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Test Code QHV6P Human Herpesvirus-6 A and B DNA Detection and Quantification, PCR, Plasma


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 Plasma

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

Reporting Name

HHV-6 A and B DNA Quant PCR, P

Specimen Type

Plasma EDTA

Specimen Minimum Volume

Plasma: 0.3 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma EDTA Refrigerated (preferred) 7 days
  Frozen  7 days
  Ambient  24 hours

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Heparin Reject

Reference Values

Undetected

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 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.

Method Description

The RealStar HHV-6 (human herpesvirus-6) PCR (polymerase chain reaction) Kit 1.0 (Altona Diagnostics) and the Exact Diagnostics HHV6-A/B Verification Panels and controls (Bio-Rad) are utilized for this assay. The assay employs TaqMan hydrolysis probe chemistry, with production of visible amplification curves and associated crossing point (Cp) values; no melting temperature curve is produced. A probe specific for HHV-6A DNA is labeled with the fluorophore FAM and is detected on the 465-510 channel. A probe specific for HHV-6B DNA is labeled with the fluorophore Cy5 and is detected on the 533-580 channel. The probe specific for the Internal Control (IC) is labeled with the fluorophore JOE, is detected on the 618-660 channel, and will be used within the mastermix. Using probes linked to distinguishable dyes enables the parallel detection and differentiation of HHV-6A and HHV-6B DNA as well as the detection of the IC in corresponding detector channels of the LC480 II instrument. The MagNA Pure 96 instrument (Roche Diagnostics) using the MP96 DNA and Viral NA small volume kit with an input of 200 mcL and a final elution volume of 100 mcL is utilized for viral nucleic acid extraction. The Pathogen Universal 200 protocol is used.(Package insert: RealStar HHV-6 Virus PCR Kit 1.0. Altona Diagnostics; Version 09/2018)

Day(s) Performed

Monday through Friday

Report Available

1 to 5 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87533

LOINC Code Information

Test ID Test Order Name Order LOINC Value
QHV6P HHV-6 A and B DNA Quant PCR, P 49392-4

 

Result ID Test Result Name Result LOINC Value
622169 HHV6 A DNA Detect/Quant, P 49392-4
622170 HHV6 B DNA Detect/Quant, P 49392-4

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Kidney Transplant Test Request

-Microbiology Test Request (T244)