide variety of diseases. HSV infects neonates, children and adults, and, by the fourth decade, more than 90% of the adult population demonstrates antibodies to HSV.1 HSV transmission can result from direct contact with infected secretions from either a symptomatic or an asymptomatic host.

Herpes simplex virus has been characterized into 2 distinct serotypes: HSV-1 and HSV-2. HSV-1 is generally associated with infection in the tongue, mouth, lips, pharynx and eyes, whereas HSV-2 is primarily associated with genital and neonate infection.

Viral isolation, direct fluorescent antibody (DFA) testing, and serology can be used to diagnose HSV infections. Positive culture and DFA are the most definitive and viral isolation allows typing of the viral isolate. However, length of culture time, specimen collection and transport difficulties, procedural complexity, and other variables are associated with DFA and culture.1, 2

Studies have shown that nucleic acid amplification tests such as PCR are more sensitive than viral isolation and antigen detection methods for the detection of HSV from a variety of sites.3-5

The MultiCode-RTx HSV 1&2 Kit utilizes real-time PCR molecular detection. MultiCode-RTx technology site-specifically incorporates an isoG triphosphate, covalently attached to a DABCYL quencher, opposite an isoC base that is adjacent to a 5' fluorescent label in one of the primers. MultiCode-RTx technology does not require probes because specific amplification during PCR can be measured by a decrease in fluorescence.

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

References:

  1. Aurelian, L. Herpes Simplex Viruses. 473-497. In Specter, S & G Lancz (eds.). Clinical Virology Manual. 2nd Ed. Elsevier, New York. (1992).
  2. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR 2002:5 1 (No. RR-6).
  3. Arvin, A. C. Prober. Herpes Simplex Viruses. 876-883. In Murray, P., E. Baron, M. Pfaller, F. Tenover, and R. Yolkenet (eds.). Manual of Clinical Microbiology. 6th Ed. ASM, Washington, D.C. (1995).
  4. Koenig M, K. S. Reynolds, W. Aldous, and M. Hickman. 2001. Comparison of Light-Cycler PCR, enzyme immunoassay, and tissue culture for detection of herpes simplex virus. Diagn. Microbiol. Infect. Dis. 40(3):107-10.
  5. Filén F., A. Strand, A. Allard, J. Blomberg, and B. Herrmann. 2004. Duplex real-time polymerase chain reaction assay for detection and quantification of herpes simplex virus type 1 and herpes simplex virus type 2 in genital and cutaneous lesions. Sex. Transm. Dis. 31(6):331-6.

 

 

 

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Description

The MultiCode-RTx HSV 1&2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV1&2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.

Features

  • Probe-free, MultiCode-RTx technology for real-time PCR detection and typing of HSV DNA from vaginal lesion swabs
  • Same day results for rapid turnaround time
  • Streamlined workflow simplifies implementation for both large and small laboratories
  • Utilizes commonly available instrumentation for extraction and PCR
  • Established sensitivity and specificity1
  • Reproducibility: overall agreement of 99.7%1
  • Includes Sample Processing Control for monitoring extraction and amplification
  • MultiCode-RTx HSV 1&2 Kit Software for automatic analysis and result reporting

Warning: The device is not FDA-cleared for use with cerebral spinal fluid (CSF) or any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening or for females under the age of 18 years.

 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

References:

    1. MultiCode-RTx HSV 1&2 Kit Package Insert, Version 6, August 2011.

 

 

 

 

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MultiCode-RTx Software

The MultiCode-RTx HSV 1&2 Kit Software is a powerful, easy-to-use software package that is used to interpret Luminex’s MultiCode-RTx HSV 1&2 Kit data generated on the LightCycler® 1.2 instrument. The software automatically determines results for the specimens based on the amplification cycle threshold (Ct) and the melting temperature (Tm).

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

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Downloads

Document Language Download
MSDS
   
MSDS (click to search database)    
Package Insert    
MultiCode-RTx HSV1&2 Kit Package Insert English download
Qualified Ancillary Reagents
   
Qualified Ancillary Reagents for IVD English download
Brochures    
MultiCode-RTx HSV1&2 Kit Brochure English download
MultiCode Technology Sheet English download
Certificates of Analysis (CA)    
Certificates of Analysis (click to search database)    
Certificates of Conformance (CC)    
Certificates of Conformance (click to search database)    

 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

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Support Information

Luminex offers comprehensive support to aid companies and laboratories to obtain quick, accurate and cost-effective results while optimizing the Luminex customer experience.

Technical Support Contact Information
Customer Support Center: 1-877-785-2323 (Press 3, then 7)
Email: [email protected]
1224 Deming Way
Madison, WI 53717-1944 USA

 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

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Ordering Information

Luminex Direct

Luminex Customer Service
Email: [email protected]
Phone: 608-662-9000
Toll Free: 866-327-3290
Fax: 608-662-9185
1224 Deming Way
Madison, WI 53717-1944 USA

 

Product Name Part Number
MultiCode-RTx HSV 1&2 Kit 3711
MultiCode-RTx HSV 1&2 Kit Analysis Software and Package Insert 3712
Instructions for Use 4042

 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

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