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*
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) |
Accuracy & Precision Parvovirus B19 Quantitation on Procleix Panther System
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
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%)
| Number of specimens tested | HAV 95% (95% CI) | B19 1000 IU/mL cutoff (95% CI) | B19 500 IU/mL cutoff (95% CI) |
|---|---|---|---|
|
2010 |
100% |
100% |
99.90% |
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