Procleix Plasmodium Assay (CE Marked)
Single-tube, highly sensitive detection of the 18S ribosomal RNA of the Plasmodium parasite in whole blood specimens.
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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