| Peer-Reviewed

Comparison of Two Molecular Tests, Roche COBAS®AmpliPrep/COBAS®TaqMan® and Abbott-RealTime in the HIV-1 Early Infants Diagnosis

Received: 16 March 2023    Accepted: 6 April 2023    Published: 18 April 2023
Views:       Downloads:
Abstract

Background: Prompt diagnosis and treatment of infants born to parents living with HIV is essential to reduce infant mortality. The availability of several high-throughput automated molecular tests is necessary to increase the services of early diagnosis tests in infants, especially in countries with limited resources such as Senegal. Objective: The objective of this study was to compare two automated molecular tests, Roche COBAS®AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative and Abbott RealTime HIV-1 Qualitative in the early diagnosis of HIV-1 infection in children born to HIV-positive mothers in Senegal. Methods: The study was conducted exclusively at the molecular biology laboratory of the armed forces AIDS programme at the Ouakam Military Hospital, Dakar, Senegal, between September 2020 and December 2021. It involved 136 children aged between 1 and 18 months born to HIV-1 infected mothers. The samples were taken from blood obtained from the baby's heel, dried on blotting paper (DBS) and sent to the molecular biology laboratory. They were then stored at room temperature before being tested for the study. After these samples were analysed on both molecular techniques, the Abbott Qualitative results were compared to diagnostic tests performed with Roche COBAS®AmpliPrep/COBAS®TaqMan®HIV-1 Qualitative, which is the reference molecular technique. R Studio software version 099.902, 2016 was used to calculate specificity and sensitivity and Kappa coefficient. For statistical tests, they are considered significant when the P-value is less than 5%. Results: Out of a total of 136 samples tested, the overall positive and negative concordance was 94.84%, 79.41% and 93.58% respectively. The concordance coefficient, Cohen's Kappa coefficient, was also analysed. It gave a value of 0.853 (95% CI: [74.7-95.8]). A discrepancy was found between the two tests. Seven samples, which had previously tested positive on Roche Cobas, tested negative on Abbott Qualitative. Conclusion: The result showed a comparable performance characterized by very good negative, positive and global concordances and also, a very high Cohen's Kappa coefficient κ. The present study showed that the two molecular tests are comparable and that the Abbott Qualitative is a practical alternative for the diagnosis of HIV in infants.

Published in International Journal of Biochemistry, Biophysics & Molecular Biology (Volume 8, Issue 1)
DOI 10.11648/j.ijbbmb.20230801.11
Page(s) 1-5
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

HIV-1-Early Infant Diagnosis, Roche COBAS®AmpliPrep/COBAS® TaqMan®, Abbott RealTime

