Procleix Plasmodium Assay (CE Marked)
Procleix Assays

Procleix Plasmodium Assay (CE Marked)

Ref. GRF-PROCLEIX-PLASMODIUM-ASSAY

Single-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
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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: 12,812IC Invalids: 12True Negative: 12,799False Positive: 1Specificity (%): 99.9995% confidence interval: 99.96 - 100
Specificity in fresh whole blood specimens from blood donors - 16-sample pool # of samples: 283IC Invalids: 0True Negative: 283False Positive: 0Specificity (%): 10095% 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