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HSV 1 and 2 DNA Ampliification Assay
Test CodeLAB917
Alias/See Also
HSV12
Preferred Specimen
Human cutaneous and mucocutaneous lesion swab samples in viral transport media.
Transport Container
Place swab(s) in a viral transport medium.
Transport Temperature
2-8'C
Specimen Stability
Refrigerated (2-8'C) 7 days
Methodology
illumigene HSV 1&2 is based on loop-mediated amplification (LAMP)1, 2 technology. Loop-mediated amplification uses specially designed primers to provide for specific and continuous isothermal DNA amplification.
Setup Schedule
Daily
Limitations
1. Performance of illumigene HSV 1&2 has been established with prospective, male and female cutaneous and mucocutaneous lesion specimens only. Performance with other specimen types (frozen specimens or CSF) has not been established.
2. The assay is not intended to be used for prenatal screening.
3. Medications containing the active ingredient Zincum Gluconicum produced invalid results when tested at 7% v/v with illumigene HSV 1&2. Lower concentrations were not tested. The effect of Zincum Gluconicum on illumigene HSV 1&2 results have not been determined using clinical specimens.
4. Casein at concentrations greater than 5 mg/mL was found to interfere with the illumigene HSV 1&2 assay.
5. Due to confirmed unacceptable results, refrigerated storge (2-8 C) will not be considered an acceptable storage condition for SMP PREP III processed specimens to be tested with the illumigene HSV 1&2 DNA Amplification Assay.
6. Negative results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions.This product can only be used with the illumipro-10 instrument.
7. illumigene HSV 1&2 is a qualitative assay and does not provide quantitative values or information about organism load.
8. The detection of nucleic acids is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedure in any one of these steps can lead to incorrect results.
9. Organism nucleic acid may persist in vivo, independent of organism viability. The illumigene HSV 1&2 does not distinguish between viable and nonviable organisms.
10. As with all molecular based diagnostic tests, (A) False-negative results may occur from the presence of inhibitors, mutations or polymorphisms in the HSV target region, technical error, sample mix-up or low numbers of organisms in the clinical specimen; (B) False-positive results may occur from the presence of crosscontamination by target organisms, their nucleic acids or amplified product, and from nonspecific signals.
2. The assay is not intended to be used for prenatal screening.
3. Medications containing the active ingredient Zincum Gluconicum produced invalid results when tested at 7% v/v with illumigene HSV 1&2. Lower concentrations were not tested. The effect of Zincum Gluconicum on illumigene HSV 1&2 results have not been determined using clinical specimens.
4. Casein at concentrations greater than 5 mg/mL was found to interfere with the illumigene HSV 1&2 assay.
5. Due to confirmed unacceptable results, refrigerated storge (2-8 C) will not be considered an acceptable storage condition for SMP PREP III processed specimens to be tested with the illumigene HSV 1&2 DNA Amplification Assay.
6. Negative results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions.This product can only be used with the illumipro-10 instrument.
7. illumigene HSV 1&2 is a qualitative assay and does not provide quantitative values or information about organism load.
8. The detection of nucleic acids is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedure in any one of these steps can lead to incorrect results.
9. Organism nucleic acid may persist in vivo, independent of organism viability. The illumigene HSV 1&2 does not distinguish between viable and nonviable organisms.
10. As with all molecular based diagnostic tests, (A) False-negative results may occur from the presence of inhibitors, mutations or polymorphisms in the HSV target region, technical error, sample mix-up or low numbers of organisms in the clinical specimen; (B) False-positive results may occur from the presence of crosscontamination by target organisms, their nucleic acids or amplified product, and from nonspecific signals.
Clinical Significance
Herpes simplex virus causes chronic, recurrent infections and viral meningitis in adults and children. Infection with herpes simplex virus
type 1 (HSV-1) is relatively common, with an overall seroprevalence approaching 54% of the United States population. Herpes simplex
virus Type 2 (HSV-2) is the primary cause of genital herpes. It is estimated that 50 million people in the US and >400 million worldwide are
infected with HSV-2 genital herpes, or about 1 out of every 5 people. While either HSV-1 or HSV-2 is capable of oral or genital infections,
HSV-1 is typically associated with oral lesions and HSV-2 is typically associated with genital lesions. However, the frequency of HSV-1
genital infection is increasing. HSV transmission to neonates can occur during birth, causing symptoms ranging from disseminated
disease (CNS and visceral organs) to infection of the skin, eye, and mouth.
HSV infection can be diagnosed using microscopy, cell culture, molecular, and serological methods; cell culture and PCR are the preferred diagnostic methods recommended by the Centers for Disease Control. The sensitivity of viral culture is low, particularly for recurrent or healing lesions, due to limited quantity of viable virus. The HSV type cannot be directly determined from viral culture, requiring additional typing methods (such as ELVIS). NAAT methods are more sensitive than culture, have the ability to differentiate between HSV types, and provide more rapid results.
type 1 (HSV-1) is relatively common, with an overall seroprevalence approaching 54% of the United States population. Herpes simplex
virus Type 2 (HSV-2) is the primary cause of genital herpes. It is estimated that 50 million people in the US and >400 million worldwide are
infected with HSV-2 genital herpes, or about 1 out of every 5 people. While either HSV-1 or HSV-2 is capable of oral or genital infections,
HSV-1 is typically associated with oral lesions and HSV-2 is typically associated with genital lesions. However, the frequency of HSV-1
genital infection is increasing. HSV transmission to neonates can occur during birth, causing symptoms ranging from disseminated
disease (CNS and visceral organs) to infection of the skin, eye, and mouth.
HSV infection can be diagnosed using microscopy, cell culture, molecular, and serological methods; cell culture and PCR are the preferred diagnostic methods recommended by the Centers for Disease Control. The sensitivity of viral culture is low, particularly for recurrent or healing lesions, due to limited quantity of viable virus. The HSV type cannot be directly determined from viral culture, requiring additional typing methods (such as ELVIS). NAAT methods are more sensitive than culture, have the ability to differentiate between HSV types, and provide more rapid results.
