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. 2022 Aug 22;17(8):e0269838.
doi: 10.1371/journal.pone.0269838. eCollection 2022.

Comparison of the performance of Aptima HIV-1 Quant Dx Assay with Abbott RealTime HIV Assay for viral load monitoring using plasma and Dried Blood Spots collected in Kenya

Matilu Mwau  1 , Sven Schaffer  2 , Humphrey Kimani  1 , Purity Kasiano  1 , Francis Ogolla  1 , Elizabeth Ajema  1 , Scriven Adoyo  1 , Ednah Nyairo  1 , Norah Saleri  1 , Sangeetha Vijaysri Nair  3
Affiliations

Comparison of the performance of Aptima HIV-1 Quant Dx Assay with Abbott RealTime HIV Assay for viral load monitoring using plasma and Dried Blood Spots collected in Kenya

Matilu Mwau et al. PLoS One. .

Abstract

Introduction: HIV-1 viral Load (VL) testing is recommended for the monitoring of antiretroviral treatment. Dried Blood Spots (DBS) are an effective sample type in resource limited settings, where safe phlebotomy and reliable shipping are hard to guarantee. In HIV high burden countries, high throughput assays can improve access to testing services. The Hologic Aptima HIV-1 Quant Dx Assay (Aptima Assay) is a high throughput assay that runs on the CE-IVD approved Panther platform. The objectives of this study were to assess the performance characteristics of Aptima for VL monitoring using plasma and venous DBS specimens and to determine the stability of HIV-1 RNA in DBS.

Materials and methods: This was a cross-sectional study of 2227 HIV infected adults visiting health facilities in Nairobi and Busia, Kenya. Each provided a venous blood sample; plasma was prepared from 1312 samples while paired DBS samples and plasma were prepared from the remaining 915 samples. The agreement between the Aptima assay and the Abbott RealTime HIV-1 Assay (Abbott RT) was analysed by comparing the HIV-1 VL in both assays at the medical decision point of 1000 copies/mL. To assess stability of HIV-1 RNA in DBS, VL in DBS spotted on day 0 were compared with that from the same DBS card after 21 days of storage at room temperature.

Results: Overall, 436 plasma samples had quantifiable results in both Aptima and Abbott RT. The agreement between the two assays at 1000 copies/mL was 97.48% with a Pearson's correlation coefficient (r) of 0.9589 and gave a mean bias of 0.33 log copies/mL on Bland-Altman analysis. For fresh DBS, the agreement in both assays was 94.64% at 1000 copies/mL, with an r of 0.8692 and a mean bias of 0.35 log copies/mL. The overall agreement between DBS tested in Aptima on day 0 versus day 21 was 95.71%, with a mean bias of -0.154.

Conclusion: The Aptima HIV-1 Quant Dx assay is an accurate test for VL monitoring of HIV-1 using DBS and plasma sample types in Kenya.

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Conflict of interest statement

Hologic, Inc. provided the funds and materials for the study. Sangeetha Nair and Sven Schaffer were employees of Hologic, Inc at the time of the study. The rest of the authors are employees of the Kenya Medical Research Institute and declare no conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. HIV VL comparison for 436 plasma samples tested in Aptima and Abbott RT assays.
Fig 2
Fig 2. Bland Altman analysis of HIV VL results for 436 plasma samples tested in Aptima and Abbott RT assays.
Fig 3
Fig 3. HIV VL comparison in fresh DBS tested in Aptima and Abbott RT assays.
Fig 4
Fig 4. Bland Altman analysis of HIV VL results in fresh DBS tested in Aptima and Abbott RT assays.
Fig 5
Fig 5. HIV VL in DBS tested on day 0 and day 21 in the Aptima assay.
Fig 6
Fig 6. Bland Altman analysis of HIV VL in DBS tested on day 0 and day 21 in the Aptima assay.
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