Test Catalog

Test Id : PARVP

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Parvovirus B19, Molecular Detection, PCR, Plasma

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Overview

Test Catalog

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

Diagnosing parvovirus B19 infection in plasma specimens

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

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

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

Parvovirus B19 PCR, P

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

B19

Erythrovirus B19

Fifth Disease-Parvovirus

Human Parvovirus B19

Parvovirus B19 PCR

Parvovirus PCR

Parvovirus-Fifth Disease

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

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

Supplies: Sarstedt 5 mL Aliquot Tube (T914)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Spin down and submit plasma in aliquot tube.

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.3 mL

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

Gross hemolysis 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
Plasma EDTA Refrigerated (preferred) 7 days
Frozen 7 days

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

Diagnosing parvovirus B19 infection in plasma specimens

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

Parvovirus B19 is a DNA virus that preferentially replicates in erythroid progenitor cells.(1) Infection with parvovirus B19 can occur at any age, but is most common early in life. Antibody prevalence ranges from 2% to 15% in children 1 to 5 years old to 30% to 60% in adults.(1) The virus is transmitted by respiratory secretions and occasionally by blood products.

 

Parvovirus B19 infections can be asymptomatic or produce a wide spectrum of disease ranging from erythema infectiosum (“fifth disease” characterized by a classic “slapped cheek” rash) in children to arthropathy, severe anemia, and systemic manifestations involving the central nervous system, heart, and liver depending on the immune competence of the host.(2,3) Infection with parvovirus B19 in pregnant women may cause hydrops fetalis, congenital anemia, spontaneous abortion, or stillbirth of the fetus.(4) Parvovirus B19 is also the causative agent of transient aplastic crisis and chronic aplasia usually, but not exclusively, in immunocompromised or transplant patients, and those with preexisting hematologic disorders (eg, sickle cell disease).

 

Most acute infections with parvovirus B19 are diagnosed in the laboratory by serologically detecting IgG- and IgM-class antibodies with enzyme-linked immunosorbent assay testing.

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.

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates that parvovirus B19 DNA is present in the clinical sample. However, a positive result does not differentiate between actively replicating virus, transient infection that may be asymptomatic, or the presence of remnant viral nucleic acid.

 

A negative result suggests the absence of parvovirus B19 infection.

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

A negative result does not necessarily indicate the absence of parvovirus B19 infection. False-negative results may be due to the virus being present at levels below the limit of detection for this assay, or to inhibitory substances that may be present in the specimen.

 

This assay has only been validated for the detection of genotype 1 parvovirus B19 and its ability to detect the less common genotypes 2 and 3 is unknown.

Supportive Data

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

 

Accuracy/Diagnostic Sensitivity and Specificity:

Results from this real-time PCR assay on the LightCycler (LC PCR) were compared to a Centers for Disease Control and Prevention (CDC) PCR-based assay on tissue biopsy specimens of temporal artery. Using the CDC PCR method as the gold standard, the diagnostic sensitivity and specificity for detection of parvovirus B19 was 97%.

 

Supplemental Data:

To supplement the above data, 30 negative cerebrospinal fluid, body fluids, and tissues and 45 negative blood specimens were spiked with parvovirus B19-positive control plasmid at the limit of detection (LoD) (10-20 targets/microliter). The 30 spiked specimens (45 bloods) were run in a blinded manner along with 30 negative (nonspiked) specimens (45 bloods). Results showed 97% to 100% of the spiked specimens were positive and 100% of the nonspiked specimens were negative.

 

Analytical Sensitivity/LoD:

The lower LoD of this assay is 10 to 20 targets/microliter in sample matrix.

 

Analytical Specificity:

No PCR signal was obtained with extracts of 11 viral and bacterial isolates that may cause symptoms similar to infection with parvovirus, including herpes simplex virus, varicella-zoster virus, cytomegalovirus, human herpesvirus-6, -7, and -8.

 

Precision:

Interassay precision was 100% and intra-assay precision was 97%.

 

Reference Range:

Although the reference range is typically "negative" for this assay, this assay may detect viremia in asymptomatic individuals or remnant viral nucleic acid. However, this assay is only to be used for patients with a clinical history and symptoms consistent with parvovirus B19 infection, and must be interpreted in context of clinical picture. This test should not be used to screen asymptomatic patients.

 

Reportable Range:

This is a qualitative assay, and results are reported as either negative or positive for targeted parvovirus B19.

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

1. Heegaard ED, Brown KE: Human parvovirus B19. Clin Microbiol Ref 2002;15:485-505

2. Bultmann BD, Klingel K, Soltar K, et al: Fatal parvovirus B19 associated myocarditis clinically mimicking ischemic heart disease: an endothelial cell-mediated disease. Hum Pathol 2003;34:92-95

3. Rerolle JP, Helal I, Morelon E: Parvovirus B19 infection after renal transplantation. Nephrologie 2003;24:309-315

4. Chisaka H, Morita E, Yaegashi N: Parvovirus B19 and the pathogenesis of anaemia. Rev Med Virol 2003;16:347-359

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

Viral DNA is extracted from 0.2 mL of specimen by the MagNA Pure automated instrument (Roche Applied Science). LightCycler PCR primers and probes detect target B19 DNA (nonstructural protein). The LightCycler instrument amplifies and monitors by fluorescence the development of target nucleic acid sequences after the annealing step during PCR cycling. This automated PCR system can rapidly detect (30-40 minutes) amplicon development through stringent air-controlled temperature cycling in capillary cuvettes. The detection of amplified products is based on the fluorescence resonance energy transfer (FRET) principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3' end is excited by an external light source and emits light that is absorbed by a second hybridization probe with an acceptor fluorophore, LC-Red 640, at the 5' end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product. Melting curve analysis is performed following PCR amplification. Starting at 45 degrees C, the temperature in the thermal chamber is slowly raised to 80 degrees C and the fluorescence is measured at frequent intervals. Analysis of the PCR amplification and the probe melting curves is accomplished through the use of LightCycler software.(Soares RM, Durigon El, Bersano JG, Richtzenhain LG: Detection of porcine parvovirus DNA by the polymerase chain reaction assay using primers to the highly conserved nonstructural protein gene, NS-1. J Virol Methods 1999;78:1-2;191-198)

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 Friday

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

1 week

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.

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  • 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. This test 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
PARVP Parvovirus B19 PCR, P 9571-1
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.
56075 Parvovirus B19 By Rapid PCR 9571-1
SS008 Source 31208-2

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