References
[1] UNAIDS, 2021. https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_fr.pdf
[2] CNLS, 2021. https://www.cnls-senegal.org/wp-content/uploads/2022/06/Rapport-CNLS-2021-1.pdf.
[3] Kourtis, A. P., & Bulterys, M. (2010). Mother-to-child transmission of HIV: pathogenesis, mechanisms and pathways. Clinics in perinatology, 37 (4), 721-737. Doi: https://doi.org/10.1016/j.clp.2010.08.004.
[4] Dunning, L., Kroon, M., Hsiao, N. Y., & Myer, L. (2017). Field evaluation of HIV point-of-care testing for early infant diagnosis in Cape Town, South Africa. PloS one, 12 (12), e0189226. Doi: https://doi.org/10.1371/journal.pone.0189226.
[5] Wexler, C., Nazir, N., Gautney, B., Maloba, M., Brown, M., Goggin, K.,... & Finocchario-Kessler, S. (2020). Predictors of early ART initiation among HIV+ infants in Kenya: a retrospective review of HITSystem data from 2013 to 2017. Maternal and child health journal, 24, 739-747. Doi: https://link.springer.com/article/10.1007/s10995-020-02909-3.
[6] Kramvis, A. (2016). The clinical implications of hepatitis B virus genotypes and HBeAg in pediatrics. Reviews in medical virology, 26 (4), 285-303. Doi: http://dx.doi.org/10.1002/rmv.1885.
[7] CNLS, UNAIDS, 2019: https://www.cnls-senegal.org/nos_actualites/rapport-onusida-2019-pour-plus-dimplication-des-communautes/.
[8] Stevens W, Sherman G, Downing R, Parsons LM, Ou CY, Crowley S, Gershy-Damet GM, Fransen K, Bulterys M, Lu L, Homsy J, Finkbeiner T, Nkengasong JN. Role of the laboratory in ensuring global access to ARV treatment for HIV-infected children: consensus statement on the performance of laboratory assays for early infant diagnosis. Open AIDS J. 2008b; 2: 17–25. [PubMed: 18923696]. Doi: 10.2174/1874613600802010017.
[9] Nelson, J.; Hawkins, T.; Schanz, M.; Miller, M.; Schmitz, J.; Fiscus, S. Comparison of Abbott HIV-1 total nucleic acid qualitative assay to Roche HIV-1 DNA assay using dried blood spots. 18th Conference on Retroviruses and Opportunistic Infections (CROI); Boston, MA, USA. 2011. Poster 658.
[10] Amplicor HIV-1 DNA Test, 1.5 package insert. Roche Diagnostics, 2006; https://www.fda.gov/media/73991/download.
[11] Schumacher, W., Frick, E., Kauselmann, M., Maier-Hoyle, V., van der Vliet, R., & Babiel, R. (2007). Fully automated quantification of human immunodeficiency virus (HIV) type 1 RNA in human plasma by the COBAS® AmpliPrep/COBAS® TaqMan® system. Journal of Clinical Virology, 38 (4), 304-312. [PubMed: 17329164]. Doi: 10.1016/j.jcv.2006.12.022.
[12] Jani, I. V., Sabatier, J., Vubil, A., Subbarao, S., Bila, D., de Sousa, A.,... & Ramos, A. (2012). Evaluation of a high-throughput diagnostic system for detection of HIV-1 in dried blood spot samples from infants in Mozambique. Journal of clinical microbiology, 50 (4), 1458-1460. [PubMed: 22278838]. Doi: https://doi.org/10.1128/JCM.00107-12.
[13] Kageha, S., Okoth, V., Kadima, S., Vihenda, S., Okapesi, E., Nyambura, E.,... & Mwau, M. (2012). Discrepant test findings in early infant diagnosis of HIV in a national reference laboratory in Kenya: challenges and opportunities for programs. Journal of tropical pediatrics, 58 (4), 247-252. [PubMed: 22052701]. Doi: https://doi.org/10.1093/tropej/fmr076.
[14] Maritz, J., Preiser, W., & van Zyl, G. U. (2012). Establishing diagnostic cut-off criteria for the COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative test through validation against the Amplicor DNA test v1. 5 for infant diagnosis using dried blood spots. Journal of Clinical Virology, 53 (2), 106-109. [PubMed: 22196872]. Doi: https://doi.org/10.1016/j.jcv.2011.12.002.
[15] COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test v2.0. https://diagnostics.roche.com/global/en/products/params/cobas-ampliprep-cobas-taqman-hiv-1-qualitative-test-v2-0.html
[16] Abbott RealTime HIV-1 Qualitative. https://www.molecular.abbott/int/en/products/infectious-disease/realtime-hiv-1-qualitative
[17] Hölzl, G., Stöcher, M., Leb, V., Stekel, H., & Berg, J. (2003). Entirely automated quantification of human immunodeficiency virus type 1 (HIV-1) RNA in plasma by using the ultrasensitive COBAS AMPLICOR HIV-1 monitor test and RNA purification on the MagNA pure LC instrument. Journal of Clinical Microbiology, 41 (3), 1248-1251. Doi: https://doi.org/10.1128/JCM.41.3.1248-1251.2003.
[18] Chang, J., Omuomo, K., Anyango, E., Kingwara, L., Basiye, F., Morwabe, A.,... & Ellenberger, D. (2014). Field evaluation of Abbott Real Time HIV-1 Qualitative test for early infant diagnosis using dried blood spots samples in comparison to Roche COBAS Ampliprep/COBAS TaqMan HIV-1 Qual test in Kenya. Journal of virological methods, 204, 25-30. Doi: https://doi.org/10.1016/j.jviromet.2014.03.010.
[19] Zeh, C., Ndiege, K., Inzaule, S., Achieng, R., Williamson, J., Chih-Wei Chang, J.,... & Nkengasong, J. (2017). Evaluation of the performance of Abbott m2000 and Roche COBAS Ampliprep/COBAS Taqman assays for HIV-1 viral load determination using dried blood spots and dried plasma spots in Kenya. PloS one, 12 (6), e0179316. Doi: https://doi.org/10.1371/journal.pone.0179316.
[20] Templer, S. P., Seiverth, B., Baum, P., Stevens, W., Seguin-Devaux, C., & Carmona, S. (2016). Improved sensitivity of a dual-target HIV-1 qualitative test for plasma and dried blood spots. Journal of clinical microbiology, 54 (7), 1877-1882. Doi: https://doi.org/10.1128/JCM.00128-16.
[21] Landis, J. R., Koch, G. G., 1977. The measurement of observer agreement for categorical data. Biometrics 33, 159–174. https://pubmed.ncbi.nlm.nih.gov/843571/.
[22] Kone, B., Goita, D., Dolo, O., Traore, D., Sogoba, D., Somboro, A., & Maiga, M. (2020). Performance Comparison of Xpert HIV-1 Viral Load Assay and Roche Taqman and Abbott M2000 RT in Bamako, Mali. Journal of AIDS & clinical research, 11 (7). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8294115/.
[23] Ibrahim, M., Moyo, S., Mohammed, T., Mupfumi, L., Gaseitsiwe, S., Maswabi, K.,... & Shapiro, R. L. (2017). High sensitivity and specificity of the Cepheid Xpert® HIV-1 Qualitative Point-of-Care test among newborns in Botswana. Journal of acquired immune deficiency syndromes (1999), 75 (5), e128. Doi: 10.1097/QAI.0000000000001384.
Cite This Article
  • APA Style

