Performance characteristics of finger-stick dried blood spots (DBS) on the determination of human immunodeficiency virus (HIV) treatment failure in a pediatric population in Mozambique

Chang, Joy; Sousa, Amina de; Sabatier, Jennifer; Assane, Mariamo; Zhang, Guoqing; Bila, Dulce; Alfredo, Charity; Cossa, Loide; Bhatt, Nilesh; Koumans, Emilia H.; Yang, Chunfu; Rivadeneira, Emilia; Jani, Ilesh; Houston, James

doi:10.1371/journal.pone.0181054

Cited by 12 publications

(17 citation statements)

References 27 publications

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“…The positive and negative agreement of Aptima FS and VB DBS VL compared to Abbott RT VL observed in this study was equivalent or better than those reported by other investigators for comparisons of DBS and plasma VL results in Abbott RT assays and NucliSENS Easy-Q HIV-1 version 2.0 assays [28][29][30][31][32][33]. The negative agreement (92.2%) between FS and VB VL versus Abbott plasma VL seen in this study was significantly better than the 17% negative agreement reported for testing DBS in Roche CAP/CTM at MDP of 3.0 log copies/mL [28].…”

Section: Plos Onesupporting

confidence: 76%

Prospective evaluation of accuracy of HIV viral load monitoring using the Aptima HIV Quant Dx assay with fingerstick and venous dried blood spots prepared under field conditions in Kenya

et al. 2021

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Quantification of HIV-1 RNA is essential for clinical management of HIV patients. The limited throughput and significant hands-on time required by most HIV Viral load (VL) tests makes it challenging for laboratories with high test volume, to turn around patient results quickly. The Hologic Aptima HIV-1 Quant Dx Assay (Aptima), has the potential to alleviate this burden as it is high throughput and fully automated. This assay is validated for both plasma and dried blood spots (DBS), which are commonly used in resource limited settings. The objective of this study was to compare the performance of Aptima to Abbott RealTime HIV-1 Assay (Abbott RT), which was used as reference. This was a cross-sectional prospective study where HIV VL in finger stick (FS) DBS, venous blood (VB) DBS and plasma, collected from 258 consenting adults visiting 5 medical facilities in Kenya, Africa were tested in Aptima. The results were compared to plasma VL in Abbott RT at the medical decision point (MDP) of 1000 copies/mL and across Aptima assay range. The total agreement at MDP between plasma HIV VL in Abbott RT and plasma, FS and VB DBS tested in Aptima were 97.7%, 92.2% and 95.3% respectively with kappa statistic of 0.95, 0.84 and 0.90. The positive and negative agreement for all 3 sample types were >92%. Regression analysis between VL in Abbott RT plasma and various sample types tested in Aptima had a Pearson’s correlation coefficient ≥0.91 with systematic bias of < 0.20 log copies/mL on Bland-Altman analysis. The high level of agreement in Aptima HIV VL results for all 3 sample types with Abbott RT plasma VL along with the high throughput, complete automation, and ease of use of the Panther platform makes Aptima a good option for HIV VL monitoring for busy laboratories with high volume of testing.

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Section: Plos Onesupporting

confidence: 76%

Prospective evaluation of accuracy of HIV viral load monitoring using the Aptima HIV Quant Dx assay with fingerstick and venous dried blood spots prepared under field conditions in Kenya

et al. 2021

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“…The impact of interference of cell-associated viral nucleic acids in viral load measures is highest when plasma viral load is low, as in patients successfully treated with ART. Indeed, most DBSs perform poorly at thresholds of around 1,000 copies/ml (25, 29–31). Several DBS protocols have been designed to minimize the contribution of cell-associated viral nucleic acid by selectively purifying RNA during sample preparation or by preferentially eluting plasma-associated virus from a DBS, with some success (32, 33).…”

Section: Discussionmentioning

confidence: 99%

Separation of Plasma from Whole Blood by Use of the cobas Plasma Separation Card: a Compelling Alternative to Dried Blood Spots for Quantification of HIV-1 Viral Load

et al. 2019

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Plasma HIV viral load testing is the preferred means of monitoring antiretroviral treatment response. Dried blood spots (DBSs) hold considerable logistical advantages over EDTA samples, but they more frequently misclassify virological failure and have higher limits of detection (LoD). Plasma separation cards (PSCs) may overcome these limitations. Health workers collected EDTA whole blood by venipuncture and 140 μl of finger-prick blood by capillary tube from 53 HIV-infected adults. Capillary blood was immediately transferred to PSCs. Additionally, 432 EDTA samples from HIV-infected adults were spotted onto PSCs and analyzed together with the finger-prick samples. Specificity and sensitivity of PSC with paired EDTA-PSC samples tested on a cobas 6800/8800 system with the cobas HIV-1 test (cobas HIV) was determined. LoD (3rd HIV-1 WHO International Standard) and stability at a range of temperatures and storage durations was determined using cobas HIV and cobas AmpliPrep/cobas TaqMan HIV-1 test v2.0 (CAP/CTM). Of 132 specimens with quantitative values for paired EDTA-PSC samples, the mean log10difference between samples was 0.05 copies/ml (95% confidence interval [CI], −0.01 to 0.11). The LoD for cobas HIV was 790.2 copies/ml and for CAP/CTM was 737.9 copies/ml. At 1,000 copies/ml, PSC sensitivity was 97.0% (128/132) and specificity was 97.2% (343/353). Results correlated well with those from EDTA samples (DemingR2= 0.90). PSC results were unaffected by temperature and storage conditions. PSC samples correlate well with plasma viral load and have adequate sensitivity and specificity. The improved performance may be as a result of a reduction in contribution from cell-associated viral nucleic acids. The card provides an alternative sample collection technology to DBSs.

