Assay Performance Characteristics*

Platform

Assay chemistry

Procleix Panther system

Qualitative, transcription-mediated amplification (TMA)

Indication

Procleix Panther system

Blood screening, source plasma, cadaveric (non-heart-beating) donors

Collection tube

Procleix Panther system

Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples

Pool sizes

Procleix Panther system

ID-NAT, 4, 8, 16

Assay kit size

Procleix Panther system

1000 or 5000 tests

Detected virus

Procleix Panther system

HEV (genotypes 1-4)***

Platform Procleix Panther system

Assay chemistry

Qualitative, transcription-mediated amplification (TMA)

Indication

Blood screening, source plasma, cadaveric (non-heart-beating) donors

Collection tube

Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples

Pool sizes

ID-NAT, 4, 8, 16

Assay kit size

1000 or 5000 tests

Detected virus

HEV (genotypes 1-4)***

Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens

# of samples

4494

Specificity %

99.98

95% confidence interval

99.87 - 100

# of samples Specificity % 95% confidence interval

4494

99.98

99.87 - 100

Analytical Sensitivity

Detection Probability (IU/mL)

Panel Tested

HEV WHO international standard**

50% (95% fiducial limits)

2.02 (1.71 - 2.32)

95% (95% fiducial limits)

7.89 (6.63 - 9.83)

 

 

References:

* Procleix HEV assay package insert, HEV-2.0-IFU-en
** PEI code: 6329/10
*** HEV1, HEV2, HEV3a, HEV3b, HEV3c, HEV3f, and HEV4c

Panel Tested 50% (95% fiducial limits) 95% (95% fiducial limits)

HEV WHO international standard**

2.02 (1.71 - 2.32)

7.89 (6.63 - 9.83)

Explore other Procleix Assays

Expand your blood screening with a comprehensive NAT assay portfolio.