DONOR SCREENING

Procleix Parvo/HAV Assay (CE Marked)

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.

Assay Performance Characteristics*

Platform

Assay chemistry

Procleix Panther system: Quantitative Parvo B19, qualitative HAV, transcription-mediated amplification (TMA)

Indication

Procleix Panther system: Blood screening, source plasma

Collection tube

Procleix Panther system: Serum or plasma from EDTA, ACD, heparin, or sodium citrate anti-coagulated samples

Pool sizes

Procleix Panther system: ID-NAT, 4, 8, 16, 48, 96, 256, 512

Assay kit size

Procleix Panther system: 1000 tests

Detected virus

Procleix Panther system: Parvovirus B19 (genotypes 1, 2, and 3a)
HAV (genotypes I, II, and III)

Platform	Procleix Panther system
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
Assay kit size	1000 tests
Detected virus	Parvovirus B19 (genotypes 1, 2, and 3a) HAV (genotypes I, II, and III)

Accuracy & Precision Parvovirus B19 Quantitation on Procleix Panther System

B19 (IU/mL)

100,000

N (number of replicates tested): 54

Input and Observed log (IU/mL): 5.00 | 5.12

% Accuracy: 102.5

Mean log difference (IU/mL): 0.12

Standard deviation (%CV): 0.13 (2.6%)

30,000

N (number of replicates tested): 54

Input and Observed log (IU/mL): 4.48 | 4.55

% Accuracy: 101.5

Mean log difference (IU/mL): 0.07

Standard deviation (%CV): 0.15 (3.3%)

10,000

N (number of replicates tested): 54

Input and Observed log (IU/mL): 4.00 | 3.94

% Accuracy: 98.6

Mean log difference (IU/mL): -0.06

Standard deviation (%CV): 0.10 (2.5%)

3000

N (number of replicates tested): 59

Input and Observed log (IU/mL): 3.48 | 3.43

% Accuracy: 98.5

Mean log difference (IU/mL): -0.05

Standard deviation (%CV): 0.11 (3.2%)

1000

N (number of replicates tested): 60

Input and Observed log (IU/mL): 3.00 | 3.00

% Accuracy: 99.9

Mean log difference (IU/mL): 0.00

Standard deviation (%CV): 0.20 (6.6%)

500

N (number of replicates tested): 189

Input and Observed log (IU/mL): 2.70 | 2.69

% Accuracy: 99.7

Mean log difference (IU/mL): -0.01

Standard deviation (%CV): 0.20 (7.3%)

B19 (IU/mL)	N (number of replicates tested)	Input and Observed log (IU/mL)	% Accuracy	Mean log difference (IU/mL)	Standard deviation (%CV)
100,000	54	5.00 \| 5.12	102.5	0.12	0.13 (2.6%)
30,000	54	4.48 \| 4.55	101.5	0.07	0.15 (3.3%)
10,000	54	4.00 \| 3.94	98.6	-0.06	0.10 (2.5%)
3000	59	3.48 \| 3.43	98.5	-0.05	0.11 (3.2%)
1000	60	3.00 \| 3.00	99.9	0.00	0.20 (6.6%)
500	189	2.70 \| 2.69	99.7	-0.01	0.20 (7.3%)

Specificity of the Procleix Parvo/HAV Assay

Number of specimens tested

2010

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%)

References:

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

References:

* Procleix Parvo/HAV assay on the Procleix Panther system CE marked package insert, AW-12749-001 Rev. 007
Number of specimens tested	HAV 95% (95% CI)	B19 1000 IU/mL cutoff (95% CI)	B19 500 IU/mL cutoff (95% CI)
2010	100% (99.81‐100.00%)	100% (99.81‐100.00%)	99.90% (99.64‐99.97%)

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