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HelpEpic Test Code LAB3782 Human Herpesvirus-6 A and B DNA Detection and Quantification, PCR, Plasma
Additional Codes
MML: QHV6P
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube:
Preferred: Plastic vial
Acceptable: Screw-capped, sterile container
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot plasma into a plastic vial.
Useful For
As an adjunct in the rapid diagnosis of human herpesvirus-6 infection using plasma specimens
This test should not be used to screen asymptomatic patients
Method Name
Real-Time Polymerase Chain Reaction (PCR)
Reporting Name
HHV-6 A and B DNA Quant PCR, PSpecimen Type
Plasma EDTASpecimen Minimum Volume
0.3 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma EDTA | Refrigerated (preferred) | 7 days | |
| Frozen | 7 days | ||
| Ambient | 24 hours |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Heparin | Reject |
Clinical Information
Human herpesvirus-6 (HHV-6) is a member of the Herpesviridae family. These DNA viruses contain a capsid surrounded by a lipid envelope. Among members of this group, this virus is most closely related to cytomegalovirus (CMV) and HHV-7. As with other members of the herpesvirus group (herpes simplex virus [HSV]-1, HSV-2, varicella-zoster virus, CMV, Epstein-Barr virus, HHV-7, HHV-8), HHV-6 may cause primary and reactivated infections.(1) Infection with HHV-6 occurs early in childhood. Most adults (80%-90%) have been infected with this virus.
Human herpesvirus-6 was first linked with exanthem subitum (roseola infantum) in 1998; since then, the virus has been associated with central nervous system disease almost exclusively in patients who are immunocompromised.(1) HHV-6 is commonly detected in patients post transplantation. Clinical symptoms associated with this viral infection include febrile illness, pneumonitis, hepatitis, and encephalitis. However, most HHV-6 infections are asymptomatic.(2)
Human herpesvirus-6 is designated as variant A (HHV-6A) or variant B (HHV-6B) depending on restriction enzyme digestion patterns and its reaction with monoclonal antibodies. Generally, variant B has been associated with exanthem subitum, whereas variant A has been found in many immunosuppressed patients.(3) Infection with HHV-6 is very common, approaching 100% seroprevalence in developed countries.(4) In about 1% of the population, HHV-6 can integrate into the host genome. Often asymptomatic in immunocompetent hosts, reactivation can cause serious disease in immunocompromised individuals, particularly those with AIDS and transplant recipients, which can cause rejection of the transplanted organ and even death.(1)
This assay will be used to assist with diagnosis and monitoring of HHV-6 disease in patients who are suspected of having disease due to HHV-6 infection. It will also be used as an initial indicator of infection versus chromosomally-integrated HHV-6.
Reference Values
Undetected
Interpretation
The quantification range of this assay is 500 to 5,000,000 copies/mL (2.70 log to 6.70 log copies/mL)
An "Undetected" test result indicates the absence of human herpesvirus-6 (HHV-6) DNA in plasma.
A test result of "<500 copies/mL (<2.70 log copies/mL)" indicates that HHV-6 DNA is detected in the plasma, but the assay cannot accurately quantify the level of HHV-6 DNA.
A test result of ">5,000,000 copies/mL (>6.70 log copies/mL)" indicates that the HHV-6 DNA level present in plasma is above 5,000,000 copies/mL (6.70 log copies/mL), and the assay cannot accurately quantify the level of HHV-6 DNA. A viral load above 5,000,000 copies/mL should raise suspicion for chromosomally-integrated HHV-6 (ciHHV-6), and additional testing to rule out ciHHV-6 may be needed.
An "Inconclusive" result indicates that the presence or absence of HHV-6 DNA in the plasma specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to inhibition or the presence of an interfering substance. If clinically indicated, submission of a new specimen for testing is recommended.
Cautions
The sensitivity of the assay is dependent upon the quality of the specimen submitted.
A negative result does not exclude human herpesvirus-6 (HHV-6) infection. Therefore, the results obtained should be used in conjunction with clinical findings to make an accurate diagnosis.
This assay detects nucleic acid and, therefore, cannot distinguish between replicating and nonreplicating virus (ie, remnant viral nucleic acid). Test performance depends on the viral load in the specimen and may not correlate with cell culture performed on the same specimen.
Although this assay may detect dual infections of HHV-6A and HHV-6B, low level infections may be masked when in the presence of a higher concentration of an HHV-6 subtype.
Viral loads may vary between laboratory-developed assays. When monitoring a patient’s HHV-6 viral load, the same method and sample type should be used.
This test cannot be converted to IU/mL. It is recommended to utilize the same test for the duration of the clinical care for consistency in reporting units (copies/mL).
Supportive Data
Analytical Sensitivity/Limit of Detection:
Spiked specimens in plasma with human herpesvirus-6 (HHV-6) DNA subtypes A/B (40 for each subtype) for a total of 80 positive specimens were used for establishment of the limit of detection (LOD). The lower LOD of this assay was determined to be 500 copies/mL for HHV-6A and 250 copies/mL for HHV-6B.
Analytical Specificity:
DNA from a panel of 10 organisms from culture collections along with well characterized laboratory strains that cause similar disease or organisms commonly found in plasma were tested to determine if there is any cross-reactivity against the Altona RealStar HHV-6 PCR (polymerase chain reaction) Kit 1.0. No cross-reactivity was observed with the specificity panel. Analytical specificity was determined by the kit manufacturer (Altona Diagnostics) and did not exhibit cross-reactivity with any of the following targets: BK virus, cytomegalovirus, Epstein-Barr virus, hepatitis A virus, hepatitis B virus, hepatitis C virus, herpes simplex virus 1, herpes simplex virus 2, human herpesvirus 7, human herpesvirus 8, human parvovirus B19, JC virus, varicella-zoster virus.
Due to new sequence data, cross reactivity of the HHV6-B detection systems (Cy5/Cy5.5) with some strains of HHV-6A cannot be ruled out. A weak signal in the HHV-6A detection channel (FAM) and HHV-6B (Cy5/Cy5.5) can be observed. This is a known limitation of the assay and will be incorporated in analysis and reporting processes.
Reference Range:
A total of 20 plasma samples collected from healthy donors were analyzed by the Altona RealStar HHV-6 PCR assay. All 20 samples were negative for HHV-6 DNA.
Although the reference range is typically "negative" for this assay, this assay may detect viral DNA in asymptomatic individuals. However, this assay is only to be used for patients with a clinical history and symptoms consistent with HHV-6 infection and must be interpreted in the context of the clinical picture. This test should not be used to screen asymptomatic patients.
Reportable Range:
The reportable range for this assay is 500 copies/mL to 5,000,000 copies/mL.
Day(s) Performed
Monday through Friday
Report Available
4 to 6 daysSpecimen Retention Time
7 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
87533