    Babacar Faye, Fahimat Ahamada, Micailou Magassouba, Doudou Georges Massar Niang, Maguette Deme Sylla Niang, et al. (2023). Comparison of Two Molecular Tests, Roche COBAS®AmpliPrep/COBAS®TaqMan® and Abbott-RealTime in the HIV-1 Early Infants Diagnosis. International Journal of Biochemistry, Biophysics & Molecular Biology, 8(1), 1-5. https://doi.org/10.11648/j.ijbbmb.20230801.11

    Copy | Download

    ACS Style

    Babacar Faye; Fahimat Ahamada; Micailou Magassouba; Doudou Georges Massar Niang; Maguette Deme Sylla Niang, et al. Comparison of Two Molecular Tests, Roche COBAS®AmpliPrep/COBAS®TaqMan® and Abbott-RealTime in the HIV-1 Early Infants Diagnosis. Int. J. Biochem. Biophys. Mol. Biol. 2023, 8(1), 1-5. doi: 10.11648/j.ijbbmb.20230801.11

    Copy | Download

    AMA Style

    Babacar Faye, Fahimat Ahamada, Micailou Magassouba, Doudou Georges Massar Niang, Maguette Deme Sylla Niang, et al. Comparison of Two Molecular Tests, Roche COBAS®AmpliPrep/COBAS®TaqMan® and Abbott-RealTime in the HIV-1 Early Infants Diagnosis. Int J Biochem Biophys Mol Biol. 2023;8(1):1-5. doi: 10.11648/j.ijbbmb.20230801.11

    Copy | Download

  • @article{10.11648/j.ijbbmb.20230801.11,
      author = {Babacar Faye and Fahimat Ahamada and Micailou Magassouba and Doudou Georges Massar Niang and Maguette Deme Sylla Niang and Babacar Mbengue and Alioune Dieye},
      title = {Comparison of Two Molecular Tests, Roche COBAS®AmpliPrep/COBAS®TaqMan® and Abbott-RealTime in the HIV-1 Early Infants Diagnosis},
      journal = {International Journal of Biochemistry, Biophysics & Molecular Biology},
      volume = {8},
      number = {1},
      pages = {1-5},
      doi = {10.11648/j.ijbbmb.20230801.11},
      url = {https://doi.org/10.11648/j.ijbbmb.20230801.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijbbmb.20230801.11},
      abstract = {Background: Prompt diagnosis and treatment of infants born to parents living with HIV is essential to reduce infant mortality. The availability of several high-throughput automated molecular tests is necessary to increase the services of early diagnosis tests in infants, especially in countries with limited resources such as Senegal. Objective: The objective of this study was to compare two automated molecular tests, Roche COBAS®AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative and Abbott RealTime HIV-1 Qualitative in the early diagnosis of HIV-1 infection in children born to HIV-positive mothers in Senegal. Methods: The study was conducted exclusively at the molecular biology laboratory of the armed forces AIDS programme at the Ouakam Military Hospital, Dakar, Senegal, between September 2020 and December 2021. It involved 136 children aged between 1 and 18 months born to HIV-1 infected mothers. The samples were taken from blood obtained from the baby's heel, dried on blotting paper (DBS) and sent to the molecular biology laboratory. They were then stored at room temperature before being tested for the study. After these samples were analysed on both molecular techniques, the Abbott Qualitative results were compared to diagnostic tests performed with Roche COBAS®AmpliPrep/COBAS®TaqMan®HIV-1 Qualitative, which is the reference molecular technique. R Studio software version 099.902, 2016 was used to calculate specificity and sensitivity and Kappa coefficient. For statistical tests, they are considered significant when the P-value is less than 5%. Results: Out of a total of 136 samples tested, the overall positive and negative concordance was 94.84%, 79.41% and 93.58% respectively. The concordance coefficient, Cohen's Kappa coefficient, was also analysed. It gave a value of 0.853 (95% CI: [74.7-95.8]). A discrepancy was found between the two tests. Seven samples, which had previously tested positive on Roche Cobas, tested negative on Abbott Qualitative. Conclusion: The result showed a comparable performance characterized by very good negative, positive and global concordances and also, a very high Cohen's Kappa coefficient κ. The present study showed that the two molecular tests are comparable and that the Abbott Qualitative is a practical alternative for the diagnosis of HIV in infants.},
     year = {2023}
    }
    

