The Procleix Plasmodium assay is CE marked. This assay is not available for commercial sale in the US.

The Procleix Plasmodium assay is CE marked. This assay is not available for commercial sale in the US.

Assay Performance Characteristics*

Platform

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

Sample Type

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

Plasmodium species

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

Plasmodium species

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)

 

 

References:

Procleix Plasmodium assay package insert, GDSS-IFU-000069-EN v. 1.0

 

 

References:

Procleix Plasmodium assay package insert, GDSS-IFU-000069-EN v. 1.0
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)

Explore other Procleix Assays

Expand your blood screening with a comprehensive NAT assay portfolio.

Go to page