Procleix Babesia Assay (FDA Approved and CE Marked)
Procleix Assays

Procleix Babesia Assay (FDA Approved and CE Marked)

Ref. GRF-PROCLEIX-BABESIA-ASSAY

Single-tube, highly sensitive detection of the ribosomal RNA of the Babesia parasite in whole blood specimens.

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About the Product

Single-tube, highly sensitive detection of the ribosomal RNA of the Babesia parasite in whole blood specimens.

The Procleix Babesia assay is CE marked and FDA approved.

*includes 6 true positive donations identified in individual donation testing: 1 individual doantion with an initial reactive Procleix Babesia assay result confirmed by IFA was not detected in a 16-sample pool.

References: * Procleix Babesia assay package insert, GDSS-IFU-000030

** B. divergens and B. duncani were washed in PBS prior to dilution in human whole blood to remove free parasitic ribosomal RNA

*** Not quantifiable due to frozen specimen

Technical Characteristics

Regulatory status FDA Approved and 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, 8, 16
Detected pathogen Babesia parasite (species B. microti, B. divergens, B. duncani, and B. venatorum)
Specificity in whole blood specimens - Individual donations # of samples: 11,067True negative: 11,060True positive: 100False positive: 7Specificity %: 095% SCORE confidence interval: 99.97-100
Specificity in whole blood specimens - 16-sample-pools # of samples: 11,038True negative: 10,977True positive: 100False positive: 60*Specificity %: 095% SCORE confidence interval: 99.97-100
Analytical sensitivity, in vitro transcripts (copies/mL) - B. microti
  • 50% Detection Probability (95% Fiducial Limits): 2.06 (1.55–2.56)
  • 95% Detection Probability (95% Fiducial Limits): 8.91 (6.88–12.88)
Analytical sensitivity, in vitro transcripts (copies/mL) - B. divergens
  • 50% Detection Probability (95% Fiducial Limits): 3.90 (3.21–4.62)
  • 95% Detection Probability (95% Fiducial Limits): 11.58 (9.38–15.44)
Analytical sensitivity, in vitro transcripts (copies/mL) - B. duncani
  • 50% Detection Probability (95% Fiducial Limits): 2.54 (2.11–3.01)
  • 95% Detection Probability (95% Fiducial Limits): 6.73 (5.32–9.69)
Analytical sensitivity, in vitro transcripts (copies/mL) - B. venatorum
  • 50% Detection Probability (95% Fiducial Limits): 2.99 (2.33–3.67)
  • 95% Detection Probability (95% Fiducial Limits): 12.44 (9.62–17.87)
Analytical sensitivity, Babesia parasites (parasites/mL**) - B. microti
  • 50% Detection Probability (95% Fiducial Limits): 0.61 (0.43–0.76)
  • 95% Detection Probability (95% Fiducial Limits): 2.98 (2.40–4.09)
Analytical sensitivity, Babesia parasites (parasites/mL**) - B. divergens
  • 50% Detection Probability (95% Fiducial Limits): 0.48 (0.34–0.60)
  • 95% Detection Probability (95% Fiducial Limits): 1.77 (1.45–2.41)
Analytical sensitivity, Babesia parasites (parasites/mL**) - B. duncani
  • 50% Detection Probability (95% Fiducial Limits): 0.72 (0.54–0.88)
  • 95% Detection Probability (95% Fiducial Limits): 3.10 (2.53–4.11)
Analytical sensitivity, Babesia parasites (parasites/mL**) - B. venatorum
  • 50% Detection Probability (95% Fiducial Limits): n/a***
  • 95% Detection Probability (95% Fiducial Limits): n/a***

Technical Information

No technical information available for this product.

Compatibility

Platform: Procleix Panther system

Packaging

No packaging information available for this product.