Preclinical Assessment of a Cartridge-Based Flow-Through Assay for Determination of Adult CD4 T-Cell Count
Simon Bystryak1, *, Chitrangada Acharya1, Kyle Dobiszewski1, #, Hongying Zhu1, Rajiv P. Bandwar1
Identifiers and Pagination:Year: 2020
First Page: 50
Last Page: 60
Publisher ID: TOAIDJ-14-50
Article History:Received Date: 16/01/2020
Revision Received Date: 02/04/2020
Acceptance Date: 04/04/2020
Electronic publication date: 23/05/2020
Collection year: 2020
open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Despite the emphasis on viral load testing, current HIV testing guidelines consider CD4 T-cell count measurement as an important criterion for assessing disease progression, making decisions about anti-retroviral therapy regime changes, and treating HIV infected individuals with opportunistic infections. The CD4 counting by established methods (e.g., flow cytometry) presents challenges not only in resource-scarce settings due to cost and lack of skilled technicians but also in resource-rich areas where it is limited to centralized facilities.
Current options for Point-Of-Care (POC) CD4 enumeration are few and labor-intensive, prompting the need for newer technological methods that can overcome the aforementioned challenges.
The novel and patented flow-through cell counting assay (FTCA) described previously (Bystryak et al., 2019) was developed further into a point-of-care CD4 testing system using a disposable cartridge device and a portable imaging instrument. A pilot study with ~100 samples using this device was conducted to assess the validity of FTCA as a POC test for the measurement of CD4 count.
The FTCA signal was found to be linear over a wide range (17 - 1540 cells/μL) of CD4 T-cell concentration. The FTCA method also exhibits a strong agreement with flow cytometry, with very low bias (− 7 cells/μL) towards CD4 count measurement.
The cartridge-based FTCA method has great potential to be a fully quantitative method with low complexity, portability, low-cost, and wide applicability in clinical practice.