Performance evaluation of the FACSCount system: A dedicated system for clinical cellular analysis

Abstract

Flow cytometers are instruments that can determine multiparameter data simultaneously and have a great potential in providing unique information about cells. The FACSCount System is designed as the first dedicated flow cytometer for the clinical laboratory. Its current configuration provides CD4, CD8, and CD3 absolute counts from 100 microliters of whole blood. Adapting the FACSCount System to the clinical setting are minimal sample handling, lysis free cell preparation, automated fluorescence gating, built-in calibrated reference beads, and appropriate error code reporting. Quality control checks ensure that reported CD4 counts, important for clinical follow-up and patient management, are accurate, precise, and reproducible across instruments over time.

New BD FACSCount™ CD4 reagent system for simultaneous enumeration of percent and absolute CD4 T-lymphocytes in HIV-1-infected pediatric patients

“…Interestingly, this new FACSCount system has a higher throughput than the original FACSCount system as it requires a shorter incubation time (30 min vs. 60 min) and shorter sample running time (1.5-4 min vs. 3-8 min). Similar to the standard FACSCount system, the new FACSCount system employs minimal sample handling, lysis-free cell preparation, automated gating of fluorescent events using built-in calibrated reference microbeads, and error-code reporting (13). With the burden of high numbers of HIV-infected individuals, particularly in the resource-constrained countries, health care system is under increasing pressure to operate with more cost effectiveness, and it is difficult to justify having two separate instruments for CD41 T-lymphocyte enumeration of adult and pediatric patients, given the perishable nature and relatively high cost of reagents.…”

“…These counts are derived from the ratio of CD41 T-lymphocyte events to a known number of fluorescent microbeads admixed to a known volume of CD41-stained whole blood. FACSCount TM system, the first SP CD41 T-lymphocyteenumerating FCM, was launched by Becton Dickinson Biosciences (BDB)/Immunocytometry Systems over 12 years ago (13), and represented a remarkable achievement at a time when the international guidelines still called for 12 monoclonal antibodies in six tubes using dual-color strategy (8). This system was the first to count CD41 and CD81 T-lymphocytes in a twin tube using a whole blood, no lysis, SP absolute cell count method.…”

Evaluation of a New Single-Parameter Volumetric Flow Cytometer (CyFlow green ) for Enumeration of Absolute CD4 + T Lymphocytes in Human Immunodeficiency Virus Type 1-Infected Thai Patients

“…However, there are two main drawbacks of such a method: (i) many studies have highlighted problems associated with the DPderived CD4 ϩ T-lymphocyte count, especially in relation to the generation of an absolute lymphocyte count by the hematology analyzer (1,3,11,16,23); and (ii) the cost of DP FCM CD4 testing in Thailand remains relatively high ($12 to $20). Several single-platform (SP) flow cytometric technologies, including FCM volumetric counting and microfluorometry (8,9,13,14,19), as well as, most commonly, the bead-based flow cytometric method for measurement of the absolute CD4 ϩ T-lymphocyte counts, have been developed and successfully evaluated (21,25). Although this bead-based flow cytometric method eliminates the need for multiple technologies, it is still limited by the high cost of the currently available FCMs and fluorescent beads.…”

Evaluation of Three Medium Throughput Flow Cytometers for Monitoring People Living with HIV in Resources Limited Laboratories: How to Choose?

“…Many flow cytometers have been tested [16][17][18][19][20][21][22][23][24]. However, some of this first generation has a few limitations: (i) it was not possible to get CD4 percentage which is very important in children monitoring or (ii) the use of FCM software requires good computer skills by the operator.…”