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“…Nurses in two primary healthcare centres performed the collection of the cobas 1 PSC specimens for this study, attesting to the feasibility of implementing this new method in resourcelimited health systems. The procedures for collecting cobas 1 PSC specimens are similar to those for DBS, which health professionals throughout sub-Saharan Africa have been using in HIV viral load testing and early infant diagnosis for many years [6,[8][9][10]. Additionally, in this study viral load testing using cobas 1 PSC specimens was executed in a laboratory that routinely tests for viral load and early infant diagnosis, with no additional equipment required.…”

Section: Discussionmentioning

confidence: 99%

“…Many countries have implemented dried blood spots (DBS) to simplify the logistics of transporting clinical specimens to laboratories for viral load testing [3][4][5][6][7]. Whole capillary or venous blood is spotted onto filter paper cards to prepare DBS.…”

Section: Introductionmentioning

confidence: 99%

“…The comparative advantages of DBS include their ease of transportation, lack of cold chain needs and low biosafety requirements. However, HIV viral loads performed on DBS specimens are poorly correlated to those determined in plasma since whole blood contains also cell-associated RNA molecules and proviral DNA [6,[11][12][13]. Hence, viral load results from DBS specimens at clinicaly relevant threshold of 1000 copies/ml are frequently inaccurate and can mislead clinicaldecision making.…”

Section: Introductionmentioning

confidence: 99%

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Accurate HIV viral load measurement in primary health care settings using the cobas® plasma separation card

et al. 2020

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Introduction Plasma is considered the gold standard for HIV viral load (VL) testing, however its use is challenging due to the need for phlebotomy and centrifugation services, as well as cold chain for transporting to laboratories for testing. The use of Dried Blood Spot (DBS) specimen has allowed a rapid expansion of antiretroviral therapy (ART) monitoring in remote areas in many African countries, however, the VL in DBS may overestimate the copies of viral RNA result at the clinically relevant range of 1000 copies/ml, due to proviral DNA and intracellular RNA. The characteristics of the cobas ® Plasma Separation Card (PSC) specimen are similar to fresh plasma (gold standard), so a better performance of HIV VL is expetected in PSC specimen and can be an alternative to DBS. This study aims to evaluate the performance of cobas ® PSC for VL testing at primary health care facilities in Mozambique. Methodology HIV-1 infected adults on ART were enrolled consecutively in two health facilities in Mozambique, between August 2018 and October 2018. Capillary and venous cobas ® PSC, DBS and fresh plasma specimens were collected from each patient. All specimens were tested for VL using CAP/CTM v2.0. Sensitivity and specificity of viral load using DBS, capillary and venous PSC specimens were estimated. Viral load obtained in fresh plasma specimen was used as reference and a threshold of 1000 copies/ml was considered for the analyses. Results From the total 613 patients included for the study, 2444 specimens including DBS (613), plasma (613), venous cobas ® PSC (609) and capillary cobas ® PSC (609) were collected and 2407 results were obtained. Sensitivity and specificity of the VL using venous cobas ® PSC specimen at 1000 copies/ml threshold were 99.8% and 98.1% respectively, whereas for capillary cobas ® PSC sensitivity was 99.6% and specificity was 97.2%. For DBS VL, sensitivity was 96.9% and specificity was 81.8%. Misclassification rate was more prominent in DBS

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Performance characteristics of finger-stick dried blood spots (DBS) on the determination of human immunodeficiency virus (HIV) treatment failure in a pediatric population in Mozambique

Cited by 12 publications

References 27 publications

Prospective evaluation of accuracy of HIV viral load monitoring using the Aptima HIV Quant Dx assay with fingerstick and venous dried blood spots prepared under field conditions in Kenya

Prospective evaluation of accuracy of HIV viral load monitoring using the Aptima HIV Quant Dx assay with fingerstick and venous dried blood spots prepared under field conditions in Kenya

Separation of Plasma from Whole Blood by Use of the cobas Plasma Separation Card: a Compelling Alternative to Dried Blood Spots for Quantification of HIV-1 Viral Load

Accurate HIV viral load measurement in primary health care settings using the cobas® plasma separation card

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