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MultiCode®-RTx HSV 1&2 Kit

MultiCode-RTx HSV 1&2 Test Kit

Improve your sensitivity and specificity while streamlining your HSV testing workflow

MultiCode®-RTx HSV 1&2 Kit

 

The MultiCode®-RTx HSV 1&2 Kit is the first FDA-cleared, PCR-based IVD test for detection and typing of herpes simplex virus 1 and 2 (HSV-1 and HSV-2) in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.. It uses real-time PCR molecular detection to improve sensitivity and specificity over traditional culture methods. Gain confidence in your results and save time with the MultiCode-RTx HSV 1&2 Kit.

 

Herpes Simplex Virus (HSV) Background

 

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 two 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 neonatal 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

 

Click here to learn more about MultiCode®-RTx Technology.

 

Software

 

The MultiCode-RTx HSV 1&2 Kit software is a powerful, easy to use software package that interprets the sample data. The software automatically determines results from the specimens based on the amplification cycle threshold (Ct) and the melting temperature (Tm) for differential detection of HSV-1 and HSV-2.

Same day results for rapid turnaround time

Our novel chemistry can streamline assay workflow—reducing turnaround time in the laboratory.
 

Established sensitivity and specificity

Melt curves allow confirmation of target amplification and detection of multiple analytes.
 

Reproducibility: overall agreement of 99.7%

Reproducible and reliable detection coupled with sample processing controls to monitor your sample extraction through analysis.

Clinical Performance: Results from a Prospective Clinical Study

 

Herpes Simplex Virus Type 1 Comparison Results
Reference Methoda
    Positive Negative Total
MultiCode-RTx HSV 1&2 Kit Positive 97 16b 113
Negative 8c 920 928
Total 105 936 1041
  Value 95% CI
Sensitivity 92.4% 85.7%-96.1%
Specificity 98.3% 97.2%-98.9%
a. Cell culture based ELVIS® HSV ID/Typing Test System.
 
b. Sequence analysis detected HSV-1 in 12 of the 16 discordant samples identified as HSV-1 by MultiCode-RTx. Sequence analysis did not detect HSV-1 in 4 of the discordant samples.
 
c. Sequence analysis detected HSV-1 in 1 of the 8 discordant samples identified as HSV-1 negative by MultiCode-RTx. Sequence analysis did not detect HSV-1 in 7 of the discordant samples. Of these 7 discordant samples: 4 of the samples were identified as HSV-2 by both MultiCode-RTx and sequencing, 2 of the samples were negative by MultiCode-RTx and not detected by sequencing, and 1 sample was negative by MultiCode-RTx and HSV-2 positive by sequencing.

 

 

Herpes Simplex Virus Type 2 Comparison Results
Reference Methoda
    Positive Negative Total
MultiCode-RTx HSV 1&2 Kit Positive 198 53b 251
Negative 10c 780 790
Total 208 833 1041
  Value 95% CI
Sensitivity 95.2% 91.4%-97.4%
Specificity 93.6% 91.8%-95.1%
a. Cell culture based ELVIS® HSV ID/Typing Test System.
 
b. Sequence analysis detected HSV-2 in 43 of the 53 discordant samples identified as HSV-2 by MultiCode-RTx. Sequence analysis did not detect HSV-2 in 10 of the discordant samples.
 
c. Sequence analysis detected HSV-2 in 2 of the 10 discordant samples identified as HSV-2 negative by MultiCode-RTx. Sequence analysis did not detect HSV-2 in 8 of the discordant samples. These 8 samples were identified as HSV-1 by both MultiCode-RTx and sequencing.

 

 

Please see the Package Insert for more detailed information.

MultiCode-RTx HSV 1&2 Workflow

 

Detection and typing of HSV 1&2 is completed in less than four hours.

 

MultiCode®-RTx HSV 1&2 Kit Workflow

 

The workflow for the MultiCode-RTx HSV 1&2 Kit is simple—making implementation easy. Our amplification and sample processing controls provide reliable detection from sample processing through report generating—delivering confidence in your results.

Specimen Processing:

 

Step 1

Vaginal lesion swab specimens are collected from symptomatic patients.

 

Addition of DNA Sample Processing Control (SPC) is added to control for specimen lysis, recovery of extracted nucleic acid, inhibitory substances and PCR reagent and instrument integrity.

 

Step 2

Nucleic acid isolation and extraction is performed.

Amplification:

 

Step 3

MultiCode-RTx Reaction Preparation.

 

Step 4

Addition of extracted nucleic acid and amplification.

Detection and Typing:

 

Step 5

Detection and typing is achieved through the use of Ct values and melt curve analysis. Report generation and analysis using MultiCode-RTx HSV 1&2 Kit Analysis Software.

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.

  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 AC. Prober. Herpes Simplex Viruses. 876-883. In Murray P, Baron E, Pfaller M, Tenover F, Yolkenet R (eds.). Manual of Clinical Microbiology. 6th Ed. ASM, Washington, D.C. (1995).
  4. Koenig M, Reynolds KS, Aldous A, Hickman M. 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, Strand A, Allard A, Blomberg J, Herrmann B. 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.

 

Intended Use (US-IVD):

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 (HSV 1&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.

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.