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Vol 11, No 2 (2018)
Research paper
Published online: 2018-09-07
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Performance evaluation of cobas MPX test on cobas 6800 and cobas p 680 (Roche) for automatic testing of blood donors for RNA of hepatitis C virus (HCV), RNA human immunodeficiency virus (HIV) and DNA of hepatitis B virus (HBV)

Aneta Kopacz, Dorota Kubicka-Russel, Grzegorz Liszewski, Paulina Zwolińska, Ewa Sulkowska, Magdalena Łętowska, Piotr Grabarczyk
Journal of Transfusion Medicine 2018;11(2):39-51.

open access

Vol 11, No 2 (2018)
ORIGINAL PAPERS
Published online: 2018-09-07

Abstract

Background. The cobas MPX test for use with the cobas 6800 System is a qualitative, real-time PCR test for the detection of HIV-1 Groups M and O RNA, HIV-2 RNA, HCV RNA and HBV DNA in human plasma and serum. The test simultaneously identifies HIV, HCV and HBV (multiplex). Optional component to the cobas 6800 System is the cobas p 680 instrument that creates pools from individual samples. Aim. To evaluate the cobas MPX test in individual donations and in plasma pools using the cobas p 680 instrument. Material and methods. Analytical sensitivity was assessed with serial dilutions of the WHO International Standards (IS): HCV, HIV-1, HIV-2, HBV and Performance Panel HIV-1 (O) (Sera Care). Correct identification of reactive donations was evaluated by testing 473 negative and 7 reactive donations in minipools (≤ MP6). Results. Limits of detection (with 95% confidence limits) of cobas MPX were 7.12 IU/mL (4.40–15.62), and 31.33 IU/mL (17.84–76.80) for HCV and HIV-1, respectively. For HBV it was related to dilutions used for Probit analysis and equaled 3.97 IU/mL (2.25–9.75): 1,33 IU/mL (0,89–4,25); 2,05 IU/mL (1.45–3.40). All dilutions of the HIV-1 group O (100–10 copies/mL) and HIV-2 (31.6–10 IU/mL) samples were detected. Results of MPX tests imitating blood screening with the cobas6800 system were in accordance with expected results. Overall, false reactive rates for pooled samples were 0.1%. Conclusions. The cobas MPX test on the cobas 6800 System, including the cobas p 680 instrument demonstrated high sensitivity and satisfactory specificity required in Polish blood donation system. The cobas MPX test correctly identified infected donations without a significant risk of false results.

Abstract

Background. The cobas MPX test for use with the cobas 6800 System is a qualitative, real-time PCR test for the detection of HIV-1 Groups M and O RNA, HIV-2 RNA, HCV RNA and HBV DNA in human plasma and serum. The test simultaneously identifies HIV, HCV and HBV (multiplex). Optional component to the cobas 6800 System is the cobas p 680 instrument that creates pools from individual samples. Aim. To evaluate the cobas MPX test in individual donations and in plasma pools using the cobas p 680 instrument. Material and methods. Analytical sensitivity was assessed with serial dilutions of the WHO International Standards (IS): HCV, HIV-1, HIV-2, HBV and Performance Panel HIV-1 (O) (Sera Care). Correct identification of reactive donations was evaluated by testing 473 negative and 7 reactive donations in minipools (≤ MP6). Results. Limits of detection (with 95% confidence limits) of cobas MPX were 7.12 IU/mL (4.40–15.62), and 31.33 IU/mL (17.84–76.80) for HCV and HIV-1, respectively. For HBV it was related to dilutions used for Probit analysis and equaled 3.97 IU/mL (2.25–9.75): 1,33 IU/mL (0,89–4,25); 2,05 IU/mL (1.45–3.40). All dilutions of the HIV-1 group O (100–10 copies/mL) and HIV-2 (31.6–10 IU/mL) samples were detected. Results of MPX tests imitating blood screening with the cobas6800 system were in accordance with expected results. Overall, false reactive rates for pooled samples were 0.1%. Conclusions. The cobas MPX test on the cobas 6800 System, including the cobas p 680 instrument demonstrated high sensitivity and satisfactory specificity required in Polish blood donation system. The cobas MPX test correctly identified infected donations without a significant risk of false results.
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Keywords

RNA HCV; DNA HBV; RNA HIV; blood donation screening

About this article
Title

Performance evaluation of cobas MPX test on cobas 6800 and cobas p 680 (Roche) for automatic testing of blood donors for RNA of hepatitis C virus (HCV), RNA human immunodeficiency virus (HIV) and DNA of hepatitis B virus (HBV)

Journal

Journal of Transfusion Medicine

Issue

Vol 11, No 2 (2018)

Article type

Research paper

Pages

39-51

Published online

2018-09-07

Bibliographic record

Journal of Transfusion Medicine 2018;11(2):39-51.

Keywords

RNA HCV
DNA HBV
RNA HIV
blood donation screening

Authors

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

References (16)
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