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.

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.

Performance evaluation of the Aptima HIV-1 Quant Dx assay for detection of HIV in infants in Kenya.

BACKGROUND: Early infant diagnosis (EID) of HIV-1 exposed infants enables timely initiation of antiretroviral therapy (ART), thereby allowing early diagnosis and treatment to slow disease progression and reduce mortality. Turn-around time to results, partially caused by low to medium throughput technology, remains a hindrance to early treatment. A major solution to this challenge is to incorporate high throughput and accurate technologies in the testing process. The Hologic Aptima Quant Dx Assay (Aptima) is a CE marked Real-Time TMA assay running on the high throughput Panther system. OBJECTIVES: The objective of this study was to evaluate the performance of Aptima for EID using dried blood spots. STUDY DESIGN: This was a cross-sectional prospective study of 2,048 infants seeking HIV services from health facilities in Western Kenya, Africa. Capillary Dried Blood Spot samples DBS were collected from infants with the consent of their mothers. The qualitative performance of Aptima was compared with the Roche COBAS Ampliprep/ COBAS Taqman HIV-1 Qualitative Test v2.0 (CAP/CTM), using these DBS. Demographic information of the participants was also collected. RESULTS: A total of 1,975 successful comparisons between the two platforms were included in the analysis. The overall agreement between the assays was 99.65 %. The sensitivity and specificity of Aptima was 95.24 % (95 % CI 88.40-98.19 %) and 99.84 % (95 % CI 99.49-99.92 %) respectively. CONCLUSIONS: Aptima assay has performance characteristics that are comparable to those of the Roche CAP/CTM for qualitative testing on DBS taken from infants. The two assays can therefore be used interchangeably for Early Infant Diagnosis of HIV.

Performance and usability of mPIMA™ HIV 1/2 viral load test in point of care settings in Kenya.

BACKGROUND: HIV viral load testing is the standard of care for monitoring antiretroviral therapy. In resource-limited settings such as Kenya, access to HIV viral load monitoring is suboptimal due to reliance on centralized laboratory based in vitro diagnostics. Point of care technologies have the potential to improve access and reduce test to result turnaround time. OBJECTIVE: To determine the performance and usability of the mPIMA™ HIV-1/2 Viral Load (VL) test in point of care settings in Kenya. METHOD: This was a cross-sectional study conducted amongst 568 HIV positive adults recruited from selected health facilities in Western Kenya between June and November 2018. Five hundred and sixty-six plasma samples (566) were tested successfully on Abbott™ RealTime HIV-1 quantitative test (reference assay) and mPIMA™ HIV-1/2 Viral Load test to determine diagnostic accuracy. Usability data was collected through simple structured questionnaires. Statistical analysis was done using Stata/MP Version 14 for Mac OSX. Concordance and misclassification values were calculated at the clinical cut-off of 1000 copies/ml. RESULTS: The positive, negative and overall agreement of the mPIMA™ HIV-1/2 V L test were 95.45% (95% CI 89.49-98.11%), 95.96% (95% CI 93.66-97.44%) and 95.86% respectively. All users (7/7, 100%) reported that the machine was easy to use and that the results interpretation and workflow were simple. The test to result turnaround time was 69 min. All clinicians (4/4, 100%) felt that a Point of care test would fit easily within their workflow and would facilitate decision-making. There were 44 (7.77%) errors in 566 tests; 38 (6.71%) were user related and four (4, 0.71%) were software related. CONCLUSION: The mPIMA™ HIV-1/2 V L test can be used interchangeably with reference assays for HIV viral load monitoring. At the point of care, mPIMA™'s simple workflow, ease of use and short test to result turnaround time have the potential to improve access to HIV viral load monitoring.

On-demand controlled release of anti-inflammatory and analgesic drugs from conducting polymer films to aid in wound healing.

An electronically-controlled drug delivery system (eDDS) for the on-demand release of anti-inflammatory, anti-microbial and analgesic agents to aid in wound healing is currently under development. The loading of several drugs into conductive polymer films and their subsequent on-demand, controlled release upon application of an electrical potential to the polymer film has been demonstrated. The loading and release (active and passive) of Ibuprofen sodium salt - a negatively charged analgesic and anti-inflammatory agent - from polypyrrole films is described. Major challenges identified include precise control over drug loading and passive release from the conducting polymers in the absence of an applied potential.