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Table 2 Overview of pathogen reduction/inactivation technologies compatible with platelet concentrates

From: Bacterial contamination of platelets for transfusion: strategies for prevention

 

INTERCEPT™ Blood System for Platelets

Mirasol® Pathogen Reduction Technology System

THERAFLEX® UV-Platelets

Manufacturer

Cerus Corporation

Terumo BCT

MacoPharma

FDA approval for platelets

Yes

No

No

CE mark approval

CE class III

CE class IIB

CE class IIB

Principle of method

UVA illumination in the presence of a photosensitizer

Broad-spectrum UV illumination in the presence of a photosensitizer

UVC illumination and intense platelet bag agitation

Photosensitizer

Amotosalen

Riboflavin

None

UV wavelength and dose

UVA, 320–400 nm, 3 J/cm2

UVB/UVA/UVC (100%/60%/20%), 265–370 nm, 6.2 J/mL

UVC, 254 nm, 0.2–0.3 J/cm2

Pathogens targeted

Bacteria (Gram-positive and Gram-negative), viruses (enveloped and non-enveloped), parasites

Bacteria (Gram-positive and Gram-negative), viruses (enveloped and non-enveloped), parasites

Bacteria (Gram-positive and Gram-negative), viruses (enveloped and non-enveloped), parasites

Toxicology testinga

Acute toxicology, carcinogenicity, general pharmacology, genotoxicity, phototoxicity, repeated dose, reproductive toxicology (plus others)

Acute toxicology, genotoxicity, phototoxicity, repeated dose, reproductive toxicology (plus others)

Not applicable (no exogenous photosensitizer)

Bacterial inactivation (log reduction)b

 Gram-positive

3.6 to >6.9

1.9 to 4.8

4.3 to >4.9

 Gram-negative

4.5 to >6.7

2.8 to 5.4

>4.0 to >4.9

Maximum approved storagec

5 and 7 days

7 days

5 days

  1. Abbreviations: CE Conformité Européene (“European Conformity”), FDA US Food and Drug Administration, UV ultraviolet
  2. aSee [43, 44] for additional details
  3. bSee [43, 44] for data on individual bacterial species tested
  4. cDepending on country