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 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.