    Copy | Download

  • TY  - JOUR
    T1  - Comparison of Two Molecular Tests, Roche COBAS®AmpliPrep/COBAS®TaqMan® and Abbott-RealTime in the HIV-1 Early Infants Diagnosis
    AU  - Babacar Faye
    AU  - Fahimat Ahamada
    AU  - Micailou Magassouba
    AU  - Doudou Georges Massar Niang
    AU  - Maguette Deme Sylla Niang
    AU  - Babacar Mbengue
    AU  - Alioune Dieye
    Y1  - 2023/04/18
    PY  - 2023
    N1  - https://doi.org/10.11648/j.ijbbmb.20230801.11
    DO  - 10.11648/j.ijbbmb.20230801.11
    T2  - International Journal of Biochemistry, Biophysics & Molecular Biology
    JF  - International Journal of Biochemistry, Biophysics & Molecular Biology
    JO  - International Journal of Biochemistry, Biophysics & Molecular Biology
    SP  - 1
    EP  - 5
    PB  - Science Publishing Group
    SN  - 2575-5862
    UR  - https://doi.org/10.11648/j.ijbbmb.20230801.11
    AB  - Background: Prompt diagnosis and treatment of infants born to parents living with HIV is essential to reduce infant mortality. The availability of several high-throughput automated molecular tests is necessary to increase the services of early diagnosis tests in infants, especially in countries with limited resources such as Senegal. Objective: The objective of this study was to compare two automated molecular tests, Roche COBAS®AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative and Abbott RealTime HIV-1 Qualitative in the early diagnosis of HIV-1 infection in children born to HIV-positive mothers in Senegal. Methods: The study was conducted exclusively at the molecular biology laboratory of the armed forces AIDS programme at the Ouakam Military Hospital, Dakar, Senegal, between September 2020 and December 2021. It involved 136 children aged between 1 and 18 months born to HIV-1 infected mothers. The samples were taken from blood obtained from the baby's heel, dried on blotting paper (DBS) and sent to the molecular biology laboratory. They were then stored at room temperature before being tested for the study. After these samples were analysed on both molecular techniques, the Abbott Qualitative results were compared to diagnostic tests performed with Roche COBAS®AmpliPrep/COBAS®TaqMan®HIV-1 Qualitative, which is the reference molecular technique. R Studio software version 099.902, 2016 was used to calculate specificity and sensitivity and Kappa coefficient. For statistical tests, they are considered significant when the P-value is less than 5%. Results: Out of a total of 136 samples tested, the overall positive and negative concordance was 94.84%, 79.41% and 93.58% respectively. The concordance coefficient, Cohen's Kappa coefficient, was also analysed. It gave a value of 0.853 (95% CI: [74.7-95.8]). A discrepancy was found between the two tests. Seven samples, which had previously tested positive on Roche Cobas, tested negative on Abbott Qualitative. Conclusion: The result showed a comparable performance characterized by very good negative, positive and global concordances and also, a very high Cohen's Kappa coefficient κ. The present study showed that the two molecular tests are comparable and that the Abbott Qualitative is a practical alternative for the diagnosis of HIV in infants.
    VL  - 8
    IS  - 1
    ER  - 

    Copy | Download

Author Information
  • Laboratory of Molecular Biology, Military Hospital of Ouakam, Dakar, Senegal; AIDS Program of the Senegalese Armed Forces, Military Hospital of Ouakam, Dakar, Senegal; Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology of the Cheikh Anta Diop University of Dakar, Dakar, Senegal

  • Laboratory of Molecular Biology, Military Hospital of Ouakam, Dakar, Senegal

  • National Alliance of Communities for Health, Dakar, Senegal

  • Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology of the Cheikh Anta Diop University of Dakar, Dakar, Senegal

  • Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology of the Cheikh Anta Diop University of Dakar, Dakar, Senegal

  • Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology of the Cheikh Anta Diop University of Dakar, Dakar, Senegal

  • Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology of the Cheikh Anta Diop University of Dakar, Dakar, Senegal

  • Sections