Nat
Procleix Plasmodium Assay (CE Marked)
Ref. GRF-PROCLEIX-PLASMODIUM-ASSAYSingle-tube, highly sensitive detection of the 18S ribosomal RNA of the Plasmodium parasite in whole blood specimens.
Tests per card
—
Packaging
1000 or 5000 tests
Contact us for product availability and technical details.
About the Product
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.
References: Procleix Plasmodium assay package insert, GDSS-IFU-000069-EN v. 1.0
Technical Characteristics
| Regulatory status | CE Marked |
|---|---|
| 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 |
| 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 |
| Specificity in fresh whole blood specimens from blood donors - 16-sample pool | # of samples: 283; IC Invalids: 0; True Negative: 283; False Positive: 0; Specificity (%): 100; 95% confidence interval: 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) |
| Analytical sensitivity, in vitro transcript (copies/mL) - 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) |
| Analytical sensitivity, in vitro transcript (copies/mL) - 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) |
| Analytical sensitivity, in vitro transcript (copies/mL) - 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) |
| Analytical sensitivity, in vitro transcript (copies/mL) - 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) |
| Analytical sensitivity, 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) |
| Analytical sensitivity, infected RBCs (cells/mL) - 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) |
| Analytical sensitivity, infected RBCs (cells/mL) - 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) |
| Analytical sensitivity, infected RBCs (cells/mL) - 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) |
| Analytical sensitivity, infected RBCs (cells/mL) - 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) |
Technical Information
No technical information available for this product.
Compatibility
Platform: Procleix Panther system
Packaging
1000 or 5000 tests