open access

Vol 11, No 3 (2018)
Research paper
Published online: 2019-01-15
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Evaluation of the Roche cobas DPX Test performed on the cobas® 6800 system and cobas p 680 instrument for parvovirus B19 DNA and HAV RNA detection in blood donations

Aneta Kopacz, Dorota Kubicka-Russel, Grzegorz Liszewski, Paulina Zwolińska, Ewa Sulkowska, Aleksandra Kalińska, Jolanta Korzeniowska, Magdalena Łętowska, Piotr Grabarczyk
Journal of Transfusion Medicine 2018;11(3):91-99.

open access

Vol 11, No 3 (2018)
ORIGINAL PAPERS
Published online: 2019-01-15

Abstract

Introduction The cobas DPX test for use on the cobas 6800 system, is real-time PCR test for the identification and quantitation of human parvovirus B19 (B19V) DNA and the detection of hepatitis A virus (HAV) RNA in human plasma. Optional component to the cobas 6800 system is the cobas p 680 instrument that creates pools from individual samples. Aim To evaluate the performance of cobas® DPX test and to demonstrate its ability to detect HAV and polymorphic forms of B19V during plasma testing. Sensitivity, correct identification of reactive donations and risk of false positive results was estimated. Material and method The analytical sensitivity of cobas® DPX test was assessed by testing dilutions of the WHO B19V Genotype 1-3 Reference Panels (09/110) and IS WHO RNA HAV (00/562) dilution panel. Six dilutions of each B19 panel were tested ranging from 31.6 IU/mL to 0.1 IU /mL of genotype 1, 2, 3 and six dilutions of RNA HAV panel ranging from 10-0,03 IU/ml (24 replicates/dilution). Detection and identification of reactive donations tested in minipools were evaluated by testing 767 negative and 1 high DNA B19V reactive donations in 8 pools. Results The 95% limits of detection [LOD] (95% confidence range) of the cobas® DPX test for DNA B19V were respectively: genotype 1 - 8.70 IU/mL (4.92-21.69), genotype 2 - 37.80 IU/ml (22.24 – 93.65), genotype 3 - 29.84 IU/ml (19.04-65.60) and for RNA HAV were: 0.82 IU/ml (0.49 -1.96). Results of the cobas® DPX test from samples analyzed in minipools were 100% concordant with the expected results. No false reactive or invalid results was observed during donation screening. Conclusion The cobas® DPX test on the cobas 6800 system allows to identify donations infected with HAV and genotypes 1-3 of B19V that could result contamination of plasma production pools with HAV and B19V beyond acceptable level (>104 IU/mL, according to recommendations). There was no significant risk of false results during evaluation procedure.

Abstract

Introduction The cobas DPX test for use on the cobas 6800 system, is real-time PCR test for the identification and quantitation of human parvovirus B19 (B19V) DNA and the detection of hepatitis A virus (HAV) RNA in human plasma. Optional component to the cobas 6800 system is the cobas p 680 instrument that creates pools from individual samples. Aim To evaluate the performance of cobas® DPX test and to demonstrate its ability to detect HAV and polymorphic forms of B19V during plasma testing. Sensitivity, correct identification of reactive donations and risk of false positive results was estimated. Material and method The analytical sensitivity of cobas® DPX test was assessed by testing dilutions of the WHO B19V Genotype 1-3 Reference Panels (09/110) and IS WHO RNA HAV (00/562) dilution panel. Six dilutions of each B19 panel were tested ranging from 31.6 IU/mL to 0.1 IU /mL of genotype 1, 2, 3 and six dilutions of RNA HAV panel ranging from 10-0,03 IU/ml (24 replicates/dilution). Detection and identification of reactive donations tested in minipools were evaluated by testing 767 negative and 1 high DNA B19V reactive donations in 8 pools. Results The 95% limits of detection [LOD] (95% confidence range) of the cobas® DPX test for DNA B19V were respectively: genotype 1 - 8.70 IU/mL (4.92-21.69), genotype 2 - 37.80 IU/ml (22.24 – 93.65), genotype 3 - 29.84 IU/ml (19.04-65.60) and for RNA HAV were: 0.82 IU/ml (0.49 -1.96). Results of the cobas® DPX test from samples analyzed in minipools were 100% concordant with the expected results. No false reactive or invalid results was observed during donation screening. Conclusion The cobas® DPX test on the cobas 6800 system allows to identify donations infected with HAV and genotypes 1-3 of B19V that could result contamination of plasma production pools with HAV and B19V beyond acceptable level (>104 IU/mL, according to recommendations). There was no significant risk of false results during evaluation procedure.
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Keywords

DNA B19V, parvowirus B19, RNA HAV, hepatitis A, blood donation screening

About this article
Title

Evaluation of the Roche cobas DPX Test performed on the cobas® 6800 system and cobas p 680 instrument for parvovirus B19 DNA and HAV RNA detection in blood donations

Journal

Journal of Transfusion Medicine

Issue

Vol 11, No 3 (2018)

Article type

Research paper

Pages

91-99

Published online

2019-01-15

Bibliographic record

Journal of Transfusion Medicine 2018;11(3):91-99.

Keywords

DNA B19V
parvowirus B19
RNA HAV
hepatitis A
blood donation screening

Authors

Aneta Kopacz
Dorota Kubicka-Russel
Grzegorz Liszewski
Paulina Zwolińska
Ewa Sulkowska
Aleksandra Kalińska
Jolanta Korzeniowska
Magdalena Łętowska
Piotr Grabarczyk

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