Procleix Plasmodium Assay (CE Marked)
Single-tube, highly sensitive detection of the 18S ribosomal RNA of the Plasmodium parasite in whole blood specimens.
The Procleix Plasmodium assay is CE marked. This assay is not available for commercial sale in the US.
Assay Performance Characteristics*
Assay chemistry
- Procleix Panther system
-
Qualitative, transcription-mediated amplification (TMA)
Indication
- Procleix Panther system
-
Whole blood and blood component screening
Collection tube
- Procleix Panther system
-
Whole blood from K2EDTA, K3EDTA, sodium citrate, and citrate phosphate dextrose adenine solution (CPDA) anti-coagulated samples
Pool sizes
- Procleix Panther system
-
ID-NAT, 4, 8, 16
Assay kit size
- Procleix Panther system
-
1000 or 5000 tests
Detected pathogen
- Procleix Panther system
-
Plasmodium parasite (species: P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax)
| Platform | Procleix Panther system |
|---|---|
|
Assay chemistry |
Qualitative, transcription-mediated amplification (TMA) |
|
Indication |
Whole blood and blood component screening |
|
Collection tube |
Whole blood from K2EDTA, K3EDTA, sodium citrate, and citrate phosphate dextrose adenine solution (CPDA) anti-coagulated samples |
|
Pool sizes |
ID-NAT, 4, 8, 16 |
|
Assay kit size |
1000 or 5000 tests |
|
Detected pathogen |
Plasmodium parasite (species: P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) |
Specificity in Fresh Whole Blood Specimens from Blood Donors
Individual donations
- # of samples
-
12,812
- IC Invalids
-
12
- True Negative
-
12,799
- False Positive
-
1
- Specificity (%)
-
99.99
- 95% confidence interval
-
99.96 - 100
16-sample pool
- # of samples
-
283
- IC Invalids
-
0
- True Negative
-
283
- False Positive
-
0
- Specificity (%)
-
100
- 95% confidence interval
-
98.71 - 100
| Sample Type | # of samples | IC Invalids | True Negative | False Positive | Specificity (%) | 95% confidence interval |
|---|---|---|---|---|---|---|
|
Individual donations |
12,812 |
12 |
12,799 |
1 |
99.99 |
99.96 - 100 |
|
16-sample pool |
283 |
0 |
283 |
0 |
100 |
98.71 - 100 |
Analytical Sensitivity
In vitro transcript, copies/mL
P. falciparum
- 50% Detection Probability (95% fiducial limits)
-
3.35 (2.63 - 4.09)
- 95% Detection Probability (95% fiducial limits)
-
11.37 (8.88 - 16.19)
P. knowlesi
- 50% Detection Probability (95% fiducial limits)
-
3.00 (2.39 - 3.63)
- 95% Detection Probability (95% fiducial limits)
-
9.08 (7.21 - 12.58)
P. malariae
- 50% Detection Probability (95% fiducial limits)
-
2.96 (2.38 - 3.57)
- 95% Detection Probability (95% fiducial limits)
-
8.47 (6.80 - 11.45)
P. ovale
- 50% Detection Probability (95% fiducial limits)
-
2.14 (1.51 - 2.76)
- 95% Detection Probability (95% fiducial limits)
-
11.16 (8.15 - 18.01)
P. vivax
- 50% Detection Probability (95% fiducial limits)
-
2.97 (2.27 - 3.70)
- 95% Detection Probability (95% fiducial limits)
-
11.89 (9.04 - 17.74)
| Plasmodium species | 50% Detection Probability (95% fiducial limits) | 95% Detection Probability (95% fiducial limits) |
|---|---|---|
|
P. falciparum |
3.35 (2.63 - 4.09) |
11.37 (8.88 - 16.19) |
|
P. knowlesi |
3.00 (2.39 - 3.63) |
9.08 (7.21 - 12.58) |
|
P. malariae |
2.96 (2.38 - 3.57) |
8.47 (6.80 - 11.45) |
|
P. ovale |
2.14 (1.51 - 2.76) |
11.16 (8.15 - 18.01) |
|
P. vivax |
2.97 (2.27 - 3.70) |
11.89 (9.04 - 17.74) |
Infected RBCs, cells/mL
P. falciparum
- 50% Detection Probability (95% fiducial limits)
-
0.82 (0.61 - 1.00)
- 95% Detection Probability (95% fiducial limits)
-
3.50 (2.85 - 4.62)
P. knowlesi
- 50% Detection Probability (95% fiducial limits)
-
0.66 (0.50 - 0.79)
- 95% Detection Probability (95% fiducial limits)
-
2.10 (1.72 - 2.87)
P. malariae
- 50% Detection Probability (95% fiducial limits)
-
0.38 (0.21 - 0.54)
- 95% Detection Probability (95% fiducial limits)
-
2.39 (1.85 - 3.59)
P. ovale
- 50% Detection Probability (95% fiducial limits)
-
1.65 (1.33 - 1.96)
- 95% Detection Probability (95% fiducial limits)
-
6.82 (5.63 - 8.75)
P. vivax
- 50% Detection Probability (95% fiducial limits)
-
0.61 (0.08 - 1.08)
- 95% Detection Probability (95% fiducial limits)
-
2.85 (1.66 - 16.75)
| Plasmodium species | 50% Detection Probability (95% fiducial limits) | 95% Detection Probability (95% fiducial limits) |
|---|---|---|
|
P. falciparum |
0.82 (0.61 - 1.00) |
3.50 (2.85 - 4.62) |
|
P. knowlesi |
0.66 (0.50 - 0.79) |
2.10 (1.72 - 2.87) |
|
P. malariae |
0.38 (0.21 - 0.54) |
2.39 (1.85 - 3.59) |
|
P. ovale |
1.65 (1.33 - 1.96) |
6.82 (5.63 - 8.75) |
|
P. vivax |
0.61 (0.08 - 1.08) |
2.85 (1.66 - 16.75) |
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