RESEARCH ARTICLE
Preclinical Assessment of a Cartridge-Based Flow-Through Assay for Determination of Adult CD4 T-Cell Count
Simon Bystryak1, *
Article Information
Identifiers and Pagination:
Year: 2020Volume: 14
First Page: 50
Last Page: 60
Publisher ID: TOAIDJ-14-50
DOI: 10.2174/1874613602014010050
Article History:
Received Date: 16/01/2020Revision 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.
Abstract
Background:
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.
Objective:
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.
Methods:
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.
Results:
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.
Conclusion:
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.
