Test Catalog

Test Id : HRTVS

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Heartland Virus, RNA, Molecular Detection, PCR, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of central nervous system infection caused by Heartland virus using serum specimens

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Meningitis/Encephalitis Panel Algorithm.

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Heartland Virus, PCR, Serum

Aliases
Lists additional common names for a test, as an aid in searching

Heartland

Tick-borne illness

HRTV

HTV

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Meningitis/Encephalitis Panel Algorithm.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

Patients with a history of symptoms for more than 1 week may be negative by molecular tests (ie, real-time polymerase chain reaction) and may require serologic testing, which is available through the Centers for Disease Control and Prevention.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container: Sterile container

Specimen Volume: 0.5 mL

Collection Instructions:

1. Within 2 hours of collection centrifuge and aliquot serum into a sterile container.

2. Serum specimens not aliquoted from the serum gel collection tube into a sterile container will be rejected.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Heat-inactivated specimen Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
Frozen 14 days
Ambient 24 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of central nervous system infection caused by Heartland virus using serum specimens

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Meningitis/Encephalitis Panel Algorithm.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Heartland virus (HRTV) disease is an emerging zoonosis, transmitted to humans through the bite of infected Amblyomma americanum (Lone Star) ticks. HRTV possesses a single-stranded negative-sense RNA genome encoded on small, medium, and large segments. HRTV is a member of the Bandavirus genus, which includes other arthropod-borne viruses (arboviruses), such as severe fever with thrombocytopenia syndrome virus (SFTSV). Reports of human HRTV disease are relatively rare, with fewer than 100 cases reported to date, most from the Central, Southern, and Northeastern United States. Symptoms generally occur within 2 weeks of a tick bite and may include non-specific symptoms such as headache, fever, fatigue, anorexia, nausea, diarrhea, and muscle or joint pain. Leukopenia, thrombocytopenia, and elevation of liver transaminases are also common laboratory findings. Rarely, multisystem organ failure and death occur. While there is no targeted antiviral therapy and treatment is entirely supportive care, diagnosis is important for several reasons, including the ability to discontinue empiric antibiotics and to provide prognostic information for patients and families.

 

Detection of HRTV nucleic acid in serum is a marker for acute infection caused by this virus. Importantly, the period of time that the virus can be detected in serum and cerebrospinal fluid is brief. Therefore, molecular testing should be performed within the first week following onset of symptoms. After this time, serologic testing is the preferred method for diagnosis of HRTV infection. Serologic testing is currently only available through the Centers for Disease Control and Prevention.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

Positive:

The detection of Heartland virus (HRTV) nucleic acid in serum is consistent with acute-phase infection. HRTV nucleic acid may be detectable during the first week following the onset of symptoms.

 

Negative:

The absence of HRTV nucleic acid is consistent with the lack of acute-phase infection but does not rule out infection. Additional serologic testing may be indicated.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Results should be used in conjunction with clinical presentation and exposure history.

 

Negative Heartland virus (HRTV) polymerase chain reaction results may occur if the specimen was collected more than 7 days following symptom onset. Serologic testing for the presence of antibodies to HRTV may be recommended in such cases.

Supportive Data

The following validation data supports the use of this assay for clinical testing.

 

Accuracy/Diagnostic Sensitivity and Specificity:

Heartland virus (HRTV) accuracy results produced greater than or equal to 90% positive, negative, and overall agreement among 70 total contrived samples for each matrix (cerebrospinal fluid [CSF] and serum).

 

Analytical Sensitivity/Limit of Detection:

The HRTV reverse transcription polymerase chain reaction (RT-PCR) assay analytical sensitivity was established and confirmed at 2.5 genome copies/microliter of RNA extract (2500 genome copies/mL) in both CSF and serum.

 

Precision:

Greater than or equal to 95% qualitative concordance among test replicates for HRTV inter-assay and intra-assay reproducibility.

 

Specificity:

Panel of 13 organisms with similar phylogenetic association, clinical presentation, vector/transmission mode and/or sample type were tested by the HRTV RT-PCR assay and did not show any amplification. Additionally, NCBI BLAST searches of HRTV assay forward/reverse primers and PCR amplicon sequences against a panel of 82 organisms causing similar diseases or commonly found in CSF or serum were also used to determine potential cross-reactivity of notable organisms. The data indicate that HRTV RT-PCR assay will not detect any organisms other than HRTV.

 

Reportable Range:

This is a qualitative assay, and the results are reported as either negative or positive for targeted HRTV.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Savage HM, Godsey MS, Lambert A, et al. First detection of heartland virus (Bunyaviridae: Phlebovirus) from field collected arthropods. Am J Trop Med Hyg. 2013;89(3):445-452. doi:10.4269/ajtmh.13-0209

2. Brault AC, Savage HM, Duggal NK, Eisen RJ, Staples JE. Heartland virus epidemiology, vector association, and disease potential. Viruses. 2018;10(9):498. doi:10.3390/v10090498

3. Staples JE, Pastula DM, Panella AJ, et al. Investigation of Heartland virus disease throughout the United States, 2013–2017. Open Forum Infect Dis. 2020;7(5):ofaa125. Published 2020 Apr 11. doi:10.1093/ofid/ofaa125

Method Description
Describes how the test is performed and provides a method-specific reference

This Heartland virus (HRTV) real-time reverse transcription polymerase chain reaction (RT-PCR) laboratory-developed test is based on primer and probe sequences reported by Savage et al.(CDC assay, 1). It provides qualitative detection of HRTV RNA from serum and CSF of patients with suspected infection. HRTV RNA in clinical specimens is first extracted using the Roche MagNA Pure 96 instrument. RT-PCR testing is then performed on the Roche LightCycler 480 II (LC480).

 

This RT-PCR assay employs oligonucleotide forward and reverse primers and a TaqMan hydrolysis probe specific to the small segment of the non-structural protein region of Heartland virus. A reverse transcription step is first performed to convert RNA to complementary DNA (cDNA). The primers then bind to the target cDNA sequence and facilitate amplification of an 86 base pair amplicon product during PCR. Using the LC480 software, analysis of the resultant amplification curves is performed to allow for detection of HRTV RNA. Generation of an amplification curve and a crossing point (Cp) value indicates the presence of HRTV RNA in the specimen and may be used to support the diagnosis of acute HRTV infection in the appropriate clinical and epidemiologic setting.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87798

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HRTVS Heartland Virus, PCR, Serum 94183-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
620057 Heartland Virus, PCR, Serum 94183-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2023-08-29