Procleix Parvo/HAV Assay (CE Marked)
Procleix Assays

Procleix Parvo/HAV Assay (CE Marked)

Ref. GRF-PROCLEIX-PARVO-HAV-ASSAY

Single-tube, highly sensitive detection of the parvovirus B19 DNA and hepatitis A virus RNA in blood and plasma donations.

Tests per card —
Packaging 1000 tests
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About the Product

Single-tube, highly sensitive detection of the parvovirus B19 DNA and hepatitis A virus RNA in blood and plasma donations.

The Procleix Parvo/HAV assay is CE marked, and is available as an in-process test in the US. The performance characteristics of this product have not been established in the US.

References: * Procleix Parvo/HAV assay on the Procleix Panther system CE marked package insert, AW-12749-001 Rev. 007

Technical Characteristics

Regulatory status CE Marked
Assay chemistry Quantitative Parvo B19, qualitative HAV, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma
Collection tube Serum or plasma from EDTA, ACD, heparin, or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16, 48, 96, 256, 512
Detected virus
  • Parvovirus B19 (genotypes 1, 2, and 3a)
  • HAV (genotypes I, II, and III)
Accuracy & precision, Parvovirus B19 quantitation - B19 100,000 IU/mL N (number of replicates tested): 54Input and Observed log (IU/mL): 5.00 | 5.12% Accuracy: 102.5Mean log difference (IU/mL): 0.12Standard deviation (%CV): 0.13 (2.6%)
Accuracy & precision, Parvovirus B19 quantitation - B19 30,000 IU/mL N (number of replicates tested): 54Input and Observed log (IU/mL): 4.48 | 4.55% Accuracy: 101.5Mean log difference (IU/mL): 0.07Standard deviation (%CV): 0.15 (3.3%)
Accuracy & precision, Parvovirus B19 quantitation - B19 10,000 IU/mL N (number of replicates tested): 54Input and Observed log (IU/mL): 4.00 | 3.94% Accuracy: 98.6Mean log difference (IU/mL): -0.06Standard deviation (%CV): 0.10 (2.5%)
Accuracy & precision, Parvovirus B19 quantitation - B19 3000 IU/mL N (number of replicates tested): 59Input and Observed log (IU/mL): 3.48 | 3.43% Accuracy: 98.5Mean log difference (IU/mL): -0.05Standard deviation (%CV): 0.11 (3.2%)
Accuracy & precision, Parvovirus B19 quantitation - B19 1000 IU/mL N (number of replicates tested): 60Input and Observed log (IU/mL): 3.00 | 3.00% Accuracy: 99.9Mean log difference (IU/mL): 0.00Standard deviation (%CV): 0.20 (6.6%)
Accuracy & precision, Parvovirus B19 quantitation - B19 500 IU/mL N (number of replicates tested): 189Input and Observed log (IU/mL): 2.70 | 2.69% Accuracy: 99.7Mean log difference (IU/mL): -0.01Standard deviation (%CV): 0.20 (7.3%)
Specificity of the Procleix Parvo/HAV Assay (2010 specimens tested)
  • HAV 95% (95% CI): 100% (99.81-100.00%)
  • B19 1000 IU/mL cutoff (95% CI): 100% (99.81-100.00%)
  • B19 500 IU/mL cutoff (95% CI): 99.90% (99.64-99.97%)

Technical Information

No technical information available for this product.

Compatibility

Platform: Procleix Panther system

Packaging

1000 tests