Sign in →

Epic Test Code LAB2509 Parvovirus B19, Molecular Detection, PCR, Varies

Additional Codes

MML Code: PARVO

LIS Code: PB19P

NY State Approved

Yes

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Reporting Name

Parvovirus B19 PCR

Method Name

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

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
  Frozen  7 days


Necessary Information


Specimen source is required.



Specimen Required


Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Amniotic fluid

Container/Tube: Amniotic fluid container

Specimen Volume: 0.5 mL

Collection Instructions:

1. Do not centrifuge.

2. Label specimen as amniotic fluid.

 

Specimen Type: Spinal fluid

Container/Tube: Sterile vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Do not centrifuge.

2. Label specimen as spinal fluid.

 

Specimen Type: Synovial fluid

Container/Tube: Sterile vial or lavender top (EDTA)

Specimen Volume: 0.5 mL

Collection Instructions: Label specimen as synovial fluid.

 

Alternate:

Specimen Type: Bone marrow

Container/Tube: Sterile container or lavender top (EDTA)

Specimen Volume: 0.5 mL

Collection Instructions: Label specimen as bone marrow.


Specimen Type

Varies

Specimen Minimum Volume

Amniotic Fluid, Bone Marrow, and Spinal Fluid 0.3 mL; Synovial fluid 0.5 mL

Reference Values

Negative

Report Available

Same day/1 to 3 days

Day(s) Performed

Monday through Friday

CPT Code Information

87798

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Useful For

Diagnosing parvovirus B19 infection

Clinical Information

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.

Interpretation

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

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 polymerase chain reaction (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 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 (non-spiked) specimens (45 bloods). Results showed 97% to 100% of the spiked specimens were positive and 100% of the non-spiked specimens were negative.

 

Analytical Sensitivity/LOD:

The 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, and 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, it 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 is not to 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.

Specimen Retention Time

1 week

Forms

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