The following abstract from the Partec copany of Muenster, Germany, outlines the most recent success of the Cyflow CD4% machine, measuring critical health indicators in the blood of HIV-AIDS patients.
Through a complex series of political, business, and research maneuvers (many of them demonstrably corrupt), a competing technology provider has managed to get Cyflow counters banned in Tanzania. This despite the fact that Cyflows contine to provide excellent care at the TANWAT and Ikonda Hospitals. In fact, Cylfow systems work dependably for thousands of local patients while the competing technology lies broken down and idle in other hospitals in the area.
This issues has received considerable attention by local and international media, but the problem remians unresolved. Suspicions run high that fears of corruption investigation and criminal proceedings now block reasonable resolution of the problem.
Abstract Preview - Step 3/4
Category: PS-7 HIV / Vaccines / Microbiology
Title: Implementation and Quality Control of a large quantity of Flow Cytometry Instruments for
CD4 absolute and CD4% counting within HIV Monitoring and AIDS Patient Follow-up under
the National Treatment Program in India
Author(s): Nasdala I.1, Ost V.1, Göhde R.2
Institute(s): 1Partec GmbH, Partec Science & Application, Münster, Germany, 2Partec GmbH, Partec Essential
Healthcare, Görlitz, Germany
Text: The demand for easy-to-use, accurate and affordable cell counting devices performing precise
determinations of CD4+ T cell concentration for adult patients and CD4+ T cell percentages
among lymphocytes (CD4%) for pediatric patients within HIV monitoring and AIDS patient followup
is rapidly increasing. Many countries especially in Africa, Asia and Latin America have started
to significantly scale up the national treatment programs for HIV/AIDS patients. CyFlow Counter
and CyFlow SL instruments have been designed for securing efficient and cost-saving operation
even under very difficult environmental and infrastructural conditions and are therefore well suited
also for use in rural areas and resource-poor settings far away from central laboratories. Since
2002, already 800 CyFlow CD4 counting devices have been successfully implemented in Africa
and Asia, covering more than 500,000 patients at cost of approximately USD 2 per test, while
using previously introduced techniques in such countries showed average test cost of USD 40
(WHO, 2002). India has an estimated population of 1.1 billion and 2,470,000 people living with
HIV - the prevalence rate is 0.36% (UNGASS Country Progress Report 2008). The National AIDS
Control Organization (NACO) under the government of India and in cooperation with the United
Nations Office for Project Services (UNOPS) has recently procured 67 CyFlow Counter
instruments for supporting the nationwide HIV monitoring program. A key issue for laboratory
instrumentation is the internal and external quality control and quality assessment which should be
performed regularly and documented well. The cost (labour and material) should be kept at a
possible minimum. It is shown that QC/QA can be performed highly economical for the CyFlow
technique using precounted control material with approved concentration (Count Check Beads
green, Partec, Germany) and blood samples prepared for CD4 and CD4% counting using
dedicated IVD approved and CE marked reagent kits with monoclonal antibodies (CD4 easy count
kit and CD4% easy count kit, Partec, Germany). For the first time ever in flow cytometry, a QC/QA
program including an evaluation of the intermachine variation was run in parallel with such a large
quantity of instruments. Within only 4 days, all 67 CyFlow flow cytometers have been installed in
India and checked for their general performance and counting accuracy using first the same
approved lot of precounted control bead material and subsequently three different blood samples
stained in bulk for CD4 analysis. The coeffient of variation (CV) was 4.7% for CD4 absolute count
results and 3.3% for the control bead material on all 67 instruments. This result evidences a high
degree of reproducibility and standardization in flow cytometry as well as instrument manufacturing
which is especially important for considerations in context to the targeted large scale increase of
national treatment programs in the global fight against HIV/AIDS.